Author Archives: Diana Mahoney

Could Everybody Just Be Quiet?

The disquieting association between higher-than-recommended levels of nighttime hospital noises and clinically significant sleep loss reported Jan. 9 in the Archives of Internal Medicine  would be an assault to the ears of Dr. Julia  Barnett Rice, the founder of the Society for the Suppression of Unnecessary Noise.

Courtesy Flickr user Swaraie/Creative Commons

Dubbed the “anti-noise queen” for her turn-of-the-century crusade against “preventable” noises such as the night-time whistles of tugboats traversing the Hudson near her New York City home, Dr. Rice (1859-1929) also campaigned tirelessly for the promotion of quiet zones near hospitals, decrying the too-loud and too-frequent environmental noises as murderers of sleep and menaces to health.

Fast-forward 100 years, and it appears that researchers at the University of Chicago have proven her point.

In an effort to confirm previous observations that noisy hospital rooms keep inpatients from getting quality sleep, medical student Jordan C. Yoder and colleagues, under the direction of Dr. Vineet M. Arora of the Sleep, Metabolism, and Health Center at the University of Chicago, sought to objectively measure noise and sleep duration in ambulatory adult hospital patients at the university’s medical center. Toward this end, they collected sleep and/or sound data from 106 consenting patients between April 2010 and May 2011, excluding individuals with  known sleep disorders, those with cognitive impairment, and those under respiratory isolation or who had been admitted for more than 72 hours (Arch. Intern. Med. 2012 Jan. 9 [172]:68-9).

They found that patient room noise levels were significantly higher than the World Health Organization’s (WHO) recommendations for average noise levels. Further, peak noise level “approached that of a chain saw,” according to their research letter. Nighttime sound levels were lower than daytime levels, but all still significantly exceeded recommendations for maximum noise level and 94% exceeded recommendations for average noise level.

More than 40% of the patients reported noise disruptions of sleep, which were associated with higher maximum noise levels.

Sleep actigraphy data demonstrated that ”patients slept significantly less in the hospital than their self reported baseline sleep,” the authors observed, and mean sleep efficiency when hospitalized was low, with more than half of the recorded nights measuring below the normal lower boundary of 80% efficiency for adults.

While roommates, alarms, intercoms, and pagers were all associated with substantial percentages of noise disruption, the most disruptive source of environmental noise, it appears, was chatty staffers, as the percentage of noise disruption attributed to staff conversation was 65%.

Dr. Arora noted that “some amount of sleep loss in the hospital may be expected given the unfamiliar environment.” In fact, she said in an interview, “our next studies are actually looking at this and the component that may be driven by loss of control or stress.” In the current study, however, “patients lost more sleep in the hospital when noise levels were loudest after accounting for baseline sleep characteristics, so at least noise seems like an independent predictor of hospital sleep, highlighting the importance of optimizing the hospital environment.” The magnitude of the difference, she explained, is one hour less sleep, “which is pretty significant,” Further, patients in noisier rooms reported more complaints of noise, indicating that noise is an issue, she said.

Based on their findings, the authors concluded that “hospitals should implement interventions to reduce nighttime noise levels in an effort to improve patient sleep.” One possibility, Dr. Arora suggested, is a device called a Yacker Tracker, which measures noise and provides feedback to the staff about when the noise level exceeds a certain threshold.

And now that patient report of noise is now a reported measure on Medicare’s Hospital Compare, it will be in the best interest of hospitals as well as patients to implement noise-reduction measures, Dr. Arora noted. “Noisy hospitals will want to optimize patient noise to provide the best experience possible,” she stressed.

The Society for the Suppression of Unnecessary Noise, and its founder, would be well pleased.

—Diana Mahoney

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Bundled Dialysis Payments May Leave Some Shortchanged

It’s difficult not to equate the Centers for Medicare and Medicaid Services’ bundled payment system for outpatient hemodialysis with, say, handing a 12-year-old boy a $10 bill to buy lunch and telling him to keep the change.

That the 12 year old might decide to forego the healthful $9.95 veggie wrap with a side of fruit in favor of the $1 Snickers bar so he can pocket the $9 profit is well within the realm of possibility. In the same vein, should we really be surprised to learn that hemodialysis facilities might not be optimizing patient care when they are being paid a flat fee vs. separate payments for each service —  if not to make a buck, to avoid losing one? A study reported during Kidney Week 2011, the annual meeting of the American Society of Nephrology, hints at just such a scenario.

Image courtesy of Image Courtesy Wikimedia Commons/Elembis/Creative Commons

Using data from the nationally representative Dialysis Outcomes and Practice Patterns Study (DOPPS) practice monitor, investigators with the Ann Arbor Research Collaborative for Health in Michigan determined that uncontrolled secondary hyperparathyroidism has been on the rise among black hemodialysis patients since the implementation in January 2011 of the CMS’s prospective payment system for dialysis services. The system bundles payments for dialysis treatments, supplies, drugs, and lab tests. It rewards facilities for meeting or exceeding quality measures in the Medicare fee-for-service system.

Although the revised payment system is intended to “improve patient outcomes and promote efficient delivery of health care services,” in the words of CMS administrator Donald Berwick, the Ann Arbor investigators hypothesized that the increased financial constraints may lead to less use of intravenous vitamin D analogs, and thus poorer control of secondary hyperparathyroidism (SHPT). Black patients would be left especially vulnerable because they require higher vitamin D doses on average than other patients, according to lead investigator Dr. Francesca Tentori.

To test the hypothesis, the investigators examined trends in parathyroid hormone (PTH) values and SHPT in dialysis patients from July 2010-February 2011 and observed a notable increase in PTH levels overall and in severe, uncontrolled SHPT (defined as a PTH level greater than 600 pg/ml) among black patients.

Specifically, the median PTH value rose among blacks from 296 to 379 pg/ml and from 244 to 283 among non-blacks, and the prevalence of SHPT rose significantly from 16-25% among blacks and slightly, from 9-11% among nonblacks,  Dr. Tentori reported.

Based on preliminary analysis, “these changes don’t appear to be related to decreased overall use of [SHPT] treatments, as the percentage of prescribed intravenous vitamin D rose slightly in both groups, or to changes in serum calcium or phosphorous,” Dr. Tentori said. The findings warrant further evaluation to tease out the cause of the trend, particularly because untreated SHPT has been linked to increased mortality risk in dialysis patients, she stressed.

Dr. Tentori disclosed financial relationships with Amgen, Genzyme, KHK, Abbott, and Baxter.

—Diana Mahoney

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Attacking Obesity

The diversity of disciplines represented at the annual meeting of The Obesity Society parallels the reach of the obesity epidemic itself.

Primary care physicians, endocrinologists, pharmacologists, bariatric surgeons, psychiatrists, psychologists, social workers, educators, nutritionists, and food service workers have spent the past five days in Orlando, Fla., wrestling the obesity beast, trying to shed light on why it is so intractable and discussing interventions that may tame it. Following are a few observations from the meeting:

Courtesy of the Rudd Center for Food Policy & Obesity

1. Although obesity in the United States is being attacked full-force from all sides with drugs, surgery, and psychosocial and behavioral interventions, its prevalence is expected to continue to climb as those born in the 1980s (when the obesity epidemic began) age into their “prime years of obesity incidence,” according to data presented by Whitney Robinson, Ph.D. of the University of North Carolina at Chapel Hill. Dr. Robinson and colleagues used height and weight data measured from 1971-2008 in the National Health and Nutrition Examination Survey (NHANES) to quantify cohort effects as a way to estimate obesity trends. They determined that cohorts born in the 1980s had significantly increased obesity risk versus those born in the late 1960s. The cohort effects, which are those not attributable to the additive effects of age and period, for the 1979-1983 and the 1984-1988 birth cohorts relative to the late 1960s cohort were 1.18 and 1.21, respectively.

Although it is well understood that period effects representing widespread environmental influences have driven increases in obesity prevalence, Dr. Robinson reported, “obesity in adults born in the 1980s shows positive cohort effects as well.”  This finding suggests that even if the obesigenic environment stabilizes, obesity prevalence could continue to increase, particularly in the absence of widespread environmental change.

2. Technology is becoming an ubiquitous weapon in the obesity armamentarium, as evidenced by the many presentations focusing on computer-, Internet- and even smart phone-based strategies. For example, in one late-breaking presentation, Kelly H. Webber, Ph.D. and Dr. Stephanie A. Rose of the University of Kentucky, Lexington, described a pilot study comparing the impact of an Internet behavioral weight loss program alone and in combination with portion-controlled food provision. The study demonstrated that the short-term effect of the combination approach was particularly beneficial.

Similarly, Melissa A. Napolitano, Ph.D. of Temple University in Philadelphia presented a pilot trial of a virtual reality-based psycho-educational intervention for modeling weight loss skills. The findings demonstrated short-term success, with outcomes approximating those found in conventional behavioral weight loss programs.

Finally, a comprehensive evaluation of available iPhone apps for weight loss, presented by Penny Deck, a Ph.D. student at Simon Fraser University, demonstrated the considerable variation in the degree to which the applications follow evidence-based recommendations for weight loss. In particular, she noted, “most of the apps demonstrated poor adherence to such recommendations as basing goals on behaviors vs. weight and advocating small sustainable changes.”

All of the technology interventions are still too young to have long-term outcomes data. It is therefore too early to determine whether their short-term efficacy is a function of the interventions themselves or their novelty. In a presentation describing the apparent benefits of a church-based telemedicine weight loss intervention, Gary Foster, Ph.D., of Temple University observed that most behavioral weight loss interventions are effective in the short term, “but what we really need are long-term studies to evaluate their continued efficacy over time.”

3. Anti-obesity prejudice is pervasive in all sectors of society, including among individuals and organizations in positions of influence. In response to a query from an attendee about the FDA’s reluctance to approve amphetamines for weight loss but not for attention deficit disorder, Dr. George Bray, chief of the division of Clinical Obesity and Metabolism at Pennington Biomedical Research Center in Baton Rouge, La., attributed the double standard to the cultural perception that obesity is an aesthetic problem. “ADHD is viewed as a disease, while obesity is perceived to be a moral deficit,” he said.

The cultural stigma is perpetuated by the news media and even by medical professionals through the photographic and video portrayal of overweight people using headless body shots, primarily focusing on unflattering views of the abdomen or lower body, often in sloppy attire and eating unhealthfully, according to Dr. Arya Sharma, chair in obesity research and management at the University of Alberta in Edmonton, Canada.

To counter the prejudice, the Rudd Center for Food Policy and Obesity at Yale University and The Obesity Society have developed a document called Guidelines for the Portrayal of Obese Persons in the Media, which was available in the meeting press room. The Rudd Center also offers a gallery of more positive images that it makes available to the press.

–By Diana Mahoney



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Street Food May Contribute to Obesity. Surprise.

What about the guys selling food on the street? That was the primary research question posed by Dr. Sean Lucan of Albert Einstein College of Medicine in New York and colleagues as part of a study evaluating whether the fare offered by mobile food vendors in New York contributes to an “obesigenic” food environment. Hmm. Did we really need a study to give us the answer?

Courtesy Wikimedia Commons/Totya/Creative Commons License

The team scoured the Bronx looking for mobile food stalls during the summer and fall of 2010, querying the vendors about what they sold, then assessing the health value of the items. “Only 10% of vendors selling prepared food sold any produce,” Dr. Lucan reported in a poster presentation at the annual meeting of the Obesity Society in Orlando.

In addition, low-fat milk and whole grains were “essentially absent” among the 372 food vendors surveyed, he said. Items high in fat, calories, salt, and/or added sugar were plentiful while fruits and vegetables were limited. Of the 28% of vendors offering any fruit or vegetable, one offered a single whole grain item, while all offered multiple prepared and processed foods. The investigators concluded that the overall contribution of street food vendors “may be unhealthy and obesigenic on balance.” Go figure.

A more enlightening study might consider whether consumers would bite if more healthful street food options were available.  

–Diana Mahoney

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Money is Only Part of the COI Story

“Any senior scientist will tell you that the biggest conflict of interest he or she has doesn’t have anything to do with the [corporate or other] interests that they list on their PowerPoints or at the end of their publications,” Dr. Paul M. Ridker said recently during his presentation on the inflammatory hypothesis of atherosclerosis at the annual meeting of the International Society on Hypertension in Blacks. “It has to do with our individual belief in the biology of what we’re doing.”

For this reason, the lengthy disclosure slide that served as the backdrop to his talk was less relevant, he said, than his fundamental bias, which is his belief that inflammation is “part and parcel, if not the cause of, atherosclerosis.” That type of bias, not industry support, “is what drives my work, and it is what drives most scientists,” stressed Dr. Ridker of Brigham and Women’s Hospital in Boston.

Image courtesy of Flickr user Neubie by Creative Commons license.

Dr. Ridker’s contention is likely a nod to the diatribe that followed the publication of results from the 2008 JUPITER trial on the effects of rosuvastatin (Crestor) in which he and his co-investigators attributed a 44% reduction in cardiovascular events to the agent’s ability to both lower LDL cholesterol and reduce C-Reactive Protein (CRP) levels (N. Engl. J. Med. 2008 Nov. [359]: 2195-207).

Following the publication of the findings, cardiology colleagues questioned the interpretation and veracity of the data in the face of what they deemed to be an unacceptable degree of commercial bias. They were referring not only to the fact that the study was funded by AstraZeneca, the drug’s manufacturer, and that nine of the 14 authors disclosed financial ties to the company, but also that Dr. Ridker holds the legal patent on CRP testing technology. Without question, the skeptics argued, Dr. Ridker had much to gain from the acceptance of his research (Arch Intern Med. 2010 [170]:1032-36).

For his part, Dr. Ridker vigorously defended and continues to defend the quality of the JUPITER data. He has also introduced a salient argument: the conflicts of interest that have the most potential to bias research are not the tangible ones listed at the end of a paper. They are the intellectual and emotional ones that defy enumeration. He doesn’t argue against financial disclosures, but he does warn that they don’t tell the “whole story.”

—Diana Mahoney

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The Value of Sleep

Sleep is big business. People need it. They want it. They’ll spend money to get it. And, according to the bulk of presentations at the 25th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society in Minneapolis (SLEEP 2011) last week, the demand for it continues to far outpace the supply. Given these conditions, it’s not surprising that Americans spend nearly $24 billion on sleep-related goods and services annually, and the market for insomnia drugs is predicted to grow by nearly 80%, to approximately $3.9 billion, in 2012, according to market research conducted by Marketdata Enterprises.

Image via Flickr user deansouglass by Creative Commons License.

Evidence of the anything-but-restful sleep market was plentiful in the SLEEP 2011 exhibit hall, with booth after booth of vendors showcasing everything from pharmaceuticals and nutraceuticals to earplugs, continuous positive airway pressure devices, breathing masks, light therapy boxes, aromatherapy sprays, premium mattresses, and customized pillows. There was also row upon row of posters highlighting the latest research on the multiple and varied sleep-related problems that are keeping the vendors in business.

During a walk through the exhibit hall, however, it didn’t take long for the ironic reality of the sleep conundrum to set in. Americans are spending billions of dollars on sleep-related goods and services and researchers are spending billions of dollars seeking insight into the global sleep deficit that, according to the meeting’s scientific program presentations, is leaving children, adolescents, and adults overtired, anxious, depressed, and suboptimally functional and is putting them at risk for a range of adverse health outcomes, including cardiovascular disease, asthma, diabetes, stroke, and obesity. Yet we, as a society, don’t value sleep.

For example, in March of this year, the Centers for Disease Control and Prevention reported that nearly one third of the country’s adults get less than the minimum recommended 7 hours of sleep per night, and it’s not because they’re not tired: nearly 40% of the survey population reported unintentionally falling asleep during the day and nearly 5% reported nodding off while driving in the preceding 30 days.

Notwithstanding suboptimal sleep quality or quantity resulting from chronic sleep disorders, such as insomnia, obstructive sleep apnea, restless leg syndrome, bruxism, narcolepsy, and sleepwalking, the country’s pervasive sleepiness is often a symptom of what has become a “24-hour society,” in which there’s not enough time in a day to do everything we want to do, according to Dr. Michel Cramer Bornemann, co-director of the Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center in Minneapolis. Not only have we become accustomed to trading sleep for work, he said in a session on sleep forensics, “we wear sleep deprivation as a badge of honor, as if lack of sleep is synonymous with hard work or achievement, when really it can impede both.”

Sleep is a biological imperative, Dr. Bornemann stressed. When it’s not valued as such,  “everybody pays.”

— Diana Mahoney (on Twitter @DMPM1)

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Rheumatology’s PR Problem

Overheard on the steps of the ExCeL London convention center on the last day of the annual European Congress of Rheumatology:

Attendee 1: “What is rheumatism?”

Attendee 2: “You know. Achy legs and such.”

Attendee 1: “Sounds dull.”

Attendee 2: “They’re probably saying that about us.”

Attendee 1: “Doubt it.”

In the interest of full disclosure, I should explain that not only was it the last day of this year’s EULAR congress, it was also the second day of the MCM Expo London Comic Con, which was taking place at the west end of the same convention center. The above discourse occurred between a giant insect and an anime character.

Photo by Diana Mahoney

It was impossible not to be amused by the unlikely juxtaposition of the two gatherings, particularly because the facility’s main entrance was on the building’s west side,. To get to the EULAR events, thousands of suited and serious rheumatologists had to weave in, out, and around the Comic Con crowd, all of whom were dressed as their favorite comic, manga, anime, film, game, and cult entertainment stars and were engaged in various modes of role play.

Despite the apparent incongruity, however, the above discourse seemed inherently relevant, as it came on the heels of a presentation that elucidated some persistent obstacles to the early diagnosis and optimal treatment of early rheumatologic disease, which I have come to think of as collective symptoms of rheumatology’s PR crisis.

In short, a lot of people don’t know what rheumatology is, and the opinions of those who have some vague sense of it continue to be colored by myths and misconceptions, including the belief that arthritis (or “rheumatism,” as per the arachnid quoted above) is a single entity and that there’s not much that can be done for it.

With respect to rheumatoid arthritis, in particular, this lack of awareness contributes to diagnostic and treatment delays that can have devastating consequences. While much effort has been spent recently on the development of early arthritis clinics within rheumatology centers as a way to streamline patient management, their success is limited. They can address the needs of only those patients who walk through the doors, not those of people who don’t seek treatment when their symptoms develop and persist or whose symptoms are inadequately assessed and managed initially by primary care physicians, according to session panelist Dr. Vivian Bykerk from Brigham and Women’s Hospital in Boston. “We have to remove all of the  roadblocks that are keeping very early inflammatory arthritis patients from getting to the rheumatologist,” she said.

Among the strategies recommended by Dr. Bykerk and co-panelist Dr. Paul Emery, EULAR president and head of musculoskeletal diseases at Chapel Allerton Hospital in the United Kingdom, were the possibility of prescreening referrals, the development of a specialized rheumatology referral form to help primary care physicians identify urgent referrals, the implementation of central triage clinics, and protocols for educating physicians and patients about the signs and symptoms of rheumatologic diseases and the value of early intervention. In other words, rheumatology needs better PR.

—Diana Mahoney

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