JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT Tuesday, February 10, 2009)
JAMA NEWS RELEASES
Obesity During Pregnancy Associated With Increased Risk of Birth Defects
New Surgical Technique Shows Promise for Improving Function of Artificial Arms
Demonstration Projects of Coordinated Care Programs for Medicare Beneficiaries With Chronic Illnesses Find That Most Do Not Show Benefit
Dietary Education Program for Patients With Kidney Disease Appears Effective for Reducing Serum Phosphorus Levels
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Quicktime
STUDY FINDS SIGNALS SENT BY REATTACHED NERVES MAY ALLOW UPPER-LIMB AMPUTEES BETTER CONTROL OF ADVANCED ARTIFICIAL ARMS
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TV Note: This week's JAMA Report video is on a new surgical technique for improving function for artificial arms. The report will be fed Tuesday, February 10, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 28 (C-Band), Transponder 19, downlink frequency: 4080 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, February 10, 2009
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Obesity During Pregnancy Associated With Increased Risk of Birth Defects
CHICAGO—For women who are obese during pregnancy there is an associated increased risk of certain birth defects, such as spina bifida and neural tube defects, although the absolute increase in risk is likely to be small, according to an analysis of previous studies, reported in the February 11 issue of JAMA.
Obesity is a major public health and economic concern. In the United States, a third of women age 15 years and older were obese (body mass index [BMI] greater than 30) in 2004. There are significant health implications of prepregnancy maternal obesity for both mother and child. There is evidence that suggests that maternal obesity may be associated with the development of some congenital anomalies (abnormality present at birth). Congenital anomalies are a leading cause of stillbirth and infant death, accounting for 1 in 5 infant deaths in the United States, and are important contributors to preterm birth and childhood illnesses, according to background information in the article.
Katherine J. Stothard, Ph.D., and colleagues from Newcastle University, Newcastle upon Tyne, U.K., conducted a review and meta-analysis of studies to assess the relationship between maternal overweight and obesity and the risk of congenital anomaly in newborns. The researchers identified 39 articles that were included in a systematic review and 18 articles in the meta-analysis.
"In women who were obese at the start of pregnancy, the meta-analysis demonstrated a significantly increased risk of a pregnancy affected by a neural tube defect [nearly twice the odds], including spina bifida [more than twice the odds]; cardiovascular anomaly, including a septal anomaly [heart defect]; cleft palate and cleft lip and palate; anorectal atresia [abnormality of the anus/rectum]; hydrocephaly [abnormal enlargement of the ventricles of the brain due to accumulation of cerebrospinal fluid]; and a limb reduction anomaly," the authors write.
The risk of gastroschisis (abdominal wall defect) among obese mothers was significantly reduced.
"An estimated 3 percent of all livebirths in the United States are affected by a structural anomaly with 0.68 per 1,000 births being affected by a neural tube defect and 2.25 per 1,000 births being affected by a serious heart anomaly. Given the findings of this review, and the BMI profile of the female population during the period when these estimates were generated, we calculate that the absolute risk of a pregnancy affected by a neural tube defect or a serious heart anomaly is respectively 0.47 per 1,000 births and 0.61 per 1,000 births greater in an obese woman than a woman of recommended BMI in prepregnancy or early pregnancy. This has health implications, particularly given the continued rise in the prevalence of obesity in many countries," the authors write.
They add that further studies are needed to confirm whether maternal overweight is also implicated.
(JAMA. 2009;301[6]:636-650. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, February 10, 2009
Media Advisory: To contact Todd A. Kuiken, M.D., Ph.D., call Katie Lorenz at 312-238-6044 or email klorenz{at}ric.org. To contact editorial author Gerald E. Loeb, M.D., call Meghan Lewit at 323-442-3941 or email lewit{at}usc.edu.
New Surgical Technique Shows Promise for Improving Function of Artificial Arms
CHICAGO—A surgical technique known as targeted muscle reinnervation appears to enable patients with arm amputations to have improved control of functions with an artificial arm, according to a study in the February 11 issue of JAMA.
Currently available prostheses following upper-limb amputation do not adequately restore the function of an individual's arm and hand. The most commonly used prostheses are body-powered, which capture remaining shoulder motion with a harness and transfer this movement through a cable to operate the hand, wrist, or elbow. With this control method, only one joint can be operated at a time, according to background information in the article.
Improving the function of prosthetic arms remains a challenge, because access to the nerve-control information for the arm is lost during amputation. With the surgical procedure, targeted muscle reinnervation (TMR), remaining arm nerves are transferred to chest or upper-arm muscles that are no longer biomechanically functional due to loss of the limb. The goal of this procedure is to improve control of prostheses that use electromyogram (EMG) signals (the electrical signals generated during muscle contraction) from residual limb muscles to control motorized arm joints. Once reinnervated (restore nerve function), these muscles provide physiologically appropriate EMG signals for control of the elbow, wrist, and hand. It is unknown whether reinnervated muscles can stably and accurately provide myoelectric (electrical impulses in muscle) signals for real-time control of multifunction prostheses.
Todd A. Kuiken, M.D., Ph.D., of the Rehabilitation Institute of Chicago, and colleagues assessed the performance of five patients with upper-limb amputation who had undergone TMR surgery. The study, conducted between January 2007 and January 2008, also included 5 control participants without amputation. All participants were instructed to perform various arm movements, and their abilities to control the virtual prosthetic arm were measured.
The average motion selection times for elbow and wrist movements (elbow flexion/extension, wrist rotation, and wrist flexion/extension) were 0.22 seconds for TMR patients and 0.16 seconds for control participants. The average motion completion rate for elbow and wrist movements was high (96.3 percent for TMR patients and 100 percent for control participants). The average motion completion times for elbow and wrist movements were 1.29 seconds for TMR patients and 1.08 seconds for control participants. For both groups, hand grasps took longer to complete than arm movements; the average motion completion times for hand grasps were 1.54 seconds for TMR patients and 1.26 seconds for control participants.
Three of the patients were able to demonstrate the use of the control system in advanced prostheses, including motorized shoulders, elbows, wrists, and hands.
"These early trials demonstrate the feasibility of using TMR to control complex multifunction prostheses. Additional research and development need to be conducted before field trials can be performed," the authors write. "The prosthetic arms tested in this study performed very well as early prototypes. Further improvements are needed and have been planned, including reducing the size and weight and increasing the robustness of these advanced prostheses."
(JAMA. 2009;301[6]:619-628. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Taking Control of Prosthetic Arms
In an accompanying editorial, Gerald E. Loeb, M.D., of the University of Southern California, Los Angeles, comments on the findings regarding the use of TMR.
"Kuiken et al have reported on an exciting and promising work in progress, with many opportunities available to improve both the technology and the clinical implementation. Such revolutions develop slowly at best, but their effects tend to be profound. With increasing functional capabilities, patients with upper-extremity amputations may derive exceptional benefit from prosthetic arms, just as legions of patients with lower-extremity amputations now lead remarkably normal and even athletic lives."
(JAMA. 2009;301[6]:670-671. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc
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Embargoed for Release: 3:00 p.m. CT, Tuesday, February 10, 2009
Media Advisory: To contact corresponding author Randall Brown, Ph.D., call Joanne Pfleiderer at 609-275-2372 or email JPfleiderer{at}mathematica-mpr.com. To contact editorial author John Z. Ayanian, M.D., M.P.P., call David Cameron at 617-432-0441 or email david_cameron{at}hms.harvard.edu.
Demonstration Projects of Coordinated Care Programs for Medicare Beneficiaries With Chronic Illnesses Find That Most Do Not Show Benefit
CHICAGO—Only 2 of 15 Medicare programs designed to improve care and costs for patients with chronic illnesses resulted in reduced hospital admissions, and none of the programs generated net savings, according to a study in the February 11 issue of JAMA.
Chronic illnesses pose a significant expense to the Medicare program. The high expenditures generated by these beneficiaries are driven primarily by hospital admissions and readmissions, according to background information in the article. Several factors appear to contribute to the high rate of hospitalizations, including patients receiving inadequate counseling on diet, medication, and self-care; not having ready access to medical help other than the emergency department; and poor communication betweens patients and physicians. Some studies have suggested that interventions to address the barriers faced by chronically ill patients could reduce avoidable hospitalizations and decrease Medicare expenditures.
To study whether care coordination improves the quality of care and reduces Medicare expenditures, the Centers for Medicare & Medicaid Services (CMS) in 2002 competitively awarded 15 demonstration programs to various health care programs. Deborah Peikes, Ph.D., and colleagues from the Mathematica Policy Research Inc., Princeton, N.J., analyzed the results from randomized controlled trials of these 15 programs on how they affected Medicare expenditures and quality of care. The programs included eligible fee-for-service Medicare patients (primarily with congestive heart failure, coronary artery disease, and diabetes) who volunteered to participate between April 2002 and June 2005 and were randomly assigned to treatment or control (usual care).
Hospitalizations, Medicare expenditures and some quality-of-care outcomes were measured with claims data for 18,309 patients (n = 178 to 2,657 per program) from patients' enrollment through June 2006. A patient survey 7 to 12 months after enrollment provided additional quality-of-care measures. Nurses provided patient education and monitoring (mostly via telephone) to improve the ability to communicate with physicians and adherence to medication, diet, exercise and self-care regimens. Patients were contacted twice per month on average; frequency varied widely.
The researchers found that 13 of the 15 programs showed no significant differences in hospitalizations. Mercy Medical Center, in northwestern Iowa, significantly reduced hospitalizations by 17 percent, and Charlestown retirement community in Maryland had an increase of 19 percent more hospitalizations.
None of the programs reduced regular Medicare expenditures. Treatment group members in 3 programs (Health Quality Partners [HQP, in Pa.], Georgetown, [a medical center in Washington, D.C.] and Mercy) had monthly Medicare expenditures less than the control group by 9 percent to 14 percent. Savings offset fees for HQP and Georgetown but not for Mercy; Georgetown was too small to be sustainable. For total Medicare expenditures including program fees, the treatment groups for 9 programs had 8 percent to 41 percent higher total expenditures than the control groups did, all statistically significant.
For the survey-based outcomes-of-care measures, despite reporting much higher rates of being taught self-management skills, treatment group members were no more likely than control group members to say they understood proper diet and exercise, or to state that they were adhering to prescribed or recommended diet, exercise, and medications.
The authors add that a comparison of the two programs with the most positive results with the other programs indicates there were a number of noteworthy differences, including higher rates of in-person contact per month per patient; treatment group members were significantly more likely than control group members to report being taught how to take their medications; care coordinators for both HQP and Mercy worked closely with local hospitals, which provided the programs with timely information on patient hospitalizations and improved their potential to manage transitions and reduce short-term readmissions; and care coordinators in both programs had frequent opportunities to interact informally with physicians.
"Despite these underwhelming results for care coordination interventions in general, the favorable findings for Mercy and HQP suggest that the potential exists for care coordination interventions to be cost-neutral and to improve patients' well-being," the researchers write.
(JAMA. 2009;301[6]:603-618. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: The Elusive Quest for Quality and Cost Savings in the Medicare Program
John Z. Ayanian, M.D., M.P.P., of Brigham and Women's Hospital and Harvard Medical School, Boston, writes in an accompanying editorial that despite these findings, this study offers two important insights to guide Medicare policy on coordination of chronic disease care going forward.
"First, care coordinators must interact in person with patients and not simply educate or assist them by telephone. Only 4 of the 15 programs emphasized in-person contact between coordinators and participants, including both of the programs that CMS allowed to continue."
"A second crucial lesson is that care coordinators must collaborate closely with patients' physicians to have a reasonable prospect of influencing care. Only 4 of the 15 programs had coordinators who were based in physicians' offices or who attended patients' medical appointments, including both of the programs that were authorized by CMS to continue."
(JAMA. 2009;301[6]:668-670. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, February 10, 2009
Media Advisory: To contact corresponding author Ashwini R. Sehgal, M.D., call Susan Christopher at 216-778-5078 or email schristopher{at}metrohealth.org.
Dietary Education Program for Patients With Kidney Disease Appears Effective for Reducing Serum Phosphorus Levels
CHICAGO—Patients with end-stage renal disease (ESRD) who participated in an education program to limit their intake of phosphorus-containing food additives lowered their blood levels of the chemical, according to a study in the February 11 issue of JAMA.
Individuals with moderate to severe kidney disease have an impaired ability to excrete phosphorus, and as a result, they tend to develop hyperphosphatemia (abnormally high concentration of phosphates in the blood), especially if their intake of phosphorus is high. Elevated serum phosphorus levels are associated with an increased risk of death and illness, with levels greater than the 5.5-mg/dL level recommended by practice guidelines associated with a 20 percent to 40 percent increase in the risk of death among patients with ESRD. In addition, hyperphosphatemia appears to be involved in the development of a number of health risks, including heart disease and bone disease, according to background information in the article.
To prevent hyperphosphatemia, patients with ESRD limit their intake of foods that are naturally high in phosphorus such as meats, dairy products, whole grains and nuts. However, phosphorus-containing additives are increasingly being added to processed and fast foods, particularly meats, cheeses, baked goods and beverages. The effect of such additives on serum phosphorus levels is unclear.
Catherine Sullivan, M.S., R.D., L.D., of MetroHealth Medical Center and Case Western Reserve University, Cleveland, and colleagues tested an educational intervention to reduce the intake of additive-containing processed and fast foods to determine if there is a causal relationship between additive consumption and hyperphosphatemia among patients with ESRD. The study included 279 patients with elevated baseline serum phosphorus levels (greater than 5.5 mg/dL). About half of participants reported eating fast food more frequently than once a week. Intervention participants (n = 145) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants. Control participants (n = 134) continued to receive usual care.
At the beginning of the trial, the average serum phosphorus level was 7.2 mg/dL among intervention participants and 7.1 mg/dL among control participants. After 3 months, serum phosphorus levels declined by 1.0 mg/dL among intervention participants and by 0.4 mg/dL among control participants, a difference of 0.6 mg/dL. Intervention participants also had significantly larger increases in reading ingredient lists and nutrition facts labels compared with control participants.
"The 0.6-mg/dL larger decline in average phosphorus level among intervention participants compared with control participants corresponds to a 5 percent to 15 percent reduction in relative mortality risk in observational studies," the researchers write.
"Our findings raise the possibility that typical intakes of processed and fast foods contribute to the persistent hyperphosphatemia, cardiovascular events, and bone disease observed among patients with ESRD. Our results have important implications for patients, clinicians, researchers, and policy makers. Patients with ESRD and clinicians should learn about both naturally occurring phosphorus and phosphorus-containing additives, and patients should limit their total phosphorus intake to 800 to 1,000 mg/d as recommended by practice guidelines."
The authors add that researchers should focus on developing more potent approaches to preventing and treating hyperphosphatemia, and policy makers should consider approaches to address this problem, such as mandating that phosphorus content be listed on nutrition facts labels.
"Further work is needed to enhance the potency of our intervention and to understand the impact of phosphorus-containing additives on patients with less severe renal disease and on the general public," the researchers conclude.
(JAMA. 2009;301[6]:629-635. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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JAMA REPORTS
VIDEO: Quicktime
STUDY FINDS SIGNALS SENT BY REATTACHED NERVES MAY ALLOW UPPER-LIMB AMPUTEES BETTER CONTROL OF ADVANCED ARTIFICIAL ARMS
INTRO:
Most people with arm amputations have drastically reduced capabilities and use prosthetics that can seem cumbersome and difficult to control. But new research shows that for patients who have undergone surgery to have residual arm nerves reattached, real-time control of advanced artificial arms may be possible. Haley Weldon explains in this week's JAMA Report.
VIDEO:
B-ROLL
Jesse in lab
Super @: :00
File Footage – Rehabilitation Institute of Chicago
AUDIO:
SEVERAL MONTHS AFTER LOSING BOTH OF HIS ARMS WHILE WORKING AS AN ELECTRICAL LINEMAN, JESSE SULLIVAN BECAME THE FIRST PERSON TO UNDERGO AN EXPERIMENTAL SURGERY CALLED "TARGETED MUSCLE REINNERVATION", OR "TMR".
VIDEO:
SOT/FULL
Super @: :11
Jesse Sullivan
Double amputee
AUDIO:
I was kind of scared a little bit because you know I didn't know what was going to happen but I didn't have anything to lose, nothing to lose - everything to gain.
VIDEO:
SOT/FULL
Super @: :19
Todd Kuiken, M.D., Ph.D.
Rehabilitation Institute of Chicago
AUDIO:
We developed a technique to take the arm nerves and move them to different muscles in the residual limb or chest. Now when the patient thinks close hand for example, a little piece of muscle in their biceps or in their chest contracts - we can use that signal to tell them to have their prosthetic hand close.
VIDEO:
B-ROLL
Jesse Sullivan w/Dr. Kuiken, female patient in lab
Super @: :38
File Footage – Rehabilitation Institute of Chicago
B-ROLL
Dr. Kuiken and colleague
Jesse in lab with technician
AUDIO:
JESSE'S SURGERY WAS A SUCCESS, AND PAVED THE WAY FOR DOZENS OF OTHER PEOPLE WITH AMPUTATIONS TO BENEFIT FROM TMR. NOW DR. TODD KUIKEN AND HIS TEAM AT THE REHABILITATION INSTITUTE OF CHICAGO HAVE DEVELOPED A COMPUTER PROGRAM THEY HOPE WILL EVEN BETTER READ THESE MUSCLE CONTRACTIONS - OR "EMG SIGNALS" - SENT BY REATTACHED NERVES.
VIDEO:
SOT/FULL
Todd Kuiken, M.D., Ph.D.
AUDIO:
In this study, we've moved on and used some advanced computer algorithms to decode the signals; not just tell a, so a patient now just doesn't say I want to open and close my hand, but we're able to control to a degree freedom of wrist, with flexion and extension and rotation, as well as multifunction hands that allow multiple hand grasp patterns.
VIDEO:
GFX/JAMA COVER
B-ROLL
Virtual Testing
B-ROLL
Physical Testing
Super @ : 1:32
File Footage – Rehabilitation Institute of Chicago
AUDIO:
FEATURED THIS WEEK IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, THE STUDY FOUND THAT THIS NEW CONTROL SYSTEM ALLOWED THE 5 TMR PATIENT/PARTICIPANTS TO COMPLETE 10 DIFFERENT ELBOW, WRIST AND HAND MOTIONS QUICKLY AND CONSISTENTLY WITH A VIRTUAL ARM.
THE THREE PATIENTS WHO THEN WENT ON TO "PHYSICAL TESTING" WERE ABLE TO USE THE SYSTEM TO SUCCESSFULLY CONTROL VERY ADVANCED PROSTHETIC PROTOTYPES, EVEN WITH A LIMITED AMOUNT OF TRAINING.
VIDEO:
Cont. BROLL then
SOT/FULL
Jesse Sullivan
AUDIO:
There's a whole lot more movement there than before because now when I go home instead of just open/close, I practice all of these movements.
VIDEO:
SOT/FULL
Todd Kuiken, M.D., Ph.D.
AUDIO:
It demonstrates that we can control complex hands and wrists and we can do better than we are right now. And as the corollary to that, I think it gives a lot of hope for our patients that better things are coming.
VIDEO:
SOT/FULL
Jesse Sullivan
AUDIO:
The future of these, it's just going to get better. I hope I'm in on it!
VIDEO:
B-ROLL
Super @ 2:01
File Footage – Rehabilitation Institute of Chicago
AUDIO:
HALEY WELDON, THE JAMA REPORT.
TAG:
Researchers plan to refine the control system further and would like to eventually give people with amputations the ability to feel where their arm is as they move it.
Please see the complete study for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
