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: 3:00 p.m. CT, Tuesday, November 21, 2006)
JAMA NEWS RELEASES
RANDOMIZED STUDY INDICATES THAT PATIENTS WITH HERNIATED DISK IMPROVED WITH OR WITHOUT SURGERY
PHYSICIANS RATE INVOLVEMENT IN PUBLIC ROLES AS IMPORTANT
USE OF UNLICENSED, HIGHLY-CONCENTRATED BOTULINUM PREPARATION FOR COSMETIC INJECTIONS CAN RESULT IN SEVERE, LIFE-THREATENING ILLNESS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
SURGERY SLIGHTLY MORE EFFECTIVE THAN NON-SURGICAL TREATMENT FOR HERNIATED DISK
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA Report video is on the comparison of outcomes for treating a herniated disk with or without surgery. The report will be fed Tuesday, November 21, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band), Downlink Freq: 3920 MHz Vertical, Audio: 6.20/6.80. For more information, call 312/464-JAMA.
Please Note: The FOR THE MEDIA Web site now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org.
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Go to www.jamamedia.org for more information and to apply for access.
Embargoed for Release: 3:00 p.m. CT, Tuesday, November 21, 2006
Media Advisory: To contact James N. Weinstein, D.O., M.Sc., call Deborah Kimbell or Susan Knapp at 603-646-3661. To contact editorial author David R. Flum, M.D., M.P.H., call Justin Reedy at 206-685-0382. To contact editorial author Eugene Carragee, M.D., call Ruthann Richter at 650-725-8047.
RANDOMIZED STUDY INDICATES THAT PATIENTS WITH HERNIATED DISK IMPROVED WITH OR WITHOUT SURGERY
CHICAGO—Patients with lumbar disk herniation who had surgery or nonoperative treatments showed similar levels of improvement in the reduction of pain over a 2-year period, according to a randomized trial in the November 22/29 issue of JAMA. In all cases patients who had surgery did slightly better.
Lumbar diskectomy (surgical removal, in part or whole, of an intervertebral disk) is the most common surgical procedure performed in the United States for patients having back and leg pain. The vast majority of the procedures are elective. However, lumbar disk herniation (protrusion from its normal position) is often seen on imaging studies in the absence of symptoms and can regress over time without surgery, according to background information in the article. High variation in regional diskectomy rates in the U.S. and lower rates internationally raise questions regarding the appropriateness and effectiveness of some of these surgeries, compared to nonoperative care, with evidence inconclusive on the optimal treatment.
James N. Weinstein, D.O., M.Sc., of Dartmouth Medical School, Hanover, N.H., and colleagues compared the outcomes of surgical and nonoperative treatment for lumbar intervertebral disk herniation in the Spine Patient Outcomes Research Trial (SPORT), which included both a randomized trial study group and an observational study group who declined to be randomized in favor of designating their own treatment.
The randomized clinical trial enrolled patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 U.S. states. The participants included 472 patients (average age, 42 years; 42 percent women) who were candidates for surgery, with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy (involvement of the spinal nerve roots characterized by pain that radiates from the spine, such as down the leg) for at least 6 weeks. Patients were randomized to undergo diskectomy (n = 232) vs. nonoperative treatment (n = 240), which included physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. There was follow-up at 6 weeks, 3 months, 6 months, and 1 and 2 years.
The researchers found that adherence to assigned treatment was limited: 50 percent of patients assigned to surgery received surgery within 3 months of enrollment, while 30 percent of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses (in which group outcomes were assessed based on the therapy to which the patient was initially assigned) demonstrated substantial improvements for all primary (pain and physical function measures) and secondary outcomes (sciatica severity, satisfaction with symptoms, self-reported improvement, and employment status) in both treatment groups. The intent-to-treat analysis likely underrepresents the true treatment effect, while the as-treated analysis likely overestimates the true treatment effect. In all cases, the patients who had surgery did slightly better.
“Patients in both the surgery and nonoperative treatment groups improved substantially over the first 2 years,” the authors write. “Between-group differences in improvements were consistently in favor of surgery for all outcomes and at all time periods but were small and not statistically significant except for the secondary measures of sciatica severity and self-rated improvement. Because of the high numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis alone.”
(JAMA. 2006;296:2441-2450. 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.
OBSERVATIONAL STUDY DEMONSTRATES THAT PATIENTS WHO CHOSE SURGERY HAD GREATER IMPROVEMENT
In the companion article, which was the observational study of SPORT, patients with persistent sciatica who had diskectomy or usual care reported improvement over 2 years, although patients who chose surgery experienced greater improvement.
The observational study group, treated at 13 spine clinics in 11 U.S. states between March 2000 and March 2003, included patients who met SPORT eligibility criteria but declined randomization. Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care.
At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain, physical function, and on a disability index. These differences narrowed somewhat at 2 years.
“In this nonrandomized evaluation of patients with persistent sciatica from lumbar disk herniation who had operative or usual care, both treatment groups improved considerably over 2 years. Nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously. Nevertheless, patients who underwent diskectomy had significantly better self-reported outcomes than those who had usual care,” the authors conclude.
(JAMA. 2006;296:2451-2459. 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: INTERPRETING SURGICAL TRIALS WITH SUBJECTIVE OUTCOMES
In an accompanying editorial, David R. Flum, M.D., M.P.H., of the University of Washington, Seattle, and a Contributing Editor, JAMA, comments on the SPORT articles.
“Although at first this finding [from the observational study] suggests that surgery is more beneficial than usual care, this interpretation may be flawed. Patients who elected to have surgery were different in many ways than those who did not. A higher level of disease severity among operative-care patients might be considered a conservative bias in that treatment effects among patients with similar disability might be even greater. But if anything has been learned from the legacy of sham [placebo procedure similar to intervention] -controlled trials, these differences may also include a greater expectation of success among patients having the more invasive intervention.”
“Helping balance the competing risks and benefits of operative and nonoperative approaches to discogenic [disorder originating in or from an intervertebral disk] pain and neurologic symptoms was the goal of the SPORT trial. Because of limitations in design and study operation, the proper role and benefits of these competing interventions are still unclear. Given the large number of patients potentially exposed to the risks of these strategies, a sham surgical trial may be the only effective and ethical next step.”
(JAMA. 2006;296:2483-2485. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Financial disclosures - none reported.
EDITORIAL: SURGICAL TREATMENT OF LUMBAR DISK DISORDERS
In another editorial, Eugene Carragee, M.D., of Stanford University Medical Center, Stanford, Calif., discusses the findings of SPORT.
“These findings suggest that in most cases there is no clear reason to advocate strongly for surgery apart from patient preference. For the patient with emotional, family, and economic resources to handle mild or moderate sciatica, surgery may have little to offer. In fact, this was the profile of many patients who opted against surgery in the SPORT trial: older participants with higher income and higher education but with milder pain and disability. Furthermore, the SPORT data clearly show that the risk of serious problems (i.e. neurologic deterioration, cauda equina syndrome [characterized by intense leg pain, numbness and weakness or paralysis of legs, buttocks or genitalia], or progression of spinal instability) when receiving nonoperative care is extremely small. The fear of many patients and surgeons that not removing a large disk herniation will likely have catastrophic neurologic consequences is simply not borne out. Thus, these data help both clinicians and patients make better informed decisions based on each patient’s needs and expectations.”
(JAMA. 2006;296:2485-2487. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Dr. Carragee has received support from the U.S. Department of the Army for research in this field.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, November 21, 2006
Media Advisory: To contact Russell L. Gruen, M.B.B.S., Ph.D., email: rgruen{at}unimelb.edu.au. To contact co-author David Blumenthal, M.D., M.P.P., call the Harvard Medical School Public Affairs office at 617-432-0442.
PHYSICIANS RATE INVOLVEMENT IN PUBLIC ROLES AS IMPORTANT
CHICAGO—About two-thirds of physicians surveyed reported being actively involved in activities such as community participation, political involvement and collective advocacy, according to a study in the November 22/29 issue of JAMA.
There has been debate about the degree to which physicians should assume public roles, that is, their degree of social responsibility for addressing health-related matters beyond providing care to individual patients. Physician leaders, social commentators, and professional organizations’ mission statements have often supported the physicians’ assumption of public roles, according to background information in the article. Currently, little is known about practicing physicians’ attitudes about, or the extent to which they participate in community, political, or advocacy activities.
Russell L. Gruen, M.B.B.S., Ph.D., of the University of Melbourne, Royal Melbourne Hospital, Melbourne, Australia and colleagues from Harvard Medical School, Boston, conducted a study to determine the importance physicians assign to public roles, their participation in related activities, and sociodemographic and practice factors related to physicians’ rated levels of importance and activity. In this study, public roles were defined as community participation, political involvement, and collective advocacy.
The researchers analyzed data from the Institute on Medicine as a Profession’s (IMAP) Survey on Medical Professionalism. The IMAP survey, conducted between November 2003 and June 2004, collected data about attitudes toward and participation in activities the previous 3 years related to physician professionalism from a nationally representative sample of 1,662 U.S. physicians in 3 primary care specialties (general internal medicine, family practice, and pediatrics) and 3 nonprimary care specialties (general surgery, anesthesiology, and cardiology)
The researchers found that more than 90 percent of the physicians who responded to their survey regarded public roles as important. More than half regarded community participation and collective advocacy to be very important, and more than one-third regarded individual political involvement to be very important. Approximately two-thirds of all physicians reported participating in at least 1 public role in the previous 3 years.
Nutrition, immunization, substance abuse, and road safety issues were rated as very important by more physicians than were access-to-care issues, unemployment, or illiteracy. Factors independently related to high overall rating of importance (civic-mindedness) included age, female sex, underrepresented race/ethnicity, and graduation from a non-U.S. or non-Canadian medical school. Civic mindedness, medical specialty, practice type, underrepresented race/ethnicity, teachers of physicians in training, rural practice, and graduation from a non-U.S. or non-Canadian medical school were independently related to civic activity.
“These results indicate a high degree of consensus and previously undocumented willingness of physicians to engage in addressing U.S. public health concerns,” the authors write.
“...this study provides some important evidence for professional leaders and organizations, policy makers, and educators who may want to engage more physicians in public health and health policy concerns. First, the majority of physicians are supportive of such engagement through community participation, political involvement, and collective advocacy. Second, the perceived importance physicians assign to involvement in any particular issue appears to be, at least in part, related to how directly the issue concerns individual patients’ health. Clarifying the evidence of such causative links may therefore be critical in influencing physician participation in public roles.
“Third, a variety of personal, professional, and practice characteristics may influence physicians’ civic mindedness and civic activity. Confirming and understanding these potential influences could provide important guidance to leaders and policy makers who want to enlist the positive energy of physicians in promoting public health at a societal level,” the authors conclude.
(JAMA. 2006;296:2467-2475. 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.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, November 21, 2006
Media Advisory: To contact Daniel S. Chertow, M.D., M.P.H., call Lola Scott Russell at 404-639-7916.
USE OF UNLICENSED, HIGHLY-CONCENTRATED BOTULINUM PREPARATION FOR COSMETIC INJECTIONS CAN RESULT IN SEVERE, LIFE-THREATENING ILLNESS
CHICAGO—An examination of 4 cases of botulism following cosmetic injections to the face indicates that the adults received a highly concentrated, unlicensed preparation that resulted in toxin levels up to 40 times the estimated human lethal dose, according to a report in the November 22/29 issue of JAMA.
Botulism is a rare paralytic illness caused by the toxins of the spore-forming bacterium Clostridium botulinum and toxin-producing strains of Clostridium baratii and Clostridium butyricum. Botulism, left untreated, may result in respiratory failure and death, according to background information in the article. Two botulinum toxin preparations are licensed in the United States by the U.S. Food and Drug Administration for clinical use, BOTOX (crystalline toxin type A); and Myobloc/Neurobloc (toxin type B). Although botulinum toxin A is available by prescription for cosmetic and therapeutic use, no cases of botulism with detectable serum toxin have previously been attributed to cosmetic or therapeutic botulinum toxin injections. On November 27, 2004, four suspected botulism case-patients with a link to cosmetic botulinum toxin injections were reported to the Centers for Disease Control and Prevention.
Daniel S. Chertow, M.D., M.P.H., of the CDC, Atlanta, and colleagues investigated various aspects of the four suspected cases of botulism. They found that clinical characteristics of the four case-patients were consistent with those of naturally occurring botulism. All case-patients had been injected with a highly concentrated, unlicensed preparation of botulinum toxin A, intended for laboratory research, labeled accordingly, and not licensed or intended for human use.
Clinic staff had diluted a 100-μg vial of pure neurotoxin with diluent and drew up the resulting solution into syringes for clinical use. The physician working at the clinic administered 4 case-patients (including himself) 4 to 6 injections of this toxin solution in the facial area. All the patients eventually reported symptoms of progressive weakness and cranial neuropathies (abnormality of the nerves that control a number of functions, including movement of the facial muscles and swallowing), with two patients experiencing shortness of breath.
The researchers report the patients may have received doses 2,857 times the estimated human lethal dose by injection. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21 to 43 times the estimated human lethal dose; pretreatment serum from the fourth epidemiologically linked case-patient was not available. A 100-μg vial of toxin taken from the same manufacturer’s lot as toxin administered to the case-patients contained a toxin amount sufficient to kill approximately 14,286 adults by injection if disseminated evenly.
“Botulism is a potentially fatal disease, which invariably presents with acute bilateral cranial neuropathies, regardless of exposure mechanism. Early recognition of botulism, treatment in an intensive care setting, provision of mechanical ventilation when indicated, and rapid administration of antitoxin (optimally within 12 hours of presentation) have been associated with improved clinical outcome. Suspected cases of botulism should be reported immediately to local health authorities to facilitate rapid epidemiological investigation, provision of antitoxin when indicated, and prevention of further cases,” the researchers write.
“Physicians and patients must be aware of the hazards associated with illegitimate use of unlicensed botulinum toxin products. Only licensed products should be used clinically. Entities inappropriately marketing, selling, or using unlicensed botulinum toxin products should be sought and subjected to full criminal and civil penalties. The Code of Federal Regulations should be modified to reduce the weight threshold of individual shipments subject to regulation and should require researchers to provide legal documentation of credentials and adequate laboratory facilities prior to shipment of toxin,” the authors conclude.
(JAMA. 2006;296:2476-2479. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: No private funding or material support was received for this investigation. Support was provided by the Centers for Disease Control and Prevention and the state health departments of Florida and New Jersey. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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JAMA REPORTS
VIDEO: Windows Media | Quicktime
SURGERY SLIGHTLY MORE EFFECTIVE THAN NON-SURGICAL TREATMENT FOR HERNIATED DISK
VIDEO:
NAT SOT UP FULL FOR :07
Dr. Weinstein’s voice-close up of computer image
AUDIO:
“This disk is pushing against the nerves on the right, causing the patient to have significant right leg symptoms.”
VIDEO:
B-ROLL
Dr. Weinstein looking at image through “looks”
Woman having physical therapy lying on exam table
AUDIO:
THAT’S WHAT A HERNIATED DISK LOOKS LIKE, AND IT CAN CAUSE EXCRUCIATING PAIN IN THE BACK AND LEG.
VIDEO:
NAT SOT UP FULL FOR :02
AUDIO:
“Cries out in pain”
VIDEO:
B-ROLL
Physical therapy video, then backtime Susan from name
AUDIO:
IT DID FOR SUSAN FILSKOV, AFTER SHE HURT HER BACK SHOVELING SNOW.
VIDEO:
SOT/FULL
@ :15
Super: Susan Filskov
Had herniated disk
Runs :08
AUDIO:
“I was at the point where I couldn’t sleep in my bed. I was sleeping on the couch at night with my legs up over the back. Not sleeping very much at all, actually.”
VIDEO:
B-ROLL
Exterior of Dartmouth Medical School
Dr. Weinstein in exam room with Susan checking her knee reflexes
Surgery video starting at “The study included”
At “physical therapy” physical therapist working on man
At “researchers” more surgery video
AUDIO:
SO SHE WENT TO SEE DARTMOUTH MEDICAL SCHOOL BACK EXPERT DR. JAMES WEINSTEIN (wine-stine). SHE AGREED TO BE IN A STUDY HE WAS HELPING TO CONDUCT, LOOKING AT TREATMENTS FOR HERNIATED DISKS. THE STUDY INCLUDED MORE THAN A THOUSAND PATIENTS FROM THIRTEEN SITES ACROSS THE U.S. SOME WERE GIVEN THE CHOICE TO HAVE SURGERY OR NON-SURGICAL TREATMENT, SUCH AS PHYSICAL THERAPY. OTHER PATIENTS AGREED TO BE ASSIGNED TO HAVE ONE TREATMENT OR THE OTHER. RESEARCHERS COMPARED SURGERY TO NON-SURGERY, TRACKING BOTH TREATMENT GROUPS’ RECOVERY REGULARLY FOR TWO YEARS.
VIDEO:
SOT/FULL
@ :58
Super: James Weinstein, D.O., M.Sc.
Dartmouth Medical School
Runs :10
AUDIO:
“They both improved over time in step with each other, but the surgical patients improved a little more than the non-operative patients at each time point.”
VIDEO:
B-ROLL
Surgery video to “bubble,” then computer image of bubble
Elderly man on exercise bike
GFX/JAMA COVER
AUDIO:
IN THE SURGERY, DOCTORS REMOVE THE BUBBLE CAUSED BY THE HERNIATED DISK, THAT’S PUSHING ON THE NERVES. SURGICAL AND NON-SURGICAL PATIENTS SAW THEIR PAIN LESSEN AND FUNCTION IMPROVE WITHIN THREE MONTHS, AND THEN CONTINUE TO GET BETTER OVER TIME. THE FINDINGS APPEAR IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
James Weinstein, D.O., M.Sc.
Dartmouth Medical School
Runs :14
AUDIO:
“What patients need to do is be empowered with their doctors to be knowledgeable about the risks and benefits of surgical or non-surgical treatment and take their preferences and their values into account when making these decisions with their doctors.”
VIDEO:
B-ROLL
Susan walking outside
AUDIO:
SUSAN DECIDED TO HAVE THE SURGERY AND SAYS HER BACK AND LEG PAIN IMMEDIATELY GOT BETTER.
VIDEO:
SOT/FULL
Susan Filskov
Had herniated disk
Runs :10
AUDIO:
“If you can get physical therapy and work through it that’s great, but if you’re at the point where you just can’t tolerate anymore, there is other options, so....”
VIDEO:
B-ROLL
Dr. Weinstein talking with Susan in exam room
AUDIO:
NOW PATIENTS CAN DISCUSS THOSE OPTIONS WITH THEIR DOCTOR. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
