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September 1, 2009JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of 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 CONTENTS
JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT Tuesday, September 1, 2009)
JAMA REPORT (VIDEO SCRIPT)
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED. JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ON-LINE. Go to www.jamamedia.org for more information and to apply for access. TV Note: PLEASE NOTE, FEED TIMES ARE NOW 15 MINUTES. This week's JAMA Report video is on treatments for the facial paralysis disorder, Bell Palsy. The report will be fed Tuesday, Sept. 1, from 9:00 - 9:15 a.m. ET and 2:00 - 2:15 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. The JAMA Report video is also now available on Pathfire every Tuesday. Please look for the JAMA Report "channel". Save the Date: The Sixth International Congress on Peer Review and Biomedical Publication will be held September 10-12 in Vancouver, Canada. New research will be presented on peer review and. the other processes used to evaluate and disseminate medical information. Program and registration information is included at the end of this email. Please Note: The FOR THE MEDIA website 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 EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, September 1, 2009
Research Compares Outcomes of Immediate Versus Delayed Intervention for Patients with Acute Coronary Syndromes
CHICAGO—For some patients with acute coronary syndromes, the strategy of immediate intervention at a medical center does not appear to result in differences in outcomes in comparison with an intervention performed the next working day, according to a study in the September 2 issue of JAMA. "The optimal intervention in the treatment strategy of patients presenting with acute coronary syndromes without ST-segment elevation (NSTE-ACS) has been debated for years," the authors write in background information for the study. "Numerous studies, randomized trials, and meta-analyses have investigated the potential benefits of invasive over conservative strategies, and most have suggested a prolonged advantage of an invasive approach for the prevention of death of myocardial infarction [MI; heart attack], particularly among high-risk patients." Gilles Montalescot, M.D., Ph.D., of the Institut de Cardiologie, Centre Hospitalier Universitaire Pitie-Sapetriere, Paris, and colleagues from The Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (ABOARD) study evaluated data from 352 patients with acute coronary syndromes at 13 high-volume medical centers in France with 24-hour facilities for treatment of primary percutaneous coronary intervention (e.g, balloon angioplasty or stent placement) from August 2006 through September 2008. The patients, all of whom had acute coronary syndromes without ST-segment elevation (a certain pattern on the electrocardiogram [ECG]), were randomized to undergo an immediate invasive strategy or an invasive strategy scheduled on the next working day. The primary end point was the peak troponin value (biomarker indicating heart muscle involvement or damage) during hospitalization. The key secondary end point was the composite of death, myocardial infarction, or urgent revascularization at one-month follow-up. "Time from randomization to sheath insertion [beginning of the catheterization procedure] was 70 minutes with immediate intervention vs. 21 hours with delayed intervention," the authors report. "Troponin I release, as reflected by peak value collected during hospitalization, did not differ between the two strategies in the immediate and delayed intervention groups. The probability of MI as measured by the curves of troponin peak values was similar with either strategy." The authors also found that "the key secondary end point was observed in 13.7 percent of the group assigned to receive immediate intervention and 10.2 percent of the group assigned to receive delayed intervention. The other end points, as well as major bleeding, did not differ between the two strategies." The authors note that hospital stay was significantly reduced with the immediate strategy compared with the delayed intervention strategy.
"This study demonstrates the feasibility of immediate catheterization and revascularization in patients who present with NTSE-ACS but does not show that this strategy is superior to catheterization scheduled on the next working day," the authors write. "Thus, rapid or urgent catheterization appears preferable in high-risk or unstable patients, while the benefit in other situations may be limited to practicality and length of hospital stay," the authors conclude.
Editor's Note: Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, September 1, 2009
Study Examines Effectiveness of Laparoscopic Surgical Treatments to Alleviate Chronic Pelvic Pain
CHICAGO—A surgical procedure known as LUNA (laparoscopic uterosacral nerve ablation) did not result in improvements in chronic pelvic pain, painful menstruation, painful sexual intercourse or quality of life when compared with laparoscopic surgery that does not interrupt pelvic nerve connections, according to a study in the September 2 issue of JAMA. "Chronic pelvic pain in women is as common as asthma and chronic back pain, is one of the most difficult and perplexing of women's health problems and has a multifactorial etiology," the authors provide as context for their study. "Chronic pelvic pain has a major effect on health-related quality of life, work attendance and productivity, and health care use, accounting for 40 percent of referrals for diagnostic laparoscopy, and is an important contributor to health care expenditures. Treatments for chronic pelvic pain are often unsatisfactory." The authors add, "LUNA was adopted by many practitioners because afferent nerves from pelvic organs pass through the utero-sacral ligament and it was thought that disruption of these would reduce the perceived pain." Jane Daniels, M.Sc., from Birmingham Women's Hospital, University of Birmingham, England and colleagues from the LUNA Trial Collaboration conducted a randomized controlled study with 487 women with chronic pelvic pain at 18 hospitals in the United Kingdom between February 1998 and December 2005. The women were randomized into two groups: 243 women received the LUNA procedure and 244 received laparoscopy without pelvic denervation (no LUNA). Follow-up questionnaires were sent to study participants at three and six months and at one, two, three and five years. The primary outcome was pain and the secondary outcome was health-related quality of life. "After a median [midpoint] follow-up of 69 months, there were no significant differences reported on the visual analogue pain scales for the worst pain between the LUNA group and the no LUNA group," the authors found. There were also no significant differences found for noncyclical pain, dysmenorrhea (painful menstruation), or dyspareunia (difficult or painful sexual intercourse). Nor were there differences observed between the LUNA group and the no LUNA group for quality of life.
In conclusion the authors write, "The LUNA trial was designed to assess the effects of LUNA compared with no denervation among women undergoing diagnostic laparoscopy for chronic pelvic pain. LUNA did not alleviate any type of pain - noncyclical pain, dysmenorrhea, or dyspareunia - or improve the quality of life, irrespective of the presence or absence of mild endometriosis."
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 JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, September 1, 2009
Some Discrepancies Exist Between Primary Outcomes Indicated in Clinical Trial Registration and Reported in Subsequent Publications
CHICAGO—Comparison of the primary outcomes of registered clinical trials with their subsequent publication appears to show some discrepancies, according to a study in the September 2 issue of JAMA. In 2005, the International Committee of Medical Journal Editors (ICMJE) adopted a policy requiring researchers to deposit information about randomized controlled trials into a clinical trials registry before study participants enrolled as a precondition for publication of the study's findings in member journals. "One of the main objectives of trial registration is to help achieve transparency in results and make information about the existence and design of clinical trials publicly available," the authors provide as background information. "This policy should permit knowledge sharing about the key elements of clinical trials and help decrease the risk of selective reporting of outcomes that was previously identified in published results of RCTs [randomized controlled trials]." Sylvain Mathieu, M.D., of Hopital Bichat-Claude Bernard, Paris and colleagues conducted a search of the MEDLINE via PubMed to identify randomized controlled trials in three areas: cardiology, rheumatology, and gastroenterology, that were indexed in 2008 in the 10 general medical journals and specialty medical journals with the highest impact factors. The researchers sought to compare the primary outcomes specified in trial registries with those reported in the published articles and to determine whether outcome reporting bias favored significant primary outcomes. Of the 323 included articles, 114 (35.3 percent) were published in general medical journals and 209 (64.7 percent) in specialty journals. "A total of 147 trials (45.5 percent) were adequately registered (i.e., registered before the end of the trial, with the primary outcome clearly specified)," the authors write. "Trial registration was lacking for 89 published reports (27.6 percent), 45 trials (13.9 percent) were registered after the completion of the study, 39 (12.1 percent) were registered with no or an unclear description of the primary outcome, and 3 (0.9 percent) were registered after the completion of the study and had an unclear description of the primary outcome." The authors note that the proportion of registered trials was greater for the general medical journals than the specialty publications. "Among articles with trials adequately registered, 31 percent (46 of 147) showed some evidence of discrepancies between the outcomes registered and the outcomes published." Of those 46 articles, the authors report "19 of 23 (82.6 percent) had a discrepancy that favored statistically significant results (i.e., a new, statistically significant primary outcome was introduced in the published article or a nonsignificant primary outcome was omitted or not defined as the primary outcome in the published article)." "Trial registration provides a good opportunity for editors, peer-reviewers, and policy makers to identify outcome reporting bias, and other deviations from the planned study to prevent such distortions from reaching publication," the authors write.
"In conclusion, although trial registration is now the rule, careful implementation of trial registration, with full involvement of authors, editors, and reviewers is necessary to ensure publication of quality, unbiased results."
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 JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, September 1, 2009
Study Evaluates Use of Corticosteroids and Antiviral Agents for Treatment of Bell Palsy
CHICAGO—Among patients with Bell Palsy, a facial paralysis with unknown cause, treatment with corticosteroids is associated with a reduced risk of an unsatisfactory recovery, and treatment with a combination of corticosteroids and antiviral agents may be associated with additional benefit, according to a systematic review and meta-analysis of previously published studies, reported in the September 2 issue of JAMA. In background information provided by the authors, they note that Bell Palsy "is an acute weakness or paralysis of the facial nerve," and has an annual incidence of 20 to 30 per 100,000 population. "While 71 percent of untreated patients will completely recover and 84 percent will have complete or near normal recovery, the remainder will have persistent to moderate to severe weakness, facial contracture, or synkinesis [involuntary movement]." The authors explain that a herpes infection likely causes the disorder. DNA samples from patients have yielded herpes simplex virus type 1 (HSV-1). Varicella zoster virus (VZV) reactivation is also associated with Bell Palsy. John R. de Almeida, M.D., from Sunnybrook Hospital and the University of Toronto, Canada, and colleagues conducted a search of the medical literature for randomized controlled trials comparing treatment with either corticosteroids or antiviral agents with a control measuring unsatisfactory facial recovery (four months or more), unsatisfactory short-term recovery (six weeks to less than four months), synkinesis and autonomic dysfunction, or adverse effects. The authors identified 854 studies, of which 18 were eligible for inclusion for evaluation. The 18 studies included 2,786 patients and were conducted in 12 countries and five continents. "...high-quality evidence suggests that corticosteroids alone reduce the risk of unsatisfactory recovery by 9 percent in absolute terms, with a NNTB (number of patients needed to treat for one patient to experience benefit) of 11," the authors report. "Corticosteroid therapy combined with antiviral agents reduced the risk of unsatisfactory recovery compared with antiviral agents alone. Corticosteroids were also associated with a 14 percent absolute risk reduction of synkinesis and autonomic dysfunction (NNTB, 7; moderate quality of evidence). Corticosteroids were not associated with an increased risk of adverse effects."
"Our results suggest a possible incremental benefit of antiviral agents in addition to corticosteroids, with an absolute risk reduction of 5 percent compared with corticosteroids alone. This effect, however, is not definitive and did not quite reach statistical significance," the authors write. "Further primary studies are needed to definitively establish - or refute - an incremental benefit of combined therapy compared with corticosteroid mono therapy," the authors conclude.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Editorial: Treatment of Bell Palsy — Translating Uncertainty Into Practice
"The systematic review by de Almeida et al of medications for treatment of Bell palsy helps resolve lingering doubt about the benefits of corticosteroids, but raises questions about the adjunctive role of antiviral medications," John F. Steiner, M.D., M.P.H., of Kaiser Permanente Colorado, Denver, writes in an accompanying editorial.
"Until the next generation of clinical trials is completed, clinicians and patients will have to deal with substantial uncertainty in deciding whether to add antiviral drugs to corticosteroids for Bell palsy. By assessing how clinicians alter their prescribing patterns and how treatment guidelines are revised in response to this new evidence, it will be possible to learn more about how clinical uncertainty is translated into practice."
Editor's Note: Please see the editorial for additional information, including financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, September 1, 2009
Mass Distribution of Oral Antibiotic for Eye Disease Associated with Lower Risk of Death Among Ethiopian Children
CHICAGO—Children in Ethiopia who received the antibiotic azithromycin as a method for controlling the contagious eye disease trachoma had a lower odds of death compared to children who did not receive the antibiotic, according to a study in the September 2 issue of JAMA. "The World Health Organization has recommended mass distribution and administration of oral azithromycin as part of efforts to control blinding trachoma. Such distribution has proven effective against the ocular strains of Chlamydia trachomatis that cause the disease at both the individual and village levels," the authors write. The treatment may also have unintended consequences, both harmful and beneficial, including the inducement of antibiotic resistance. "Conversely, antibiotics may reduce both respiratory and gastrointestinal infections, and possibly reduce rates of malaria—all of which are major causes of death in children in trachoma-endemic areas such as rural Ethiopia." Travis C. Porco, Ph.D., M.P.H., of the University of California, San Francisco, and colleagues examined the effect of oral azithromycin distribution for trachoma control on mortality among children ages 1 to 9 in Ethiopia. Forty-eight communities (known as subkebeles) were randomized into 1 of 3 treatment schedules (annual treatment of all residents [15,902 participants], biannual treatment of all residents [17,288 participants], or quarterly treatment of children only [14,716 participants]) or into 1 group for which treatment was delayed by 1 year (control, 18,498 participants). Twelve subkebeles were randomized to each of the 4 schedules with all children in each of the three communities being eligible for treatment. The trial was conducted in a field setting in rural Ethiopia, May 2006 to May 2007. Antibiotic coverage rates exceeded 81 percent among children age 1 to 9 years at all visits. A total of 82 deaths were recorded for children age 1 to 9 years at the 2007 census. Comparing the mortality rates between the two groups, the researchers found that the children in the treatment group had a 49 percent lower odds of death compared with children in the control group. "It is not clear precisely why azithromycin decreased mortality, although infectious diseases are the leading cause of death in Ethiopian children, in particular pneumonia (28 percent), diarrhea (20 percent), and malaria (20 percent). In Ethiopia, azithromycin is likely effective against the major pathogenic causes of lower respiratory infections such as Streptococcus pneumoniae and Haemophilus influenzae, and may have some effect against major causes of bacterial diarrhea such as Escherichia coli and Clostridium jejuni. Azithromycin has also been shown to have efficacy in the prevention and treatment of malaria due to both Plasmodium falciparum and Plasmodium vivax," the authors write.
"The dangers of nonspecific antibiotic use have been well-described in the scientific literature. The common wisdom is that overprescribing antibiotics results in increased morbidity and mortality from drug-resistant organisms, and that society would be better off were physicians to restrain their use of the drugs. However, the effect of nonspecific mass antibiotic use on mortality has never before been assessed in a group-randomized clinical trial. In an area in which residents have very limited access to antibiotics, mass distribution of oral azithromycin appears to reduce mortality in preschool children. Further assessment of the mechanism, generalizability, effects of drug resistance or other adverse outcomes, and cost-effectiveness of antibiotic administration in impoverished rural settings may be needed to provide further insight to guide public health policy."
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 JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, September 1, 2009
Study Finds That Research at Academic Medical Centers is Active, Diverse
CHICAGO—A survey indicates that research is active and diverse at U.S. academic medical centers and that a substantial proportion of faculty conduct research and publish without sponsorship, according to a study in the September 2 issue of JAMA. "Encompassing 60 percent of all research money to universities, the academic, life-science research enterprise is large and growing, representing $28.8 billion in research and development expenditures in 2006," the authors write as background information in the article. "To establish policies and priorities, a better empirical picture is needed of what the academic medical center (AMC) research enterprise looks like, but beyond generic classifications such as 'basic' and 'applied,' these data do not exist." Darren E. Zinner, Ph.D., of Brandeis University, Waltham, Mass., and Eric G. Campbell, Ph.D., of Massachusetts General Hospital and Harvard Medical School, Boston, conducted a study to quantitatively document the state of academic research in AMCs through a survey of research faculty. The survey, conducted in 2007, was mailed to 3,080 life-science faculty at the 50 universities with medical schools that received the most funding from the National Institutes of Health in 2004. The overall response rate was 74 percent, with questions on the survey regarding the type of research (basic, translational, clinical trials, health services research/clinical epidemiology, multimode, other), total funding, industry funding, publications, professional activities, patenting behavior and industry relationships. Survey results indicated that one-third (33.6 percent) of AMC faculty members exclusively conducted basic science research as principal investigators, compared with translational researchers (9.1 percent), clinical trial investigators (7.1 percent), and health services research/clinical epidemiologists (9.0 percent). Those who solely conducted other clinical research represented 11.6 percent of research staff and were generally less focused on research. "While principal investigators garnered a mean of $410,755 in total annual research funding, 22.1 percent of all AMC research faculty were unsponsored, a proportion that ranged from 11.5 percent for basic science researchers to 46.8 percent for health services researchers. The average AMC faculty member received $33,417 in industry-sponsored funding, with most of this money concentrated among clinical trial ($110,869) and multimode ($59,916) principal investigators. Translational (61.3 percent), clinical trial (67.3 percent), and multimode (70.9 percent) researchers were significantly more likely than basic science researchers (41.9 percent) to report a relationship with industry and that these relationships contributed to their most important scientific work," the authors write.
The researchers add that these findings suggest several implications. "First, contrary to popular belief, the 'valley of death' for translational research actually appeared to be quite fertile within AMCs. At the time of this survey in 2007, 22 of 50 institutions were participating members of the Clinical and Translational Science Awards (CTSA) consortium; another 12 joined in 2008. ... Second, multimode investigators represented an understudied population. These investigators, who conducted research across the spectrum of research activities, reported both substantial scientific and commercializing characteristics. ...Third, the findings also demonstrate the important role of industrial collaboration in scientific advancement. Academic-industry relationships provide substantial, tangible benefits to both the science and the scientist."
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Editorial: Researchers, Funding, and Priorities
In an accompanying editorial, Hamilton Moses III, M.D., of the Alerion Institute, North Garden, Va., and Johns Hopkins University School of Medicine, Baltimore, writes that the authors of this study "acknowledge that one group's scientific discovery is another's clinical advance and still another's incremental cost."
"However, to date, there is no workable compromise among those competing aims. Momentum behind health reform in the United States favors coverage of the uninsured and cost control as 2 main goals. In the absence of good information about which technologies save money and which add only expense or marginal value, the result will be increasing pressure to direct investment toward the greatest burden of disease. The debate over research priorities has already begun."
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
JAMA REPORTS
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COMBINATION OF MEDICATIONS FOUND TO BE MOST EFFECTIVE IN THE TREATMENT OF BELL PALSY
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