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August 18, 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, August 18, 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 the adverse events associated with human papillomavirus vaccine. The report will be fed Tuesday, August 18, 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, August 18, 2009
Palliative Care Intervention for Patients with Advanced Cancer Provides Quality of Life and Mood Benefits
CHICAGOPatients with advanced cancer who received a palliative care intervention focused on addressing physical and psychosocial issues and care coordination that was provided at the same time as cancer treatment reported improved quality of life and mood but did not experience a significant change in the number of days in the hospital or the severity of their symptoms compared to patients who received usual care, according to a study in the August 19 issue of JAMA. "Fifty percent of persons with cancer are not cured of their disease; however, with improved treatment even patients with advanced disease may live for years. Providing palliative care concurrent with oncology treatment has been proposed to improve quality of life for patients with advanced cancer," the authors write as background information in the article. Although there are recommended guidelines for palliative care concurrent with cancer treatment (such as chemotherapy and radiation), empirical evidence to support this recommendation has been limited. Marie Bakitas, D.N.Sc., A.P.R.N., of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues conducted a study from November 2003 through May 2008 to determine the effect of a palliative care intervention on quality of life, symptom intensity, mood, and resource use in 322 patients with advanced cancer. Patients were randomized to receive either the intervention, a multicomponent, psychoeducational program conducted by advanced practice nurses and consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161); or usual cancer care (n = 161). The researchers add that the intervention used a case management, educational approach to encourage patient activation, self-management and empowerment. A number of assessment tools were used to measure quality of life, symptom intensity and mood. These measures were assessed at the beginning of the study, at 1 month and every 3 months until death or study completion. During the course of the study, there was no statistically significant difference between the groups regarding the number of participants who received parenteral (by injection) chemotherapy or radiation therapy. The researchers found that the intervention "demonstrated higher quality of life, lower depressed mood, but limited effect on symptom intensity scores and use of resources in intervention participants relative to those receiving usual cancer care. The intervention had no effect on the number of days in the hospital and ICU, the number of emergency department visits, or anticancer treatment because the proportions of participants in each group receiving these therapies were similar." In regard to symptom intensity, "there may be little room for improvement because usual care participants also reported relatively low symptom intensity scores compared with patients with advanced cancer in other studies," the authors write. "It may be unrealistic to expect to reduce symptoms further in the setting of progressive disease."
"Institute of Medicine reports, the National Consensus Project for Quality Palliative Care, other consensus panels, and oncology professional societies agree that comprehensive cancer care must incorporate more than state-of-the-art disease-modifying treatment. Comprehensive, high-quality cancer care includes interdisciplinary attention to improving physical, psychological, social, spiritual, and existential concerns for the patient and his or her family," the authors write.
Editor's Note: This study was supported by a National Cancer Institute grant. 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, August 18, 2009
Overall Antibiotic Prescription Rates for Respiratory Tract Infections Decreasing
CHICAGOFrom 1995 to 2006 the rate of antibiotic prescriptions for acute respiratory tract infections decreased significantly, attributable in part to a decline in ambulatory visits for ear infections in young children, according to a study in the August 19 issue of JAMA. But prescription rates for broad spectrum antibiotics, namely azithromycin and quinolones, increased substantially during the study period. During the past decade, a variety of initiatives in the United States have advocated the judicious use of antibiotics, particularly for acute respiratory tract infection (ARTI), which is a common cause of health care visits and antibiotic prescriptions, especially in young children. Antibiotic use can increase the likelihood for emergence of antibiotic-resistant bacteria. Infections caused by antibiotic-resistant microorganisms are associated with increased illness, death and substantial economic costs, according to background information in the article. Recent measurements of antibiotic prescription patterns in the United States have not been available. Carlos G. Grijalva, M.D., M.P.H., of Vanderbilt University School of Medicine, Nashville, Tenn., and colleagues conducted a study to assess the national trends in antibiotic prescriptions for ARTI in ambulatory settings, using data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey (1995-2006). For children younger than 5 years, annual ARTI-associated visit rates decreased by 17 percent (from 1,883 per 1,000 population in 1995-1996 to 1,560 per 1,000 population in 2005-2006) and annual antibiotic prescription rates in all visits decreased by 27 percent (from 1,552 to 1,128 per 1,000 population). This decrease was due to a 36 percent reduction in ARTI-associated antibiotic prescriptions (from 1,216 per 1,000 in 1995-1996 to 779 per 1,000 in 2005-2006). Annual otitis media (OM; ear infection) visit rates decreased by 33 percent (950 to 634 per 1,000 population) over the study period and rates of antibiotic prescriptions for OM decreased by 36 percent (1,216 to 779 per 1,000 population). Among persons age 5 years or older, ARTI visit rates remained stable but associated antibiotic prescription rates decreased by 18 percent (from 178 to 146 per 1,000 population). Antibiotic prescription rates for non-OM ARTI for which antibiotics are rarely indicated decreased by 15 percent for this group. "Overall, ARTI-associated prescription rates for penicillin, cephalosporin, and sulfonamide/tetracycline decreased. Prescription rates for azithromycin increased and it became the most commonly prescribed macrolide [a type of antibiotic] for ARTI and OM (10 percent of OM visits). Among adults, quinolone prescriptions increased," the authors write.
"Our results indicate that overall antibiotic prescription rates have decreased significantly. These changes coincided with efforts to reduce inappropriate antibiotic prescribing and the initiation of routine infant immunization with pneumococcal conjugate vaccine. Further efforts to improve antibiotic selection are needed."
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, August 18, 2009
Death Rate Decreases Following Hospitalization for Heart Attack
CHICAGOFrom 1995 to 2006, hospital 30-day death rates decreased significantly for Medicare patients hospitalized for a heart attack, as did the variation in the rate between hospitals, according to a study in the August 19 issue of JAMA. "Over the last 2 decades, health care professional, consumer, and payer organizations have sought to improve outcomes for patients hospitalized with acute myocardial infarction [AMI; heart attack]," the authors write. However, little has been known about whether hospitals have been achieving better short-term mortality rates for AMI or if there has been a reduction in between-hospital variation in short-term mortality rates, according to background information in the article. Harlan M. Krumholz, M.D., S.M., of Yale University School of Medicine, New Haven, Conn., and colleagues examined 30-day risk-standardized mortality rates (RSMRs) for acute care hospitals in the United States in the period between 1995 and 2006 for Medicare patients, 65 years or older (average age, 78 years) who were hospitalized with an AMI. The study included data on 3,195,672 discharges in 2,755,370 patients. The researchers found that the all-cause and in-hospital death rates decreased over the study period. "The 30-day mortality rate decreased from 18.9 percent in 1995 to 16.1 percent in 2006, and in-hospital mortality decreased from 14.6 percent to 10.1 percent. In contrast, the 30-day mortality rate for all other conditions was 9.0 percent in 1995 and 8.6 percent in 2006." The RSMR, which takes into account the differences in the types of patients across hospitals and is currently being used by the Centers for Medicare and Medicaid Services (CMS) to profile hospital performance, decreased from 18.8 percent in 1995 to 15.8 percent in 2006, and a reduction in between-hospital differences in mortality rates was also observed.
"Between 1995 and 2006, the RSMR for patients admitted with AMI showed a marked and significant decrease, as did between-hospital variation. Although the cause of the reduction cannot be determined with certainty, this finding may reflect the success of the many individuals and organizations dedicated to improving care during this period," 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. 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, August 18, 2009
Study Examines Adverse Events Associated With Human Papillomavirus Vaccine
CHICAGOAn analysis of the adverse events reported following distribution of quadrivalent human papillomavirus recombinant vaccine since 2006 indicates that adverse event rates were consistent with pre-licensing data and expected background rates of other vaccines, with the exception of a higher proportion of reports of fainting and blood clots, according to a study in the August 19 issue of JAMA. In June 2006 the Food and Drug Administration (FDA) licensed the quadrivalent human papillomavirus recombinant vaccine (qHPV) for females age 9 to 26 years to prevent infection with genital human papillomavirus (HPV) types 6, 11, 16, and 18. Shortly after that, the Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination of females age 11 to 12 years with 3 doses of qHPV and catch-up vaccination for females age 13 to 26 years. Doses are administered on a schedule of 0, 2, and 6 months, according to background information in the article. "The viruses HPV-16 and HPV-18 can cause cervical cancer, other anogenital cancers, and precancerous or dysplastic [abnormal development of cells or tissue] lesions and are responsible for about 70 percent of cervical cancers worldwide. The viruses HPV-6 and HPV-11 are the most common causes of genital warts," the authors write. Prior to licensing, clinical trials were conducted with more than 21,000 women. The incidence of clinical adverse events following immunization (AEFIs) was similar in the vaccine group (59 percent) and the placebo group (60 percent), and the rates of serious AEFIs were comparable between the two groups (less than 0.1 percent). "With more than 23 million qHPV doses distributed in the United States as of December 31, 2008, postlicensure safety monitoring can detect AEFIs too rare to have been detected during prelicensure trials," the researchers note. Barbara A. Slade, M.D., M.S., of the Centers for Disease Control and Prevention, Atlanta, and colleagues analyzed reports of adverse events following qHPV immunization received by the U.S. Vaccine Adverse Event Reporting System (VAERS; a national, voluntary, surveillance system) from June 1, 2006, through December 31, 2008. Additional analyses were performed for some AEFIs in prelicensure trials, those of unusual severity, or those that had received public attention. During the study period, VAERS received 12,424 reports of AEFIs following receipt of qHPV, an overall reporting rate of 53.9 reports per 100,000 vaccine doses distributed. Of the 8,247 reports that included onset interval, 4,393 (40 percent) occurred on the day of vaccination. Among 9,396 reports (77 percent) with dose information, 5,772 (61 percent) followed the first dose, 2,380 (25 percent) followed the second dose and 1,183 (13 percent) followed the third dose of qHPV. Among the 12,424 AEFI reports, 772 (6.2 percent) were serious, including 32 reports of death. The reporting rates per 100,000 qHPV doses distributed were 8.2 for syncope (fainting); 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria (skin rash); 0.2 for venous thromboembolic events (blood clots), autoimmune disorders, and Guillain-Barré syndrome (disorder in which the body's immune system attacks part of the peripheral nervous system); and 0.1 for anaphylaxis (hypersensitivity reaction to a substance) and death. Analysis indicated a disproportional reporting of fainting and blood clot events.
"The postlicensure safety profile presented here is broadly consistent with safety data from prelicensure trials. Because VAERS data must be interpreted cautiously and cannot generally be used to infer causal associations between vaccines and AEFIs, postlicensure monitoring will continue, and identified signals may be evaluated using epidemiologic observational studies," 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: The Risks and Benefits of HPV Vaccination
In an accompanying editorial, Charlotte Haug, M.D., Ph.D., M.Sc., of The Journal of the Norwegian Medical Association, Oslo, Norway, comments on the safety of the HPV vaccine.
"Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine."
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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STUDY REVIEWS SAFETY OF HPV VACCINE
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