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, November 1, 2005)
JAMA NEWS RELEASES
CERVICAL CANCER SCREENING PROGRAMS FOR LOW-RESOURCE AREAS APPEAR EFFECTIVE AND SAFE
SINGLE-VISIT PROGRAM FOR CERVICAL CANCER SCREENING INCREASES RATE OF FOLLOW-UP, TREATMENT
CHILDREN WITH NEUROLOGICAL AND NEUROMUSCULAR DISEASES AT INCREASED RISK FOR FLU-RELATED RESPIRATORY FAILURE
CLINICAL TRIALS STOPPED EARLY FOR BENEFIT WARRANT SKEPTICISM FROM PHYSICIANS
JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)
VIDEO: Windows Media | Quicktime
STUDY SHOWS WHY CHILDREN WITH CONDITIONS SUCH AS CEREBRAL PALSY AND MUSCULAR DYSTROPHY NEED ANNUAL FLU VACCINE
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA video news release is on the risk factors for respiratory failure for children hospitalized with flu. The release will be fed Tuesday, November 1, from 9:00 - 9:30 a.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Intelsat America 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).
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Embargoed for Release: 3 p.m. CT, Tuesday, November 1, 2005
Media Advisory: To contact corresponding author Thomas C. Wright, Jr., M.D., call Elizabeth Streich at 212-305-6535. To contact editorial co-author Paul D. Blumenthal, M.D., M.P.H., call Elizabeth Tracey at 410-955-2877.
CERVICAL CANCER SCREENING PROGRAMS FOR LOW-RESOURCE AREAS APPEAR EFFECTIVE AND SAFE
CHICAGO—Two "screen and treat" cervical cancer prevention programs developed for high-risk women in low-resource settings resulted in a lower prevalence of precancerous cervical lesions and cervical cancer, according to a study in the November 2 issue of JAMA.
Each year 471,000 cases and 233,000 deaths occur from cervical cancer worldwide, of which 80 percent occur in less-developed countries that have access to less than 5 percent of global cancer treatment resources, according to background information in the article. The lifetime risk of a woman developing cervical cancer in a low-resource setting is approximately 2 percent to 4 percent. Cytology (cell) -based screening programs have markedly reduced the incidence of cervical cancer in developed countries that have the infrastructure to support these programs. However, these screening programs have been difficult to implement in low-resource settings.
Recently, a novel approach to cervical cancer prevention has been proposed that avoids the complex health infrastructure required by traditional approaches. This approach incorporates non–cytology-based screening methods such as human papillomavirus (HPV) DNA testing or visual inspection with acetic acid (VIA; a weak acidic solution) followed by treatment of lesions using cryotherapy (medical treatment that involves application of nitrous oxide to lesions and a device using very low temperatures) of all eligible women with positive test results. Cryotherapy is a relatively low-technology treatment method. These approaches have advantages for low-resource settings because they are not cytology-based screening programs and do not require colposcopy (specialized equipment for examination of the vagina and the cervix), which overcome two of the greatest barriers to cervical cancer prevention. However, the efficacy of these screen-and-treat approaches has not been established, and there has been only limited safety data.
Lynette Denny, M.D., Ph.D., of the University of Cape Town, South Africa, and colleagues conducted a study to determine the safety and efficacy of two screen-and-treat approaches for cervical cancer prevention. The randomized clinical trial included 6,555 nonpregnant women, aged 35 to 65 years, and was conducted between June 2000 and December 2002 at ambulatory women’s health clinics in Khayelitsha, South Africa. All patients were screened using human papillomavirus (HPV) DNA testing and visual inspection with VIA. Women were subsequently randomized to 1 of 3 groups: cryotherapy if she had a positive HPV DNA test result; cryotherapy if she had a positive VIA test result; or to delayed evaluation.
The researchers found that compared with the delayed evaluation group, the prevalence of biopsy-confirmed high-grade cervical intraepithelial neoplasia and cancer (CIN 2+) at 6 months was significantly less in both the HPV DNA and VIA groups. At 6 months, CIN grade 2+ was diagnosed in 0.80 percent of the women in the HPV DNA group and 2.23 percent in the VIA group compared with 3.55 percent in the delayed evaluation group. "Thus, the screen-and-treat approach using HPV DNA testing was associated with a 77 percent lower prevalence of CIN 2+ than in the delayed evaluation group at 6 months, whereas the screen-and-treat approach using VIA was associated with a 37 percent lower prevalence," the authors write.
Data were obtained from 2,708 women (74 percent of those scheduled to be examined) and the cumulative prevalence of CIN 2+ by 12 months in both screen-and-treat groups continued to be lower than in the delayed evaluation group. In the HPV DNA group, 1.42 percent had CIN 2+ by 12 months compared with 2.91 percent in the VIA group and 5.41 percent in the delayed evaluation group. "This translates into 1 case of CIN 2+ being averted for every 25 women enrolled in the HPV DNA group and 1 case being averted for every 40 women enrolled in the VIA group," the researchers write.
Although minor complaints, such as discharge and bleeding, were common after cryotherapy, major complications were rare.
"This trial has shown that screening and treating women based on the results of two alternative screening tests to cytology, HPV DNA testing and VIA, is safe and has a significant impact on the prevalence of CIN 2+ among women participating in such a program. In low-resource settings, screen-and-treat approaches may be able to reduce the risk of a common and easily preventable cancer in women," the authors conclude.
(JAMA. 2005;294:2173-2181. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was funded by the Bill and Melinda Gates Foundation through a grant to the Alliance for Cervical Cancer Prevention, the Cancer Association of South Africa, and the Department of National Health, South Africa.
EDITORIAL: CERVICAL CANCER PREVENTION—MAKING PROGRAMS MORE APPROPRIATE AND PRAGMATIC
In an accompanying editorial, Paul D. Blumenthal, M.D., M.P.H., of Johns Hopkins University, Baltimore, and Lynne Gaffikin, Dr.P.H., of Evaluation and Research Technologies for Health Inc., Oakland, Calif., comment on the studies in this week’s JAMA on screening for cervical cancer.
"When faced with a challenge, identifying and seizing an opportunity can be the first step toward triumph. That is what public health approaches are often about. An important lesson from the work of Brewster et al and Denny et al is that whether in southern California or southern Africa, safe, acceptable, effective, and pragmatic public health approaches to cervical cancer prevention can be designed."
"The advent of a vaccine to prevent human papillomavirus infection, widely perceived to be just around the corner, is eagerly awaited to advance preventive capabilities. Recent data reported by Skjeldstad and colleagues made this development increasingly likely. However, even if a vaccine became available tomorrow, several generations of women worldwide would still need conventional care. To provide care to all women, future cervical cancer prevention programs worldwide will need to be designed to reach women who are at highest risk for disease and to ensure that the critical components of testing, treatment, and follow-up are realized as appropriate for every woman. Programs that build on the experience reported in these articles will have a good start in achieving those goals," they write.
(JAMA. 2005;294:2225-2228. Available pre-embargo to the media at www.jamamedia.org)
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 p.m. CT, Tuesday, November 1, 2005
Media Advisory: To contact Wendy R. Brewster, M.D., Ph.D., call Tom Vasich at 949-824-6455.
SINGLE-VISIT PROGRAM FOR CERVICAL CANCER SCREENING INCREASES RATE OF FOLLOW-UP, TREATMENT
CHICAGO—Low-income women with abnormal Pap tests who participated in a program that combines screening and treatment in one visit had a higher rate of treatment and follow-up than women who did not participate, according to a study in the November 2 issue of JAMA.
Cervical cancer incidence rates in the United States have progressively declined because of the widespread application of cervical cancer screening and treatment of precancerous lesions, according to background information in the article. The majority of cervical cancers diagnosed in this country are among women who have never received a Papanicolaou test or who are noncompliant with screening and follow-up. The incidence of cervical cancer is higher among low-income and minority women. The barriers to cervical cancer screening and management include poverty, lack of health insurance, limited transportation, language difficulties, lack of child care and lack of telephone access. The researchers believe that the usual approach to cervical cancer screening, diagnosis, and management accentuates some of these barriers because it is cumbersome and expensive, ordinarily involving multiple clinic or hospital visits and requiring a period of months to complete. Previous research has reported that between 20 percent and 50 percent of women with abnormal Papanicolaou test results do not have follow-up.
Wendy R. Brewster, M.D., Ph.D., of the University of California, Irvine, and colleagues developed a cancer control program to simplify cervical screening and management of high-grade cervical dysplasia among predominantly Latina women from underserved communities. They hypothesized that women who received results and explanations about the importance of follow-up for an abnormal Papanicolaou test result on the same day as the test would be more likely to follow up. The randomized trial included 3,521 women aged 18 or older recruited between January 1999 and April 2002 from U.S. community health centers, located in predominantly Latino underserved areas.
Women randomized to usual care (n=1,805) were discharged immediately after examination. Women randomized to the single-visit group (n=1,716) remained at the clinic until the results of their conventional Papanicolaou test were available. Large loop electrosurgical excision procedure was performed in single-visit patients with either a diagnosis of a high-grade squamous intraepithelial lesion (HGSIL)/atypical glandular cells of undetermined significance (AGUS) or suspicion of carcinoma. All other patients with abnormal Papanicolaou test results were referred to abnormal cytology clinics or elected to receive follow-up care outside the study’s medical system.
Approximately 4 percent of all Papanicolaou test results in each of the 2 groups were abnormal, and 1 percent of results showed high-grade lesions. The researchers found that 53 percent of the women in the usual care group received definitive treatment within 6 months for their severe dysplasia compared with 88 percent of single-visit patients. Overall, 36 percent of women in each group presented for a follow-up Papanicolaou test 1 year later. Women in the single-visit group with high-grade lesions were significantly more likely to follow up for their Papanicolaou tests 12 months later than women with similar lesions in the usual care group (10 [63 percent] of 16 compared with 4 [21 percent] of 19. Examination of the other Papanicolaou test classifications did not demonstrate a difference in the follow-up rate 1 year later.
The average visit time for patients in the single-visit group, defined as the duration from when they came into the clinic until they left, was 2.8 hours. Slightly more than 1 hour (66 minutes) of this time was spent waiting for the transportation, processing, and reading of the Papanicolaou test. In comparison, the average visit time for the usual care group was 75 minutes. The acceptability of the visit duration was 76 percent in the single-visit group and 89 percent in the usual care group.
The researchers add that although the number of women at high risk of cervical cancer in this study was small, this program could prevent most cervical cancer if applied to all women with severely abnormal Papanicolaou test results. "In this era, when effective treatment of precancerous lesions is available, it is not acceptable for any woman to develop this disease."
"In summary, we have demonstrated that a single-visit cervical cancer screening and treatment program is feasible and the degree of acceptability is high. We believe that this strategy is best applied to practices of underserved groups with high rates of loss of follow-up. Single-visit programs provide an opportunity to ensure that severe cervical lesions are treated," the authors write.
(JAMA. 2005;294:2182-2187. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This project was funded by the National Cancer Institute.
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 p.m. CT, Tuesday, November 1, 2005
Media Advisory: To contact Ron Keren, M.D., M.P.H., call Rachel Salis-Silverman at 267-426-6063.
CHILDREN WITH NEUROLOGICAL AND NEUROMUSCULAR DISEASES AT INCREASED RISK FOR FLU-RELATED RESPIRATORY FAILURE
CHICAGO—Children with neurological and neuromuscular diseases should receive an annual influenza vaccination because of a higher risk of respiratory failure if they are hospitalized with influenza, according to a study in the November 2 issue of JAMA.
Influenza is a common disease of childhood and is responsible for significant illness, according to background information in the article. Healthy young children are hospitalized for influenza-related illness at rates similar to those for elderly persons and adults with chronic medical conditions. Perhaps most concerning to parents and physicians is the potential for serious influenza-associated complications, including carditis (inflammation of the heart), encephalitis, myositis (inflammation of muscle tissue), pneumonia, respiratory failure, and death.
Population-based studies suggest that individuals with certain chronic medical conditions are at increased risk of serious complications of influenza infection. The Advisory Committee on Immunization Practices (ACIP) has identified 9 groups of chronic medical conditions for which annual influenza vaccination is recommended. They include asthma, chronic lung disease, cardiac disease, immunosuppression, hemoglobinopathies (a blood disease characterized by the presence of abnormal hemoglobins in the blood), chronic renal dysfunction, metabolic and endocrine conditions, long-term salicylate (aspirin and some other drugs) therapy, and pregnancy. Despite the frequency of influenza infection and the prevalence of these chronic medical conditions, little is known about their relative contribution to the development of serious influenza-associated complications.
Ron Keren, M.D., M.P.H., of The Children’s Hospital of Philadelphia, and colleagues conducted a study to identify chronic medical conditions that were associated with respiratory failure in children hospitalized with influenza. In addition to the current ACIP-designated high-risk conditions, the researchers also examined three other categories of chronic medical conditions—neurological and neuromuscular disease (NNMD, such as muscular dystrophy), gastroesophageal reflux disease (GERD), and history of prematurity, that in recent studies have been associated with influenza hospitalization and severe influenza-related complications. The study included patients aged 21 years or younger hospitalized at The Children’s Hospital of Philadelphia, with community-acquired laboratory-confirmed influenza during 4 consecutive influenza seasons (June 2000 through May 2004).
Of 745 children hospitalized with influenza, 322 (43 percent) had one or more ACIP-designated high-risk chronic medical conditions. NNMD, GERD, and history of prematurity were present in 12 percent, 14 percent, and 3 percent, of children, respectively. Thirty-two children (4.3 percent) developed respiratory failure. In further analyses, conditions associated with respiratory failure included NNMD (6 times increased risk), chronic pulmonary disease other than asthma (4.8 times increased risk), and cardiac disease (4 times increased risk). The predicted probabilities of respiratory failure derived from the multivariate model were 12 percent, 9 percent, and 8 percent for children with NNMD, chronic pulmonary disease, and cardiac disease, respectively. Children hospitalized with influenza who had 2 of these 3 chronic conditions had a 31 percent to 39 percent predicted probability of respiratory failure.
"The significantly increased probability of respiratory failure in children with NNMD hospitalized with influenza supports the ACIP’s recent decision to add NNMD that may compromise respiratory function to the list of chronic conditions that warrant annual influenza vaccination. Coordinated efforts are needed to educate parents, primary care pediatricians, and pediatric neurologists about the risks of serious influenza complications and the need for annual vaccination for children with NNMD. Future studies should determine the risk of hospitalization among children with NNMD, the number of additional children with NNMD who will require annual vaccination, as well as the effectiveness and cost-effectiveness of the influenza vaccine in preventing hospitalizations and serious complications in these children," the authors conclude.
(JAMA. 2005;294:2188-2194. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note:This work was supported by a grant from the Centers for Disease Control and Prevention (CDC). Dr. Keren was supported by a grant from the National Institute of Child Health and Human Development, Bethesda, Md.
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 p.m. CT, Tuesday, November 1, 2005
Media Advisory: To contact corresponding author Gordon H. Guyatt, M.D., M.Sc., call Susan Emigh at 905-525-9140 ext. 22555. To contact editorial author Stuart J. Pocock, Ph.D., call + 44 7798 656561 or email: stuart.pocock{at}lshtm.ac.uk.
CLINICAL TRIALS STOPPED EARLY FOR BENEFIT WARRANT SKEPTICISM FROM PHYSICIANS
CHICAGO—A review article in the November 2 issue of JAMA suggests clinicians ought to view with skepticism the results of randomized clinical trials stopped early because of apparent benefit.
Victor M. Montori, M.D., M.Sc., from McMaster University, Hamilton, Ontario, and colleagues conducted a review of the medical literature to identify randomized clinical trials (RCTs) of any intervention reported as having been stopped earlier than planned because of results favoring the experimental intervention.
"Of 143 RCTs stopped early for benefit, the majority (92) were published in 5 high-impact medical journals. Typically, these were industry-funded drug trials in cardiology, cancer, and human immunodeficiency virus/AIDS," the authors found. "The proportion of all RCTs published in high-impact journals that were stopped early for benefit increased from 0.5 percent in 1990 – 1994 to 1.2 percent in 2000 – 2004. On average, RCTs recruited 63 percent of the planned sample and stopped after a median (mid-point) of 13 months of follow-up, one interim analysis, and when a median of 66 patients had experienced the end point driving study termination (event)." The authors also note that "trials with fewer events yielded greater treatment effects."
The authors conclude: "RCTs stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trials with skepticism."
(JAMA. 2005;294:2203–2209. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note:Please see JAMA study for authors’ funding/support information.
EDITORIAL: WHEN (NOT) TO STOP A CLINICAL TRIAL FOR BENEFIT
In an accompanying editorial, Stuart J. Pocock, Ph.D., from the London School of Hygiene and Tropical Medicine, writes: "In this issue of JAMA, Montori and colleagues provide a valuable extensive and critical systemic review of clinical trials that were stopped early for benefit."
"The skeptic should ask first whether correct and appropriate structures were in place for analyzing and reviewing, and making decisions based on, the trial’s accumulating interim data. Having the members of an effective independent data monitoring committee (DMC) or data and safety monitoring board as the only individuals accessing and interpreting interim data split by treatment group is now considered an essential part of good practice for major randomized trials. Still, a substantial minority of reported major trials appear not to have a DMC in place. Second, with or without a formal DMC recommendation, another question is whether the decision to stop a trial early and report the results was an appropriate judgment."
Dr. Pocock notes, "The ethical dilemma is to safeguard the interests of patients randomized in the current trial while also protecting society from overzealous premature claims of treatment benefit."
"In summary, all major randomized trials should have an independent DMC that functions effectively and makes wise judgments aided by stringent statistical stopping boundaries for benefit. It is critical that the DMC, principal investigators, executive committees, and sponsors all recognize the full public health implications of their recommendations and decisions."
(JAMA. 2005;294:2228–2230. Available pre-embargo to the media at www.jamamedia.org)
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
STUDY SHOWS WHY CHILDREN WITH CONDITIONS SUCH AS CEREBRAL PALSY AND MUSCULAR DYSTROPHY NEED ANNUAL FLU VACCINE
VIDEO:
B-ROLL
Doctor listening with stethoscope to Ky-rra’s breathing
Nurse preparing vaccine
AUDIO:
SIX-YEAR-OLD KY-RRA (key-ARE-ah) HAS ASTHMA. ASTHMA IS ON THE LIST OF CHRONIC CONDITIONS THAT PUT KIDS AT RISK FOR SERIOUS COMPLICATIONS FROM THE FLU. SO CHILDREN WITH SUCH CONDITIONS SHOULD GET THE FLU VACCINE EACH YEAR.
VIDEO:
NAT SOT UP FULL for :04
Little girl in exam room
AUDIO:
"She’s going to get her flu vaccine today"
VIDEO:
B-ROLL
Debrianna on mom’s lap
Lab tech working in lab
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THREE-YEAR-OLD DEBRIANNA (dee-bree-ah-na) HAS A DIFFERENT KIND OF CHRONIC CONDITION. SHE HAS A NEUROMUSCULAR DISORDER, WHICH MAKES SOME OF HER MUSCLES UNUSUALLY WEAK. DOCTORS OFTEN STUDY NEUROMUSCULAR DISEASES AND NEUROLOGICAL DISEASES TOGETHER.
VIDEO:
SOT/FULL
@:27
Super: Ron Keren, M.D., M.P.H.
Children’s Hospital of Philadelphia
Runs :13
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"Neurological diseases include diseases like cerebral palsy, seizure disorders. Neuromuscular diseases include conditions like muscular dystrophy or spinal muscular atrophy."
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Debrianna on mom’s lap
GFX/JAMA COVER
Ambulance driving down street
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A NEW STUDY SHOWS WHY DOCTORS NOW RECOMMEND THAT KIDS WHO HAVE NEUROLOGICAL OR NEUROMUSCULAR DISEASES GET THE FLU VACCINE. THE STUDY, PUBLISHED IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, FOCUSED ON CHILDREN ALREADY HOSPITALIZED WITH THE FLU.
VIDEO:
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Ron Keren, M.D., M.P.H.
Children’s Hospital of Philadelphia
Runs :08
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"Children with neurological and neuromuscular disease were at the greatest risk of developing breathing problems that would require them to be put on a breathing machine."
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Dr. Keren at computer looking at image of lungs on screen
Full screen graphic over image of lungs–
Title: Study of Children Hospitalized with Flu
(Reveal) Children with neurological or neuromuscular disease were more likely to have the most dangerous breathing problems
AUDIO:
DR. RON KEREN (Karen) AND COLLEAGUES FROM CHILDREN’S HOSPITAL OF PHILADELPHIA, AND A NUMBER OF OTHER INSTITUTIONS, CONDUCTED THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION STUDY. AMONG CHILDREN HOSPITALIZED WITH THE FLU, THOSE WITH NEUROLOGICAL OR NEUROMUSCULAR DISEASE WERE MORE LIKELY TO HAVE THE MOST DANGEROUS BREATHING PROBLEMS, EVEN COMPARED TO CHILDREN WITH ASTHMA OR LUNG DISEASE.
VIDEO:
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Ron Keren, M.D., M.P.H.
Children’s Hospital of Philadelphia
Runs :17
AUDIO:
"Children with neurological and neuromuscular disease shouldn’t have priority over children with other chronic medical conditions, but should receive the influenza vaccination just like children with heart disease, lung disease, diabetes or sickle cell disease."
VIDEO:
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Ky-rra getting flu shot
AUDIO:
SO KY-RRA IS GETTING HER FLU SHOT...
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NAT SOT UP FULL FOR :02
Debrianna getting flu shot
AUDIO:
(Debrianna crying)
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Debrianna getting flu shot
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AND SO IS DEBRIANNA. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
