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July 12, 2005

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, July 12, 2005)


JAMA NEWS RELEASES

>   WOMEN REPORT VARIOUS SYMPTOMS AFTER STOPPING HORMONE THERAPY

>   HEPATITIS A IN U.S. DROPS SUBSTANTIALLY AFTER IMPLEMENTATION OF VACCINATION PROGRAM

>   HOSPICE REFERRAL RATES FOR NURSING HOME RESIDENTS AND FAMILY RATINGS OF END-OF-LIFE CARE INCREASE WITH INTERVENTION IMPROVING COMMUNICATION

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   NEW STUDY TRACKS RECURRENCE OF MENOPAUSAL SYMPTOMS IN WOMEN AFTER DISCONTINIUING HORMONES


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 symptoms women experience after stopping hormone therapy. The release will be fed Tuesday, July 12, 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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Go to www.jamamedia.org for more information and to apply for access.

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

Embargoed for Release: 3 p.m. CT, Tuesday, July 12, 2005
Media Advisory: To contact Judith K. Ockene, Ph.D., M.Ed., call Alison Duffy at 508-856-2000. To contact editorial author Diana B. Petitti, M.D., call Mike Burn at 626-405-5528.

WOMEN REPORT VARIOUS SYMPTOMS AFTER STOPPING HORMONE THERAPY

CHICAGO—Over half of women who began menopausal hormone therapy because of symptoms such as hot flashes or night sweats experience those symptoms when they discontinue hormone therapy, according to a study in the July 13 issue of JAMA.

Recommended guidelines and prescribing practices for menopausal hormone therapy (MHT) have changed significantly since publication of the Women's Health Initiative (WHI) estrogen plus progestin (E + P) trial findings that the overall health risks of taking conjugated equine estrogens and medroxyprogesterone acetate for disease prevention exceed the benefits, according to background information in the article. Women frequently cite relief from vasomotor symptoms (hot flashes or night sweats) and improvement in well-being as reasons for starting or continuing MHT. Current recommendations for MHT focus on treatment of symptoms at the lowest effective dosage for the shortest duration possible, yet there is little information about the effects of stopping MHT on either symptoms or health-related quality of life.

Judith K. Ockene, Ph.D., M.Ed., of the University of Massachusetts Medical School, Worcester, Mass., and colleagues conducted a study to determine symptoms the WHI E + P trial participants experienced when they ceased hormone therapy. The study included a survey of 8,405 women at 40 clinical centers who were still taking study pills (conjugated equine estrogens and medroxyprogesterone [CEE + MPA] or placebo) when the estrogen plus progestin intervention (part of the WHI study) was stopped. Surveys were mailed 8 to 12 months after the stop date. The average age of the respondents at the end of the trial was 69.1 years. They averaged 5.7 years of taking study pills.

The researchers found that moderate or severe vasomotor symptoms after discontinuing study pill use were reported by 21.2 percent of former CEE + MPA and 4.8 percent of placebo group respondents overall and by 55.5 percent and 21.3 percent, respectively, with these symptoms at baseline. Moderate or severe vasomotor symptoms were nearly 6 times more likely, and pain or stiffness symptoms more than twice as likely, in the former CEE + MPA group than in the placebo group. Both vasomotor and pain or stiffness symptoms were more likely in women with these symptoms at baseline.

"Short term use of CEE + MPA may only alleviate symptoms temporarily for many women, including older women, who may experience a return of menopausal symptoms after stopping MHT. A wide range of lifestyle and medical strategies to manage symptoms may help. Further testing of the efficacy of these management strategies for women whose symptoms recur after discontinuing short-term MHT is warranted," the authors conclude.
(JAMA. 2005;294:183-193. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: For funding/support and financial disclosure information, please see the JAMA article.

EDITORIAL: SOME SURPRISES, SOME ANSWERS, AND MORE QUESTIONS ABOUT HORMONE THERAPY

In an accompanying editorial, Diana B. Petitti, M.D., of Kaiser Permanente Southern California, Pasadena, discusses the findings in the study by Ockene et al.

"Middle age is a time of change physically, psychologically, socially, and economically, and these changes affect the body and the mind. Aches, pains, fatigue, and some other symptoms that are reported frequently by middle-aged women may be a consequence of simple (or not so simple) aging. Delineation of which symptoms are truly due to ovarian aging and which are due to general aging would permit more specific symptom management strategies. Hormone therapy could be used for the symptoms resulting from a decline in natural hormone levels. Treatments that carry minimal risk, including self-management strategies and positive changes in lifestyle, could be recommended for women with other symptoms."

"Most clinicians would agree with the American College of Obstetricians and Gynecologists that when symptoms of menopause necessitate hormone therapy, treatment should be prescribed at the lowest effective dose for the shortest possible time. The high frequency of symptoms reported by the WHI participants may be a result of the abrupt withdrawal from hormone (or placebo) therapy. Thus, when it is time to consider discontinuing hormone therapy, gradual tapering of the dose would be a logical clinical strategy arising from these new observations from the WHI."

"As has been the experience with prior reports from the WHI, these latest results bring some surprises, some answers to important clinical concerns, and some new questions for future investigation," Dr. Petitti concludes.
(JAMA. 2005;294:245-246. 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, July 12, 2005
Media Advisory: To contact Annemarie Wasley, Sc.D., call Von Roebuck at 404-639-7284. To contact the lead author of the 2nd study, Ron Dagan, M.D., email: rdagan{at}bgu.ac.il. To contact editorial co-author Pierre Van Damme, M.D., Ph.D., email: pierre.vandamme{at}ua.ac.be.

HEPATITIS A IN U.S. DROPS SUBSTANTIALLY AFTER IMPLEMENTATION OF VACCINATION PROGRAM

CHICAGO—Following implementation of an expanded program of hepatitis A vaccination of children, the overall hepatitis A rate in the U.S. has declined by 76 percent, according to a study in the July 13 issue of JAMA.

In the United States, an average of 26,000 hepatitis A cases were reported annually to public health agencies during the 1980s and 1990s, representing an estimated 270,000 infections per year when anicteric (without jaundice) disease and asymptomatic infections are taken into account, according to background information in the article. More than half of the estimated infections occurred among children. In 1995, highly effective hepatitis A vaccines became available in the United States for use among persons aged 2 years or older, providing an opportunity to substantially reduce hepatitis A incidence. In 1996 the Advisory Committee on Immunization Practices recommended targeted hepatitis A vaccination of selected high-risk populations and routine vaccination for children living in communities with the highest hepatitis A rates. In 1999, this committee expanded its recommendations for routine vaccination of children to include children living in 17 states that had consistently elevated hepatitis A rates and a distinctive pattern of hepatitis A epidemiology.

Annemarie Wasley, Sc.D., of the Centers for Disease Control and Prevention, Atlanta, and colleagues analyzed data from a national hepatitis A surveillance to determine changes in the incidence and epidemiology of hepatitis A in the United States since 1990 and following implementation of recommendations for hepatitis A vaccination.

The researchers found that between the baseline period (1990-1997) and 2003, overall hepatitis A rates declined 76 percent to 2.6 per 100,000, significantly lower than previous lows in 1983 (9.2/100,000) and 1992 (9.1/100,000). The rate of hepatitis A in vaccinating states declined 88 percent to 2.5 per 100,000 compared with 53 percent elsewhere (to 2.7/100,000). In 2003, cases from vaccinating states accounted for 33 percent of the national total vs. 65 percent during baseline period. Declines were greater among children aged 2 to 18 years (87 percent) than among persons older than age 18 years (69 percent); the proportion of cases in children dropped from 35 percent to 19 percent. Since 2001, rates in adults have been higher than among children, with the highest rates now among men aged 25 through 39 years.

"In summary, we report early apparent impact of implementation of a novel, and to our knowledge, unique vaccination strategy. This strategy is based on distinctive features of hepatitis A epidemiology, including the geographic clustering of areas with consistently elevated rates, the important role of children in sustaining transmission, and the hypothesized large effect of herd immunity. These features lent themselves to a geographically focused strategy using a vaccine that could not be readily integrated into the routine vaccination schedule, and maximized the impact of limited vaccination. The changes we describe represent a transformation in hepatitis A epidemiology in the United States. However, because hepatitis A incidence has historically exhibited a pattern of periodic increases, further monitoring is needed to determine the extent to which the declines that have occurred will be sustained and are attributable to vaccination. In addition, more data on vaccine coverage levels are needed to better describe the relationship between hepatitis A vaccine usage and disease rates," the authors write.

"Sustaining and further reducing hepatitis A incidence can be achieved by improving vaccination coverage in groups for which it is currently recommended, including children living in the historically higher-rate states and children and adults in high-risk groups. Elimination of hepatitis A virus transmission will require expansion of existing recommendations to include routine vaccination of all U.S. children," the researchers conclude.
(JAMA. 2005;294:194-201. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Support for the analyses presented here was provided by the Centers for Disease Control and Prevention.

UNIVERSAL IMMUNIZATION OF TODDLERS IN ISRAEL REDUCES HEPATITIS A RATES SIGNIFICANTLY

A national immunization program for infants in Israel has resulted in a 95 percent reduction in overall hepatitis A incidence, according to a study in the July 13 issue of JAMA.

Until 1999, Israel was considered a country with intermediate hepatitis A virus endemicity (a disease constantly present to greater extent in a particular locality). Although the overall incidence has been progressively decreasing since the 1960s, the annual reported incidence during the 1992-1998 period ranged from 33 to 70 per 100,000 population, with marked fluctuations. Reports of outbreaks, especially those involving young children, increased. Because most young children have asymptomatic or unrecognized infection, they play an important role in hepatitis A virus transmission as a source of infection. Therefore, routine childhood vaccination would theoretically prevent infection in age groups that account for a substantial proportion of cases, eliminate a major source of infection for other children and adults, and eventually prevent infections in older persons as vaccinated children grow to adulthood, because immunity to hepatitis A virus by vaccination is long-lasting.

Health officials in Israel decided to introduce universal vaccination of toddlers against hepatitis A because of epidemiologic evidence and a cost-benefit analysis of the program. The program started in July 1999 and is included in the National Health Services list so that the vaccine is given free of charge. A dose is given at ages 18 and 24 months. Immunization of older high-risk groups, such as drug users, continued.

Ron Dagan, M.D., of Ben-Gurion University of the Negev, Beer-Sheva, Israel, and colleagues examined the impact of the toddlers-only vaccination program of hepatitis A disease in all ages in the 5.5 years following initiation of the program. Overall vaccine coverage in Israel in 2001-2002 was 90 percent for the first dose and 85 percent for the second dose.

A decline in disease rates was observed before 1999 among the Jewish but not the non-Jewish population. The researchers found that after initiation of the program, a sharp decrease in disease rates was observed in both populations. The annual hepatitis A incidence rate of 2.2 to 2.5 per 100,000 during 2002-2004 represents a 95 percent or greater reduction for each year with respect to the average incidence during 1993-1998 (50.4 per 100,000). For children aged 1 through 4 years, a 98.2 percent reduction in hepatitis A disease was observed in 2002-2004, compared with the prevaccination period. However, a sharp decline was also observed in all other age groups (84.3 percent [less than 1 year], 96.5 percent [5-9 years], 95.2 percent [10-14 years], 91.3 percent [15-44 years], 90.6 percent [45-64 years], and 77.3 percent [65 years or older]). Among the Jewish population in the Jerusalem district, in whom the active surveillance program was successfully conducted, a more than 90 percent reduction of disease was demonstrated. Of the 433 cases reported nationwide in 2002-2004 in whom vaccination status could be ascertained, 424 (97.9 percent) received no vaccine and none received 2 doses.

"In the next decade, many regions worldwide will move from a state of high endemicity to a state of intermediate endemicity. The Israeli program of universal toddlers-only vaccination can serve as a paradigm of a simplified model of effective vaccination for both developed and developing countries," the authors conclude.
(JAMA. 2005;294:202-210. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: This study was funded in part by an unrestricted grant from GlaxoSmithKline Biologicals.

EDITORIAL: EFFECT OF HEPATITIS A VACCINATION PROGRAMS

In an accompanying editorial, Pierre Van Damme, M.D., Ph.D., and Koen Van Herck, M.D., of the University of Antwerp, Belgium, comment on the studies in this week's JAMA on hepatitis A vaccination programs.

"The baseline differences in disease incidence between vaccinating and nonvaccinating states in the United States on which the universal vaccination recommendations were determined were eliminated and the incidence gap between high and intermediate endemic populations in Israel was narrowed or almost closed. Vaccination was a major contributor to these declines but, as discussed by both sets of authors, it is difficult to evaluate to what extent the observed reduction of the hepatitis A virus incidence rate could be attributed to improved environmental and hygienic conditions or to the epidemic cycles that characterized the epidemiology of hepatitis A virus in the past. Only continued disease surveillance will allow confirmation of the real impact and added value of these mass vaccination programs."

"...if administration of multiple vaccines or combination vaccines is not an issue, and if the vaccine cost is reasonable, toddlers-only or childhood immunization programs could become a realistic strategy in countries and regions where endemicity is shifting from high to intermediate, a situation that will increase in the next decade worldwide," the authors conclude.
(JAMA. 2005;294:246-248. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Drs. Van Damme and Van Herck have been principal investigators of vaccine trials for several vaccine manufacturers for which the University of Antwerp receives research grants.

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, July 12, 2005
Media Advisory: To contact David Casarett, M.D., M.A., call Rebecca Harmon at 215-349-5660.

HOSPICE REFERRAL RATES FOR NURSING HOME RESIDENTS AND FAMILY RATINGS OF END-OF-LIFE CARE INCREASE WITH INTERVENTION IMPROVING COMMUNICATION

CHICAGO—A simple information and communication intervention between a patient and physician can increase hospice referral rates among nursing home residents, increase their families' ratings of end-of-life care, and may decrease use of acute care resources, according to an article in the July 13 issue of JAMA.

"At least one in four Americans dies in a nursing home, and considerable evidence indicates that nursing home residents do not receive optimal end-of-life care," background information in the article states. Approximately 25 percent of residents with daily cancer pain receive no pain medications, and residents are often transferred to an acute care setting to receive aggressive treatment in the last weeks of life. Families often express dissatisfaction with the end-of-life care their relative receives in nursing homes. Nursing home residents receiving hospice care are more likely to receive better pain management, have their pain assessed and have lower rates of inappropriate medications and physical restraint use. Despite its benefits, however, only one in four nursing home residents enrolls in hospice care before death.

David Casarett, M.D., M.A., from the Philadelphia Veterans Affairs Medical Center, Philadelphia, and colleagues conducted a randomized trial of nursing home residents and their decision makers to determine whether promoting communication about hospice would increase hospice enrollment and improve the quality of end-of-life treatment. For the intervention, the researchers interviewed residents and/or their surrogate decision-makers to identify those whose goals and needs for care, and treatment preferences made them appropriate for hospice. The physicians of residents classified as appropriate for hospice were notified and asked to authorize a hospice informational visit. The trial was conducted from December 2003 to December 2004. Residents were followed up for six months or until death.

One-hundred seven of the 205 residents in the study were randomly assigned to receive the intervention, and 98 received usual care. Those in the intervention group were more likely than usual care residents to enroll in hospice within 30 days (20 percent vs. 1 percent) and to enroll in hospice during the follow-up period (25 percent vs. 6 percent). Intervention residents received more hospice care than usual care residents (average: 64 vs. 14 days), although intervention residents were not more likely to be enrolled in hospice at the time of their death (36 percent vs. 38 percent). These intervention residents had fewer acute care admissions and spent fewer days in the acute care setting. Families of intervention residents rated the resident's care more highly than the families of usual care residents did (on a 1-5 scale, average: 4.1 vs. 2.5).

"The results reported herein show that a simple communication intervention can improve the quality of end-of-life care and decrease resource utilization by promoting earlier access to hospice care in nursing homes," the authors write. "If there is a surprise in these findings, it is that such a simple, inexpensive, and easily exportable intervention can contribute so much to improving care. As Americans spend more time in nursing homes near the end of life, it will becomes increasingly important to emphasize simple, low-cost interventions like this one that can help to ensure that residents and their families have access to the best possible quality of care."
(JAMA.2005;294:211-217. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Dr. Casarett is the recipient of an Advanced Research Career Development Award from the Department of Veterans Affairs and a Paul Beeson Physician Faculty Scholars Award.

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

NEW STUDY TRACKS RECURRENCE OF MENOPAUSAL SYMPTOMS IN WOMEN AFTER DISCONTINIUING HORMONES

VIDEO:
B-ROLL
Beverly taking bone strength pill
Estrogen plus progestin pills being poured/counted

AUDIO:
62-YEAR OLD BEVERLY FISKE (fisk) IS TAKING MEDICATION TO HELP INCREASE HER BONE STRENGTH. SHE USED TO TAKE HORMONES FOR THAT PURPOSE, AND TO HELP EASE HER MENOPAUSAL SYMPTOMS. BUT WHEN SHE LEARNED OF THE INCREASED RISK OF CANCER AND HEART DISEASE, SHE QUIT THE HORMONES.

VIDEO:
SOT/FULL
@ :14
Super:Beverly Fiske
Quit taking hormones
Runs :13

AUDIO:
"The menopausal symptoms reoccurred and I was uncomfortable with hot flashes, with the mood swings."

VIDEO:
B-ROLL
Women walking on sidewalk – no faces showing
GFX/JAMA COVER

AUDIO:
THAT RECURRENCE IS QUITE COMMON IN SOME WOMEN, ACCORDING TO A NEW STUDY IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL
@ :34
Super: Judith Ockene, Ph.D., M.Ed.
University of Massachusetts Medical School
Runs :20

AUDIO:
"If you go on hormones to deal with menopausal symptoms, you’ve experienced menopausal symptoms, you’re now using hormones to deal with that, you may, you need to think about the fact that you may experience a reoccurrence of those symptoms once you stop your hormones."

VIDEO:
B-ROLL
Dr. Ockene with colleague
More hormone pills
FULL SCREEN GRAPHICS
Title – Life After Hormones
Women who had menopausal symptoms before starting hormones – 55% saw symptoms recur
Women on placebo – 21% saw symptoms recur

AUDIO:
DR. JUDITH OCKENE (oh-KEEN) AND COLLEAGUES SURVEYED MORE THAN EIGHT-THOUSAND WOMEN. ABOUT HALF THE WOMEN HAD TAKEN HORMONES, FOR AN AVERAGE OF SIX YEARS. THE REST HAD TAKEN PLACEBO. IN WOMEN WHO HAD MENOPAUSAL SYMPTOMS BEFORE STARTING ON HORMONES, ABOUT 55 PERCENT SAW SYMPTOMS RECUR AFTER THEY STOPPED HORMONES, COMPARED WITH ABOUT 21 PERCENT OF WOMEN ON PLACEBO.

VIDEO:
SOT/FULL
Judith Ockene, Ph.D., M.Ed.
University of Massachusetts Medical School
Runs :15

AUDIO:
"What this is perhaps telling us is that for some women, they need to go through these symptoms, so if you give, if they take hormone therapy, that will just delay it and eventually, when they stop, they will experience those symptoms."

VIDEO:
B-ROLL
Women walking on sidewalk/parking lot
Beverly cleaning/skimming her swimming pool

AUDIO:
YOUNGER WOMEN WERE MORE LIKELY TO EXPERIENCE RECURRENCE OF SYMPTOMS THAN OLDER WOMEN. WOMEN ON HORMONES ALSO EXPERIENCED MORE PAIN AND STIFFNESS WHEN THEY STOPPED TAKING THEM. BEVERLY SAYS HER BONE STRENGTH HAS IMPROVED, AND THOUGH SHE’S NOT DOING ANYTHING TO TREAT HER HOT FLASHES OR NIGHT SWEATS, THEY ARE SLOWLY GETTING BETTER.

VIDEO:
SOT/FULL
Beverly Fiske
Quit taking hormones
Runs :09

AUDIO:
"Kind of like, letting these natural menopausal symptoms go its route."

VIDEO:
B-ROLL
Women walking on sidewalk/parking lot

AUDIO:
THAT MAY BE WHAT SOME WOMEN JUST HAVE TO DO. THIS IS MAVIS PRALL WITH THE JAMA REPORT.


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