c
 


  
 

  in the operating room or to care for patients "regardless of underlying disease,

even when they have disease that might place the HCP at some risk."
August 31, 2010 Ȅ Healthcare professionals should be required to get
vaccinated against seasonal influenza or else lose their jobs and professional "One hopes that, in the interests of protecting both patients and their
privileges, the Society for Healthcare Epidemiology of America (SHEA) says in members, these organizations will not oppose mandatory programs that are
a position paper released today. developed in collaboration with employees," the position paper states.

The paper, endorsed by the Infectious Diseases Society of America, argues that X     
 
     
allowing healthcare workers to go unvaccinated except for recognized medical       
  
 
  
contraindications is just as unacceptable as allowing physicians and nurses to     !"#$!    !
 
forgo scrubbing before a surgical procedure. %
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"SHEA views influenza vaccination of HCP [healthcare personnel] as a core ,
- ( 
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patient and HCP safety practice with which non-compliance should not be !
'   /+  0 1

  

tolerated," according to the position paper, published in this month'sá
  
  
 
  
 
 
  
 

 
. "SHEA endorses a policy in which
annual influenza vaccination is a condition of both initial and continued HCP
employment and/or professional privileges."
The goal of HCP vaccination is not only preventing virus transmission to
patients, but also reducing the risk for infection of HCPs, which in turn
preserves an adequate healthcare workforce, the position paper notes. At the
same time, HCPs who get vaccinated contribute to "herd immunity" and set a
good example.
The position paper, which updates a SHEA statement issued in 2005,
recommends mandatory vaccination of all HCP working in all healthcare
settings, regardless of whether they come into contact with patients and
whether they are directly employed by the facility. The recommendation
extends to students, volunteers, and contract workers.
c
 
August 31, 2010 Ȅ Healthcare professionals should be required to get
vaccinated against seasonal influenza or else lose their jobs and professional
privileges, the Society for Healthcare Epidemiology of America (SHEA) says in
a position paper released today.
The paper, endorsed by the Infectious Diseases Society of America, argues that
allowing healthcare workers to go unvaccinated except for recognized medical
contraindications is just as unacceptable as allowing physicians and nurses to
forgo scrubbing before a surgical procedure.
"SHEA views influenza vaccination of HCP [healthcare personnel] as a core
patient and HCP safety practice with which non-compliance should not be
tolerated," according to the position paper, published in this month'sá
 



 c

   
 

 
. "SHEA endorses a policy in which
The recommendations from SHEA come on the verge of the 2010-2011
influenza season and follow a previous season in which seasonal influenza
vaccination among HCP reached an all-time high of 62% as of mid-January
2010, according to the US Centers for Disease Control and Prevention.
Physicians, physician' assistants, nurse practitioners, and dentists posted the
highest immunization rate as a group among HCP Ȅ 77%. In contrast, the
immunization rate among all HCP against the H1N1 influenza virus stood at
37%.
SHEA believes a voluntary approach will not dramatically increase HCP
immunization rates. Its position paper points to several healthcare
organizations such as Virginia Mason Medical Center (VMMC) in Seattle,
Washington, and BJC Healthcare in St. Louis, Missouri, that have achieved
immunizations rates surpassing 98% by mandating vaccination of HCPs.
annual influenza vaccination is a condition of both initial and continued HCP
employment and/or professional privileges."
The goal of HCP vaccination is not only preventing virus transmission to
patients, but also reducing the risk for infection of HCPs, which in turn
preserves an adequate healthcare workforce, the position paper notes. At the
same time, HCPs who get vaccinated contribute to "herd immunity" and set a
good example.
The position paper, which updates a SHEA statement issued in 2005,
recommends mandatory vaccination of all HCP working in all healthcare
settings, regardless of whether they come into contact with patients and
whether they are directly employed by the facility. The recommendation
extends to students, volunteers, and contract workers.
c
 



 c


The success of institutions like VMMC and BJC notwithstanding, some HCP
have not taken kindly to vaccine mandates.
During the H1N1 influenza pandemic of 2009-2010, for example, the state of
New York ordered its healthcare workers to get vaccinated against both
seasonal and pandemic influenza only to rescind the requirement several
months later. At the time, New York Gov. David Patterson said the mandate
turned out to be impractical in light of a shortage of pandemic influenza
vaccine, but the state also had encountered several lawsuits and opposition
from a large healthcare union.
Noting the possibility of continued resistance by labor unions to vaccine
mandates, the SHEA position paper states that requiring HCPs to get
immunized is just as reasonable as requiring them to wear appropriate attire
The recommendations from SHEA come on the verge of the 2010-2011
influenza season and follow a previous season in which seasonal influenza
vaccination among HCP reached an all-time high of 62% as of mid-January
2010, according to the US Centers for Disease Control and Prevention.
Physicians, physician' assistants, nurse practitioners, and dentists posted the
highest immunization rate as a group among HCP Ȅ 77%. In contrast, the
immunization rate among all HCP against the H1N1 influenza virus stood at
37%.
SHEA believes a voluntary approach will not dramatically increase HCP
immunization rates. Its position paper points to several healthcare
organizations such as Virginia Mason Medical Center (VMMC) in Seattle,
Washington, and BJC Healthcare in St. Louis, Missouri, that have achieved
immunizations rates surpassing 98% by mandating vaccination of HCPs.
The success of institutions like VMMC and BJC notwithstanding, some HCP Good 2856 1.0 1.0 1.0 1.0
have not taken kindly to vaccine mandates.
Intermediate 1920 1.3 1.5 1.2 1.3

During the H1N1 influenza pandemic of 2009-2010, for example, the state of Poor 717 1.8 2.1 1.6 1.8
New York ordered its healthcare workers to get vaccinated against both Very poor 95 3.4 3.7 2.8 5.0
seasonal and pandemic influenza only to rescind the requirement several
,value Ȃ <.0001 <.0001 <.0001 <.0001
months later. At the time, New York Gov. David Patterson said the mandate
turned out to be impractical in light of a shortage of pandemic influenza
vaccine, but the state also had encountered several lawsuits and opposition
from a large healthcare union. 4 . 
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mandates, the SHEA position paper states that requiring HCPs to get ''.-) c
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immunized is just as reasonable as requiring them to wear appropriate attire
in the operating room or to care for patients "regardless of underlying disease, Good 2827 1.0 1.0 1.0
even when they have disease that might place the HCP at some risk." Intermediate 1897 1.0 1.3 1.3

"One hopes that, in the interests of protecting both patients and their Poor 712 1.4 1.9 2.0
members, these organizations will not oppose mandatory programs that are Very poor 93 1.2 3.7 5.0
developed in collaboration with employees," the position paper states.
, value Ȃ .103 <.0001 <.0001

X     

 
     
      
  
 
  
    !"#$!    !
  This study shows overweight, low physical activity, and smoking are
%
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$á  independently and in combination associated with recurrent headache among
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,
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   In an accompanying editorial, Dr. Andrew Hershey and Dr. Richard Lipton say

  
 
  
 
  that "this study is a vital step toward a better understanding of lifestyle effects
August 19, 2010 Ȅ Teenagers who get little exercise, are overweight, or who
smoke are more likely to have frequent headaches or migraines, report
researchers.
"There was a significant trend for stronger associations between the number
of negative lifestyle factors that were present and the different headache
diagnoses and headache frequency," point out the investigators led by John-
Anker Zwart, MD, from Oslo University in Norway. "We believe that the
associations observed and the additive effect of these negative lifestyle factors
on the prevalence of recurrent headache strongly indicates that these lifestyle
factors are possible targets for headache preventive measures."
The new study appears in the August 18 issue of * 
. As part of the active and abstaining from alcohol, caffeine, and tobacco could help prevent
cross-sectional study, researchers interviewed more than 5500 students
about headache complaints. The adolescents also completed a questionnaire
and underwent a clinical examination with height and weight measurements.
Investigators classified adolescents who were very physically fit and who
were not current smokers as having a good lifestyle. Negative lifestyle factors
were surprisingly common with low physical activity in 31%, smoking in 19%,
and overweight in 16% of these teens.
In adjusted multivariate analyses, recurrent headache was associated with
overweight (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.2 Ȃ 1.6; ,<
.0001), low physical activity (OR, 1.2; 95% CI, 1.1 Ȃ 1.4; ,2.002), and smoking
(OR, 1.5; 95% CI, 1.3 Ȃ 1.7; ,3.0001). The presence of more than 1 negative
and the potential for behavioral interventions for adolescents with headache
disorders."
Dr. Hershey is at the University of Cincinnati in Ohio and Dr. Lipton is at the
Albert Einstein College of Medicine in the Bronx, New York. They point out the
effects of each negative lifestyle factor were similar in magnitude for each
headache type. "This lack of specificity for headache type raises the possibility
that these factors may be associated not just with headache but with all-cause
pain."
These results mirror those of another study published in June in the
journal Headache. Investigators led by Rudiger von Kries, MD, from Ludwig-
Maximilians-University in Munich, Germany, found that being physically
headaches in adolescents.
The study included 1260 students, and after controlling for socioeconomic
variables, the prevalence of any headache was increased in teens who
reported regularly drinking cocktails (OR, 2.0; 95% CI, 1.3 Ȃ 3.0), who drank at
least 1 cup of coffee per day (OR, 2.0; 95% CI, 1.2 Ȃ 3.5), and who were
physically less active (OR, 2.0; 95% CI, 1.3 Ȃ 3.1). Smoking daily had an OR of
1.8.
These findings, say editorialists, suggest that a better understanding of
modifiable risk factors and trigger factors may lead to novel intervention
strategies.
lifestyle factor heightened the risk of headache. !  !   
  
 
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August 18, 2010 Ȅ Patients with major depressive disorder who fail to
respond to treatment with serotonin reuptake inhibitors (SRIs) may benefit
from the addition of the nutritional supplement S-adenosyl methionine
(SAMe), according to results of the first placebo-controlled trial of the
supplement in refractory depression.
"The results of this study provide preliminary evidence suggesting that SAMe
can be an effective, relatively well-tolerated, and safe adjunctive treatment
strategy for SRI nonresponders with major depressive disorder and our
findings warrant replication," the study authors conclude in the August issue
of the    

, . action of other antidepressants. Administration of SAMe may ameliorate these
Included in the single-center, 6-week study were 73 adults with major
depressive disorder in whom a prior selective SRI trial had failed at an
adequate dose for at least 6 weeks. Thirty-nine were randomly assigned to
SAMe (at a target dose of 800 mg twice a day) and 34 to matching placebo,
added to their ongoing antidepressant regimen. Fifty-five patients (75.3%)
completed the 6-week study: 31 (79.4%) in the SAMe arm and 24 (70.5%) in
the placebo arm.
According to the investigators, led by George I. Papakostas, MD, of the Center
for Treatment-Resistant Depression at Massachusetts General Hospital and
Harvard Medical School in Boston, during the study, significantly more SAMe-
treated than placebo-treated patients (36.1% vs 17.6%) experienced a clinical
response on the 17-item Hamilton Depression Rating Scale (HAM-D), which
was the primary study outcome. Remission rates (ie, HAM-D score of ζ7) were
also higher with SAMe than with placebo (25.8% vs 11.7%).
The between-group differences in response and remission rates were
"statistically significant and clinically meaningful," Craig T. Nelson, MD, of the
University of California, San Francisco, notes in an accompanying editorial.
The number needed to treat was about 1 in 6 for response and about 1 in 7 for
remission.
"The positive finding, although preliminary, is of considerable clinical
importance given the high rate of non- or limited response to initial trials of
antidepressants," Matthew V. Rudorfer, MD, director of treatment research at
the National Institute of Mental Health in Bethesda, Maryland, who was not
In his editorial, Dr. Nelson points out that low levels of SAMe in cerebrospinal
fluid have been reported in severely depressed individuals. Oral and
parenteral administration fuel a rise in cerebrospinal fluid SAMe
concentrations, indicating that the compound crosses the blood-brain barrier.
An increase in SAMe concentrations has been linked to improvement in
depressive symptoms.
"In short," Dr. Nelson writes, low SAMe levels "may limit synthesis of brain
neurotransmitters such as serotonin, norepinephrine, and dopamine. This
may directly contribute to depressive symptoms or interfere with or limit the
deficiencies or augment antidepressants and facilitate neurotransmission.
"Further research," Dr. Rudorfer said, "should help identify the mediators and
moderators of response to SAMe augmentation, including underlying
biological markers or Ǯbiosignaturesǯ and genetic factors, with the hope of
identifying individuals (and perhaps the initial prescription antidepressant)
best suited for this augmentation intervention."
"  !"
All in all, the results reported by Dr. Papakostas and colleagues are
"persuasive," Dr. Nelson writes, adding "SAMe offers a novel mechanism of
treatment action and opens up a new era for future exploration."
Still, he emphasizes that the clinical trial results need to be replicated and
numerous other questions answered. For example, studies examining the
long-term safety and efficacy of add-on SAMe, comparisons with other
adjunctive agents, and selection of appropriate patients need to be conducted.
In their report, Dr. Papakostas and colleagues emphasize that their study
"aimed to provide preliminary evidence on the efficacy, safety, and tolerability
of adjunct oral SAMe in major depressive disorder and, as a result, was
probably underpowered to consistently detect moderate effect sizes.
The results, they add, "both those that do and do not reach statistical
thresholds, suggest that this adjunctive intervention shows significant
promise to justify larger-scale, adequately powered tests."
The lack of a differential dose treatment arm, which could have generated
involved in the study, noted in an email to $$
*.
important information on the effect of higher and lower target doses, is
There was no significant difference in the proportion of SAMe-treated and another limitation of the study. An active treatment comparator arm could
placebo-treated patients who discontinued the trial because of adverse events also have yielded "interesting information."
(5.1% vs 8.8%).




5
#5
Dr. Papakostas and colleagues report that they noted a greater increase in
Dr. Rudofer points out that although active SAMe was clearly superior to
supine systolic blood pressure (,= .04) among SAMe-treated patients relative
placebo as an adjunctive intervention in this study, "the clear downward trend
to placebo-treated patients, which, they say, may be of clinical relevance if
in depression ratings during the 6-week add-on study even in the placebo
noted in future studies. However, in his editorial, Dr. Nelson says the "slight
group is striking.
increase of 1.6 mm Hg in supine systolic blood pressure with SAMe versus 0.3
mm Hg with placebo seems of questionable importance."
"While placebo augmentation is not appropriate in actual practice, these


 c

3 results do suggest that some individuals might require, and benefit from, a
longer than average initial trial of antidepressant medication," he said.
SAMe is a naturally occurring compound available in Europe since the late
(
 #  
* 
á 
$ 
 

1970s as a treatment for depression and other conditions and in the United
!$  
#   #,  
States since 1999 as an over-the-counter enteric coated dietary supplement.

   )!$ ,) 

  
SAMe is found throughout the body and in particularly high concentrations in
*
 
    
    



the liver, adrenal glands, and pineal gland. It also appears to be uniformly


 
 
    
 

distributed in the brain, where it acts as a major methyl donor for the
synthesis of neuronal messengers and phospholipid cell membranes.
v
 
4 4 3
 
 
August 13, 2010 (Adelaide, Australia)Ȅ A small Australian study looking at


whether it would be practical to give people dark chocolate as a treatment to
lower blood pressure long term surprisingly found that half of those who were
assigned to the chocolate found it difficult to eat every day; they preferred to
take a lycopene capsule [1].
Although many people may find these results difficult to digest, lead
researcher 6 
 (University of Adelaide, Australia)
told K
that it appears there is a difference between "consuming a food
item voluntarily or having to eat it on a daily basis for 12 weeks." The
participants in the study, who had to eat half a bar of dark chocolate a day,
"reported strong taste and concerns about fat/sugar content as reasons for
unacceptability of chocolate as a long-term treatment option," she said. Ried
writes about her study, which was published last year, in a letter
4
c  
44 $8
#
Egan says the recent literature review he and his colleagues performed did
show that one brand of dark chocolate, consisting of 50% cocoa (Ritter Sport
dark chocolate), has consistently lowered blood pressure in four studies,
"while another manufacturer's chocolate (Mars Dove chocolate) has never
lowered BP," he notes, so "we think it makes a difference which dark chocolate
is selected and how the cocoa beans are processed.
"If BP is altered differentially by various brands of dark chocolate, this
information could facilitate efforts to identify the source of those differences,
maximize the BP benefits of cocoa/dark chocolate, and produce nutraceuticals
that lower BP," he and his colleagues conclude.
 3
v 
3
 /$
 3
  4 

to $ August 10, 2010 [2].
NEW YORK (Reuters Health) Aug 13 - Mammographic density in
4
c#
(Medical University of South Carolina, Charleston), who postmenopausal women is not affected by their intake of vitamin D or calcium
recently wrote a review on the role of dark chocolate in the prevention and from food or supplements, U.S. researchers say.
management of hypertension [3], told  K
: "The Australian group has
done a very nice study, and they have a history of doing high-quality High mammographic density is a risk factor for breast cancer, and there has

research." However, there is another way of looking at this work, he said. been some evidence that vitamin D may be inversely related to the risk of

"Fifty percent of the people said they were happy to eat the chocolate and breast cancer, "possibly by affecting mammographic density," the researchers

liked it. And 73% said they would consume that amount of chocolate if it were say.

known to have health benefits."

But only a few studies have assessed the relationship between vitamin D and

"If we have an intervention that's beneficial and that half the people would calcium and mammographic density in postmenopausal women, and those

accept, that's pretty good, because clearly half of the people don't want to have had inconsistent results.

exercise vigorously and half certainly don't want to change their diet," Egan
To address this, lead author Dr. Elizabeth R. Bertone-Johnson, of the
noted.
University of Massachusetts, Amherst, and colleagues performed a cross-

44
7O!

v
   4 3
 #4 sectional analysis in 808 participants of the Mammogram Density Ancillary
Study of the Women's Health Initiative.
Egan is keen to stress, however, that it is far too soon to be recommending
dark chocolate as a treatment for high blood pressure. "Clearly more research As they report in a July 7th online article in Menopause, they found no

is needed; we don't think the state of the art is there yet. The number of association between vitamin D or calcium intake and mammographic density

studies is relatively small, few people have been studied, and the number of after adjustment for a number of factors, including age, body mass index,

products that have been investigated is also too small to be making general breast cancer risk factors, and solar irradiation.

health recommendations for the world."

Among women who reported total vitamin D intakes of less than 100, 100 to

Ried and her colleagues have also recently published a meta-analysis of 15 199, 200 to 399, 400 to 599, and 600 or greater IU/day, the mean

trials looking at this subject [4], and she says they too concluded that the mammographic densities were 5.8%, 10.4%, 6.2%, 3.8%, and 5.1%,

studies "are too diverse to give confident answers on optimal dosage or respectively (p trend = 0.67).

duration of treatment." Their main finding, she says, "was that chocolate may
As for calcium, the mean mammographic densities in women who reported
help people with high blood pressure but not with normal blood pressure"--
total daily intake of less than 500, 500 to 749, 750 to 999, 1000 to 1199, and
they found BP reductions of around 5 mm Hg systolic, which, "albeit modest, is
1200 mg or greater were 7.3%, 4.9%, 7.3%, 6.9%, and 7.1%, respectively (p
comparable to the effects of 30 daily minutes of moderate exercise," she says.
trend = 0.51).

But hypertension expert 4
 3 (University of Leicester, UK),

There was no effect modification by overall level of mammographic density or
who also discussed the study with K
, says he doesn't "ever see
solar irradiance. Vitamin D supplements were associated with lower density
chocolate becoming a mainstream treatment for high blood pressure, although
in younger women, ages 50-59 (p interaction = 0.009).
the observations are of interest.

"We feel that additional studies are needed to further evaluate the association
"There is some reasonable science suggesting that there might be a modest
of mammographic density and blood levels of vitamin D, which take into
effect [of chocolate on BP], but the whole issue is plagued by the possibility of
account not just vitamin D from dietary and supplemental sources but also
publication bias," Williams adds. "Obviously, journals are excited about
vitamin D produced in the body after exposure to sunlight," Dr. Bertone-
positive studies with chocolate because they know very well it's likely to be
Johnson told Reuters Health by e-mail.
well read and well cited, but if you sent a paper in saying, 'We've just done a
mega-study showing that chocolate does nothing for BP,' it's probably not
Also, she said, "The relationship between vitamin D and mammographic
going to be as exciting."
density may be different in premenopausal women than in postmenopausal
women, due to differences in levels of hormones such as estrogen and IGF-1,
Another problem, says Williams, "is that any modest reduction in blood
and this warrants further study."
pressure--even if we give it the benefit of the doubt and say there is one--is
likely to be offset by an increase in weight gain." O
 3

9
O

c  O3 
August 13, 2010 Ȅ Acetaminophen use in adolescents is linked to
  
 á!á   
  .áá/(5,   
development and/or maintenance of asthma, rhinoconjunctivitis, and eczema,  
 
  

*4
  
according to the results of a global study reported online August 13 in      
*4
 
 
    
the    

    
 $   )6$
    1)$
 
  %
1

*4
 *4"   
"This study has identified that the reported use of acetaminophen in 13- and  4 *4
 %
1

á   
$


 
14-year-old adolescent children was associated with an exposure-dependent    
   
 ,(  áá 
increased risk of asthma symptoms," said first author Richard W. Beasley, MD, 
professor of medicine at the Medical Research Institute of New Zealand in
Wellington, in a news release, on behalf of the International Study of Asthma 4

#

 
  
3

and Allergies in Childhood (ISAAC).
At 113 centers throughout 50 countries, 322,959 adolescent children (aged 13
- 14 years) enrolled in ISAAC Phase Three completed written and video

questionnaires regarding current symptoms of asthma, rhinoconjunctivitis,
and eczema. They also completed a written environmental questionnaire
regarding potential risk factors such as acetaminophen exposure in the
preceding 12 months. Logistic regression allowed calculation of the odds ratio
(OR) of current asthma symptoms associated with acetaminophen use, which
was the main study endpoint.
Recent use of acetaminophen was associated with an exposure-dependent
greater risk for current asthma symptoms, based on multivariate analyses. For
medium use (at least once in the last year) vs no use, the OR was 1.43 (95%
confidence interval [CI], 1.33 - 1.53). For high use (at least once in the last
month) vs no use, the OR was 2.51 (95% CI, 2.33 - 2.70).
"The overall population attributable risks for current symptoms of severe
asthma were around 40 percent, suggesting that if the associations were
causal, they would be of major public health significance," Dr. Beasley said.
"Randomized controlled trials are now urgently required to investigate this
relationship further and to guide the use of antipyretics, not only in children
but in pregnancy and adult life."
In multivariate analysis, there was also an acetaminophen exposureȂ
dependent increased risk for current symptoms of rhinoconjunctivitis (OR,
1.38 [95% CI, 1.29 - 1.47] and OR, 2.39 [95% CI, 2.24 - 2.55] for medium and
high use, respectively) and eczema (OR, 1.31 [95% CI, 1.21 - 1.42] and OR,
1.99 [95% CI, 1.82 - 2.16] for medium and high use, respectively).
"Acetaminophen use may represent an important risk factor for the
development and/or maintenance of asthma, rhinoconjunctivitis and eczema
in adolescent children," the study authors write.
An accompanying "at a glance commentary" notes that potential mechanisms
for these effects of acetaminophen include oxidant-induced airways
inflammation and enhanced Th2 responses.
Limitations of this study include cross-sectional design, precluding
determination of causality; and potential confounding factors.
August 17, 2010 Ȅ Consumption of regular, but not light, beer is associated
with an increased risk for the development of psoriasis among women, but
other alcoholic beverages do not increase this risk, according to new research
published Online First August 16 in the  
 
"Psoriasis is a common immune-mediated skin disease. The association
between alcohol consumption and increased risk of psoriasis onset and
psoriasis worsening has long been suspected," write Abrar A. Qureshi, MD,
MPH, from Brigham and Women's Hospital and Harvard Medical School,
Boston, Massachusetts, and colleagues. "Risk for psoriasis may vary by type of
alcoholic beverage, given previous evidence that different types of alcoholic
beverages have conferred deleterious effects in other inflammatory diseases."
If this were so, then it would have practical implications for psoriasis
prevention and management, the study authors write. The aim of this study,
therefore, was to evaluate the independent association between alcohol
consumption and the risk for the development of psoriasis. The study authors
also sought to determine if there was an association between the type of
alcoholic beverage and the risk for psoriasis.
Dr. Qureshi and colleagues assessed data from 82,869 women who were aged
27 to 44 years in 1991. The women were participants in the Nurses' Health
Study II, an ongoing longitudinal study of 116,430 registered nurses from 15
states in the United States. Responding to biennial questionnaires, the women
reported the amount and type of alcohol they consumed. They also reported
whether they had received a diagnosis of psoriasis. The period of follow-up
was from 1991 to 2005.
During this time, there were 1150 cases of incident psoriasis, 1069 of which
were used for analysis. Compared with women who did not drink alcohol, the
risk for psoriasis was 72% greater among women who had an average of 2.3
drinks per week or more (multivariate relative risk [RR], 1.72; 95%
confidence interval [CI], 1.15 - 2.57). When this risk was examined by type of
alcoholic beverage, the researchers found that women who drank 5 or more
regular beers per week had a 1.8-fold greater risk for the development of
psoriasis (multivariate RR for η 5 drinks per week, 1.76; 95% CI, 1.15 - 2.69),
but that consumption of light beer, red or white wine, and liquor was not
associated with this risk.
The association between psoriasis and regular beer intake became stronger in
a subset of women with a confirmed diagnosis, who had provided more details
4:vOv


about their condition on a 7-item self-assessment questionnaire. In this

Also in the same issue of the    


    
  subset, the risk for psoriasis was 2.3 times higher for women who drank 5 or

$  is a small, longitudinal study of the risk for asthma and allergies more beers per week than women who did not drink beer (multivariate RR for

associated with acetaminophen use in a population in Ethiopia. This birth- η 5 drinks per week, 2.29; 95% CI, 1.36 - 3.85).

cohort study by Alemayehu Amberbir and colleagues from Addis Ababa

"Nonlight beer was the only alcoholic beverage that increased the risk for
University, Addis Ababa, Ethiopia, showed a temporal relationship between
psoriasis, suggesting that certain non-alcoholic components of beer, which are
acetaminophen use and development of asthma and allergy symptoms,
not found in wine or liquor, may play an important role in new-onset
supporting a causal role for acetaminophen.
psoriasis," the study authors write. "One of these components may be the

( 
   

#    )á!,(  starch source used in making beer. Beer is one of the few nondistilled

 
 #    

(  
 alcoholic beverages that use a starch source for fermentation, which is
commonly barley...Starch sources such as barley contain gluten, which has positively associated with HDL cholesterol and inversely associated with total
been shown to be associated with psoriasis." and LDL cholesterol and with triglycerides.

Noting the limitations of their study, the authors state that the retrospective

recall of psoriasis onset may have led to misclassifications of psoriasis onset.
They were also unable to examine whether the risk for psoriasis differed
regarding early-onset vs later-onset psoriasis given the age of the study
cohort. Finally, the study was observational, and the cohort consisted of well-
educated women and does not represent a random sample of US women, they
write.
"Women with a high risk of psoriasis may consider avoiding higher intake of
nonlight beer," the study authors conclude. "We suggest conducting further
investigations into the potential mechanisms of nonlight beer inducing new-
onset psoriasis."
 3
 " / 
8##
August 19, 2010 Ȅ Eggs are behind a nationwide salmonella outbreak that
caused hundreds of illnesses each week in June and July.
The nationwide egg recall has expanded to include eggs made from five plants
owned by Wright County Egg of Galt, Iowa. It now involves more than a dozen
major brands that got eggs from this company. The New York Times reports
that the recall now includes 380 million eggs.
Eggs were traced to the company after the CDC noticed a four-fold increase in
Salmonella Enteritidis isolates from people suffering food poisoning. State
investigators in California, Colorado, and Minnesota found clusters of illness
from this salmonella strain among people who ate eggs at the same
v$! 4#c
 v
 restaurants. Those restaurants got eggs that came from Wright County Egg.
August 18, 2010 (Chapel Hill, North Carolina) Ȅ Cholesterol levels in women
vary significantly across the different phases of the menstrual cycle, a new
study has shown [1]. The results, according to investigators, have practical
implications as well as implications for future clinical trials that include
women.
"Cyclic variations in lipoprotein-cholesterol levels observed in the present
study may have clinical implications regarding the appropriate timing of
lipoprotein-cholesterol measurement during the cycle and may need to be
accounted for in the design and interpretation of studies in women of
reproductive age," write lead investigator 

c3
Investigations continue in Arizona, Connecticut, Massachusetts, Maryland,
North Carolina, Nevada, Oregon, Pennsylvania, Tennessee, and
Texas. According to a CDC spokeswoman, the outbreak is "pretty much
nationwide."
Meanwhile, the FDA is conducting a thorough investigation of the Iowa firm to
which the contaminated eggs were traced. The company says it already has
sent all its remaining eggs to a breaker, where they will be pasteurized to kill
any salmonella.
(University of
Shell eggs included in the recall were shipped since May to food wholesalers,
North Carolina, Chapel Hill) and colleagues in a report published online June 9,
distribution centers, and food service companies in eight states, from which
2010 in the  


 
   
 $#
.
they were distributed nationwide.
In their paper, the authors point out that hormone therapy in the 3
;
The brand names included in the expanded recall include Albertsons, Farm
 
 ! (WHI) and  
#
< #

3

Fresh, James Farms, Glenview, Mountain Dairy, Ralphs, Boomsma, Lund,
 (HERS) improved lipoprotein profiles, even though it was ultimately
Kemps, and Pacific Coast. Stamped on the end of the recalled egg cartons are
associated with increased rates of cardiovascular disease. With exogenous
Julian dates ranging from 136 to 225 and plant numbers 1720 and 1942.
estrogen altering the lipid profile, the hypothesis entering this analysis was
Recalled eggs are in six, dozen, and 18-egg cartons, as well as loose eggs for
that endogenous estrogens might also have a similar effect on lipids.
institutional use and repackaging.
The researchers assessed the total cholesterol, HDL cholesterol, LDL
The brand names included in the original recall are Lucerne, Albertsons,
cholesterol, and triglycerides of 259 healthy, premenopausal women currently
Mountain Dairy, Ralph's, Boomsma's, Sunshine, Hillandale, Trafficanda, Farm
not taking oral contraceptives or other medications. Among these women,
Fresh, Shoreland, Lund, Dutch Farms, and Kemps. Recalled eggs are in six,
total cholesterol, LDL cholesterol, and triglycerides were highest during the
dozen, and 18-egg cartons. Stamped on the end of the recalled egg cartons are
follicular phase of the cycle and declined during the luteal phase. LDL
Julian dates ranging from 136 to 229 and plant numbers 1720 and 1942, 1026,
cholesterol, for example, declined 4.9% from the midfollicular phase to the
1413, and 1946.
midluteal phase of the menstrual cycle, while total cholesterol declined 3.0%.
HDL cholesterol levels were highest during ovulation but did not change
The plant number begins with the letter P and then the number. The Julian
during the other phases of the cycle.
date follows the plant number, for example: P-1946 223. Recalled eggs may
be returned to the store for a full refund.
When assessed during the follicular phase of the cycle, 14% of women had
high total-cholesterol levels, whereas 8% of women measured during the late
The salmonella strain causing the outbreak is !
 

Enteritidis, the most

luteal phase had total-cholesterol levels considered high. Results were similar
common salmonella strain. Usually the CDC gets about 50 reports a week
when assessing women with high LDL-cholesterol levels.
of !
 

Enteritidis food poisoning; beginning in May there was a

fourfold increase in salmonella reports. Each week in late June and early July
"Although the total-cholesterol and LDL changes observed were modest, only
the CDC received some 200 salmonella samples isolated from patients, all with
5% to 8%, on average, women [crossed] between clinical boundaries of
the same DNA fingerprint.
acceptable levels," write Mumford and colleagues. "While treatment decisions
regarding the lipid profile may still require repeated samples above the
Symptoms of infection begin 12 to 72 hours after consuming contaminated
recommended level, standardizing the timing of lipid measurements may
foods or beverages and include fever, abdominal cramps, and diarrhea.
improve the interpretability of results and consequently reduce the overall
Symptoms usually last four to seven days.
number of tests."

Most people recover without antibiotic treatment, but severe cases can be
In a linear-effects model testing acute-phase associations, meaning between
fatal. People prone to severe illness -- particularly severe diarrhea -- include
measurements taken on the same day, the group showed that estradiol was
the elderly, infants, and those with impaired immune systems, including In the August issue of Obstetrics and Gynecology, Dr. Livingston from Duke
people on immune suppressive therapy such as cancer chemotherapy. University in Durham, North Carolina, and colleagues report that overall, 3.6%
of infants had respiratory distress syndrome. The incidence was 4.4% in the
#
:"
4 c /

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#v

 
By Frederik Joelving
NEW YORK (Reuters Health) Aug 13 - Women who use estrogen-only
hormone replacement therapy don't appear to be at increased risk of dying
from lung cancer.
That's according to a new analysis of data from the Women's Health Initiative
on postmenopausal women who had hysterectomies.
The new results agree with a large study published earlier this year that found
no link between estrogen-only HRT and lung cancer risk (see Reuters Health
story of Feb 24, 2010).
In the current study, estrogen alone resulted in only one more lung cancer
death than placebo pills over a mean follow-up of nearly eight years, Dr.
Rowan T. Chlebowski, of Harbor-UCLA Medical Center in Torrance, California,
and colleagues reported Friday.
elective cesarean group, 7.4% in the non-elective group and 1.6% in the
vaginal group. After adjustment, the mode of delivery was not significantly
associated with infant respiratory distress syndrome - although there was a
trend toward a higher risk with cesarean birth.
"Due to respiratory risk for the neonate, HIV-negative women generally have
their cesarean at or beyond 39 weeks," Dr. Livingston continued. "Our study
showed the respiratory risk to the infant delivered at 38 weeks is low. HIV-
infected pregnant women can choose to undergo cesarean section at 38 weeks
to protect their babies from HIV infection without excessive concern that their
infants will have respiratory problems."
Summing up, Dr. Livingston added that "prevention of HIV transmission from
mother to infant is one of the most successful obstetric advances for
prevention of neonatal disease in the last 50 years. It is satisfying to be at the
point where prevention of HIV transmission is possible and we can begin to
worry about side effects of our interventions."
OO!/ 


.++:.+ 

Overall, the researchers calculated that eight in 10,000 women would die from
lung cancer every year, regardless of whether they took estrogen or placebo
pills.
"These findings should be reassuring for women with previous hysterectomy,
who use estrogen alone" for menopause symptoms, they reported online
today in the Journal of the National Cancer Institute.
The new study was based on more than 10,000 women, aged 50 to 79 years,
who were randomly assigned to take either a once-daily 0.625-mg tablet of
conjugated equine estrogen or placebo.
In the hormone group, 61 women (0.15% per year) developed lung cancer,
compared to 54 (0.13% per year) in the placebo group. The researchers found
this small difference could easily have been due to chance, but they say it
requires further investigation.
Thirty-four women in the estrogen group and 33 in the placebo group died of
their lung cancer.
"Unlike use of estrogen plus progestin, which increased deaths from lung
cancer, use of conjugated equine estrogen alone did not increase incidence or
death from lung cancer," the researchers conclude
August 2, 2010 Ȅ The US Food and Drug Administration (FDA) has approved
vaccines for the 2010 to 2011 flu season that protect against 3 strains of
influenza, including the 2009 H1N1 pandemic swine flu virus.
Last year, 2 separate vaccines were required for seasonal flu and H1N1
prophylaxis. The new vaccine protects against:
@Y A/California/7/09 (H1N1)-like virus (pandemic H1N1 2009
influenza virus),
@Y A/Perth /16/2009 (H3N2)-like virus, and
@Y B/Brisbane/60/2008-like virus.
The components were selected by the FDA's Vaccines and Related Biological
Products Advisory Committee as likely to cause the most illness in the
upcoming season, based on an evaluation of surveillance data related to the
epidemiology and antigenic characteristics of recent influenza isolates.
Although the match between predicted and actual circulating strains may not
prove optimal, vaccinated individuals who contract influenza may have less
severe illness or a reduced risk for complications.
"The best way to protect yourself and your family against influenza is to get
vaccinated every year," said Karen Midthun, MD, acting director of FDA's
v 
 $ "


#
 c
By David Douglas
NEW YORK (Reuters Health) Aug 16 - Rates of respiratory distress syndrome
after elective cesarean delivery are no higher in babies born to HIV-infected
mothers, researchers report.
"Despite the woman's and her physician's best efforts, some HIV infected
pregnant women will continue to have circulating virus as they approach their
due date," lead author Dr. Elizabeth G. Livingston told Reuters Health by email.
"We have known that cesarean before labor and ruptured membranes can
help protect the infant from vertical transmission of virus."
To examine the potential respiratory effects of cesarean delivery in these
babies, the team analyzed data on 1194 mother-infant pairs. In all, 412 had
elective cesarean at a median of 38.1 weeks, 216 had non-elective cesarean at
a median of 38.0 weeks and the remaining 566 had vaginal delivery at a
median of 38.8 weeks.
Center for Biologics Evaluation and Research, in an agency news release. "The
availability of a new seasonal influenza vaccine each year is an important tool
in the prevention of influenza related illnesses and death."
New guidelines from the Centers for Disease Control and Prevention taking
effect this season advise annual influenza vaccination for all people aged 6
months and older, including low-risk individuals aged 19 to 49 years.
The Advisory Committee on Immunization Practices recommended the
change based on evidence that yearly flu shots are a "safe and effective
preventive health action with potential benefit in all age groups," and
concerns that a "substantial proportion" of young adults may be susceptible to
H1N1-like viruses that continue to circulate.
The FDA emphasizes that it is also important for healthcare professionals to
get vaccinated to protect themselves, their patients, their family, and the
community from influenza.
This season's influenza vaccine will be marketed as 

  (CSL (or who received seasonal vaccine for the first time in 2009-2010
Limited),  

 (Novartis Vaccines and but received only 1 dose in their first year of vaccination), as well as
Diagnostics),
  (GlaxoSmithKline Biologicals),
"
(GlaxoSmithKline to children who did not receive at least 1 dose of an influenza A
Biologicals),
$ (MedImmune Vaccines, Inc),
  (Novartis Vaccines (H1N1) 2009 monovalent vaccine regardless of previous influenza
and Diagnostics Ltd), and
- 0
- 
7 (Sanofi Pasteur, Inc). vaccine history;
@Y Vaccines should contain the 2010-2011 trivalent vaccine virus
The safety labeling for Afluria has been updated this season to inform strains A/California/7/2009 (H1N1)-like (the same strain as was
clinicians about the increased rate of fever and febrile seizure observed used for 2009 H1N1 monovalent vaccines), A/Perth/16/2009
among young children, mostly younger than 5 years, in Australia and New (H3N2)-like, and B/Brisbane/60/2008-like antigens;
Zealand during the southern hemisphere's flu season. The FDA is requiring the @Y The report describes
- 
7 (sanofi pasteur), a newly
manufacturer to conduct a pediatric study for additional information approved vaccine for persons at least 65 years old; and
regarding these events. @Y The report also provides information about other newly approved,
standard-dose influenza vaccines and expanded age indications for
FDA officials note that 0.25-mL single-dose prefilled syringes of Afluria will
previously approved vaccines.
not be available this year for use in children aged 6 to 35 months; the 0.5-mL
single-dose prefilled syringes and 5-mL multidose vials will be distributed.
The updated guidelines recommend starting vaccination efforts as soon as the
2010-2011 seasonal influenza vaccine is available and continuing throughout
According to the Centers for Disease Control and Prevention, more than
the influenza season, and they also provide a summary of safety data for US-
200,000 individuals are hospitalized and about 36,000 die each year from
licensed influenza vaccines. During the 2010-2011 influenza season,
influenza-related complications. Those at increased risk for potentially fatal
vaccination and healthcare providers should check CDC's influenza Web
complications include the elderly, young children, and people with chronic
site for any updates or supplements that might be needed to these
medical conditions.
recommendations, as well as for recommendations for influenza diagnosis and
antiviral use published before the start of the 2010-2011 influenza season.
Ov 9 =

 !


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> 




33
 
 .++
August 3, 2010 Ȅ The US Centers for Disease Control and Prevention (CDC)
Advisory Committee on Immunization Practices (ACIP) has issued new 2010 A summary of recommendations for influenza vaccination for 2010 is as
recommendations for prevention and control of influenza with vaccines, follows:
according to guidelines reported early release in the July 29 issue of $ #
 $ 
1)
 . This report updates the 2009 ACIP @Y Annual vaccination is recommended for all persons aged 6 months
recommendations concerning the use of influenza vaccine for influenza or older.
prevention and control. @Y As providers and programs make the transition to routine
vaccination of all persons aged 6 months or older, a focus of
The report also describes a US Food and Drug Administration labeling change vaccination efforts should continue to be protection of persons at
for 

  (CSL Biotherapies) influenza virus vaccine to reflect the risk for higher risk for influenza-related complications.
fever and febrile seizure. @Y When vaccine supply is limited, vaccination efforts should prioritize
persons who:
"Influenza A subtypes that are generated by a major genetic reassortment (i.e.,
àY Are aged 6 to 59 months or at least 50 years;
antigenic shift) or that are substantially different from viruses that have
àY Have chronic pulmonary (including asthma),
caused infections over the previous several decades have the potential to
cardiovascular (except hypertension), renal, hepatic,
cause a pandemic," write Anthony E. Fiore, MD, from the Influenza Division,
neurologic, hematologic, or metabolic disorders
National Center for Immunization and Respiratory Diseases, CDC, Atlanta,
(including diabetes mellitus);
Georgia, and colleagues.
àY Have disorders of immunosuppression, including those
caused by medications or by HIV);
"In April 2009, a novel influenza A (H1N1) virus, 2009 influenza A (H1N1),
àY Are or will be pregnant during the influenza season;
that is similar to but genetically and antigenically distinct from influenza A
àY Might be at risk for Reye's syndrome after influenza virus
(H1N1) viruses previously identified in swine, was determined to be the cause
infection because they are aged 6 months to 18 years and
of respiratory illnesses that spread across North America and were identified
are receiving long-term aspirin therapy;
in many areas of the world by May 2009. Influenza morbidity caused by 2009
àY Are residents of nursing homes and other long-term care
pandemic influenza A (H1N1) remained above seasonal baselines throughout
facilities; American Indians/Alaska Natives; morbidly
spring and summer 2009 and was the cause of the first pandemic since 1968."
obese (body mass index η 40 kg/m2); and/or healthcare

## .++=
 personnel;

àY Are household contacts and caregivers of persons with
The 2010 guidelines emphasize the following: medical conditions putting them at greater risk for
severe complications from influenza, or of children
@Y All persons at least 6 months old should receive annual vaccination younger than 5 years and adults 50 years or older. The

for the 2010-2011 influenza season; guidelines particularly emphasize vaccinating contacts of

@Y During the 2010-2011 season, 2 doses of a 2010-2011 seasonal children younger than 6 months.

influenza vaccine should be given at a minimal interval of 4 weeks

to children aged 6 months to 8 years with unknown vaccination "Emphasis on providing routine vaccination annually to certain groups at
status who have never received seasonal influenza vaccine before higher risk for influenza infection or complications is advised, including all
children aged 6 monthsȂ18 years, all persons aged η50 years, and other
persons at risk for medical complications from influenza," the authors of the
report write. "Despite a recommendation for vaccination for approximately
85% of the U.S. population over the past two seasons, <50% of the U.S.
population received a seasonal influenza vaccination in 2008Ȃ09 or 2009Ȃ10.
Estimated vaccine coverage for the 2009 H1N1 monovalent vaccine coverage
was <40%."
avoiding the hour-long wait for results from a laboratory using traditional
chemistry methods.
"No other analyzer can provide lab-quality tBili results in the [neonatal
intensive care unit]," said Ramon Benet, vice president of US sales and
worldwide service and marketing at Instrumentation Laboratory, in a
company news release.

; 




3;v
"

6 Bilirubin is a toxin naturally produced in newborns as fetal red blood cells are
NEW YORK (Reuters Health) Aug 02 - Postconcussion syndrome (PCS) really
does exist in kids, say the authors of a new report.
They found that three months after mild traumatic brain injury (mTBI), 14%
of children over six still had increased fatigue, emotionality, irritability,
headaches and other symptoms characteristic of postconcussion syndrome
(PCS).
But the researchers also say that the children's symptoms "are likely to
resolve within 12 months after injury."
In adults with mTBI, estimated prevalences of PCS range from 11% to 64%,
and the few studies in children have put the prevalence at 6% to 35%. But
skeptics have said the diagnosis may not be valid in children. They say what
appears to be PCS might really reflect behavioral disturbances after the injury
and medicolegal concerns, according to the researchers.
For the current report, published online July 26th in Pediatrics, lead author
Dr. Karen Maria Barlow of the Alberta Children's Hospital in Calgary, Canada,
and her colleagues followed 670 kids with mTBI and 197 with extracranial
injuries (ECI).
A month after injury, 58.5% of the mTBI group and 38.5% of the ECI group
still had symptoms. Three months afterward, 11% of children with mTBI were
symptomatic, compared to 0.5% of children with ECI. A year after the injury,
2.5% of the mTBI patients still had symptoms.
broken down during the first few days of life. Abnormally high concentrations
occur in 70% of newborns and present as jaundice Ȅ the number one
condition requiring medical attention in this age group. For 8% to 10% of
these newborns, their jaundice can evolve to severe hyperbilirubinemia; if left
untreated, kernicterus Ȅ an untreatable form of permanent brain damage Ȅ
can ensue. Because of this risk, the American Academy of Pediatrics
recommends an evaluation of bilirubin levels for all newborns.
The National Quality Forum considers kernicterus one of 28 "Never Events,"
defined as "adverse events that are serious, largely preventable," and
considered "inexcusable outcomes in a healthcare setting." Unfortunately,
"over the past decade, kernicterus has reemerged, due to a variety of factors,"
noted Anthony Napolitano, MD, medical director, Neonatal/Pediatric
Transport Program at All Children's Hospital, St. Petersburg, Florida, and
medical director, Sarasota Memorial Hospital, Sarasota, Florida, in the news
release. "The ability to assess bilirubin in the [neonatal intensive care unit]
with accuracy and precision is a tremendous advantage and has the potential
to prevent this absolutely devastating outcome and reduce hospital
readmissions."
Tests performed on the critical care analyzer are not affected by moderate
turbidity or hemolysis, thereby ensuring accuracy. Additional measurements
obtained from the single sample include blood gas, electrolytes, glucose,
lactate, and full CO-oximetry, allowing an efficient and comprehensive
assessment of newborn status.

"Fatigue," "more emotional," "irritability," and "headaches" were the most 
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9
common symptoms. Children with more severe injuries, as well as those over August 2, 2010 Ȅ Maternal prenatal anxiety and stress are associated with
6, were more likely to continue to have symptoms. Injury severity largely infant illnesses and antibiotic use early in life, according to the results of a
explained the difference in symptom duration between younger and older
children.
Differences between the mTBI and ECI groups could not be explained by
injury status, age, family dysfunction, or maternal adjustment, the researchers
say.
"Although long-term outcomes are good, 14% of school-aged children with
mTBI have significant morbidity for several months," Dr. Barlow's team points
out.
"Provision of proper education and reassurance soon after injury can reduce
postconcussive symptoms in adults, but as yet there is strikingly little
evidence to guide the management and treatment of PCS in children," they
add.
study reported online July 19 in, .
"Evidence from both animals and humans suggests that maternal prenatal
anxiety and stress can have adverse consequences on the offspring's
development," write Roseriet Beijers, MSc, from the Behavioural Science
Institute in Nijmegen, the Netherlands, and colleagues. "Animal models also
show that prenatal stress has programming effects on the physical health of
the offspring, such as immune functioning. In human studies, however,
physical health outcomes are often restricted to birth complications; studies
on the effects of acquiring illnesses are scarce."
The goal of the study was to determine whether maternal prenatal anxiety
and stress are related to more infant illnesses and antibiotic use during the
first year of life. The study sample consisted of 174 mothers with normal
pregnancies and term deliveries who completed third-trimester
questionnaires on general and pregnancy-specific anxiety and stress and who
Ov   
:
:v 4
4
/8

were tested for circadian cortisol levels in saliva.
July 30, 2010 Ȅ The US Food and Drug Administration (FDA) has granted
510(k) clearance to market the first-ever, rapid point-of-care, laboratory- Of the offspring, 71 were firstborns and 91 were boys. Monthly interviews of
quality blood test for measuring total bilirubin in newborns (
 assay; the mother during the infant's first year of life allowed collection of data
Instrumentation Laboratory). concerning infant illnesses and antibiotic use.

Performed on the company's automated %$,  8999 critical care Even after adjustment for many relevant confounders, prenatal anxiety and
analyzer, the total bilirubin assay provides on-the-spot results in 90 seconds, stress predicted considerable variance in infant illnesses and antibiotic use
(9.3% for respiratory tract disease, 10.7% for general disease, 8.9% for skin
diseases, and 7.6% for antibiotic use), based on hierarchic multiple
regressions. In contrast, prenatal anxiety and stress were not associated with
digestive tract illnesses.
Limitations of this study include poor generalizability because nearly all
mothers were highly educated, lived together with their partner, had healthy
pregnancies, and reported relatively mild or moderate prenatal stress. In
addition, this study examined prenatal anxiety and stress only during late
gestation, and infant health data were based on maternal report.
"This study is 1 of the first to link maternal prenatal anxiety and stress to
infant illnesses and antibiotic use early in life," the study authors write. "As
such, it provides a starting point for future research in larger and clinical
samples. Follow-up studies are necessary to determine whether the effects of
prenatal anxiety and stress on infant susceptibility to illnesses are transient,
persistent, or even progressive."
(*
reported, 9.7% were expose to more than 1 substance and 51% of the patients
were exposed to at least 1 sedating agent.
Of the 18 total deaths that occurred (mean age, 1.6 years), "94% were exposed
to sedating agents, including an antihistamine (8 cases)," report the study
authors.
In fact, exposure to a sedating agent (adjusted odds ratio [OR], 3.6) or to
multiple agents (OR, 3.0) and being younger than 2 years at the time of the
report (OR, 1.9) were all significant risk factors for worse outcomes.
Possible reasons cited for sedation given by a caregiver included wanting to
stop an infant's crying or "as a respite from the responsibilities of childcare.
Even though the caregiver probably is not strictly intending to harm the child,
this still constitutes maltreatment," the study authors write.
"Malicious is a term that the poison center uses when they code calls,"
explained Dr. Yin. "I personally think that there probably are cases where the
 X  - 
 ! 
  ( parent or caregiver is not intending to harm their child. But they are giving
 
  
 
  
 
  them a drug for some other purpose than what was intended. If you're giving
your child some drug because you want to take some time off or go do
5c 
5O3
 

  3


v

 something else, then I would say that does cross over to child abuse."
August 3, 2010 Ȅ The intentional, malicious use of pharmaceuticals (such as
benzodiazepines, acetaminophen, and dextromethorphan with decongestant ( 
  
 
  
 
 
and/or antihistamine) in children is increasing Ȅ with almost 160 cases

!

c 
O##
O
: "
3

reported per year on average, according to a new retrospective study that
looked at reports from the US National Poison Data System (NPDS).
In addition, 13.8% of these malicious use cases resulted in moderate or major
outcomes of death compared with just 0.9% of those reported in 2007.
"This is more than a 15-fold increase, [yet] it remains an under-recognized
problem," write investigators led by Shan Yin, MD, MPH, University of
Colorado School of Medicine in Aurora.
"The nontherapeutic use of pharmaceuticals does not cleanly fit into the
4

August 3, 2010 Ȅ In teenagers visiting the emergency department (ED), a 35-
minute intervention involving therapist counseling may reduce violence-
related outcomes at 3 months, whereas a therapist or a similar computer-
based intervention may decrease alcohol-related consequences at 6 months,
according to new research.
Maureen A. Walton, MPH, PhD, with the Department of Psychiatry at the
University of Michigan, in Ann Arbor, and colleagues reported the findings in
the August 4 issue of the  

  $
 .

traditional classification of child maltreatment," the study authors write, who

suggest that a comprehensive drug screening "should perhaps be considered
in the initial evaluation of a child suspected to be the victim of
maltreatment...as it may prevent more serious sequelae."
"I think the number 1 thing for clinicians is mainly just to be aware and to be
"Adolescents seeking care in the ED are an important population for injury
prevention based on increased risk of problems related to alcohol and
violence," the study authors write. "...few ED studies have examined brief
interventions that address reductions in violence or the combination of co-
occurring risk behaviors," they add.
on the lookout for this," Dr. Yin told$$
*
The study population was accrued from patients aged 14 to 18 years visiting a
The study was published online July 22 in the  

,  level I trauma ED who presented for medical illness or injury between 2006
and 2009. All participants responded affirmatively to whether they had shown
 
#cO#
?
 any past-year aggression (peer, dating, weapon carriage/use) and also to the
For this study, the investigators evaluated 1244 NPDS reports of malicious
pharmaceutical incidents involving children younger than 7 years (median
age, 2 years) between 2000 and 2008.
Except for ethanol, cases involving nonpharmaceuticals were excluded.
"Ethanol...is widely available, is one of the most commonly abused substances
in the US, and has been well documented to facilitate malicious activity,"
explain the study authors.
Malicious intent was defined as "patients who are victims of another person's
intent to harm them."
Results showed that although analgesics; stimulants and street drugs;
sedatives, hypnotics, and antipsychotics; cough and cold preparations; and
ethanol were the most common major pharmaceutical misuse categories
question, "In the past 12 months, have you had a drink of beer, wine or liquor
more than two to three times?"
Of the screened patients, 726 met the criteria for alcohol use and aggression
and were randomly assigned to 1 of 3 groups: (1) computerized brief
intervention (using interactive animation and audio given through
headphones), (2) a therapist brief intervention (using therapists trained in
nonjudgmental interviewing techniques), and (3) a control group (no
intervention). All 3 groups also received a brochure with information on
community resources.
According to the researchers, the interventions were designed to have similar
content but given through different modes of presentation. Content included
role playing to practice skills in anger management, conflict resolution, alcohol
refusal, and not drinking and driving.
At 3 months of follow-up, the therapist intervention reduced the occurrence of the cochlea. In children with inner-ear malformations such as wide
self-reported peer aggression, peer violence, and consequences from violence vestibular aqueduct syndrome or Mondini-type malformation,
by up to 30% vs control intervention. At 6 months, both interventions showed which are associated with a higher likelihood of CSF fistulas after
reductions in alcohol consequences of more than 40% relative to control. cochlear implantation, the cochleostomy must be sealed during the
cochlear implant surgery to reduce the risk for bacterial meningitis.
In a related editorial, Richard Saitz, MD, MPH, and Timothy S. Naimi, MD, MPH, @Y Tympanostomy tube placement should be considered before
from the Boston University School of Medicine in Boston, Massachusetts, note cochlear implantation for otitis-prone children or children with
that the results from this study were "mixed" and the effects were "modest." persistent middle-ear effusion.
@Y All doses of 13-valent pneumococcal conjugate vaccine (PCV13; or
If the researchers had measured "more objective outcomes such as physician-
heptavalent pneumococcal conjugate vaccine [PCV7] if PCV13 is not
documented injury events or school-based reports of violent incidents, rather
yet available) and



 -type b conjugate vaccine
than self-reported risk behaviors, the findings might have been more
should be given according to the routine recommended schedule to
convincing," the editorialists note.
all children, including those with severe hearing impairment or
infants with profound deafness. At ages 2, 4, 6, and 12 to 15
They add that until these findings can be replicated, "...brief interventions for
months, 1 dose of each should be given, but a dose of

violence prevention in emergency departments do not seem promising.


 - type b is not needed at 6 months if PRP-OMP was given
However, existing evidence supports the implementation of screening and
for the first 2 doses (recommendation A).
brief intervention for unhealthy alcohol use in adult primary care settings,
@Y Starting at age 2 years and at least 2 months after the last dose of
especially for young adults in whom the prevalence of this risky behavior is
PCV13 (or PCV7 if PCV13 is unavailable), a dose of 23-valent
greatest."
pneumococcal polysaccharide vaccine (PPSV23) should be given to
children scheduled for cochlear implantation (or after cochlear
( #* 
á  

# 
implantation if not previously given) and to children with an inner-


( 
  
 
  
 
 
ear malformation with a CSF communication (recommendation B).
 !-
 
  
 
 * 
 The doses of PCV13 and PPSV23 should be completed at least 2
á 


$
  á

 & ,    weeks before implant surgery for maximal benefit.
5  
$  5  á 
 

 @Y Children aged 24 to 71 months given 2 or less previous doses of
* 
á  

# 

$ PCV13 (or PCV7) before age 24 months should receive 2 doses of
$
! $
 
%   !
 PCV13 at least 2 months apart. Those given 3 previous doses of
 $   ! !

  * PCV13 (or PCV7) should be given 1 dose of PCV13. Two months
  
  * 
á 


     after completion of the PCV13 (PCV7) series, PPSV23 should be
  
 

 

#5!,#


 given. Administration of 1 dose of PCV13 should be considered for
!  children older than 71 months who have not received PCV13, and
all such children should receive PPSV23 (2 months after PCV13 if
O3

O
3
  
 3

v
 3
 PCV13 is given) if they have not already received it

v

(recommendation B). Giving more than 1 dose of PPSV23 is not
July 30, 2010 Ȅ The American Academy of Pediatrics (AAP) has issued a recommended for children with cochlear implants.
statement on cochlear implants in children, published in the August issue @Y Children aged 14 to 71 months who have been fully immunized
of , . The new policy statement covers surgical site infections and with PCV7 should receive a single supplemental dose of PCV13, but
prevention and treatment of acute otitis media (AOM) and meningitis. this is not needed if the fourth dose of PCV given at age 12 months
or older was PCV13.
"[T]here is a need for guidelines for prevention, recognition, and management
@Y Regardless of previous doses of PCV7 and PPSV23, a single dose or
of cochlear implantȂrelated infections, acute otitis media, and bacterial
supplemental dose of PCV13 may be given to pediatric patients
meningitis in children with cochlear implants," write Lorry G. Rubin, MD,
aged 6 through 18 years who have or who are scheduled to receive
Blake Papsin, MD, and colleagues from the AAP Committee on Infectious
a cochlear implant.
Diseases and Section on OtolaryngologyȂHead and Neck Surgery. "Potential
@Y Clinicians taking a history of previous immunization with
infectious complications of cochlear implants include postoperative wound
pneumococcal vaccines should avoid confusing past immunization
and device-related infections and bacterial meningitis. In children with
with other vaccines that could be considered "meningitis vaccines"
cochlear implants, an episode of acute otitis media may lead to inner-ear
(ie,


 -type b and quadrivalent meningococcal
infection, device infection, device extrusion, device failure, and/or meningitis."
polysaccharide or conjugate vaccines) with doses of PCV7 and
PPSV23.




33
 

@Y On the basis of current evidence, cochlear implant recipients should
not be considered a group at high risk for invasive meningococcal
All recommendations in the statement were classified as "I" indicating
disease, and they should therefore receive meningococcal conjugate
insufficient evidence by the US Preventive Services Task Force Ratings
criteria, except as noted below. Specific recommendations were as follows: vaccine in accordance with routine recommendations. Children
younger than 11 years should not be immunized routinely.
@Y Annual administration of influenza vaccine with trivalent
@Y Before cochlear implantation, all children with congenital deafness
inactivated vaccine or live attenuated nasal vaccine (if there are no
and all patients with profound hearing impairment and a history of
medical contraindications) is recommended for patients with a
bacterial meningitis (if not known to have normal hearing before
cochlear implant, and influenza immunization of their household
meningitis) should undergo imaging of the temporal bone/inner
contacts should be strongly considered (recommendation B).
ear. This test should identify patients with inner-ear
malformations/cerebrospinal fluid (CSF) fistulas or ossification of
 @Y If there are recurrent episodes of AOM after cochlear implantation, July 29, 2010 Ȅ Recent media reports of potential misdiagnosis and
tympanostomy tube placement should be considered. overtreatment of early-stage breast cancer may be frightening women away
@Y Patients with suspected postoperative wound infection or from recommended screening for breast cancer, according to a joint news
suspected implant infection should be urgently referred to the release from Susan G. Komen for the Cure and the College of American
surgeon who performed the implant procedure, and broad- Pathologists.
spectrum antimicrobial therapy should be started, including 1 or
more drugs with activity against methicillin-susceptible and Rather than forgo screening because of fears of being misdiagnosed and
methicillin-resistant !
 . receiving unnecessary therapy, women should know what questions to ask
@Y Patients and parents should be informed of the symptoms of AOM and be confident about weighing their options, the release emphasizes.
(fever or earache) and meningitis (fever, headache, vomiting, stiff
The joint statement was released primarily in response to a recent article in
neck, or change in level of consciousness) and told to seek
the *: )(, which described the disturbing case history of a women
immediate medical attention for acute illness with these symptoms.
misdiagnosed with ductal carcinoma in situ (DCIS). The patient had a "golf-
@Y For all patients with cochlear implants presenting with fever with
ball sized" section of her breast removed, underwent radiation and
or without AOM, bacterial meningitis should be considered,
chemotherapy, and then was told a year later that she never had cancer.
especially during the first 2 years after implantation in patients
with cochlear implants without positioners and indefinitely in
According to the article, the patient stated that the fear was the worst of all.
patients with cochlear implants placed between 1999 and August
"Psychologically, it's horrible.... I never should have had to go through what I
2002 with positioners.
did," she said.
@Y Children with cochlear implants diagnosed with AOM should be
treated urgently with systemic antimicrobial therapy vs watchful
The *: )( article highlights an issue that is a subject of much
waiting. Initial empiric treatment with an oral antimicrobial agent
discussion among oncologists. Advances in mammography and other imaging
such as amoxicillin or amoxicillin/clavulanate (80 - 90 mg/kg per
technology during the last 3 decades have allowed visualization of extremely
day) is reasonable if all of the following are present: (1) AOM occurs
small lesions, according to the article. It may be particularly challenging for
at least 2 months after cochlear implantation; (2) absence of
pathologists to distinguish the difference between some benign lesions and
uncorrected Mondini-type or similar inner-ear malformation or
early-stage breast cancer.
CSF/middle-ear fistula; (3) absence of severely ill appearance and
of clinical evidence of mastoiditis or meningitis; and (4) the 
 v

cochlear implant does not have a spacer/positioner.
@Y If feasible without causing an undue delay, middle-ear fluid should
be obtained for culture just before antibiotics are started. For other
patients with a cochlear implant who do not meet these criteria,
initial treatment with a parenteral antimicrobial agent for
treatment of AOM (eg, ceftriaxone or cefotaxime) is recommended.
@Y Patients with a cochlear implant and AOM with worsening
condition despite 24 hours of antibiotics should be evaluated by an
otolaryngologist, should have middle-ear fluid culture, and should
undergo myringotomy with or without ventilation placement to
drain the middle ear.
@Y In patients with bacterial meningitis and a cochlear implant, CSF
and middle-ear fluid, if present, should be cultured. Empiric
antimicrobial therapy is similar to that for children without
implants (eg, ceftriaxone or cefotaxime plus vancomycin), except
for children who have meningitis during the first 2 weeks after
cochlear implantation. The latter group should receive broader-
spectrum antibiotics active against gram-negative bacilli (eg,
meropenem and vancomycin). Patients with a cochlear implant and
bacterial meningitis should be seen urgently by an otolaryngologist
to consider imaging and surgical exploration.
A
The diagnosis of DCIS "is a 30-year history of confusion, differences of opinion
and under- and overtreatment," said Shahla Masood, MD, the head of
pathology at the University of Florida College of Medicine in Jacksonville, in
the *: )( article. "There are studies that show that diagnosing these
borderline breast lesions occasionally comes down to the flip of a coin."
In response to concerns about the accuracy of breast pathology, the College of
American Pathologists has announced that it will begin a voluntary
certification program for pathologists who read breast samples. Among the
requirements is that pathologists must read 250 breast cases a year. In
addition, in a response to concerns that approximately 17% of DCIS cases
identified by needle biopsy may be misdiagnosed, a new study supported by
the federal government will be conducted to examine the variations in breast
pathology.
However, as noted in the *: )( article, there are currently no
mandated diagnostic standards or requirements for pathologists who evaluate
breast tissue samples. This means that diagnostic accuracy can vary among
facilities, depending on the individual expertise of the pathologists.
v  v

"Cases of bacterial meningitis in implant recipients may originate via
*, some experts believe that
pneumococcal bacteremia with hematogenous seeding of the cochlea, such as
at a site of tissue necrosis related to the electrode or positioner (locus minoris
resistentiae) with contiguous spread to the CSF and meninges," the statement
authors write. "In addition, cochlear implants themselves increase the risk of
bacterial meningitis, especially during the first 2 months after implantation."

  

As previously reported by $$
the term "carcinoma" in the phrase "ductal carcinoma in situ" is misleading
and troubling and ought to be dropped, or at least that its elimination should
be considered. In fact, in some cases experts suggest that DCIS is a possible
candidate for management by active surveillance Ȅ a treatment strategy of
growing importance in prostate cancer in which low-risk patients are
monitored but do not receive active treatment unless they progress to a


7
7   ,
higher risk.
  

#  
   # 

  (,  
    
 However, others disagree. "Although active surveillance is a step that can
 
  
 
  
#
  mitigate the harms of treatment, we doubt that it will mitigate the effects of
uncertainty and anxiety," H. Gilbert Welch, MD, Steven Woloshin, MD, and Lisa
3vc #
@
v

/v


M. Schwartz, MD, from the Department of Veterans Affairs and Dartmouth
Medical School, New Hampshire, comment in an editorial (*
  á . in which the early elective deliveries were prohibited but compliance was left
2008;100:228-229).
"To do this, we must go back a step and question the value of making the
diagnosis in the first place," they write.
The editorialists note that there "is a sea of uncertainty surrounding DCIS.
Some lesions will progress to cancer, others will not. Some women with DCIS
will develop cancer elsewhere in their breasts, whereas others will not. And
we're not sure what the chances are."
In her Medscape videoblog, Kathy Miller, MD, notes that there has been a "long
understanding that we overtreat patients DCIS," and that it is a "disease that
we rarely had to deal with in the days before mammograms."
"But with mammograms, about a third of patients diagnosed with breast
cancer are diagnosed with DCIS and they are virtually all treated," said Dr.
Miller, an associate professor of medicine at Indiana University School of
Medicine, Indianapolis. "It's almost as frightening, if not as frightening, as for
those patients diagnosed with invasive disease."
Dr. Miller noted that with advancing technology, there will come a time when
patients with DCIS can be better defined as to whether or not their disease is
likely to progress. Those patients will likely need treatment, whereas others
can simply be monitored.
"But we can't do that now," she pointed out. "If you have carcinoma in the
name, that makes doing nothing scary for patients, scary for doctors, and
prohibited purely elective deliveries before the 39th week; a "soft stop" policy
to individual doctors; and an "education only" approach that included no
formal ban on the deliveries and relied on doctors to change their practices
themselves.
Over two years, the hard-stop policy proved most effective.
At the seven hospitals that adopted the policy, the rate of elective delivery in
the 37th or 38th week fell from 8% of all deliveries to just below 2%.
In the soft-stop group, the rate dropped from just above 8% to roughly 3%.
And at the education-only hospitals, the rate went from 11% to 6% -- a
difference that was not statistically significant.
"The message here is that there is a way that this practice can be reduced," Dr.
Clark said, noting that the findings can serve as a model for other hospital
systems that are now getting "serious" about curbing early-term elective
deliveries.
He and his team also found evidence of a benefit for newborns. Across all of
the hospitals, the decline in elective deliveries was accompanied by a 16%
reduction in the number of term infants admitted to the neonatal intensive
care unit (NICU).
The researchers estimate that if the drop in elective deliveries achieved in the
hard-stop policy hospitals could be accomplished nationally, a half-million
NICU days could be avoided and close to $1 billion saved each year.
/8OO<OO=

c
#3



 3 #
untenable for everyone."
Although simply changing the name will not remove the fear, changing the
name could start to change the mindset, she added. "[It] could make it easier,
could make it possible to study which patients need treatment and which
patients don't. And [it] could go a long way to moving how we think about the
disease in a way that could be very helpful."

July 30, 2010 Ȅ The American Heart Association/American Stroke
Association has released a new guideline on the management of spontaneous
intracerebral hemorrhage (ICH).
ICH has long been recognized as one of the most severe forms of stroke,
among the most devastating neurologic injuries, and the view of many has
been that there is not much to be done for these patients, said lead study
  
c
8
! ! author Lewis B. Morgenstern, MD, from the University of Michigan, Ann Arbor.
By Amy Norton
"The clear message that we want to send with this guideline is that
NEW YORK (Reuters Health) Aug 03 - Tougher hospital policies can go a long intracerebral hemorrhage is a very treatable disorder, with very guideline-
way toward curbing the practice of scheduling a birth as soon as the fetus is

considered full-term, a new study shows.
Despite the fact that elective delivery in the 37th or 38th week is considered
to carry needless risks, the practice still accounts for an estimated 10% to
15% of all deliveries in the U.S. -- because the absolute risk of complications
for any one baby are low, said Dr. Steven L. Clark, the lead researcher on the
new study and medical director of Women's and Children's Clinical Services
for the Hospital Corporation of America (HCA).
Many women may know someone who had an elective early-term delivery,
and many obstetricians never seen a complication from the practice.
But on the national scale, even a small increase in the risk of newborn
complications translates into an important public health issue, Dr. Clark told
Reuters Health.
concordant, aggressive critical care," Dr. Morgenstern told $$
*. "There's a lot of evidence in the guideline of things that are shown to be
effective and improve outcome."
There's also a lot of evidence that if care is not aggressive, "outcome is very
bad," he added. "So the hope of the writing committee is that clinicians will
use this to guide their appropriate and aggressive treatment for patients who
have intracerebral hemorrhage."
The guideline, which has been reviewed and the educational content affirmed
by the American Academy of Neurology, as well as the American Association
of Neurological Surgeons and the Congress of Neurological Surgeons, was
published online July 22 and will appear in the September issue of ! ). The
guideline applies only to spontaneous ICH, not ICH subsequent to trauma.
9


#c

/8
33
 


The current study, reported online July 9th in the American Journal of To help clinicians, the recommendations in the document are flagged as
Obstetrics & Gynecology, is the first to look at the question of how to best curb unchanged from the previous guidelines, modified, or new, Dr. Morgenstern
elective deliveries in the 37th and 38th weeks. noted.

For the study, 27 HCA hospitals in 14 U.S. states chose one of three policies to "In general, I would say that there are many recommendations that are either
address the issue: a "hard stop" approach where the hospital strictly completely new or updated since the last version 3 years ago based on
additional new research that has come about or additional deliberations by The study also found that the mean cost per patient was $306,135 (SD,
the writing group that considered the evidence to guide clinical practice," he $285,467), and the cost for the entire cohort was $38.1 million. The estimated
said. cost for each independently functioning survivor at 1 year was $3.5 million.


#c


 
 
v

 

 The findings of this study are important for patients, families, clinicians, and
 
policy makers, the authors write, noting that the effect on the US healthcare
August 4, 2010 Ȅ Prolonged mechanical ventilation gobbles up a huge system of prolonged mechanical ventilation has probably been substantially
proportion of healthcare dollars and still results in persistent, profound underestimated.
disability. Family members or other decision makers should be informed of
this when they are considering a course of prolonged life support, researchers They also suggest that managing patients with intermediate or fair outcomes
write in a new study published in the August 3 issue of the  

á  
 Ȅ those who survive but have moderate functional dependencies Ȅ may be
$ .
"Growing numbers of critically ill patients receive prolonged mechanical
ventilation," write Mark Unroe, MD, from Duke University, Durham, North
Carolina, and colleagues. "Decision makers' hope for patient survival coupled
with an incomplete understanding of the specific implications for providing
prolonged mechanical ventilation may contribute to the increasing incidence."
The aim of this study was to describe the overall trajectories of care location
and costs for patients receiving prolonged mechanical ventilation.
The 1-year, prospective cohort study was conducted in 5 intensive care units
(ICUs), including trauma, neurologic, cardiac, cardiothoracic surgery, and
medical ICUs, at Duke University Medical Center. The study involved 126
patients who received prolonged mechanical ventilation for 4 days or more
with a tracheostomy, or ventilation for 21 days or more without a
tracheostomy, as well as 126 of their surrogate decision makers and 54 ICU
physicians.
The patients were middle-aged, had health insurance, and were well-
educated, with few premorbid conditions before ICU admission.
The patients, surrogate decision makers, and physicians were interviewed
within 48 hours of study entry, and then at 3 and 12 months after discharge
from hospital. The primary outcomes were 1-year survival, functional status,
and healthcare resource utilization. Health outcomes were described as:
@Y good, or alive with no dependencies in activities of daily living;
@Y fair, or alive with 1 to 5 dependencies in activities of daily living, or
@Y poor, or either dead or alive with dependencies in all 6 activities of
daily living.
The 103 surviving patients had 457 transitions in care location after discharge
from the ICU (median, 4; interquartile range, 3 - 5) and received a total of
14,552 days of inpatient hospital and facility care. There were 150
readmissions in 68 (67%) of the 103 hospital survivors. Most (65%) occurred
the most challenging, because of the uncertainty of their prognosis.
Nevertheless, these patients rarely improved over time, in spite of their
decision makers' initial optimism, "instead cycling frequently between
postacute care facilities and hospitals."
The circumstances under which decisions about prolonged mechanical
ventilation occur favor the pursuit of aggressive care for a variety of reasons,
they write. For one, communication between physicians and surrogates is
inadequate for fully shared decision making, as most surrogates receive no
information about functional dependency or expected 1-year survival. In
addition, both clinicians and surrogates overestimate prospects for recovery
and fail to anticipate the amount and intensity of care that will be required.
Finally, internists are often uncomfortable discussing uncertain prognoses
under such conditions, and the complex nature of critical illness can be hard
for them to explain.
To this end, the authors suggest that the health outcomes used in their study
(good, fair, poor) might help in the decision-making process.
Limitations of the study include the use of participant self-reports to quantify
the duration of postdischarge care, which may have resulted in inaccurate
assessment of costs, an inability to quantify the "notable" financial strain on
patients and their caregivers of such critical illness, and the fact that the study
was done in a single institution, and so the findings may not be not be
generalizable to other patients receiving prolonged mechanical ventilation at
other institutions or to those patients with different sociocultural or linguistic
backgrounds.
The authors conclude: "Currently, the decision-making process for prolonged
mechanical ventilation is marked by unrealistic expectations and poor
communication. It seems prudent that, in the context of prolonged mechanical
ventilation, physicians not only discuss long-term outcomes with surrogates
in terms that they can easily understand but also explicitly convey the
probable demands of treatment and the future functional dependence patients
will probably have."
within 3 months, and nearly half were caused by sepsis. ( #* 
á 


 5 

  
 
  
 
 X   !  !  
The study also found that patients spent an average of 74% (95% confidence   
 
  (  
á  
 ,7$ ;



interval [CI], 68% - 80%) of all days alive in a hospital or postacute care   
  
 
  
 
 
facility or receiving home healthcare.
At 1 year, only 11 patients (9%) had a good outcome, with no functional
dependency. Thirty-three patients (26%) had a fair outcome (alive with
moderate dependency), and the majority of patients (n = 82 [65%]) had a
poor outcome. Of these, 4 patients (21%) were alive with complete functional
dependency, and 56 (44%) had died. The patients who died during follow-up
lived a median of 79 days (interquartile range, 46 - 125 days).
Patients with poor outcomes were older, had more comorbid conditions, and
were discharged to postacute care facilities more often compared with
patients with either fair or good outcomes (, < .05 for all comparisons).
%':33)/!

 
July 30, 2010 Ȅ New research has found that 5-mm needles effectively deliver
insulin into subcutaneous fat in both adults and children.
Paul Leslie Hofman, MD,with the Liggins Institute at the University of
Auckland, in Auckland, New Zealand, and colleagues reported the findings in
the June 28 online issue of # .
According to the researchers, the goal of an injection is to deliver insulin to the
subcutaneous fat, but perpendicular insertion of longer needles (ie, 6-mm, 8-
mm, and 12.7-mm) is associated with an increased deposition into the
intramuscular layer. Conversely, shorter needles may deliver insulin too
superficially into the intradermal layer.
"Our primary aim was to establish the ideal injection techniques required to
reliably inject insulin into the subcutaneous fat in both children and adults
using 5-mm needles," Dr. Hofman and colleagues write.
The study included 259 participants, of which 122 were children or
adolescents. Each subject was injected with a 32-guage, 5-mm needle with
sterile air, equivalent to 20 units of insulin in volume. Injections into the
abdomen and thigh were evaluated when inserted perpendicularly into the
skin or at a 45-degree angle and also with or without a pinched skin fold with
ultrasound. Test medium injections into the abdomen and thigh were also
administered to assess injection leakage.
In children, 5.5% of injections were too deep and were injected into the
intramuscular layer, and 0.5% of injections were too shallow, being injected
into the intradermal layer. In adults, the incidence was 1.3% and 0.6%, for the
intramuscular and intradermal layers, respectively.
The frequency of intramuscular injections was highest in boys and was nearly
absent in adult women. Increased thickness of subcutaneous fat was
associated with a decreased risk for intramuscular injections (, < .001).
One third of patients had no pain during insulin injection, whereas children
and adolescents tended to experience more pain than adults. Injection leakage
was unrelated to injection volume and was typically negligible.
"This study has demonstrated that 32G [gauge] 5-mm needles can be reliably
inserted into subcutaneous fat, are relatively pain free, and are associated
with minimal leakage from the injection site," the study authors conclude.
They also recommend an "angled injection with a pinched skin fold for
children, while in adults the technique should be left to patient preference."
"These findings support the use of 5-mm needles in all patients," said
independent commentator Sherwyn L. Schwartz, MD, with Diabetes and
Glandular Disease Research Associates in San Antonio, Texas.
August 2, 2010 (Vienna, Austria) Ȅ Life expectancy is increasing for people
with HIV and AIDS, and with it, cancer risk and incidence, Eric A. Engels, MD,
MPH, reported here at AIDS 2010: XVIII International AIDS Conference.
This means that cancer prevention and treatment among people infected with
HIV will become more and more important in the years ahead, said Dr. Engels,
senior investigator at the Division of Cancer Epidemiology and Genetics at the
National Cancer Institute.
In an analysis of data collected by the Centers for Disease Control and
Prevention during 15 years from 15 regions of the United States, Dr. Engels
and coauthors found that the proportion of the US AIDS population aged 50
years or more increased from 8% of 93,802 people in 1991 to 29% of 399,762
people in 2005.
During the same time period, the incidence of non-AIDS-defining cancers
increased, from 416 in 1991 to 2437 in 2005, with a total of 76,558 cancers in
this cohort.
In contrast, AIDS-defining cancers such as Kaposi's sarcoma and non-
Hodgkin's lymphoma decreased from 7284 cases in 1993 to 1736 cases in
2005.
Cases of anal cancer increased from 18 in 1991 to 358 in 2005, and cases of
prostate cancer increased from 10 to 123 from 1991 to 2005, largely as a
result of rising rates of those malignancies, Dr. Engels said during an oral
abstract session. The rates of lung cancer and Hodgkin's lymphoma remained
relatively stable, but the absolute number of cases increased from 112 to 478
and from 72 to 169, respectively.
The authors also estimated cancer incidence between 2004 and 2007 for
people in 34 states who were HIV-positive but did not have AIDS. In that
population, 4388 cancers occurred, including 381 anal cancers, 892 lung
cancers, and 327 cases of Hodgkin's lymphoma.
Immunosuppression and coinfection with the human papillomavirus may
explain, in part, the dramatic rise in the number of anal cancer cases, Dr.
*.
According to Dr. Schwartz, currently available studies on needle length
indicate that glucose control is not significantly different when a shorter
needle is used in obese patients. "Patients prefer a shorter needle length, and
insulin can be delivered to the subcutaneous fat using the proper angle with a
Engels told $$
These findings are "in large part due to the increasing number of people living
with HIV infection and the fact that they are getting older," he said. "Non-
AIDS-defining cancers are now roughly as common as AIDS-defining cancers
5-mm needle," he told$$
*. [in this population] and represent a priority for cancer prevention, screening,
According to Dr. Schwartz, the angle at which the 5-mm needle is inserted is
important, depending on how much subcutaneous fat is available. "If the
patient is obese, a 90° insertion with a 5-mm needle will get insulin into the
subcutaneous fat. With children or thin adults with very little subcutaneous
fat, a 45° insertion may be more appropriate," he said.
Dr. Schwartz noted that other factors that should be considered when
selecting needle length are the patient's physical limitations. "Patients who
have ample subcutaneous fat but physical limitations such as tremors may
have a difficult time keeping a shorter needle under the skin long enough to
inject the complete dose," he said.
and treatment."
Treatment challenges among people with HIV and AIDS include
immunosuppression and drug interactions between highly active
antiretroviral therapy and chemotherapy. In addition, "many HIV-infected
people present late to care, which can impair their response to cancer
treatment," the investigator pointed out.
Strides in medications and management are allowing patients in this
population "to enter the prime years for cancer development," noted Susan E.
Krown, MD, head of the Kaposi's Sarcoma Working Group of the AIDS
Malignancy Consortium (AMC), and principal investigator at the Memorial
Sloan-Kettering Cancer Center AMC core unit in New York City.
(  #** )0!(
 . 
(  $, $    ),/ 
#** ) Patients infected with HIV "are also more likely than HIV-uninfected
0!   )
) ** )0!(   individuals to smoke and to have coinfections, such as HPV and hepatitis B

  
 
  
 
  and C, that increase the likelihood of certain cancers. A particular challenge is
to learn how best to manage the sometimes profound interactions between
.'




/
:O: v



 
#O3
# 
cancer therapeutic agents and antiretroviral drugs," said Dr. Krown, who is
 
also a medical oncologist at the Memorial Sloan-Kettering Cancer Center. She
was not involved in this research.
"The link between non-AIDS-defining cancers and HIV is not entirely clear, but
appears to be related to factors beyond HIV and the associated
immunosuppression," said Michael Fisch, MD, MPH, chairman of the
Department of General Oncology at the M.D. Anderson Cancer Center in
Houston, Texas. Along with lifestyle factors such as smoking and sexual
behavior, "testosterone replacement, and perhaps even adherence to
screening recommendations, may play a role in the association" between HIV
and non-AIDS-defining cancers, he added. Dr. Fisch was also not involved in
this study.
He took a brighter view of treatment than Dr. Krown. "In most instances,
standard cancer therapy can be safely provided to HIV-infected patients," he
For the analysis, researchers searched the MEDLINE, EMBASE, PsycINFO, and
CINAHL databases for high-quality observational studies performed in
hospitals or postȂacute care settings that were published in English or Dutch
between January 1981 and April 2010.
Patients in the studies had to have a mean or median age of 65 years or older.
Delirium had to be a study variable and follow-up had to be at least 3 months.
The final research selection included 12 studies.
Researchers performed a primary analysis on the studies that had adequate
statistical control to account for the effect of covariates that may influence the
association between delirium and poor outcome. Such covariates included
age, sex, comorbid illness or illness severity, and baseline dementia.
They performed a further analysis to examine whether the associations
told $$
*. "And I am optimistic that similar potential exists persisted regardless of the study population, the inclusion of nursing home
for the HIV population to reduce suffering and death due to cancer through residents, or patients with baseline dementia.
standard screening and advice related to lifestyle and behavioral
modifications." Mortality, institutionalization, and dementia were examined as separate
outcomes. "In the past, many people looked at mortality, but we thought we
=
B
 !3 v 

By Scott Malone and Nick Zieminski
NEW YORK (Reuters) Aug 02 - General Electric Co and Intel Corp will form a
50-50 joint venture to focus on technology that will remotely deliver health
care to seniors with chronic conditions, to help lower patients' medical costs.
Financial terms for the Sacramento-based venture, which is aimed at
developing products for the elderly whether they are living alone or in
assisted-living housing, were not disclosed.
GE, the largest U.S. conglomerate, and Intel, the world's largest chip maker,
will combine existing assets and products, technology development, and sales
and marketing staffs.
The two companies have been working on healthcare products together since
April 2009.
should not disregard survivors and their quality of life," explained Dr. van
Gool.
Analysis of adjusted hazard ratios (HRs) that included a total of 2957 patients
showed that delirium is associated with an increased mortality risk compared
with controls after an average follow-up of 22.7 months. In 7 studies, 271 of
714 patients with delirium (38%) had an increased risk for death compared
with 616 of 2243 controls (27.5%), with an HR of 1.95 (95% confidence
interval [CI], 1.51 Ȃ 2.52).
Patients who had experienced delirium were also at increased risk for
institutionalization. The primary analysis included 2579 patients in 7 studies.
Delirium was associated with an increased risk for institutionalization after a
mean follow-up of 14.6 months in 33.4% of patients with delirium vs 10.7% of
controls (odds ratio, 2.41; 95% CI, 1.77 Ȃ 3.29).
As for dementia, the primary analysis in 2 studies showed that 35 of 56
patients with delirium (62.5%) had an increased risk for dementia compared
with 15 or 185 (8.1%) of controls after 3.2 and 5 years of follow-up.
3$
 
" "
3
 

August 3, 2010 Ȅ Delirium in elderly patients is associated with an increased
risk for death, institutionalization, and dementia, and the association is
independent of age, sex, comorbid illness, and the presence of dementia at
baseline, a new meta-analysis has shown.
"Previous research also found an association, but there was always the
possibility of confounding," said senior study author Willem A. van Gool, MD,
PhD, from the Department of Neurology at the Academic Medical Center,
Amsterdam, the Netherlands. "Now, for the first time, we have established
The associations persisted even after excluding in-hospital deaths and
patients residing in an institution at baseline.
These results provide additional evidence of the link between delirium and
poor outcomes, said Dr. van Gool. "We found that there is excess mortality,
and in the survivors, there is excess dementia and excess of nursing home
placements. Taken together, these results strengthen the idea that there are
poor outcomes after delirium."
that, independent of all kinds of baseline variables, there is an effect and it's an
effect that is not short term; it holds for at least a couple of years."
Instead of focusing on risk factors or clinical characteristics of delirium, future
research should concentrate on the period after symptoms of delirium
subside, Dr. van Gool added. "After the acute stage of delirium has resolved
and the elderly patients have apparently recovered, our analysis suggests that
these patients are still vulnerable."
The research was published in the July 28 issue of the  

   Simple nonmedical measures that might prevent delirium in nursing home
 !


Because delirium can be prevented, it is important to identify patients at high
risk and implement strategies to prevent this condition. In addition to old age,
risk factors for delirium include cognitive impairment and vision problems.
Research shows that patients undergoing hip surgery still experience
delirium, but it is less severe and does not last as long if they take haloperidol,
said Dr. van Gool.
$
 Thelead study author was PhD candidate Joost Witlox, patients include reducing stimulation, putting patients in quiet rooms, and
MSc, from Medical Center Alkmaar, the Netherlands. providing them with a clock or photograph of family members to help orient
them, said Dr. van Gool. He pointed out that drugs with anticholinergic
  "
3 adverse effects tend to "lower the threshold" for delirium.
How exactly does delirium worsen outcomes in elderly patients? "That's the
thousand dollar question and to some degree we're in the dark about that,"
said Dr. van Gool. One theory is that factors precipitating delirium may incite a
detrimental sequence of events in the brain, resulting in neuroinflammation,
elevation of cortisol levels, and neurotransmitter imbalances. "Our speculation
When participants with clinically prevalent cardiovascular disease were
excluded, the association between cardiac index and total brain volume
remained (,= .02).
4 v 


v
#
4 4 
 3
is that during a period of delirium, something is switched on in the brain, and
we think it's microglial activity," said Dr. van Gool. v 
 4  3%
 ã   ! 
 ã 

 &'+2) v %
&,-.)

He believes that agents that either restore cholinergic control of microglia or Continuous 0.30 ± 0.14 .03 0.33 ± 0.14 .02
directly inhibit neuroinflammation warrant testing in clinical trials to
Tertile 1 Ϋ0.36 ± 0.17 .04 Ϋ0.41 ± 0.17 .02
determine whether delirium in vulnerable elderly patients can be averted. (low)

Tertile 2 Ϋ0.35 ± 0.17 .04 Ϋ0.34 ± 0.17 .04

A limitation of the current analysis is that the studies were pooled irrespective
(mid)
of their definition of delirium. The analysis may have overestimated the
number of patients with preexisting dementia. As well, only a small number of Tertile 3 Reference Ȅ Reference Ȅ
(high)
studies examined the risk for dementia after delirium.
+2 
 
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 4 
!
Post hoc comparisons revealed that participants in the bottom cardiac index
Approached for a comment, Richard B. Lipton, MD, professor of neurology at tertile and middle cardiac index tertile had significantly lower brain volumes
Albert Einstein College of Medicine, New York City, said he found the study than participants in the top cardiac index tertile.
results interesting but not surprising.
O
 
5
#5
"I think it's an important paper, and it supports the idea that delirium,
particularly in older adults, may be a marker for lack of brain reserve," he In an accompanying editorial, Clinton Wright, MD, and Ralph Sacco, MD, from
told $$
*. "It's not the delirium itself that predicts death the University of Miami in Florida, suggest the finding that even intermediate
and institutionalization; it's the vulnerability that the delirium unmasks that's reductions in cardiac index were associated with declines in brain volume is
the predictor." striking.

Although a healthy young adult with a high temperature may not get delirium, 
8  
  
!3
8
an older adult who has less brain reserve might become delirious if faced with 
  !  
8



a stressor such as an infection, surgery, general anesthesia, inadequate
oxygen, or high temperature, said Dr. Lipton. "In population-based studies, we tend to think that extremes are bad and the
middle is good, but in this study, it was possible to associate the brain volumes
( 
  
 
  
 
  of two thirds of a relatively healthy population with the cardiac index
exposure," they note.



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August 4, 2010 Ȅ Declining cardiac function is associated with lower total
brain volume, shows a new report using data from the Framingham Offspring
Cohort.
The findings are preliminary, but link reduced cardiac index with
neuropsychological and imaging markers of increased brain aging.
"Generally speaking, it seems that heart and brain health are related, so
proper management of cardiovascular risk factors may have important
implications on brain health," lead investigator Angela Jefferson, PhD, from
The mechanism for associations between cardiac index and markers of brain
aging is unknown. However, the study authors suggest reduced systemic
blood flow may contribute to subclinical brain injury because of its impact on
cerebral blood flow homeostasis.
"It will take years to know the fate of all 1504 Framingham participants," the
editorialists add. "Whether lower cardiac index leads to reduced brain
volumes and accelerates neurodegeneration on an eventual path to dementia
is not yet clear. What is known is that various vascular risk factors, including
decrements in cardiac function, are determinants of dementia Ȅ both
the Boston University School of Medicine in Massachusetts, told $ Alzheimer disease and variants of vascular cognitive disorders. This provides
$
*. opportunities to find interventions that modify the course of these diseases
predicted to be of major impact on our aging population."
The results were published online August 2 in  
 .
Dr. Jefferson acknowledged additional research is needed. "It is premature to
Using Framingham data, the researchers looked at 1504 participants free of
encourage screening of cardiac index values or related interventions to
clinical stroke, transient ischemic attack, or dementia. They reviewed brain
improve low cardiac index values."
and cardiac magnetic resonance images and neuropsychological and
laboratory data. (
 #* 

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á 6
 
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 #,
 
In multivariable-adjusted models, the researchers found that cardiac index
  
    ,  
- < 
was positively related to total brain volume (,= .03) and information
 5   5  


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processing speed (,= .02) but was inversely related to lateral ventricular
 

  
 
  
 
 
volume (,= .048).
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By Lynne Peeples
NEW YORK (Reuters Health) Jul 30 - Most stroke survivors will suffer falls,
and strategies to prevent them continue to be inadequate, suggests a new
meta-analysis from Australia.
Up to three in four stroke survivors fall within six months of their stroke.
"Although research has shown that fall prevention programs including
days 2 weeks apart. Thirteen (72%) of the 18 subjects completed both study
phases.
The Montgomery-Asberg Depression Rating Scale (MADRS) was used to rate
subjects at baseline and at 40, 80, 110, and 230 minutes and on days 1, 2, 3, 7,
10, and 14 after infusion. Change in MADRS score was the primary outcome.
exercise are effective for older people, it was unclear whether these, or any


other interventions, work for people with stroke," lead researcher Francis
Batchelor of the University of Melbourne told Reuters Health by e-mail.
So Batchelor and colleagues pooled and analyzed the results of 13 studies
involving nearly 1,500 people.
The studies tested a wide range of interventions to prevent falls after strokes,
from strength training to medications, the researchers reported online July
8th in Stroke.
But the only strategy their review found to be effective was vitamin D
supplementation, and even that only worked for women in nursing homes and
other institutions at least two years after they had suffered a stroke.
Overall, the team was surprised to find so few quality trials addressing this
common problem. Most of the studies were primarily designed to look at an
outcome other than falls, and the majority used stand-alone interventions that
may not have been effective enough for this high-risk group.
Batchelor noted that future trials should evaluate a multifaceted fall-reducing
program for people with stroke and should also look more closely at the
potential benefit of vitamin D supplementation on falls for both men and
women, and in earlier stages after stroke.
,+6 3
78
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According to the investigators, within 40 minutes, depressive symptoms
improved significantly in those receiving ketamine compared with those
receiving placebo (d = 0.52; 95% confidence interval [CI], 0.28 Ȃ 0.76); this
improvement was greatest at day 2 (d = 0.80; 95% CI, 0.55 Ȃ 1.04) and
remained significant through day 3.
Twelve (71%) of 17 subjects responded to ketamine, and 1 (6%) of 16
responded to placebo at some point during the study, the researchers say,
with response defined as 50% improvement from baseline on the MADRS. The
median time to response was 40 minutes. Response to ketamine lasted for an
average of 6.8 days (SE, 1.4 days); 4 patients responded for 1 week, and 3
additional patients had a response lasting 2 weeks or more.
In addition to the MADRS, statistically significant differences favoring
ketamine were also evident on the Hamilton Scale for Depression, the self-
rated Beck Depression Inventory, the visual analog scale for depression and
anxiety, and the Hamilton Anxiety Rating Scale.
"These findings are particularly noteworthy because a substantial proportion
of study participants had been prescribed complex polypharmacy regimens in
the past with substantial treatment failures," Dr. Zarate and colleagues note in
their report. The average number of past antidepressant trials was 7, and
more than 55% of participants failed to respond to electroconvulsive therapy.

4 3




4 

The drug was generally well tolerated; dissociative symptoms, only at the 40-
August 3, 2010 Ȅ A single intravenous dose of the *-methyl-D-aspartate
minute time point, was the most common adverse effect, a finding "consistent
(NMDA) antagonist ketamine hydrochloride produces a robust antidepressant
with all published studies using ketamine," the study authors note. Manic
effect within 40 minutes in patients with treatment-resistant bipolar
symptoms developed in 1 subject receiving ketamine and 1 receiving placebo.
depression (BPD), according to results of a controlled "proof-of-concept"
study published in the August issue of the  
%  
, . $
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"What is particularly noteworthy," Carlos A. Zarate, Jr., MD, told$ Joseph R. Calabrese, MD, director of the Mood Disorders Program and
$
*, "is that we demonstrated that it is possible to produce an onset codirector of the Bipolar Disorders Research Center, University Hospitals Case
of antidepressant effects in treatment-resistant BPD within 1 hour, which Medical Center, Case Western Reserve University, Cleveland, Ohio,
usually takes weeks or longer."
* that Dr. Zarate "continues to make landmark
"In my opinion, these results and other related work raise the bar in drug
development for BPD in that we should develop treatments that result in an
antidepressant response in hours instead of weeks," added Dr. Zarate, who is
chief of the Experimental Therapeutics & Pathophysiology Branch, Division of
Intramural Research Program, National Institute of Mental Health, Bethesda,
Maryland.
Several lines of evidence have recently converged to suggest that dysfunction
in the glutamatergic system, particularly the NMDA receptor complex, plays a
key role in the pathophysiology of BPD. The new study supports this line of
thinking.
The randomized, placebo-controlled, double-blind, crossover, add-on study
told $$
contributions to the field of mood disorders in general and bipolar disorder in
particular.
"His work has shown that increased glutamatergic release results in an almost
immediate acute antidepressant response in patients who are in the
depressed phase of bipolar I and II disorder. It is the depressed phase of
bipolar disorder where our patient live their symptomatic lives, suffer the
most, and, in all too many instances, end their life by completing a suicide
attempt," added Dr. Calabrese, who was not involved in the current study.
Dr. Zarate and colleagues note that the small size of the study and the
inclusion only of the subgroup of patients with treatment-resistant BPD who
were relatively late in their illness are 2 limitations of their study. The findings
can therefore not be generalized to other patients with BPD with different
involved 18 adults with   !
$ 

$ 
  
illness and course characteristics (ie, rapid cycling course and current
  , BPD resistant to lithium or valproate. The subjects had a mean
substance use disorders).
age of 47.9 years and a mean length of illness of 27.6 years.
They also say it is possible, although unlikely, that the response seen was due
They were maintained at therapeutic levels of lithium or valproate and given
to lithium or valproate rather than ketamine. It is also possible, although again
either an infusion of ketamine hydrochloride (0.5 mg/kg) or placebo on 2 test
unlikely, they say, that the patients who got better with ketamine had cycled
out of their major depressive episode.
The transitory dissociative symptoms seen with ketamine could have
compromised the study blinding.
"The primary shortcoming of this research that limits its clinical utility is the
method by which ketamine needs to be administered, by intravenous
infusions," said Dr. Calabrese. He is hopeful the pharmaceutical industry will
"use Dr. Zarate's scientific thesis and now supportive data to develop new
treatments that have not only robust short- and long-term efficacy in the
depressed phase of bipolar I or II disorder, but now, with almost immediate
onset."
The survey also revealed that overall in children receiving psychiatric care
more than 20% of preschoolers and one-third of school-aged children are
affected by insomnia.
Despite a lack of safety and efficacy data to support the use of
pharmacotherapy for the treatment of insomnia and other sleep disturbances
in children and adolescents, the study authors note that these are the primary
indications for the prescription of psychotropic medications in these patients
in the United States and abroad.
They also note that medications remain the treatment of choice even though
previous research suggests nonpharmacologic approaches, including cognitive
behavioral therapy, relaxation techniques, or sleep restriction, can be effective
in treating pediatric insomnia.
(
 #á   
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 In addition, there are currently no medications specifically approved for use
 
 !  #* 


 
   !-   as hypnotics in children younger than 18 years.

     4  
 
 
) 
   # #
  4      "Yet treatment of insomnia symptoms with both over-the-counter and
   ;     5! prescription medication is a common clinical practice, particularly for children
   
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  and adolescents with special needs and comorbid psychiatric disorders," said
Dr. Owens.

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July 30, 2010 Ȅ A national survey of child and adolescent psychiatrists shows
that insomnia affects up to a third of children and adolescents receiving
psychiatric care and that at least 25% of these patients receive either
prescription or nonprescription medications to treat the problem.
Led by Judith Owens, MD, investigators at Hasbro Children's Hospital in
"Insomnia is a significant clinical problem in children treated by child
psychiatrists for a variety of behavioral, neurodevelopmental, and psychiatric
conditions. Management with a broad array of psychotropic medications is
common and indicates a highly variable clinical approach to insomnia in this
pediatric population," the study authors conclude.
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Providence, Rhode Island, surveyed 1273 members of the American Academy
of Child and Adolescent Psychiatry to examine clinical practice patterns
regarding nonprescription and prescription medication for insomnia.
The investigators found 96% of clinicians recommended at least 1
prescription medication in a typical month and 88% recommended an over-
the-counter medication.
The investigators report that Ƚ-agonists were the most commonly prescribed
insomnia medication for attention-deficit/hyperactivity disorder (81%),
O!!
August 2, 2010 Ȅ More than one fourth of childhood cancer survivors treated
with potentially cardiotoxic therapies have an abnormal cardiac function as
young adults, according to new research.
Helena J. van der Pal, MD, with the Department of Medical Oncology, at the
Emma Children's Hospital/Academic Medical Center, Amsterdam, the
Netherlands, and colleagues reported the findings in the July 26 issue
of  
á  
$ .

significantly higher than in mental retardation/developmental delay (67%),

mood (40%), or anxiety disorders (31%). Trazodone was the most commonly
prescribed insomnia medication for children with mood (78%) and anxiety
disorders (72%).
Antidepressants as a class were also commonly used for children in these
According to Dr. van der Pal and colleagues, studies evaluating cardiovascular
toxicity in this setting have produced variable results. "Several population
based studies observed a 6- to 8-fold increased mortality owing to CVD
[cardiovascular disease] among childhood cancer survivors compared with
the general population," they note.

diagnostic groups. Atypical antipsychotics, anticonvulsants, and short-acting

hypnotics were also more likely to be used in children with mood disorders.
Melatonin was recommended by more than one-third of respondents.
"The most important rationale for the use of sleep medication among child
psychiatrists is to manage the effects of sleep disruption on daytime
To evaluate the incidence of cardiovascular toxicity further, they conducted
echocardiograms in 525 young adults who had survived at least 5 years after
treatment with potentially cardiotoxic therapies (anthracyclines, cardiac
irradiation, high-dose cyclophosphamide, or high-dose ifosfamide). Of those,
514 were assessed for left ventricular shortening fraction (LVSF).

functioning. It is important to note, however, that concerns about side effects

Overall, the median LVSF was decreased by 33.1% (range, 13.0% - 56.0%),
and the lack of evidence regarding their effectiveness were cited as significant
and 27% of patients were defined as having subclinical cardiac dysfunction,
barriers to their use," Dr. Owens said in a statement.
defined as LVSF of less than 30%.
"Despite the high frequency and use and the wide range of medications
On multivariate analysis, the strongest predictors of subclinical cardiac
chosen, practitioners also expressed a number of significant concerns about
dysfunction were higher cumulative anthracycline dose, thoracic irradiation,
the appropriateness of sleep medication in general for children," Dr. Owens
and diagnosis at a younger age.
added.

High-dose cyclophosphamide and ifosfamide were not associated with a

The study is published in the August issue of !
$ .
reduction of LVSF, whereas vincristine sulfate was associated with a trend
towards decreased cardiac function (,= .07). When adjusted for antitumor
efficacy, epirubicin hydrochloride was comparable to doxorubicin in
cardiotoxicity, and both seemed more cardiotoxic than daunorubicin
hydrochloride.
"Continued monitoring of all childhood cancer survivors treated with
potentially cardiotoxic therapy with or without subclinical cardiac dysfunction
is necessary to identify (childhood cancer survivors) who could possibly
benefit from early treatment, which could avoid further deterioration of
cardiac function," the authors conclude.
In the latest study, Dr. Newman and colleagues compared disease patterns and
selected clinicopathologic features among white and black American patients
with breast cancer and African women with breast cancer who were treated at
the Komfo Anokye Teaching Hospital in Kumasi, Ghana.
The study cohort included 1008 white American women, 581 black American
women, and 75 Ghanaians, all of whom were diagnosed with invasive breast
cancer. The mean age at the time of the diagnosis for Ghanaian women was 48
years, which was considerably lower than the median 60.7 years for black
American women and 62.4 years for white American women (, = .0019).
( #   
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 ( 
  
  The authors noted that the percentage of grade 3 lesions was also higher for

  
 
  the Ghanaian patients, as was the tumor size. Approximately three quarters
(76%) of the Ghanaian patients were also diagnosed with ER-negative tumors
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compared with 36% for black American women and 22% for white American
July 29, 2010 Ȅ A link between estrogen receptorȂnegative (ER-negative) and women. Ghanaian women also had the highest prevalence of triple-negative
triple-negative breast cancer and African ancestry has been reported again in breast cancers observed in this group.
a new study published online July 22 in  .
4 v3 

v

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Researchers from the University of Michigan Comprehensive Cancer Center in
Ann Arbor report that in their cohort, 82% of African women and 26% of  4

  =

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American women of African ancestry had triple-negative disease. This was O3

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compared with 16% of white American patients with breast cancer. Mean tumor size, cm 1.95 (0.1 - 2.30 (0.1 - 3.20 (0.9 -
<.001
(range) 14.0) 15.0) 9.0)
As previously reported by $$
*, black women tend to be 243/828 202/450
Grade 3 (%) 57/75 (76) .007
diagnosed at a younger age, present with a more advanced stage of disease at (29.3) (44.9)
diagnosis, and have a higher risk for recurrence. They are also more likely to 218/995 208/576
ER-negative (%) 57/76 (76) <.0001
(21.9) (36.1)
present with the triple-negative phenotype (negative for ER, progesterone
receptor [PR], and human epidermal growth factor receptor 2 [HER2]), and 249/827 199/443 32/48d
PR-negative (%) .0001
(30.1) (44.9) (66.7)
are more likely to be ER-negative, which makes these women ineligible for
hormone therapy. 641/836 332/442 46/48
HER2/neu-negative (%) .0001
(76.7) (75.1) (95.8)

Although the overall incidence of breast cancer among American black women ER-negative, PR-negative, 122/763 107/405 37/45
.0001
HER2-negative (%) (16.0) (26.4) (82.2)
is lower than in white women, breast cancerȂrelated mortality is higher.
ER-positive and/or PR-
However, even though multiple factors play a role in this disparity, studies 472/763 200/405
positive HER2-negative 6/45 (13.3) .019
have also shown that there may be biologic differences involved. (61.9) (49.4)
(%)

"While there are socioeconomic, cultural beliefs, and lifestyle factors involved,
we believe that molecular differences also contribute to the more aggressive
clinical features of breast tumors seen in these women," said Lori Field, PhD,
the lead author of a study on genetic differences between black and white
patients with breast cancer that was presented at the American Association
for Cancer Research 2008 Annual Meeting. Dr. Field was with the Windber
Research Institute, in Pennsylvania, when she presented her data.
Within this cohort, 28 white American women (2.8%), 46 black American
women (7.9%), and 57 Ghanaian women (76%) were diagnosed with poorly
differentiated and stage III/IV breast cancer. An absence of expression of ERs
was observed in 77.2% (n = 44) of Ghanaian women, 67.4% (n = 31) of black
American women, and 50.0% (n = 14) of white American women (, = .043)

Another recent study reported that triple-negative disease is 3-fold more
common in black women compared with other races, regardless of age or
body mass index. (   . 2009;11:R18).
# ! 

The authors also stratified the 2 cohorts of American women according to
their menopausal status and then compared this status with the frequency of
triple-negative breast cancers. Among premenopausal patients, black women
had a higher prevalence of triple-negative breast cancer compared with white

:/# !
4:/# !  women, at 32.3% vs 25.2%. Both of these percentages were significantly
"A primary message of this work is that initiation of mammography screening
at age 40 is particularly important for African-American women because of
their increased risk for early-onset disease and for disease that is biologically
more aggressive," said lead author Lisa A. Newman, MD, MPH, director of the
Breast Care Center at the University of Michigan.
"Early detection of triple-negative breast tumors is extremely important," she
lower than the rate observed among Ghanaian patients (82%), of whom the
majority was younger than the commonly used menopausal surrogate
cutpoint of 50 years. However, the authors point out that regardless of age,
non-triple-negative tumors were rare among Ghanaian patients.
"Our study documented provocative patterns of increasing frequency for early
onset/younger age at diagnosis, ER-negative/PR-negative, and triple-negative
breast cancers in association with presumed increasing extent of African
told $$
*. "I personally advocate for mammography ancestry," the authors write. Further study of the breast cancer burden in
screening beginning at age 40 for white American women as well, in accord African women could lead to identifying tumors or germline markers
with American Cancer Society and American College of Surgeons associated with high-risk disease, they suggest.
recommendations."
"Research programs that promote inclusion of African-American women onto
clinical trials are extremely exciting," said Dr. Newman, pointing out that most
National Cancer InstituteȂfunded clinical trials' cooperative groups have
Special Populations/Diversity Committees that specifically focus on enhanced
accrual of diverse patient populations.
"I am currently working with my colleagues at the University of Michigan to
develop clinical trials for breast cancer that we hope to activate in Ghana," she
added.
"To our knowledge, this is the first national observational cohort study
evaluating the impact of linezolid therapy on time to discharge, in-hospital
mortality, therapy discontinuation, and readmission," Dr. LaPlante and
colleagues note. They conclude: "Among our national cohort of MRSA infected
patients, linezolid was as effective as vancomycin with similar in-hospital
survival and readmission rates by treatment group."
Drs. LaPlante and Caffrey added one more point: "In our study population,
linezolid was utilized much less frequently than vancomycin. Small numbers
can affect our ability to detect significant differences between treatments. As
$
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more patients are treated with linezolid in the future, a clearer picture of its
By Robert Saunders effectiveness by infection type and its impact on mortality will emerge."

NEW YORK (Reuters Health) Aug 03 - Among patients hospitalized for  


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methicillin-resistant Staphylococcus aureus (MRSA) infection, treatment with
linezolid is as effective as "gold standard" treatment with vancomycin,
researchers say.
In fact, length of stay is shorter with linezolid, they report in Antimicrobial
Agents and Chemotherapy published online on July 26.
The findings are from a review of MRSA-infected patients admitted to all
Veterans Affairs hospitals over a 6-year period. The aim was to quantify the
"real-world clinical impact" of linezolid compared to vancomycin in this
diverse population, according to the three authors of the report, all based at
the University of Rhode Island in Providence.
August 3, 2010 Ȅ End-of-life discussions are difficult for doctors, a
surgeon/writer admits in an essay entitled "Letting Go" that appeared in the
August 2 issue of the *: ) magazine.
There is a fine balancing act in these discussions between not killing hope and
confronting other possibilities, including death. However, "talking about dying
is enormously fraught," writes Atul Gawande, MD, a general and endocrine
surgeon at Brigham and Women's Hospital in Boston, Massachusetts. He is
also an associate professor of surgery at Harvard Medical School, and has been
a staff writer at the magazine since 1998.
Many doctors admit to finding end-of-life discussions difficult, and often delay
*. It is an issue that
"We identified 20,107 patients treated with linezolid (3.2%) or vancomycin
(96.8%)," with the majority treated in the southern part of the U.S., the team
reports.
Two of the authors, Dr. Kerry LaPlante and Dr. Aisling R. Caffrey, commented
on the low percentage of linezolid-treated patients. "Our data show that
linezolid use has steadily increased since its approval in April of 2000," they
told Reuters Health in an e-mail. "Among our MRSA-infected population, 10%
of patients received linezolid and 71% received vancomycin. We excluded
patients that received both linezolid and vancomycin during their hospital
stay since we would not have known which drug was responsible for the
outcome. We had a lot more patients who received linezolid, but needed to
exclude 80% of them since they also received vancomycin."
Outcomes data were adjusted based on propensity scores. The median time
from starting treatment to discharge was 6 days in the linezolid group and 9
days in the vancomycin group. The length of stay was significantly shorter
among patients treated with linezolid when adjusted for propensity score
(hazard ratio 1.38) and in matched propensity analyses (HR 1.70).
"Patients who received linezolid were discharged from the hospital sooner,
but remained on the drug longer," Drs. LaPlante and Caffrey pointed out. "As
linezolid is available as an oral tablet, clinicians may be inclined to send
patients home earlier to complete their course of therapy. This is in contrast
to vancomycin which is available for treatment only as intravenous
formulations."
Furthermore, the authors report, "A significantly decreased rate of therapy
discontinuation was observed in the linezolid group (adjusted HR 0.64;
matched HR 0.49)."
During hospitalization, 7.6% of patients died. The median survival time was
not significantly different in the two treatment groups, and neither was the
readmission rate. Among patients followed after discharge, 9.2% in both
groups were readmitted within a year because of MRSA infection.
them, as previously reported by$$
many oncologists have to grapple with on a regular basis in their clinical
practice, and it is regularly discussed in scientific journals and meetings. But
in writing on the topic at length in the *: ) , a magazine known for arts
and cultural essays and humorous cartoons, Dr. Gawande brings the issue to a
public forum.
In the article, he asks: "What should medicine do when it can't save your life?"
He illustrates the piece with several case histories. One patient was a young
woman diagnosed with advanced lung cancer late in her first pregnancy.
Although terminally ill, she was always optimistic that another treatment
would help, and Dr. Gawande describes how he was "swept along by her
optimism" and was unable to confront her with her likely grim prognosis.
"Doctors are especially hesitant to trample on a patient's expectation. You
worry far more about being overly pessimistic than you do about being overly
optimistic," he writes.
At the back of his mind was the "long tail of possibility" that this patient might
be the one who defies the odds.
There is nothing wrong with such hope, he says, unless "it means we have
failed to prepare for the outcome that is vastly more probable." In the case of
the patient he was describing, this hope unfortunately left her and her family
unprepared to deal with her death.
"We've created a multimillion-dollar edifice for dispensing the medical
equivalent of lottery tickets Ȅ and have only the rudiments of a system to
prepare patients for the near-certainty that those tickets will not win," he
writes.
 
#

!
"The issue has become pressing, in recent years, for reasons of expense," he
points out. The terminally ill account for a lot of the soaring cost of healthcare
Ȅ 25% of all Medicare spending goes toward the 5% of patients in their final
year of life, and "most of that money goes for care in the last couple of months,
which is of little apparent benefit."
Spending on cancer tends to follow a pattern, he notes. There are high initial
costs as the cancer is treated, and then, if all goes well, these costs taper off.
For a breast cancer survivor, the average medical spend in 2003 was $54,000,
most of it on the initial diagnosis, surgery, and where necessary radiation and
chemotherapy.
However, for a patient with a fatal version of the disease, the cost curve is U-
shaped, rising again toward the end, he points out. For a breast cancer patient
with incurable disease, the average medical spend in the last 6 months of life
was $63,000 in 2003.
"Our medical system is excellent at trying to stave off death with $8000-per-
month chemotherapy, $3000-a-day intensive care, and $5000-an-hour
surgery. Bt ultimately death comes, and no-one is very good at knowing when
to stop."
"Fear of death (and facing death) seems to be a uniquely 20th century
American problem," suggested one reader in an online commentary. "Why
shouldn't there be continuous end-of-life discussions, held more casually
during life's progression and not under the gun (if you will) at the end of one's
life."
That reader criticized doctors for not being straightforward in discussing
death, and called for more honesty. This was also a theme that emerged from a
panel discussion at the National Comprehensive Cancer Network earlier this
year, when experts urged "straight talk with compassion."
However, Dr. Gawande questioned whether these issues "are THAT culture-
specific. I think it is common everywhere to come across people who hope
against hope that they can be saved," and suggested that this is "just human
nature."
"It seems to me that our job in medicine is to just deal with it. If we have to
wait for people to stop yearning for the long tail Ȅ for the lottery ticket Ȅ in
order to help them, we will be hurting a lot of people for a long time to come,"
Dr. Gawande said. "Instead, we need to become more effective in using the

A
techniques that experts already have for walking people through these
moments in their lives."
This question of when to stop is a modern problem, Dr. Gawande points out.

One way to improve is through training. "Experience alone does not produce
"For all but our most recent history, dying was typically a brief process. . . . The
improvement. You can communicate badly for 30 years," he pointed out.
interval between recognizing that you had a life-threatening ailment and
death was often just a matter of days or weeks."
"But deliberate practice with coaching makes for measurable improvements,"
he said. "And that's likely what we need in medicine. We train and retrain for
"These days, swift catastrophic illness is the exception; for most people, death
surgical skills. We probably need to do so for these discussions with
comes only after long medical struggle with an incurable condition Ȅ
terminally ill patients, as well," he concluded.
advanced cancer, progressive organ failure. . . . In all such cases, death is
certain, but the timing isn't. So everyone struggles with this uncertainty Ȅ the OO# 
 
O# 
 O3
 
 /3

how, and when, to accept that the battle is lost."
August 2, 2010 Ȅ As if a "black box" warning currently on the label were not
enough to get anyone's attention, today the US Food and Drug Administration
In the article, Dr. Gawande praises hospice care, and gives several examples of
(FDA) again reminded clinicians that nimodipine (*; Bayer
patients who greatly benefited from such care, including a young man with
Pharmaceuticals) should be given only by mouth or through a feeding tube
advanced pancreatic cancer. But he admits that all this was a revelation to
and never by intravenous (IV) administration, a method that could be fatal.
him; his new understanding was gained first-hand after having accompanied a
hospice nurse on her rounds.
Nimodipine, available only as an oral capsule, is used in critical-care settings
to treat neurologic complications from subarachnoid hemorrhage.
Previously, he had equated hospice with "giving up" and a morphine drip, and
he is certain that this view is shared by many doctors and patients.
The FDA states that it continues to receive reports of IV administration of the
drug, which sometimes has resulted in death or near-death events.
In a live phone-in question-and-answer session with readers, a hospice
Intravenous administration of nimodipine can cause cardiac arrest, dramatic
worker commented on how patients and their caregivers often say "we wish
drops in blood pressure, and other cardiovascular adverse events, according
we'd known about you sooner," and asks: "Shouldn't this be a wake-up for
to the agency.
physicians? For the benefit of their patients and their patient's families?"

In 1996, Bayer added a bolded statement to the drug's label to warn against
The hospice worker also noted that there appears to be a reluctance among
incorrect administration after 1 patient who received nimodipine the wrong
physicians to discuss hospice with their patients, but at the same time there is
way died. In 2006, the company added a boxed warning against giving
an enthusiasm for "palliative care." The 2 are actually very similar, she
nimodipine intravenously or by other parenteral routes.
pointed out: "What can we do to make physicians understand that hospice is
just an extension of palliative care?"
Through its Adverse Event Reporting System (AERS) and other sources,
including published literature, the FDA has identified 31 cases of nimodipine
Another person phoning in highlighted cultural differences, and described
errors between 1989 and 2009, with 25 involving the prescription or
several scenarios in the Netherlands in which patients' wishes to stop
administration of the drug intravenously. Four patients who received
treatment and die were respected. Dr. Gawande acknowledged the point, and
nimodipine intravenously died while another 5 came close. One patient
wondered if there is more of a problem in the United States than elsewhere.
suffered permanent harm, according to the agency.
He mentioned statistics from Sweden, where there has been a shift from
around 90% to 30% in cancer patients dying in hospital over the past 2
33"

 
v

8 8v 

decades, although he noted that some American centers have seen similar
shifts in end-of life care. Sometimes nimodipine is administered intravenously despite repeated
warnings to the contrary when a patient is not able to swallow the capsule.
Such patients are supposed to receive it through a nasogastric tube. The drug
comes with instructions for making a hole in both ends of the capsule with a
standard 18 gauge needle, removing the contents with a syringe, and
emptying the syringe into the tube.
The agency noted that because a standard needle will not fit on an oral
syringe, it must be attached to an intravenous syringe. "The use of intravenous
syringes to deliver nimodipine increases the chance that the medication will
be given intravenously instead of by mouth or nasogastric tube," the FDA
stated.
Clinicians can minimize confusion in these circumstances by labeling the
syringe with the words "Not for IV Use" and removing the needle, according to
the agency. They then should empty the syringe contents into the nasogastric
tube followed by 30 mL of normal saline.
More information about today's announcement is available on the FDA's Web
The FDA said it was not recommending changes in the use of positive-
displacement needleless connectors. Instead, it is referring clinicians
to infection prevention guidance issued by a task force of the Society for
Healthcare Epidemiology of America and the Infectious Diseases Society of
America. Recommendations for avoiding central-line catheterȂassociated
bloodstream infections include the following statement: "Do not routinely use
positive-pressure needleless connectors with mechanical valves before a
thorough assessment of risks, benefits, and education regarding proper use."
The agency is requiring the 9 manufacturers of positive-displacement
needleless connectors to compare their bloodstream infection rates in
patients hooked up to central-line catheters with infection rates for other
kinds of connectors, including negative-displacement, neutral-displacement,
and split-septum varieties. The manufacturers also must investigate whether
patient demographics, comorbidities, severity of illness, and device-cleansing
practice figure into the risk comparison.
site. / 3 
39
!/O



August 6, 2010 Ȅ Allowing certified registered nurse anesthetists (CRNAs) to

O4c   !:
3
/v






 provide anesthesia without physician supervision resulted in no evidence of
increased inpatient deaths or complications, a new study published in the
July 30, 2010 Ȅ The US Food and Drug Administration (FDA) is requiring 9
August issue of 


  found.
companies that make positive-displacement needleless connectors for
intravenous (IV) therapy to assess whether these devices pose a higher risk
The analysis of Medicare data for 1999 to 2005, encompassing more than
for bloodstream infections than other types of needleless connectors, the
481,000 hospitalizations, found that allowing CRNAs to work independently
agency announced yesterday.
without oversight by an anesthesiologist or surgeon had little or no effect on
mortality and morbidity rates.
Although needleless catheter connectors spare healthcare workers the danger
of contracting an infectious disease from a needle stick, such connectors have
Authors Brian Dulisse and Jerry Cromwell, health economists at the Research
increased the risk for catheter-related bloodstream infections, infection-
Triangle Institute in Waltham, Massachusetts, recommended that the Centers
control expert William Jarvis, MD, told $$
*.
for Medicare & Medicaid Services (CMS) permit the nation's 37,000 nurse
anesthetists to work independently without first requiring state governments
Yesterday's FDA announcement focuses on a single element of connector
to formally petition for an exemption, as 14 states have already done. "This
design that affects how the device operates after clinicians inject a drug or
would free surgeons from the legal responsibility for anesthesia services
fluid into the bloodstream and then disconnect a syringe or administration set.
provided by other professionals. It would also lead to more cost-effective care
In a negative-displacement connector, a vacuum is created inside the catheter
as the solo practice of CRNAs increases," the authors said.
that can fill up with blood. This backflow of blood can lead to clotting, which
requires clinicians to add an anticoagulant such as heparin to saline flushes as
The research was funded by the American Association of Nurse Anesthetists
a precaution, said Dr. Jarvis, president of the consulting firm Jason and Jarvis
(AANA), which applauded the study. "Since the late 1990s, we've been on
Associates.
record calling for the elimination of supervision for nurse anesthetist
services," AANA President-Elect Paul Santoro, CRNA, MS, told $
In contrast, the internal mechanisms of a positive-displacement connector
$
*. "This antiquated regulation places undue costs on the
create a positive pressure that keeps blood from flowing back into the
healthcare system. Local institutions should be free to decide for themselves.
catheter. Not having to contend with retrograde blood simplifies the work of
This study confirms our position and is supported by several previous
preventing catheter occlusion.
studies."

However, the FDA stated that it has received 3 reports of death associated
In a blistering response posted on its Web site yesterday, the American
with bloodstream infection and positive-displacement needleless connectors.
Society of Anesthesiologists said the 


  study "is an advocacy
In addition, the agency noted multiple clinical reports since 2006 that show a
manifesto masquerading as science and does a disservice to the public. It
link between the introduction of such connectors in a hospital or unit and a
makes dangerous public policy recommendations on the basis of inadequate
higher rate of bloodstream infections, followed by a lower rate once the
data, flawed analysis and distorted facts."
facility switched to another kind of needleless connector.

CMS reimbursement rules prohibited payments to CRNAs unless they are

Dr. Jarvis said the problem of higher infection rates appears to stem from
supervised by either an anesthesiologist or the surgeon. In 2001, CMS issued a
positive-displacement needleless connectors having a more complex design
rule that states could seek an exemption from the oversight rule.
than other connectors. The complexities make the devices harder to disinfect,
flush completely, and use correctly. (An article by Dr. Jarvis recently published
By 2005, 14 governors in mostly rural states were granted permission to opt
in á
   
( elaborates on the design of needleless connectors
out of the supervision requirement. "Solo practice by CRNAs is especially
in general.)
important in rural areas, where anesthesiologists are in short supply," Dulisse
and Cromwell write.
O 


:v
v


4 :
=



The authors used Medicare inpatient (part A) and carrier (part B) data to
study inpatient mortality and complications. It included 481,440
hospitalizations, of which 68,744 were in states that opted out of the
supervision requirement.
They found that the proportion of surgeries performed in which anesthesia
was administered by CRNAs without supervision increased by 5 percentage
points in both opt-out and non-opt-out states.
"Despite the shift to more anesthetics performed by nurse anesthetists, no
increase in adverse outcomes was found.... In fact, declining mortality was the
norm," they said. "The mortality rate for the nurse anesthetist solo group was
lower than for the anesthesiologist solo group.
"These results do not support the hypothesis that allowing states to opt out of
the supervision requirement resulted in increased surgical risks to patients.
Nor do the results support the claim that patients will be exposed to increased
risk as a consequence of more nurse anesthetists' practicing without physician
Ethnicity plays a role in earlier puberty, says researcher Frank M. Biro, MD,
director of the division of adolescent medicine at Cincinnati Children's
Hospital Medical Center, Cincinnati. So does body composition.
"We found that girls who are African-American matured before whites, and
that's been shown in several studies," Biro tells WebMD. "White girls are
maturing earlier than they had before, compared to 20 years earlier."
In his study of 1,239 girls, 10% of whites, 23% of African-Americans, and 15%
of Hispanic girls had breast development indicating onset of puberty by age 7,
Biro found.
Biro can't give an average age of puberty at this time, he says, because many
girls in the study have not yet developed breasts. Over time, further analysis is
expected to provide that and other information.
supervision," they concluded. The study is published online in the journal , 

The American Society of Anesthesiologists said the study "reflects the O#  @ 
weaknesses of billing data when used to make an assessment of safety and
Biro and his colleagues took a ''snapshot in time'' or cross-sectional look at
quality." The data do not distinguish between complications resulting from
girls who were recruited at three sites when they were aged 6 to 8 in 2004-
surgery or anesthesia, nor do they discriminate between conditions existing
2006. They lived in East Harlem, New York, Cincinnati, or the San Francisco
before surgery and those resulting from surgical or anesthetic care.
Bay area.
"The existing Medicare policy requiring physician supervision of nurse
The researchers assessed the onset of puberty by a standard measurement of
anesthesia is rooted in the overwhelming preference of patients, particularly
breast development.
Medicare beneficiaries, for a physician to be responsible for their anesthesia
care. Suggesting that this patient preference be pushed aside on the basis of
They compared the findings to a 1997 study of age of puberty. They found
flimsy analytics is irresponsible," said the statement from the American
that:
Society of Anesthesiologists.

c   /


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$
4


 @Y 10.4% of white girls in the current study had breast development,
August 9, 2010 Ȅ The influenza A (H1N1) 2009 monovalent vaccine
manufactured in 2009 in multidose vials will have a shorter expiration period
than indicated on the label, according to the manufacturer, Sanofi Pasteur. The
information was distributed last week via the Health Alert Network of the US
Centers for Disease Control and Prevention.
The expiration date will affect approximately 16 million doses of vaccine
manufactured in 2009 that have not yet been administered but have been
shipped to providers. Although still effective, the vaccine is losing potency
more rapidly than expected and will require that the shelf life be shortened.
Sanofi Pasteur has notified the US Centers for Disease Control and Prevention
and the US Food and Drug Administration of this change and will provide
more specific notification of which lots will be affected and the new expiration
date shortly. The company also will send a notification to providers who
received this product regarding the specific lot numbers and the new
expiration date.
According to the manufacturer, the new expiration date is to ensure that the
vaccine is used while it remains within its potency specification. However,
they maintain that no safety concerns are associated with the vaccine and that
individuals who were vaccinated from multidose vials do not need to be
revaccinated.
The decreased potency was detected with stability testing, which involves
measuring the strength of a vaccine over time after it has been shipped to
providers.
@=

#  
August 10, 2010 Ȅ The age of puberty is declining for girls, with more girls
developing breasts by age 7 than in years past, according to a new study.
compared to 5% in the 1997 study.
@Y 23.4% of African-American girls had beat development, compared
to 15.4% in the 1997 study.
Besides ethnicity, body mass index or BMI was found to play a role in onset of
puberty, Biro's team found. Girls who had breast development at age 7 were
more likely to have a higher BMI. Body fatness has been linked with onset of
puberty in girls, other research by Biro and others has shown.
The study was conducted within the Breast Cancer and the Environment
Research Centers (BCERC), established in late 2003 as a partnership with the
National Institute of Environmental Health Science and National Cancer
Institute, which funded the research. Research suggests that women with
breast cancer started their periods earlier, and that those with earlier onset of
periods have an increased breast cancer risk.
  @ 

#

#
The researchers also collected urine and blood specimens from the girls to
look at levels of compounds called endocrine-disrupting chemicals, Biro says,
to see what role these environmental exposures might play in early puberty.
''It appears that some of the endocrine-disrupting chemicals are interacting
with body composition and this may be the reason some girls are going into
puberty earlier and others later," Biro tells WebMD. "That would have to be
speculation," he says of the interaction idea. "But we do know BMI is doing it."
Among 6- to 11-year-olds, obesity has increased from 6.5% in 1976-1980 to
19.6% in 2007-2008, according to the CDC.
Endocrine-disrupting compounds or EDCs are found in a host of consumer In an accompanying editorial, Julia Shelley, associate professor of health and
products, ranging from personal care products such as antibacterial soaps to social development at Deakin University in Melbourne, Australia, discusses
furniture and anti-stain fabrics some of the methodologic issues regarding this study and earlier studies.

3
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O


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v


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4 
4 

August 11, 2010 Ȅ Women may not need to delay pregnancy after an initial
miscarriage, according to the results of a retrospective, Scottish populationȂ
based cohort study reported Online First August 5 in the $
"How long a couple should wait before trying for another pregnancy after a
miscarriage is controversial," write Eleanor R. Love, from the University of
Aberdeen in Aberdeen, Scotland, and colleagues. "Some clinicians believe that
there is little justification for delaying the next pregnancy, as an increased
interpregnancy interval is unlikely to improve perinatal outcomes, whereas a
new viable pregnancy and the birth of a child could enhance the women's
v

August 12, 2010 Ȅ The use of postmenopausal hormone therapy (HT)
dropped from about 40% of eligible women to about 20% after the 2002
report from the Women's Health Initiative (WHI) clinical trial that found an
elevated risk for breast cancer associated with HT, but about 30 million
women per year still use HT in the United States.
New data from the California Teachers Study might renew concern about this
link.
In a report published online August 10 in   
 ) =
chances of recovery.... Current guidelines from the World Health Organization
,   , Tanmai Saxena, an MD/PhD student at the Keck School of
recommend that women should wait for at least six months before trying
Medicine at the University of Southern California, in Los Angeles, and
again, whereas others suggest a delay of up to 18 months, based on reports
colleagues found that women who used estrogen therapy (ET) for more than
that interpregnancy intervals of 18-23 months after a live birth can enhance
15 years had a 19% greater risk of developing breast cancer than women who
maternal and perinatal outcomes in the next pregnancy."
had never used ET.

The goal of this study was to evaluate the optimal interval to subsequent
The authors also found that breast cancer risk was higher for women who
pregnancy after miscarriage in a first recorded pregnancy. At Scottish
took postmenopausal hormones for longer periods, and highest for those
hospitals between 1981 and 2000, a total of 30,937 women who had a
using combined estrogen plus progestin (EPT).
miscarriage in their first recorded pregnancy and subsequently became
pregnant were followed up during the second pregnancy. The main study
Current use of either ET or EPT was associated with higher risk than past use
outcome was miscarriage, live birth, termination, stillbirth, or ectopic
of the same regimen, and risk increased with the number of days per month of
pregnancy in the second pregnancy, and secondary endpoints were rates of
progestin in a current EPT regimen.
cesarean and preterm delivery, low birth weight infants, preeclampsia,
placenta previa, placental abruption, and induced labor in the second Notably, the results suggest that there is also an increased risk for tumors that
pregnancy. are HER2-positive. The study is one of the first to include data on HER2 status.

Compared with an interval of 6 to 12 months between the miscarriage and v ! 

second conception, an interval less than 6 months was associated with lower
risks for repeated miscarriage (adjusted odds ratio [OR], 0.66; 95%
confidence interval [CI], 0.57 - 0.77), termination (OR, 0.43; 95% CI, 0.33 -
0.57), and ectopic pregnancy (OR, 0.48; 95% CI, 0.34 - 0.69). The risk for an
ectopic second pregnancy was greater with an interpregnancy interval
exceeding 24 months (OR, 1.97; 95% CI, 1.42 - 2.72), as was the risk for
termination (OR, 2.40; 95% CI, 1.91 - 3.01).
The researchers analyzed HT use and the subsequent development of breast
cancer in 56,867 perimenopausal and postmenopausal women, 2,857 of
whom (5%) were subsequently diagnosed with pathologically confirmed
invasive breast cancer. Mean follow-up was 9.8 years. The analysis included
type, pattern, and recency of HT use.
Breast cancer expert Rowan T. Chlebowski, MD, PhD, from the University of
Compared with women who had an interpregnancy interval of 6 to 12 months,
*that clinicians should
those who conceived again within 6 months and had a live birth in the second
pregnancy were less likely to have a cesarean delivery (OR, 0.90; 95% CI, 0.83
- 0.98), preterm delivery (OR, 0.89; 95% CI, 0.81 - 0.98), or low-birth-weight
infant (OR, 0.84; 95% CI, 0.71 - 0.89). However, they were more likely to have
labor induced (OR, 1.08; 95% CI, 1.02 - 1.23).
"Women who conceive within six months of an initial miscarriage have the
best reproductive outcomes and lowest complication rates in a subsequent
pregnancy," the study authors write.
Limitations of this study include potential lack of uniformity in documenting
gestational age and outcomes of interest as well as possible misclassification.
This study also evaluated only miscarriages that led to hospital contact, and
the findings therefore cannot be generalized to all women with a miscarriage.
"Our research shows that it is unnecessary for women to delay conception
after a miscarriage," the study authors conclude. "As such the current WHO
[World Health Organization] guidelines may need to be reconsidered. In
accordance with our results, women wanting to become pregnant soon after a
California, Los Angeles, told$$
consider several points when interpreting data from this observational study.
First, Dr. Chlebowski, who was lead author of the WHI study of EPT
($2003:289:3243-3253), noted that the significant increase in breast
cancer risk in the California Teachers Study was associated with the use of
estrogen alone for 15 years or more, but that in real-world settings, few
women take any type of ET or EPT for more than a few years. "The patient
who is continuing to take ET or EPT after 15 years might also be different
from a typical patient in other ways," he said. Also, in the WHI randomized
trial, there was a strong trend toward lower breast cancer risk with ET.
Dr. Chlebowski pointed out that the California Teachers Study investigators
controlled for differences in mammography use only in the last 2 years of the
9.8-year follow-up. He said that because women taking HT are known to have
more mammograms, the data might partly reflect differences between
screened and unscreened populations. "We know that with screening we find
more, smaller, lower-grade, and [estrogen-receptor]-positive tumors," he said.


 !


  v

/ 

miscarriage should not be discouraged."
August 10, 2010 Ȅ Finasteride (,  ) has been associated with a reduction But the PCPT results aside, what dominates this whole issue is that
in the risk for prostate cancer, but its use as a chemopreventive agent remains chemoprevention involves asking a man to take a medication for the rest of
limited, according to a new survey published in the September issue of    his life, explained Dr. Mohler. Studies suggest that even if a drug has very few

 ) =,    adverse effects, many individuals Ȅ even if they are at an increased risk Ȅ
are not receptive to chemoprevention unless there is a clear benefit.
Even after the results of the Prostate Cancer Prevention Trial (PCPT) showed
that men who used finasteride had a significant reduction in prostate cancer, In an editorial published in the April 1 issue of the * 
  


the majority of physicians did not change their prescribing patterns.
The first results from the PCPT, which looked at 18,000 men, were published
in 2003 and showed that finasteride use was associated with a 25% reduction
in the risk for prostate cancer.
The American Society of Clinical Oncology and the American Urological
Association issued a joint guideline in 2009 recommending that 5-alpha
reductase inhibitors be considered for prostate cancer prevention in healthy
asymptomatic men with a prostate-specific antigen (PSA) level of 3.0 ng/mL
or less who receive regular screening for prostate cancer.
But according to the new survey, 64% of urologists and 80% of primary care
$  (2010;362;1237-1238), Patrick C. Walsh, MD, notes that dutasteride
and finasteride do not prevent prostate cancer but simply shrink tumors that
have a low lethal potential.
"Because PSA levels are suppressed, men may have a false sense of security,
and if prostate cancer ever develops, the diagnosis may be delayed until they
have high-grade disease that may be difficult to cure," cautions Dr. Walsh, a
University Distinguished Service Professor of Urology, James Buchanan Brady
Urological Institute, Johns Hopkins Medical Institutions, Baltimore, Maryland,
in his editorial.
In the new survey, the authors failed to consider several of the reasons why
finasteride isn't being widely prescribed for chemoprevention, Dr. Walsh
physicians never prescribe finasteride for prostate cancer chemoprevention.
*. "It is not . . . approved for this purpose [by the US
The authors note that 55% of urologists expressed concern about inducing
high-grade tumors, and 52% of primary care doctors were unaware that
finasteride could be used as a chemopreventive agent.
told $$
Food and Drug Administration]," he said. He added that "if men are followed
closely and have their PSA corrected for the effect of the drug, it does not
reduce the number of men with a positive biopsy."

4

33
A He also noted that with long-term treatment, there is a greater risk for high-
grade disease. This was observed in a Finnish study, where men using
4

 



3!

 3
finasteride for more than 4 years had a risk for high-grade disease that was
increased by a factor of 2.6 (   . 2009;101:843-8).
Some experts feel that it is premature to be recommending the use of 5-alpha
reductase inhibitors for chemoprevention. "In spite of the size of the PCPT,
$39O
 

=
there is no clear benefit of chemoprevention at this time," said James Mohler,
MD, associate director and senior vice-president of Translational Research,
and chair of the Department of Urology at the Roswell Park Cancer Institute in
Buffalo, New York.
Dr. Mohler was not involved in either the PCPT or this survey and was
In this survey, Linda S. Kinsinger, MD, MPH, from the VHA National Center for
Health Promotion and Disease Prevention, in Durham, North Carolina, and
colleagues hypothesized that trends in finasteride prescribing would correlate
with the publication of the PCPT. In addition, they expected that VHA
urologists would be more likely than primary care physicians to prescribe the
approached by $$
* for independent comment.
agent for chemoprevention.

"There may be a benefit, but unfortunately we're going to need further study,
They evaluated trends in monthly new and total prescriptions for finasteride
especially research designed for high-risk groups in which it would be easier
that were filled within the VHA from January 2000 to December 2005. A total
to detect an advantage to chemoprevention," he said.
of 302 urologists and 1072 primary care providers were included in the final
survey, for a total of 1374 participants.
Dr. Mohler noted that the results of the survey were very predictable, because
the results of the PCPT were published in 2003 Ȅ only 2 years before the end
During the study period, 237,286 patients received a new prescription for
of the time period covered in this survey. "The initial message conveyed was
finasteride, and use of the drug increased during the 5-year time period.
that 25% of prostate cancers were prevented, but those that were diagnosed
However, the rate of finasteride prescribing did not change significantly after
were more likely to be poorly differentiated and life-threatening," said Dr.
the publication of the PCPT. Of physicians who reported changing prescribing
Mohler.
patterns, only 0.8% of urologists and 1.4% of primary care doctors reported
being influenced by the PCPT.
In the PCPT, the proportion of high-grade tumors (Gleason grade η 7) was
27% higher in the finasteride group (6.4% vs 5.1%). Three explanations have
Of physicians who reported using finasteride for chemoprevention, 6% of
been offered for this finding, Dr. Mohler explained, but all were published in
urologists and 8% of primary care physicians reported that they "use it
2008 Ȅ which was after the period covered in the new survey.
broadly," whereas 71% of urologists and 41% of primary care physicians said
they reserve it for those perceived to be at high risk for the disease. Both
"In my mind, this study is not very important because the prescribing habits of
groups of physicians listed moderate to severe benign prostatic hypertrophy
urologists and primary care physicians should not have changed by
as the patient factor most likley to make them prescribe finasteride as a
December 2005, because the main message was still that the PCPT was a big
chemopreventive agent.
disappointment," he added. The authors "surveyed physicians at times that
were not temporally associated with knowledge in the field. Even today, with
Overall, survey respondents reported little patient interest in prostate cancer
the REDUCE trial findings concerning dutasteride for chemoprevention and
chemoprevention. The majority of primary care physicians (84%) and
more knowledge about the PCPT trial, whether one should take either remains
urologists (57%) said patients inquired about chemoprevention "never" or
unclear in my mind."
"only a few times." In a similar vein, 84% of primary care physicians and 37%
of urologists reported never raising the issue with patients; 14% and 51%, c
  $
" 
 

 
 
respectively, said they raise it "occasionally." August 6, 2010 Ȅ Worse mental health is linked to osteoarthritic (OA) pain
and pain flares, according to the results of a study reported in the July issue
Dr. Kinsinger pointed out that although they didn't directly survey patients,
.
factors such as not wanting to take a daily medication, cost, and adverse
effects could certainly affect the interest of physicians' and patients' in
prostate cancer chemoprevention.
of X    
"Pain varies over time, both over extended periods and over shorter periods,"
said lead author Barton L. Wise, from Boston University School of Medicine in
Boston, Massachusetts, and the University of California Davis Center for
4 
3 
8 3
 O>3; 
August 6, 2010 Ȅ In patients with mild Alzheimer's disease (AD), deep brain
stimulation (DBS) modulates specific brain circuits important in memory and
is safe, according to results of the first phase 1 study of DBS for AD, published
online July 30 in the  

* 
.
In addition, cognitive tests, including the AD Assessment Scale cognitive
subscale (ADAS-Cog) and the Mini-Mental State Examination (MMSE)
suggested possible improvements and/or slowing in the rate of cognitive
decline in some patients, the study team reports.
"We have been able to see that 3 of the 6 patients have deteriorated less than
one would have expected so DBS is also potentially useful in the treatment of
Alzheimer's," Andres M. Lozano, MD, PhD, FRCSC, of the University of Toronto,
Toronto Western Research Institute, in Ontario noted in a telephone interview
Healthy Aging, in a news release. "The same person can feel little or no pain in
their knee or hip, and later they can feel moderate-to-severe pain even when
the extent of damage to the knee or hip joint as seen on x-ray imaging remains
the same."
The goal of the study was to determine associations between mental health
and OA pain in a sample of 266 participants (75 men and 191 women) with
hip and/or knee OA from the Longitudinal Examination of Arthritis Pain
(LEAP) study. Mean age was 65.0 years; mean body mass index was 31.5
kg/m2; and in 82%, knee was the primary site of OA.
The Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
pain subscale and the 5-item Mental Health Inventory (MHI-5) were evaluated
in weekly interviews for 12 weeks. Using linear regression, the investigators
determined associations between MHI-5 quartiles and change in MHI-5 with
with $$
*. WOMAC pain and change in WOMAC pain 1 week later, after adjustment for
age, sex, body mass index, and medications.
Ronald C. Petersen, MD, PhD, who was not involved in the study,
told $$
*: "The fact that they were able to affect a memory- Repeated measurements correlations were accounted for with use of
relevant system in the brain is interesting and that's a good thing, but to say generalized estimating equations. In a case-crossover study, the investigators
that this could be a treatment for Alzheimer's disease I think is probably also used conditional logistic regression to determine the association of MHI-5
premature; that's a whole other kettle of fish." with the risk for pain flare.

Dr. Petersen is director of the Alzheimer's Disease Research Center at the "Pain is difficult to study in part because experiences and reporting of pain
Mayo Clinic, Rochester, Minnesota, and a member of the American Academy of differ from one person to another," Dr. Wise said. "There can be differences in
Neurology. people's central or peripheral nervous systems, past experiences of pain or
cultural differences in perceptions of pain, and these make it very complicated
3 

;
O
In this phase 1 study, Dr. Lozano said he and his colleagues leveraged their
experience using DBS in Parkinson's disease and depression. "We thought just
as you can stimulate circuits that control movement or mood, it might also be
possible to drive under performing circuits that control cognitive function and
memory in patients with Alzheimer's," he explained.
The study involved 6 patients (2 female, 4 male) who met National Institute of
Neurological and Communicative Disorders and StrokeȂAlzheimer's Disease
and Related Disorders Association diagnostic criteria for probable (mild) AD.
The subjects had a mean MMSE score at baseline of 22.3. Their mean age was
60.7 years. Two were receiving ongoing treatment with donepezil, 1 with
donepezil plus memantine, 2 with reminyl, and 1 with rivastigmine.
All patients received DBS stimulation to the fornix/hypothalamus region at 3.0
to 3.5 V with the frequency set at 130 Hz and the pulse width at 90
microseconds. Treatment lasted for 12 months. The fornix, the study authors
explain, constitutes the major inflow and output pathway from the
hippocampus and medial temporal lobe. Its importance in memory function is
supported by studies in animals and humans showing that lesions in this area
produce memory deficits.
With the targets identified, electrodes were implanted bilaterally with
fluoroscopic guidance while the patient was awake. They were discharged 1 to
3 days later with stimulators turned off and returned 2 weeks later to have the
stimulators turned on.
to look at differences in pain across individuals. Our study design helped
eliminate some of those obstacles, [but] it's likely that people's pain is the
result of a large group of different factors rather than something as simple as
one specific physiological factor."
In the quartile with the highest MHI-5, mean WOMAC score was 2.93 vs a
mean WOMAC score of 4.57 in the quartile with the lowest MHI-5 (, for trend
across quartiles < .001). Case-crossover analysis of 91 subjects revealed that
the odds of a pain flare were 2.11 times greater in periods after the worst
MHI-5 quartile vs periods with the best MHI-5 quartile (, < .001).
"We found that increased levels of pain were associated with worse mental
health at baseline," Dr. Wise said. "And further, pain flares were associated
with poorer mental health during the week prior to the pain flare."
Limitations of this study include combining participants with hip and knee OA
into 1 cohort and inability to address reverse causality.
"We have shown that worse or worsening mental health precedes reporting of
worse OA-related pain and OA pain flares," the study authors write. "With the
paucity of effective interventions for OA pain and the toxicities of some in
common use, mental health may represent a new therapeutic target for OA
pain, with potential significant opportunities for both patients and
physicians."
In an accompanying editorial, R. Geenen and J.W.J. Bijlsma from University
Medical Center and Utrecht University in Utrecht, the Netherlands, discuss
psychological management of OA pain and possible underlying mechanisms.
"Because disease-modifying therapies in OA are lacking, the management of
chronic pain is often insufficient," Drs. Geenen and Bijlsma write. "The group
of older patients with OA is at risk for comorbid problems such as sleeping
problems, loneliness, and mood problems. In selected patients with OA of the
knee or hip, life-style and therapeutic interventions that improve mental and
social well-being Ȅ and that could possibly also reduce pain Ȅ should be
considered."
(5  


 !
factors were identified," said second author Tuhina Neogi, MD, PhD, FRCPC,
from Boston University School of Medicine in Boston, Massachusetts.
"Additionally, ensuring the new criteria reflects the opinions of front-line
rheumatologists diagnosing and treating patients in clinical practice is key to
their ultimate acceptance."
Phase 3 involved integrating the findings from phases 1 and 2, refining the
scoring system, and identifying the optimal cutoff point to diagnose RA.

$ 
 á  
  
    1 6

,    "To be classified as having 'definite RA,' patients must receive a score of six or
%
!&
  %
#


X ", >  greater (out of a possible 10)," said coauthor Alan J. Silman, MD, FRCP,
16 )   #* 
á 


? FmedSci, DSc (Hons), from Arthritis Research UK in Chesterfield, United
  5  


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$ 
  Kingdom. "The scoring system takes into consideration the number and
á  
      1 6

,  ( site/size of involved joints, laboratory tests of inflammation and auto-
   

  
 
  
 
  immunity, and symptom duration."

/83 Ov  


c 

   43 
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O>3; 
August 11, 2010 Ȅ Revised American College of Rheumatology (ACR) criteria
for rheumatoid arthritis (RA), developed in collaboration with the European
League Against Rheumatism (EULAR), may allow diagnosis before joint
damage occurs, according to a report published online August 10 and
appearing in the September print issue of   =.
The rationale for developing new classification criteria for RA was that the
1987 ACR (known at that time as the American Rheumatism Association)
classification criteria were criticized for their lack of sensitivity in early
disease. Furthermore, new disease-modifying antirheumatic drugs (DMARDs)
that can prevent joint damage from RA have become available since 1987.
"The 1987 criteria actually posed a major barrier to the study of treatments
designed to prevent joint damage in RA," said senior author Gillian Hawker,
MD, MSc, FRCPC, from Women's College Hospital and University of Toronto in
Ontario, Canada, in a news release. "Many patients did not fulfill the previous
RA classification criteria until their disease was well-advanced, and in many
 and is already generating media attention.
cases joint damage had already occurred. This truly limited RA researchers
from studying the disease at its earlier phases, which is critical to the
development of new treatments to prevent damage."
v 
August 11, 2010 Ȅ Cerebrospinal fluid contains important information that
should be part of the clinical diagnosis and care of patients with mild cognitive
impairment, report researchers. Using lumbar punctures, investigators
identified 3 biomarkers that predict who is most likely to develop Alzheimer's
disease.
Researchers detected a signature of low cerebrospinal fluid levels of Ⱦ-
amyloid 1-42, high total tau protein, and elevated phosphorylated tau181P.
Overall, the diagnostic sensitivity was 90% for Alzheimer's disease with a
specificity of 64%. These results were consistent in 3 independent data sets.
The investigators, led by Geert De Meyer, PhD, from Ghent University in
Belgium, point out that the unexpected presence of these biomarkers in more
than a third of cognitively normal subjects suggests that Alzheimer's disease is
"active and detectable earlier than has heretofore been envisioned."
The work was just published in the August issue of the  

* 
The researchers report the cognitively normal group with the Alzheimer's
disease signature was enriched in apolipoprotein E ɂ4 allele carriers.


,  
These results were validated on other data sets. In a study consisting of 68
autopsy-confirmed Alzheimer's cases, 64 patients were correctly classified
Beginning in 2008, a joint working group from the ACR and EULAR developed
(94% sensitivity). Another data set with 57 patients with mild cognitive
a new, 3-phase approach to classifying RA, using an updated paradigm to
impairment followed up for 5 years showed a sensitivity of 100% in patients
identify characteristics that best discriminated between those patients newly
progressing to Alzheimer's disease.
presenting with undifferentiated inflammatory synovitis who were and those
who were not at high risk for persistent and/or erosive disease.
"We strongly recommend cerebrospinal analyses of Ⱦ-amyloid 1-42, high total
tau protein, and elevated phosphorylated tau181P in circumstances where
In the first phase, which was headed by EULAR, the panel reviewed available
having a definitive diagnosis of Alzheimer's disease is important for
evidence from patients with early RA to identify factors best predicting "high
counseling patients about such concerns as work, driving, and making other
risk of developing the more persistent and erosive arthritis that we currently
lifestyle changes," note Dr. Herskovits and Dr. Growdon.
consider to be RA," said first author Daniel Aletaha, MD, MS, from Medical
University of Vienna in Vienna, Austria.

#
33





"All classification criteria need to be built on scientific evidence, either from

The editorialists point out that most family physicians and internists are not
the literature, or as with these criteria, from extensive analysis of real patient
skilled or experienced in performing a lumbar puncture and may not embrace
data," Dr. Aletaha said.
cerebrospinal fluid analyses unless they could refer patients to a central
facility.
The ACR spearheaded the second phase of criteria development, which aimed
to determine consensus opinion among practicing rheumatologists regarding
"Neurologists are trained to perform lumbar punctures," they add, "but those
key factors reflecting the individual probability for the development of chronic
in busy practice and on the senior staff at teaching hospitals may have done
joint damage characteristic of RA.
very few since their residency. They too might welcome the idea of
establishing or expanding a lumbar puncture clinical unit in their outpatient
"Both scientific evidence and the experience of RA experts needed to be
considered in the development of the new criteria to ensure all important
practice or hospital setting and devoting a morning every week or month, Sustained immune activation can lead lymphocytes to develop DNA mutations
according to the need." that promote their proliferation and progression to NHL.

Expense is a relative measure and should be viewed in a cost-benefit context, 

Dr. Herskovits and Dr. Growdon add. In most centers, the consulting
physician's bill, the charge for neuropsychological testing, and the cost of a
magnetic resonance brain scan are all greater than obtaining cerebrospinal
fluid values.

4 $33 

August 11, 2010 Ȅ Patients with hepatitis B (HBV) infection are twice as
likely to develop diffuse large B-cell lymphoma or some other subtype of non-
Hodgkin's lymphoma (NHL), and over 3 times more likely to develop
malignant immunoproliferation than those who are negative for hepatitis B
surface antigen (HBsAg).

These are the conclusions of a study published online August 4 in the" 
X 
by Eric Engels, MD, from the National Cancer Institute, in Rockville,
Maryland, Sun Ha Jee, PhD, from the Graduate School of Public Health, Yonsei
University, in Seoul, South Korea, and colleagues.

Dr. Jee told $$

* that"the most important finding was the
increased risk of non-Hodgkin's lymphoma, particularly diffuse large B-cell
lymphoma, which is among the most common subtypes of lymphoma. This
increased risk was almost double the risk seen in uninfected people and was
present over a period ranging up to 14 years."

The researchers used data from the Korean Cancer Prevention Study to
determine whether chronic HBV infection was associated with the subsequent
development of NHL in 603,585 people.

HBV infection was endemic in South Korea until 1995, when the universal
HBV vaccination of neonates was implemented. Before that, about 7% of
South Korean adults had detectable plasma concentrations of HBsAg, which is
an indication of chronic HBV infection. HBV infection remains common in
South Korean adults because of infections acquired in childhood, before the
vaccine was available.

The analysis showed that 53,045 study subjects (9%) were positive for HBsAg
at baseline. NHL developed subsequently in 133 people who were hepatitis B
positive and in 905 who were hepatitis B negative. The NHL incidence was
19.4 per 100 000 person-years in the positive group, and 12.3 per 100 000
person-years in the negative group (hazard ratio [HR], 1·74; 95% confidence
interval [CI]. 1.45 - 2.09, adjusted for sex, age at baseline, and enrolment year).
NHL risk was consistently higher in the positive group during the 14 years of
follow-up.

The researchers also examined the risk for various NHL subtypes. They found
an increased risk for diffuse large B-cell lymphoma (HR, 2.01) and for other or
unknown subtypes (HR, 1.65).

They also found a nearly 4-fold increased risk for malignant

immunoproliferation, a constellation of immune disorders related to NHL (HR,
3.79).

Hepatitis B positivity was not associated with follicular or T-cell NHL,

Hodgkin's lymphoma, multiple myeloma, or various leukemias.

Several studies have already established a causal link between hepatitis C

(HCV) infection and increased risk for NHL, but studies on hepatitis B and NHL
have so far been small. The link to NHL for both HBV and HCV is thought to
involve chronic immune stimulation in the setting of sustained liver infection.