MedicalResearch.com Breaking Medical Research News August 30 2015

MedicalResearch.com
Exclusive Interviews with Medical Research and
Health Care Researchers from Major and Specialty Medical
Research Journals and Meetings
Editor: Marie Benz, MD
info@medicalresearch.com
August 30 2015
For Informational Purposes Only: Not for Specific Medical Advice.

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Transient Neonatal Hypoglycemia Linked To Poorer Educational Attainment Ten Years Later
MedicalResearch.com Interview with: Jeffrey R. Kaiser, MD, MA
Professor of Pediatrics and Obstetrics and Gynecology Section of Neonatology
Baylor College of Medicine Texas Children’s Hospital
Houston, TX 77030
 Medical Research: What is the background for this study? What are the main
findings?
 Dr. Kaiser: The continuous utero-placental-umbilical infusion of glucose ends at
birth, and levels decrease during the first 1–2 hours stimulating counterregulatory
hormones and promoting successful glucose homeostasis in healthy newborns. This
is important because the newborn brain principally uses glucose for energy, and
prolonged and severe hypoglycemia has been linked with poor long-term
neurodevelopment. Most previous newborn hypoglycemia-outcome studies, however,
are problematic because they did not control for maternal educational level and
socioeconomic status, factors that are highly associated with childhood
neurodevelopment and academic success. Further, little is known about whether
newborn transient hypoglycemia (1 low value followed by a second normal value),
frequently considered to be a normal physiological phenomena with no serious
sequelae, is associated with poor academic achievement. To address this knowledge
gap, we compared initial newborn glucose values from the universal glucose-
screening database, available only at the University of Arkansas for Medical Sciences
(UAMS), to their matched student achievement-test scores in 4th grade (10 years
later).
Read the rest of the interviews on MedicalResearch.com
Content NOT an endorsement of efficacy and NOT intended as specific medical advice.

Houston, TX 77030
After controlling for gestational-age group, race, gender, multifetal gestation, insurance,
maternal education, and gravidity, we observed transient hypoglycemia in a
heterogeneous cohort of newborns born at a university hospital was associated with
lower fourth-grade achievement-test scores—real-world assessments that predict high
school graduation, college attendance, and long-term adult economic success.

Houston, TX 77030
 Medical Research: What should clinicians and patients take away from your
report?
 Dr. Kaiser: It is currently recommended by National pediatric bodies to only screen
newborns with symptomatic hypoglycemia and those at high risk of developing
hypoglycemia. Our study, which evaluated both at risk and normal newborns,
however, suggests early transient newborn hypoglycemia is associated with poorer
academic performance at 10 years. Importantly, our results must be interpreted
cautiously, as we did not prove transient newborn hypoglycemia causes poor
academic performance. Until our results are corroborated by others, universal
newborn glucose screening should not be undertaken.

Houston, TX 77030
 Medical Research: What recommendations do you have for future research as
a result of this study?
 Dr. Kaiser: High-quality multicenter long-term follow-up studies should be performed
to direct future newborn hypoglycemia screening and treatment guidelines.
 Citation:
 Jeffrey R. Kaiser et al. Association Between Transient Newborn Hypoglycemia and
Fourth-Grade Achievement Test ProficiencyA Population-Based Study. JAMA
Pediatrics, 2015 DOI:10.1001/jamapediatrics.2015.1631

Use of Statins in Very Elderly Rises Sharply
MedicalResearch.com Interview with: Michael Johansen MD MS
Assistant Professor – Clinical Dept of Family Medicine
The Ohio State University
findings?
 Dr. Johansen: -Over the last 15 years there has been increasing emphasis placed
on the use of statins to decrease people’s risk of heart attacks and strokes.
Individuals with known heart disease are recommended to be on statins. However,
there is no convincing evidence that elderly individuals (>79 years of age) without
heart disease benefit from statins.
 Therefore, we investigated how use patterns of statins has changed over the last ~14
years. We identified a dramatic increase in statin use in the very elderly during the
time of the study. As of 2012, around 1/3 of very elderly individuals without heart
disease took a statin during that year.

report?
 Dr. Johansen: The application of clinical trials into clinical practice if tricky, but is
critical to provide the best care for patients. This appears to be another instance
where someone was accepted into clinical practice prior to trial evidence that shows
that it works. Patients, families, and clinicians should take another look at the use of
statins in the the very elderly. When given the risks and benefits of the drugs, some
people will continue to take them, but many will decide against continuing them.

 Dr. Johansen: Determining whether the medications are continued from younger age
or if people are started at an advanced age would be interesting. In addition,
determining if the users of statins are generally sicker would also provide value.
 Citation:
 Michael E. Johansen, Lee A. Green. Statin Use in Very Elderly Individuals, 1999-
2012. JAMA Intern Med., 2015 DOI:10.1001/jamainternmed.2015.4302

Overreaction of Brain’s Alarm Clock May Be Involved in PTSD
MedicalResearch.com Interview with: Robert C. Froemke, PhD, Assistant professor
NYU Langone and Skirball Institute of Biomolecular Medicine
New York Medical Research: What is the background for this study? What are the main
findings?
 Dr. Froemke: We studied how a brain area called the ‘locus coeruleus’ is involved in
hearing. The locus coeruleus is the brain’s alarm clock, it’s a small region deep in the
brainstem that is responsible for arousal and wakefulness, activated by surprising or
potentially dangerous events. The locus coeruleus releases the neurochemical
noradrenalin (similar to adrenalin) throughout the brain to greatly increase brain activity,
and so might convey the significance of sounds related to past events that were very
important or startling in some way (like the sound of an alarm, a baby crying, or other
sounds that require immediate attention).
 We found that sounds related to surprising events can come to directly activate the locus
coeruleus, meaning that this brain area can learn from past experience. This learning
happens quickly (within seconds to minutes) and can be incredibly long-lasting, up to
weeks as measured in our study, and we suspect indefinitely or all life-long. We studied
this by training lab rats to respond to sounds, poking their nose in a hole to get a food
reward whenever they heard a certain sound. We activated the locus coeruleus briefly in
some of these animals, and observed that they were much more sensitive to this sound
and learned much faster than other unstimulated animals. We made recordings of electrical
activity in the locus coeruleus and the auditory cortex, one of the major ‘hearing’ parts of
the brain. In stimulated animals, sounds activated the locus coeruleus within tens of
milliseconds, releasing noradrenalin into the auditory cortex to greatly boost the audio
processing there- making almost every neuron respond very vigorously to that special
sound.

New York
report?
 Dr. Froemke: The locus coeruleus is absolutely essential for brain function,
particularly waking up and paying attention to important occurrences in the
environment. Hearing- including speech and language skills- require paying attention
to certain sounds, ignoring background noise and understanding the meaning of
words and phrases, which are learned from experience. We think that the locus
coeruleus is part of this system for understanding what different sounds represent.
 Some sounds, like predator growls, gunshots, oncoming traffic or the cry of your
baby, are very important to learn about in a way that sometimes doesn’t allow much
room for error. We think that the locus coeruleus might enable these very important
sounds to be quickly learned. However, sometimes it can go too far, and there’s
evidence that the locus coeruleus and noradrenalin are involved in PTSD and anxiety
disorders, if sounds that are otherwise innocuous come to be associated with
hazards.

New York
PTSD is a very serious condition, and although the locus coeruleus and noradrenalin
have long thought to be involved in PTSD, beta-blockers (that reduce some of the action
of noradrenalin) have had limited utility as a treatment. Our results suggest instead that
other aspects of the noradrenalin system (targeted by alpha-blockers) might be involved
in the memory formation we studied here. But also that anxiety and fear memories are
widely distributed throughout the brain, making them particularly resilient to treatment.

New York
 Dr. Froemke: We are interested in determining what can reverse or augment
memory formation in the locus coeruleus, to understand if or how this process might
be related to PTSD. Also, how does sound information get into locus coeruleus, what
are the brain connections that send audio information there, and how specific is this
for certain types of sounds? Are all of these alert sounds learned from experience, or
might there be some innate preference or bias to some kinds of particularly important
or dangerous sounds?
 Citation:
 Ana Raquel O Martins & Robert C Froemke.
 Coordinated forms of noradrenergic plasticity in the locus coeruleus and primary
auditory cortex.
 Nature Neuroscience, 2015 DOI: 10.1038/nn.4090

Discontinuing Blood Pressure Medication In Older Adults Did Not Improve Cognition
MedicalResearch.com Interview with: Justine Moonen and Jessica Foster-Dingley On behalf of the principal
investigators:
Roos van der Mast, Ton de Craen, Wouter de Ruijter and Jeroen van der Grond
Department of Psychiatry, Leiden University Medical Center
Leiden, the Netherlands
findings?
 Response: Mid-life high blood pressure is a well-known risk factor for
cerebrovascular pathology and, consequently, cognitive decline in old age. However,
the effect of late-life blood pressure on cognition is less clear. It has been suggested
that at old age not a higher, but a lower blood pressure increases the risk of cognitive
decline as well as neuropsychiatric symptoms. Older persons are at risk for impaired
regulation of their cerebral blood flow, and stringently lowering their blood pressure
may compromise cerebral blood flow, and thereby cognitive function. Therefore, we
hypothesized that increasing blood pressure by discontinuation of antihypertensive
treatment would improve cognitive and psychological functioning. We performed a
community-based randomized controlled trial in a total of 385 participants aged ≥75
years with mild cognitive deficits and without serious cardiovascular disease, and
who were all receiving antihypertensive treatment. Persons were randomized to
continuation or discontinuation of antihypertensive treatment. Contradictory to our
expectation, we found that discontinuation of antihypertensive treatment in older
persons did not improve cognitive functioning at 16-week follow-up.

investigators:
report?
 Response: This trial addressed a narrowly defined research question. We can only
conclude that discontinuation of antihypertensive treatment in older persons with mild
cognitive deficits and without serious cardiovascular disease has no short-term
cognitive or psychological benefit. We cannot exclude that older persons with overt
cardiovascular disease, in whom regulation of cerebral blood flow is more likely to be
impaired, do benefit of an increase in blood pressure to improve cognitive and
psychological function. Moreover, a sustained increase in blood pressure during a
longer period than 16 weeks may be needed to prevent long-term structural cerebral
damage, such as lacunar infarcts or white matter lesions, and thereby prevent
cognitive deterioration. For the present, trials in older persons, generally including
higher functioning older persons, indicate no increased or decreased risk of cognitive
decline of antihypertensive treatment. Observational studies performed in lower
functioning older persons indicate that a lower blood pressure is associated with
increased risk of cognitive decline and total mortality. The newest recommendations
from the Eighth Joint National Committee allow blood pressures to be as high as
150/90 mm Hg for persons aged 60 years and above.

investigators:
 Response: Future randomized clinical trials with longer follow-up periods should
determine whether older persons with an impaired regulation of cerebral blood flow
might benefit from less stringent blood pressure targets. Nursing home residents
would form a study population of interest, as they often have more serious
cerebrovascular disease, and are thus prone to have an impaired regulation of
cerebral blood flow.
 Citation:
 Moonen JF, Foster-Dingley JC, de Ruijter W, et al. Effect of Discontinuation of
Antihypertensive Treatment in Elderly People on Cognitive Functioning—the DANTE
Study Leiden: A Randomized Clinical Trial. JAMA Intern Med. Published online
August 24, 2015. doi:10.1001/jamainternmed.2015.4103.

Electronic Messages Improved Timeliness of Cancer Diagnosis
MedicalResearch.com Interview with: Hardeep Singh, MD MPH Chief, Health Policy, Quality and Informatics
Program,
Houston Veterans Affairs Health Services Research Center for Innovations
Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine
Houston TX 77030
findings?
 Dr. Singh: Missed or delayed diagnoses are among the most common patient safety
concerns in outpatient settings, and measuring and reducing them is a high priority.
Our computerized triggers scanned huge amounts of patient data in the electronic
health record and flagged individuals at risk for delays in follow-up of cancer-related
abnormal clinical findings. Records of all patients flagged by the computerized trigger
algorithm in the intervention group were reviewed to determine the presence of delay
and if delay was confirmed, we communicated this information to their clinicians. We
found that patients seeing clinicians who were notified of potential delays had more
timely diagnostic evaluation for both prostate and colon cancer and more patients in
the intervention part of the study had received diagnostic evaluation by the time we
completed our final review.

Program,
Houston TX 77030
report?
 Dr. Singh: Electronic trigger-based interventions seem to be effective in reducing
time to diagnostic evaluation of colorectal and prostate cancer as well as improving
the proportion of patients who receive follow-up.Solutions that harvest and put to use
the vast amount of electronic clinical data being collected these days, are essential.

Program,
Houston TX 77030
 Dr. Singh: We need to refine and explore trigger application in other settings to
detect and monitor delays and improve timeliness of cancer diagnoses. Similar
interventions could also improve timeliness of diagnosis of other serious conditions.
 Citation:
 Electronic Trigger-Based Intervention to Reduce Delays in Diagnostic Evaluation for
Cancer: A Cluster Randomized Controlled Trial
 Daniel R. Murphy, Louis Wu, Eric J. Thomas, Samuel N. Forjuoh, Ashley N.D.
Meyer,and Hardeep Singh
 JCO JCO.2015.61.1301; published online on August 24, 2015;

Only Regular Use of Low Dose Aspirin Offers Colon Cancer Protection
MedicalResearch.com Interview with: Søren Friis, Senior Scientist, Associate Professor, MD Danish Cancer
Society Research Center
Danish Cancer Society
 Medical Research: What is the background for this study?
 Dr. Friis: Although laboratory, clinical, and epidemiological studies have all provided
strong evidence for protection against colorectal cancer from regular use of aspirin,
the optimal dose and duration of use for cancer prevention remain to be established.

 Medical Research: What are the main findings?
 Dr. Friis: Continuous use of low-dose aspirin for five or more years was associated
with a reduced risk of colorectal cancer, but overall long-term use (continuous or non-
continuous) was not. Long-term, high-intensity use (average of ≥0.3 daily doses) of
non-aspirin NSAIDs was associated with a substantially reduced risk of colorectal
cancer, particularly for NSAIDs with the highest COX-2 selectivity.
 The results for long-term continuous users of low-dose aspirin should be interpreted
cautiously, since these patients comprised only a small proportion of the low-dose
aspirin users and might have a risk profile different from that of the general
population.

report?
 Dr. Friis: Our results indicate that unless low-dose aspirin is taken continuously,
there is little protection against colorectal cancer. Our findings for non-aspirin NSAIDs
indicate a substantial protective effect against colorectal cancer from consistent long-
term use of these agents, and there was some indication that even non-continuous
use of non-aspirin NSAIDs may be effective for the prevention of colorectal cancer.
However, the use of non-aspirin NSAIDs as cancer preventive agents is hampered by
their association with cardiovascular adverse events.
 Self-medication with aspirin or non-aspirin NSAIDs is strongly discouraged, due to
the possibility of serious adverse events. The public should not take any medication
regularly without consulting with a physician.

 Dr. Friis: Additional research is needed to determine the optimal dose and duration
of aspirin use for prevention of colorectal and other cancers, with due consideration
of potential harms (gastrointestinal, cerebral) as well as other beneficial
(cardiovascular) effects.
 The cancer preventive potential of non-aspirin NSAIDs should be explored further, if
naproxen or other non-aspirin NSAIDs prove not to be associated with cardiovascular
adverse events.
 Citation:
 Søren Friis, Anders H. Riis, Rune Erichsen, John A. Baron, Henrik T. Sørensen. Low-
Dose Aspirin or Nonsteroidal Anti-inflammatory Drug Use and Colorectal Cancer
Risk. Annals of Internal Medicine, 2015; DOI:10.7326/M15-0039

Distance, Insurance and Number of Oncologists Limit Access To Chemotherapy
MedicalResearch.com Interview with: Anna Lin, MBA, PHD
Senior Epidemiologist, Health Services Research American Cancer Society, Inc.
Atlanta, GA 30303
 Dr. Lin: Evidence-based guidelines recommend the use of adjuvant chemotherapy in
patients with Stage III colon cancer within 90 days of colectomy to improve disease-
free and overall survival; however, a substantial proportion of patients do not receive
this treatment. Geographic access to care may be associated with receipt of
chemotherapy but has not been fully examined.

Atlanta, GA 30303
 Dr. Lin: The main findings of this study indicate that patients traveling more than 50
miles were less likely to receive adjuvant chemotherapy for Stage III node-positive
colon cancer. In addition, patients who had either no insurance or public (non-
private) insurance and resided in areas with low density of oncologists were less
likely to receive adjuvant chemotherapy.

Atlanta, GA 30303
report?
 Dr. Lin: While it is reassuring that most patients in this study received adjuvant
chemotherapy on time, the fact that increased travel burden was associated with a
decreased likelihood of receiving chemotherapy, regardless of insurance status is
concerning. It tells us expanded insurance coverage, while important, might not fully
address the barriers to patients receiving guideline-recommended treatment.

Atlanta, GA 30303
 Dr. Lin: Future research can perform in-depth analyses in areas that have a low
number of oncologists, to help analyze how interventions to decrease geographic
barriers might improve access to cancer treatment.
 Citation:
 Association Between Geographic Access to Cancer Care, Insurance, and Receipt of
Chemotherapy: Geographic Distribution of Oncologists and Travel Distance
 Chun Chieh Lin, Suanna S. Bruinooge, M. Kelsey Kirkwood, Christine Olsen,Ahmedin
Jemal, Dean Bajorin, Sharon H. Giordano, Michael Goldstein,B. Ashleigh
Guadagnolo, Michael Kosty, Shane Hopkins, James B. Yu, Anna Arnone,Amy Hanley,
Stephanie Stevens, and Dawn L. Hershman

How Many Screening Tests Are Needed For Psoriasis Patients on Biologics?
MedicalResearch.com Interview with: William W. Huang, MD, MPH
Assistant Professor and Program Director Wake Forest School of Medicine Department of Dermatology
Winston-Salem, NC 27104
findings?
 Dr. Huang: This particular study was an update of a previous study our group had
published in 2008 (JAAD, 6/08). As the use of biologics in dermatology has increased
dramatically in recent years, we wanted to evaluate the evidence for the screening
and monitoring tests that are routinely performed for patients with psoriasis and
psoriatic arthritis on biologic agents.
 We found that current guidelines for screening and monitoring tests varied among
various national organizations (Table 1) including the American Academy of
Dermatology, Japanese Dermatology Association, European Academy of
Dermatology and Venerology, and the British Association of Dermatologists. Using
evidence grading based on methods developed by the US Preventative Services
Task Force (USPSTF), we found that the evidence was strongest (Grade B) for
tuberculosis screening. High level evidence was in general lacking for other routine
screening and monitoring tests except in select populations (Table 2, Table 3).

report?
 Dr. Huang: In general, biologics are effective and safe treatment options for patients
with psoriasis and psoriatic arthritis who are appropriate candidates for such therapy.
The findings of this study may not necessarily be true for patients on biologics for
other medical conditions like inflammatory bowel disease and rheumatoid arthritis.
Currently the evidence is strongest for tuberculosis screening for patients with
psoriasis and psoriatic arthritis who plan to start a biologic. Other screening and
monitoring tests should be based on the provider’s assessment of a patient’s
individual risk.

 Dr. Huang: As public and private insurance carriers and other managed care
organizations are looking more and more at cost-effective care, additional studies are
needed to establish the evidence and need for screening and monitoring tests for
other treatments and medical conditions.
 Citation:
 J Am Acad Dermatol. 2015 Sep;73(3):420-428.e1. doi: 10.1016/j.jaad.2015.06.004.
Epub 2015 Jul 14.
 To test or not to test? An updated evidence-based assessment of the value of
screening and monitoring tests when using systemic biologic agents to treat psoriasis
and psoriatic arthritis.

Instant Oatmeal at Breakfast Reduced Hunger and Food Intake At Lunch MedicalResearch.com Interview
with: Candida Rebello, PhD candidate
Louisiana State University Pennington Biomedical Research Center School of Nutrition and Food Sciences
Baton Rouge , Louisiana
 MedicalResearch: What is the background for this study? What are the main
findings?
 Response: Oats contain a soluble fiber called beta-glucan. When mixed with liquids,
this fiber induces viscosity or what is commonly called thickening. The degree of
thickening depends on a number of factors such as the structure and concentration of
the fiber, its molecular weight, and the ease with which the fiber will absorb water.
These qualities of the fiber can be affected by various processing techniques used in
the preparation of food products. Viscosity affects appetite by influencing the way
foods interact with the mouth, as well as the stomach and intestines. Viscosity in the
stomach can cause distension and promote a feeling of fullness. Viscosity in the
intestinal tract delays digestion and absorption allowing nutrients to interact with cells
and release hormones that reduce hunger and keep a person full for a prolonged
period after eating a meal which is termed satiety. Viscosity in the mouth also affects
appetite and all these effects often work in concert. In animal studies, oat beta-glucan
has been shown to influence appetite regulating hormones, as well as reduce food
intake and body weight.1,2 In human trials, several studies have shown that oat beta-
glucan reduces appetite.3-10 In this study, we found that instant oatmeal eaten at
breakfast reduced hunger, increased fullness, and reduced food intake at lunch,
compared to an oat-based ready-to-eat cereal containing equal calories. Instant
oatmeal had greater viscosity than the ready-to-eat cereal.

 MedicalResearch: What should clinicians and patients take away from your
report?
 Response: While it remains to be established whether eating oatmeal every day will
result in a loss of body weight in humans, its effects on suppressing hunger,
increasing fullness, and reducing food intake are important. For most people,
adhering to a diet regimen, and coping with ill-humor stemming from hunger pangs is
difficult. This is especially so when individuals are placed on a diet, since weight loss
induces hormonal changes as well as changes in brain chemistry that increase the
impulse to eat. Foods that help individuals to cope with hunger and the desire to eat
provide a strategy for successful weight management.

 MedicalResearch: What recommendations do you have for future research as a
result of this study?
 Response: Since viscosity is important for the response in the body, more studies
are needed to understand how variations in the source, processing treatments, and
interactions with other components in food affect the fiber and the physiologic
response. This will help in the development of products containing beta-glucan that
can replace foods in the diet and keep consumers full for a prolonged period.
 Citation:
 J Am Coll Nutr. 2015 Aug 14:1-9. [Epub ahead of print]
 Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a
Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial.
 Rebello CJ1, Johnson WD, Martin CK, Han H, Chu YF, Bordenave N, van Klinken
BJ, O’Shea M, Greenway FL.

Study Finds Poor Adherence To Guidelines For Skin and Soft Tissue Infections
MedicalResearch.com Interview with: John P. Haran MD
Assistant Professor of Emergency Medicine
University of Massachusetts Medical School, Worcester, MA
findings?
 Dr. Haran: The Infectious Disease Society of America (IDSA) publishes evidence
based guidelines for the treatment of skin and soft tissue infections, however, how
closely clinicians follow these guidelines is unknown. Observation units have been
increasingly used over the past decade in emergency medicine for short-term care of
patients for many medical conditions including skin infections. These units offer a
great alternative to hospitalization especially for older adults. We set out to describe
the treatment patterns used in the observation unit of an academic institute and
compare them to the IDSA guidelines. We found that physicians had poor adherence
to these guidelines. Additionally, we discovered that older adults were at increased
risk of being over-treated while women were at increased risk for being under-treated.
These age and gender biases are not new to medicine and emergency departments
should standardize antibiotic treatments to reduce treatment bias.

University of Massachusetts Medical School, Worcester, MA
report?
 Dr. Haran: Clinicians should recognize that easy to follow guidelines are available to
help make treatment decisions for patients with a skin infection. Not using these
guidelines introduces biases and places the patient at increased risks of being either
over or under-treated for the infection. The decision to give antibiotics to a patient
with an abscess hinges on the presence of SIRS or a systemic inflammatory
response syndrome. Antibiotic abscess treatment should be given to patients with
impaired host defenses or if they are already failing antibiotic treatment. The decision
to give intravenous antibiotics for a cellulitis should depend on systemic signs of
infection, such as fever, or once again in patients with impaired host defenses or
those already failing antibiotic treatment. More aggressive antibiotic therapy does
lead to increased risks of Clostridium difficile infection and increased antibiotic
resistance while it may not be necessary for clinical treatment.

University of Massachusetts Medical School, Worcester, MA Medical Research: What recommendations do you have for future research as a result of this study?
 Dr. Haran: I would recommend two main concepts to be covered in any future research as a result of this study.
 First, these findings of poor compliance with national guidelines and biases in treatment need to be demonstrated in the
general ED population that is discharged home on antibiotics for a skin or soft tissue infection from multiple centers. One of
the main limitations of this study was that it was done at a single center.
 Second, treatment decisions need to be linked to outcomes. A patient outcome study should try to demonstrate if those
under-treated had higher rates of treatment failure and/or if those over-treated had the same rates as those that were treated
in accordance with IDSA guideline recommendations. If patients in the over-treatment category had the same failure rates
then more aggressive antibiotic treatment regimens would only lead to higher rates of antibiotic resistance and increased risk
of Clostridium difficile infection without any benefit to the individual patient.
 Citation:
 Treatment of Bacterial Skin Infections in Emergency Department Observation Units: Factors Influencing Prescribing Practice
 Haran, John P. et al.
 The American Journal of Emergency Medicine
 Received: August 7, 2015; Received in revised form: August 16, 2015; Accepted: August 17, 2015; Published
Online: August 21, 2015
 DOI: http://dx.doi.org/10.1016/j.ajem.2015.08.035

Sexual Identity More Fluid In Women
MedicalResearch.com Interview with: Elizabeth Aura McClintock PhD Assistant Professor Department of
Sociology
University of Notre Dame Notre Dame, IN 46556
 Medical Research: What is the background for this study? What are the main findings?
 Dr. McClintock: Sexual identity is a social construct that emerged in the late nineteenth century.
People have always engaged in homosexual and heterosexual behavior, but we have not always
had the concept of homosexual and heterosexual as types of personal identities. That is not to
say that sexual desire or sexual preference does not have biological origins, but the concept of
sexual identity and the specific labels that we use (gay, straight, bi-curious, etc.) are
fundamentally social in origins.
 Given that sexual identity is a social construct, social context should influence it. By social context
I mean socioeconomic position, social networks, romantic status and experience, and family,
among other factors. As a parallel example, researchers have recently shown that racial
identification depends on context–a person may be perceived differently and self-identify
differently depending as their social context changes. Extant research on sexual identity, however,
largely ignores social context. My goal was to begin to fill this gap.
 I found that several aspects of social context, including class background, educational attainment,
race, and timing of childbirth, are associated with sexual identity. Indeed, context is associated
with sexual identity net of sexual attraction. Perhaps because women have more flexible sexual
attractions (they are more likely than men to report attraction to both sexes), social context has a
larger effect on women’s sexual identity.

Sociology
report?
 Dr. McClintock: Sexual identity categories are not fixed and they are not simply a
function of sexual attraction and behavior. For example, it is not at all uncommon for
an individual to identify as heterosexual despite a capacity for same-sex attraction
and past (or current) same-sex sexual encounters. Clinicians should assess patient
needs (such as STD screening and contraception) by asking patients about sexual
behavior directly. It is not accurate to infer behavior from sexual identity. Patients
should be open with clinicians about their past and present sexual behaviors.

Sociology
 Dr. McClintock: We need more research into the processes by which sexuality
desire and behavior are translated into sexual identity. Insofar as social context may
influence this process, different groups may tend to attach a different label to the
same desires and behaviors. The implications of a given identity label for medical
needs may therefore depend on the social position of the patient.
 Citation:
 Abstract presented at the 2015 Annual Meeting of the American Sociological
Association
 The data came from the National Longitudinal Study of Adolescent to Adult
Health,

Integrating Outpatient and Hospital Electronic Health Records Is a Work In Progress
MedicalResearch.com Interview with: Professor Susan A. Sherer, Ph.D. Lehigh University
College of Business and Economics Department of Management
Bethlehem, PA 18015
 MedicalResearch: What is the background for this study? What are the main
findings?
 Dr. Sherer: With the growth in electronic health record implementation, there has
been increasing demand for integration of these records within and across practice
settings that have different work cultures, e.g. ambulatory and hospital locations. We
find that computer integration alone does not result in coordination; users must value
the integrated information and incorporate this information within their workflows.
Users must move beyond technology acceptance and adaptation to focus on and
value coordination. The system itself cannot drive these process changes; specific
work process changes must be instituted and the users must adapt these changes.

Bethlehem, PA 18015
 MedicalResearch: What should clinicians and patients take away from your
report?
 Dr. Sherer: Simply implementing electronic health records and integrating
information from disparate systems across different practice settings does not result
in coordinated care. Significant work process changes will be required to effectively
utilize this information. Implementation and integration of electronic health records
systems is an evolutionary process that requires time and work practice change in
order for clinicians to adjust, learn to trust the data, and incorporate coordination
goals. During this evolution, as clinicians use the systems and begin to recognize
their value for coordinated care, their views on the role of standardization and
electronic health records for coordinated care must evolve.

Bethlehem, PA 18015
 MedicalResearch: What recommendations do you have for future research as a
result of this study?
 Dr. Sherer: As clinicians begin to use electronic health record systems to coordinate
across the continuum of care, we need further research and development of systems
that can determine what information is most important and what needs to be
integrated and presented at different specific points of care, reducing the burden on
the clinicians to find the appropriate information. We also need research and
development of more sophisticated tools that support care, not just care coordination,
including improved decision support and practice guideline tools.
 Citation:
 Int J Med Inform. 2015 Sep;84(9):683-93. doi: 10.1016/j.ijmedinf.2015.05.010. Epub
2015 May 22.
 Integrating commercial ambulatory electronic health records with hospital systems:
An evolutionary process.
 Sherer SA1, Meyerhoefer CD2, Sheinberg M3, Levick D3.

Many Patients with Clinical Alzheimer’s Do Not Have Significant Amyloid Pathology
MedicalResearch.com Interview with: Dr. Eric Reiman MD Executive Director, Banner Alzheimer’s Institute (BAI)
Chief Executive Officer, Banner Research Clinical Director of the Neurogenomics
Director, Arizona Alzheimer’s Consortium Phoenix Arizona

findings?
 Dr. Reiman: Beta-amyloid plaque deposition is a cardinal feature of Alzheimer’s
disease. Recent positron emission tomography (PET) have suggested that about
one-fourth of patients with the clinical diagnosis of mild-to-moderate Alzheimer’s
dementia—and more than a third of those who had no copies of the APOE4 gene, the
major genetic risk factor for Alzheimer’s—do not have appreciable amyloid plaque
deposition. We wondered whether this finding reflected an absence of appreciable
brain amyloid, particularly in APOE4 non-carriers, or instead an underestimation of
amyloid plaques using PET. In those patients with minimal plaque deposition, we also
wondered what percentages had neuropathological evidence of another dementia-
causing disease, neurofibrillary tangle pathology (the other cardinal feature of
Alzheimer’s, or no known pathological contribution.

 We surveyed data from the 100 APOE4 non-carriers and 100 APOE4 carriers who
had the clinical diagnosis of mild-to-moderate Alzheimer’s dementia during their last
visit at any of the nation’s Alzheimer’s Disease Centers and had an autopsy
performed within the next 2 years.
 As we reported in JAMA Neurology, 37 percent of APOE4 non-carriers and 13
percent of APOE4 carriers with a clinical diagnosis of mild-to-moderate Alzheimer’s
had minimal evidence of neuritic or diffuse amyloid plaques—and those for whom we
had brain samples had no evidence of increased soluble amyloid. A proportion of
individuals had a different neuropathological diagnosis. While nearly half of those
patients with minimal amyloid or any other pathology had extensive tangle formation,
a similar percentage was found in cognitively unimpaired persons in the same age
range.
 Our findings suggest the PET findings are correct – that a quarter of all patients (and
more than a third of APOE4 non-carriers) with the clinical diagnosis of Alzheimer’s
dementia do not have appreciable amyloid pathology, and that about 10 to 15 percent
of patients do not have a clear explanation for their dementia.

report?
 Dr. Reiman: Current investigational therapies for the treatment and possible
prevention of Alzheimer’s disease are targeting beta-amyloid buildup in the brain. The
findings of this study suggest that a small but significant subset of patients with mild-
to-moderate Alzheimer’s may not benefit from these anti-amyloid treatments because
they do not have the cardinal beta-amyloid buildup in their brains.

 Dr. Reiman: Additional studies are needed to determine whether patients with the
clinical diagnosis of Alzheimer’s dementia without appreciable amyloid pathology
differ in their clinical features and rate of cognitive decline and to clarify the molecular
mechanisms and risk factors for this form of dementia. Our findings suggest that trials
evaluating anti-amyloid treatments in clinically affected patients should use PET or
CSF measurements to verify the presence of amyloid pathology, and that more than
a third of APOE4 non-carriers are unlikely to benefit from treatment or prevention
therapies that target amyloid, even if they are able to help those with amyloid
pathology.
 Citation:
 Monsell SE, Kukull WA, Roher AE, et al. Characterizing Apolipoprotein E ε4 Carriers
and Noncarriers With the Clinical Diagnosis of Mild to Moderate Alzheimer Dementia
and Minimal β-Amyloid Peptide Plaques . JAMA Neurol. Published online August 24,
2015. doi:10.1001/jamaneurol.2015.1721.

Communication During Handoffs Varies Greatly Among Hospital Teams
MedicalResearch.com Interview with: Alicia A. Bergman, Ph.D. Research Health Scientist VA Greater Los
Angeles Healthcare System
Center for the Study of Healthcare Innovation, Implementation & Policy North Hills, CA 91343
findings?
 Dr. Bergman: The impetus for this study comes from several sources but most
notably the IOM report of 2002 entitled, Crossing the Quality Chasm in which the IOM
estimated that between 44,000 and 98,000 lives are lost each year due to
preventable medical errors in the hospital. The IOM further reported that 80% of all
adverse outcomes in the hospital can be traced back to breakdowns in
communication during handoffs and transfers of care. A 2005 study by our VA
research team found that only 7% of medical schools in the US teach the handoff as
part of the formal curriculum. As such, handoffs represent a vulnerable gap in the
quality and safety of patient care.

We were interested to know how end of shift handoffs in medicine, nursing, and surgery
were enacted and audio and videotaped them in a single VA hospital. We found that
there was a great deal of variation in how the handoffs were conducted and similar
variations in the ways in which language was used to characterize technical and
interpersonal aspects of care. We were especially interested in what we term
“anticipatory management communication” and its functions during handoffs. While much
technical information can easily be conveyed in the electronic medical record, some
types of psychological or social information that are more informal in nature, such as “Mr.
Smith’s been our problem child today,” do not lend themselves to being transmitted in the
electronic medical record. However, such ‘heads up’ information and communication is
often critical to understanding a patient’s context, course, and outcome of care. We also
found that indirect anticipatory management communication was used among all dyads
but more commonly among nurse dyads, with instructions and tasks implied and often
inferential. We conclude that contextually sensitive information about anticipated events
is best communicated directly (and ideally face-to-face), and that talk-backs and more
explicit use of language can improve handoff quality, making them safer for patients.

report?
 Dr. Bergman: Because a handoff evolves over the course of a shift, self and situation
awareness are helpful concepts to keep in mind as clinicians are organizing which
information to share during handoffs. They might ask themselves, “what would I want
or need in terms of information about the patient if I were starting, not ending, my
shift?”. During standardized or structured handoffs, there should be agreed-upon
strategies for sharing unstructured psycho-social or contextual information relevant to
upcoming patient care. Also, clinicians should employ language that is clear and
precise in characterizing the needs for upcoming shifts, clarifying who exactly should
be starting or completing which tasks. Being aware of potential ambiguities in
language use and checking frequently to verify comprehension is also
useful. Patients can ask if there are particular concerns for their care in the
upcoming shift and keep track of tests or procedures that have been ordered but
haven’t yet taken place. Such information is useful to share with the incoming
physician/nurse to ensure that there is mutual understanding of what needs to be
done.

 Dr. Bergman: More research needs to be done linking communication during
handoffs with near misses and adverse outcomes. There is currently a gap in our
understanding of what kinds of communication breakdowns lead to suboptimal
care. There is also a need to teach and do research on the best methods for
improving handoffs. While there is a great deal of interest in handoffs worldwide,
many if not most of the interventions that have been developed do not lead to lasting
change. Better understanding of the ingredients that will lead to long term
improvements are needed.
 Citation:
 “Mr Smith’s been our problem child today…”: anticipatory management
communication (AMC) in VA end-of-shift medicine and nursing handoffs
 Alicia A Bergman, Mindy E Flanagan, Patricia R Ebright, Colleen M O’Brien,Richard
M Frankel
 BMJ Qual Saf bmjqs-2014-003694Published Online First: 28 July
2015 doi:10.1136/bmjqs-2014-003694

Misconduct During Military Service Is Strongest Predictor of Homelessness After Discharge
MedicalResearch.com Interview with:Adi V. Gundlapalli, MD, PhD Associate Professor of Internal Medicine
University of Utah School of Medicine and University of Utah Hospitals and ClinicsInformatics,
Decision Enhancement, and Analytic Sciences Center VA Salt Lake City Health Care System,
Salt Lake City, Utah Medical Research: What is the background for this study? What are the main
findings?
 Dr. Gundlapalli: We wanted to explore the hypothesis that those separated for
misconduct-related reasons would have more difficulty reintegrating into their communities
post-deployment, with homelessness as an extreme example of such difficulties.
Misconduct-related separations from the military are associated with subsequent adverse
civilian outcomes that are of substantial public health concern. This study analyzed the
association between misconduct-related separations and homelessness among recently
returned active-duty military service members. Using US Department of Veterans Affairs
(VA) data, investigators identified 448,290 Veterans who were separated from the military
(end date of last deployment) between October 1, 2001 and December 31, 2011; had been
deployed to Iraq and/or Afghanistan; and had subsequently used VA healthcare.
Homelessness was determined by an assignment of “lack of housing” during a VA
healthcare visit, by participation in a VA homelessness program, or both. Veterans’ housing
status was followed through April 30, 2012. We assessed risk for homelessness as a
function of separation category (e.g., normal, misconduct, early release), controlling for
patient demographics and military service covariates, including service-related disability,
branch, rank, and combat exposure. In our opinion, the most significant finding was that
26% of Veterans who were separated for misconduct related reasons were homeless at
their first VA encounter; and this number climbed to 28% within one year after their first VA
encounter. Additionally, the likelihood of being homeless at the first VA encounter was
nearly 5 times greater for those separated for misconduct-related reasons as compared to
normal separations; this climbed to nearly 7 times greater at one year after the first VA
encounter. Collectively, these results represent the strongest risk factor for homelessness
among US Veterans observed to date, and helps to explain the higher risk of
homelessness observed among Veterans, despite access to VA benefits and services.

Salt Lake City, Utah
report?
 Dr. Gundlapalli: Our goal is to raise awareness among all stakeholders (Veterans,
clinicians, Departments of Defense and Veterans Affairs administration/leadership)
that there seems to be a sub-population of vulnerable Veterans who are at higher risk
for homelessness as compared to other Veterans.

Salt Lake City, Utah
 Response: These findings support reports of recently returned Veterans with records
of misconduct having difficulties re-entering civilian life. This association takes on
added significance because the incidence of misconduct-related separations is
increasing at a time when ending homelessness among Veterans is a federal
government priority.
 This may represent an opportunity for investigating early identification and active
case management as strategies to prevent homelessness in this and other vulnerable
populations at the time of separation from the military. This would ideally be a joint
effort between the Department of Defense and the VA.
 As a follow-up to this study, we are exploring the resource utilization patterns and
associated costs of care received by this sub-population of Veterans in VA medical
facilities.
 Citation:
 Gundlapalli AV, Fargo JD, Metraux S, et al. Military Misconduct and Homelessness
Among US Veterans Separated From Active Duty, 2001-

Young Breast Cancer Patients Have Much Higher BRCA Mutation Than White
MedicalResearch.com Interview with: Tuya Pal MD Division of Population Sciences Department of Health
Outcomes and Behavior Moffitt Cancer Center
Tampa, Florida
 Dr. Pal: Young Black women bear a disproportionate burden associated with breast
cancer incidence and mortality compared to their White counterparts. Given that
inherited mutations in the BRCA1 and BRCA2 genes are more common among
young breast cancer survivors, we questioned to what extent mutations in these
genes might contribute to the racial disparity in breast cancer incidence among young
women.

Tampa, Florida
 Dr. Pal: Through conducting the largest U.S. based study of BRCA mutation
frequency in young black women diagnosed with breast cancer at or below age 50,
we discovered they have a much higher BRCA mutation frequency than that
previously reported among young white women with breast cancer. Specifically, of
the 396 Black women with breast cancer diagnosed at or below age 50, 12.4% had
mutations in either BRCA1 or BRCA2. Furthermore, over 40 percent of those with a
mutation had no close relatives with breast or ovarian cancer, which suggests that
family history alone may not identify those at risk for carrying a BRCA mutation.

Tampa, Florida
report?
 Dr. Pal: Our results suggest that it may be appropriate to recommend BRCA testing
in all black women with invasive breast cancer diagnosed at or below age 50,
regardless of family history. This criterion is more simple because knowledge of
family history and receptor status is not needed. Given that prior studies suggest that
family history information is often incomplete to determine eligibility for testing, many
women who are candidates may not be offered testing. In fact, there were 118
participants in our study who did not meet current national practice criteria for testing
based solely on personal history, of whom BRCA mutations were found in 7.6%.

Tampa, Florida
 Dr. Pal: It is important to recognize that testing itself does not ensure benefit; the
ultimate benefit from genetic testing comes from the uptake of cancer risk
management options, including breast cancer screening, as well as preventive
mastectomy or oophorectomy. Furthermore, it is important for those with BRCA
mutations to share this information with their close family members so they too can
benefit from this information if they so choose. Thus, future studies that evaluate
genetic testing among underserved populations should also address the uptake of
cancer risk management options and sharing of test results with family members in
order for the full potential of genetic testing for BRCA1 and BRCA2 to be realized.
 Citation:
 Pal, T., Bonner, D., Cragun, D., Monteiro, A. N.A., Phelan, C., Servais, L., Kim, J.,
Narod, S. A., Akbari, M. R. and Vadaparampil, S. T. (2015), A high frequency
of BRCA mutations in young black women with breast cancer residing in Florida.
Cancer. doi: 10.1002/cncr.29645

Radiation Protection Offered By Single Injection Post Exposure
MedicalResearch.com Interview with: Carla Kantara, Ph.D. Postdoctoral fellow
Dept. of Biochemistry and Molecular Biology
University of Texas Medical Branch at Galveston
findings?
 Dr. Kantara: The increasing threats of radiation exposure and nuclear disasters have
become a significant concern for the United States and countries worldwide. Such
concern has increased national and international recognition for the need to develop
novel medicinal countermeasures that can prevent radiation-induced tissue damage
and keep thousands of people alive, even if administered a day or more after nuclear
exposure. To date, there are only a few mitigating or radioprotective agents that are
approved by the FDA, however they are unsuccessful in treating the gastrointestinal
toxicity induced by high-dose radiation exposures, and are ineffective as a post-
exposure treatment for the thousands of potential exposed individuals.

In our study, we showed that a single injection of TP508, administered 24 hours post-
radiation, significantly increased mice survival and effectively protected the
gastrointestinal mucosa by delaying crypt dissociation and directly stimulating stem cell
regeneration. This suggests that TP508 may be an effective post-exposure medicinal
countermeasure for mitigating radiation-induced gastrointestinal damage and mortality
following a nuclear incident and may provide exposed victims additional time to be
evacuated so that they can receive additional life-saving medical treatment.

report?
 Dr. Kantara: In recent years, several agents have been reported as novel putative
radioprotective agents or mitigators, however, these agents are unable to exert
protective effects when administered post-radiation exposure, are ineffective in
initiating stem cell regeneration and/or require multiple injections for efficacy.
However, our studies show that a single injection of TP508, 24hrs post-radiation can
protect and activate the body’s own stem cells to stimulate repair and restore function
to damaged tissues and organ systems. These findings suggest that using TP508 as
a field-delivered preventive therapy could delay mortality, even in individuals exposed
to high levels of radiation, giving emergency personnel additional time to transport
victims to locations where they can receive blood transfusions and other life-saving
therapies.

 Dr. Kantara: The ability for TP508 to activate progenitor stem cells located within
tissues to initiate tissue repair and regeneration without having the complication of
isolating, or inducing, specific populations of stem cells and injecting them into
damaged tissues is a paradigm-changing “Next Generation” approach to regenerative
medicine with the potential to save lives and improve life’s quality for millions of
people. TP508 is currently being repurposed as an injectable drug to treat clinical
indications where tissue regeneration, or activation and mobilization of bone marrow
stem cells is required. Our long-term goal is to examine whether TP508 may
potentially be used to treat other diseases, specifically neurodegenerative diseases
such as ALS and Alzheimer’s which require regeneration of stem cells.
 Citation:
 Carla Kantara, Stephanie M Moya, Courtney W Houchen, Shahid Umar, Robert L
Ullrich, Pomila Singh, Darrell H Carney. Novel regenerative peptide TP508 mitigates
radiation-induced gastrointestinal damage by activating stem cells and preserving
crypt integrity. Laboratory Investigation, 2015; DOI: 10.1038/labinvest.2015.103

Microbiome Differs Between Schizophrenic Patients and Controls
MedicalResearch.com Interview with: Keith A. Crandall, PhD Director – Computational Biology Institute George
Washington University
Innovation Hall Suite 305 Ashburn, VA 20147-2766
findings?
 Dr. Crandall: We wanted to investigate whether or not there were significant
differences in the microbiome (microbial composition) of patients with schizophrenia
versus controls. The other researchers have demonstrated a connection between
microbiome diversity and brain development and behavior modulation associated
with a variety of disorders. Our initial study focuses on the oropharyngeal as a target
for the microbiome characterization, but we have additional work relating to other
microbiomes (e.g., gut) for which we are still in the process of analyzing the
data. Collected microbiome data from 16 individuals with schizophrenia and 16
controls (matched as best we could and corrected statistically for differences between
the populations), we showed differences in the microbiome taxonomic diversity and
functional diversity. Specifically, we identified a significant increase in the number of
metabolic pathways related to metabolite transport systems; whereas, carbohydrate
and lipid pathways and energy metabolism were abundant in controls.

report?
 Dr. Crandall: Our data suggests am differences in microbiome between
schizophrenic patients and controls, but from taxonomic and functional
perspectives. Thus, the microbiome at the minimum might be an important biomarker
for diagnosis and targeting treatment options. Whether or not the microbiome is
changing as a result of schizophrenia or these changes cause schizophrenia remains
to be investigated.

 Dr. Crandall: Our study is based on a relatively small sample size and a single
targeted microbiome. Future work should include increased sample sizes to
determine the robustness of these initial conclusions. Additionally, other microbiome
characterization (like gut) might be informative as well. We are really at the forefront
of understanding microbiome diversity and complexity over space and time. Novel
methods are needed to characterize microbiome diversity and statically test or
changes in the microbiome over space and time and in case/control settings. The
Crandall Lab is develop such approaches and implementing our approaches in
software packages such as PathoScope.
 Citation:
 Eduardo Castro-Nallar, Matthew L. Bendall, Marcos Pérez-Losada, Sarven
Sabuncyan, Emily G. Severance, Faith B. Dickerson, Jennifer R. Schroeder, Robert
H. Yolken, Keith A. Crandall. Composition, taxonomy and functional diversity of the
oropharynx microbiome in individuals with schizophrenia and controls. Peer J, August
25th, 2015 [link]

Cardiovascular Events Decreased Most Among Adults At Highest Risk
MedicalResearch.com Interview with: Jay R. Desai, PhD, MPH
HealthPartners Institute for Education and Research
Minneapolis, MN 55425
findings?
 Dr. Desai: SUPREME-DM is a consortium of 11 integrated health systems
throughout the United States that serve a culturally and economically diverse
population of 16 million members. This study monitors changes in cardiovascular
outcomes from 2005 through 2011 among the 1.2 million members identified with
diabetes and a matched sample of 1.2 million members without diabetes.
 We found very encouraging and sustained declines in the rates of myocardial
infarction/acute coronary syndrome (MI), stroke, heart failure (HF), and all-cause
mortality among adults with and without diabetes. Declines were greatest among the
15% adults who were already at high risk for cardiovascular events (such as people
with diabetes or a prior history of heart disease). There was less improvement in
cardiovascular event rates and mortality among the other 85% of members with low
to moderate cardiovascular risk.

report?
 Dr. Desai: We have been making good progress in reducing rates of MI, stroke, HF,
and all-cause mortality among patients already at high CV risk. We need to extend
those efforts to target lower-risk patients, and also to racial and ethnic groups that
continue to have higher rates of stroke and heart failure, such as non-Hispanic blacks
with diabetes.

 Dr. Desai: It will be important to continue monitoring cardiovascular event rates and
mortality within U.S. health systems so that we can track improvements and identify
subgroups where more tailored clinical and public health approaches may be
required. Utilizing such large, real-world, electronic databases for research will
provide further insight into what underlying patient, provider, and system
characteristics and care practices are driving cardiovascular disease outcomes and
what potential interventions can continue to improve these outcomes. Better
management of blood pressure, lipids, smoking, and other major risk factors will be
needed to sustain these improvement trends.
 Citation:
 Who Must We Target Now to Minimize Future Cardiovascular Events and Total
Mortality?: Lessons From the SUPREME-DM Cohort Study
 Jay R. Desai, Gabriela Vazquez-Benitez, Zhiyuan Xu, Emily B. Schroeder,Andrew J.
Karter, John F. Steiner, Gregory A. Nichols, Kristi Reynolds,Stanley Xu, Katherine
Newton, Ram D. Pathak, Beth Waitzfelder, Jennifer Elston Lafata, Melissa G. Butler,
H. Lester Kirchner, Abraham Thomas, andPatrick J. O’Connor

The Science Behind ‘A Good Cry’
MedicalResearch.com Interview with: Asmir Gračanin, PhD Tilburg University
Department of Medical and Clinical Psychology
& Department of Communication and Information Sciences Tilburg The Netherlands
findings?
 Dr. Gračanin: Background for this study are primarily the results from previous paper
and pencil studies in which people (retrospectively) claimed that crying made them
feel better, which also corresponds to popular cultural beliefs. The remaining
background were the results from lab studies that showed mood decreases
immediately following crying episodes that were typically induced by emotional films.
So, as you can see in both cases background is quite devoid of any theory, but it
represented enough motivation to try to see what is really happening here. In
addition, human tears are surprisingly understudied and we do not know exactly what
is their function, so any research that looks for their intra-individual as well as inter-
individual functions is badly needed.

In this laboratory study we found that those individuals that cried felt much worse
immediately after crying (which corresponds to previous lab studies), but their mood
recovered surprisingly quickly (new finding), and finally it went even above the initial
levels, that is, they felt even a bit better than before the emotional film that made them
cry (corresponds to previous retrospective but not lab studies). No mood changes were
observed in those that did not cry. Therefore, it seems that there is something to the
popular belief that crying makes one feel better. However, we suspect that people could
misinterpret that large mood improvement, which appears just necessarily after the initial
mood deterioration, as a general mood improvement. So it is a strong return to initial
mood levels that people could experience as a relief. In addition, we did observe a
general mood improvement as well, although this effect was quite small. Thus, if there is
general positive effect of crying on one’s mood, it seems to take more time. This is the
first such laboratory finding.

report?
 Dr. Gračanin: Clinicians and patients may find it interesting that there is a possibility
that crying is beneficial, but they should also have in mind that on average this effects
could be very small, which points to the previous strong conclusions of Rottenberg,
Bylsma and Vingerhoets who said that crying might be beneficial only for some
people and in certain situations. In addition, if there are positive effects to be
expected from crying, we can conclude that they are more to be the consequence of
the positive reactions from others, that crying may elicit as a potentially useful signal.
These inter-individual effects of crying are, by our opinion, the first reasons why one
can feel better after a good cry.

 Dr. Gračanin: Future research should first try to replicate these findings, also by
using other measures of well being that correspond to relief and mood improvements.
We should also be careful regarding the fact that those who are more prone to cry
might also be more prone to mood switches, so we need good methodological tricks
to test the same assumptions by excluding the possibility that criers, as emotionally
more reactive people, will at certain moment really experience a better mood than
other individuals that experienced the same situation. In that sense, we also need
long term and continuous measurements, to be able to cover many points in time.

 Then finally, if scientists observe that crying reliably results in mood improvements at
least for certain types of individuals, then we should look for mechanisms that are
responsible. At this moment our suspects are: the activity of the parasympathetic
nervous system, changes in oxytocin or endogenous opioids.
 Citation:
 Asmir Gračanin, Ad J. J. M. Vingerhoets, Igor Kardum, Marina Zupčić, Maja Šantek,
Mia Šimić. Why crying does and sometimes does not seem to alleviate mood: a
quasi-experimental study. Motivation and Emotion, 2015; DOI: 1007/s11031-015-
9507-9

Fentanyl Buccal Tablet May Provide More Rapid Relief of Cancer Pain
MedicalResearch.com Interview with: Dr. Sebastiano Mercadante MD
Director, Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit
La Maddalena Cancer Center, Palermo, Italy
findings?
 Dr. Mercadante: Breakthrough cancer pain (BTcP) has been defined as a transitory
increase in pain intensity that occurs either spontaneously, or in relation to a specific
predictable or unpredictable trigger, despite relatively stable and adequately
controlled background (1). Breakthrough cancer pain is a common problem in
patients with cancer and is associated with significant morbidity. In a recent report in
which a pragmatic definition of breakthrough cancer pain was used (2), the
prevalence of BTcP was 75% (3).

Oral morphine (OM) has been traditionally offered as a breakthrough cancer
pain medication in doses of about 1/6 of the daily opioid regimen for years, although this
approach has never been supported by any evidence. Different technologies have been
developed to provide a rapid onset of effect with potent opioid drugs such as
fentanyl (rapid onset opioids, ROOs) delivered by non-invasive routes. Fentanyl products
have been shown to be significantly superior to oral opioids, but it has been suggested
that the dose of fentanyl should be individually titrated in order to enable effective
analgesia to be delivered while minimizing the risk of clinically significant adverse
effects. The need of dose titration with rapid onset opioids has never been appropriately
assessed and this statement is derived by a series of weaknesses of papers published
for regulatory issues. Indeed, the only existing study comparing dose titration and
proportional doses, reported that proportional doses of (Fentanyl buccal tablet) FBT are
more effective and safe over dose titration method. NICE guidelines did not provide
evidence for that, at least at certain time intervals after administration.

 To scientifically compare rapid onset opioids and oral morphine, we used a similar
approach and made a strict selection of patients, according to a more specific
algorithm for a diagnosis o fbreakthrough cancer pain. Thus, patients were
randomized to receive in a crossover design Fentanyl buccal tablet and oral
morphine, both given in doses proportional to opioid daily doses, for the management
of breakthrough cancer pain.
 This comparative study has shown that, when giving the drugs for breakthrough
cancer pain in doses proportional to the opioid regimen for background pain, Fentanyl
was clearly superior for efficacy and rapidity in comparison with oral morphine. The
analgesic effect was more intense either at 15 and 30 minutes after study
medications were given. A larger number of episodes treated with Fentanyl buccal
tablet presented a decrease in pain intensity of ≥33% and ≥50% in comparison with
episodes treated with oral morphine, and a relevant difference in SPID30 was
reported. Of interest, adverse effects commonly observed in patients receiving
opioids were not severe and did not differ between the treatments, suggesting that
the use of proportional doses of both drugs are safe, reflecting what is derived by the
long-lasting experience with oral morphine.

report?
 Dr. Mercadante: Clinicians should be aware that rapid onset opioids can be more
effectively used in doses proportional to basal opioid regimen, confirming in a more
robust way a clear superiority over oral morphine in the first 30 minutes, the
approximate target for a timely intervention required to a breakthrough cancer
pain medication.

 Dr. Mercadante: Although it is expected that fentanyl products provide a similar
effects over oral morphine, as observed in some open-label studies, further studies
should confirm that all rapid onset opioids can be more effectively used in doses
proportional to basal opioid regimen, without particular risks of adverse effects.
 Citation:
 J Pain Symptom Manage. 2015 Aug 21. pii: S0885-3924(15)00411-X. doi:
10.1016/j.jpainsymman.2015.05.016. [Epub ahead of print]
 Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid
Regimen for the Management of Breakthrough Cancer Pain: A Randomized,
Crossover, Comparison Study.
 Mercadante S1, Adile C2, Cuomo A3, Aielli F4, Cortegiani A5, Casuccio A6, Porzio
G4.

MedicalResearch.com Breaking Medical Research News August 30 2015

MedicalResearch.com Breaking Medical Research News August 30 2015

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MedicalResearch.com Breaking Medical Research News August 30 2015