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IN THIS ISSUE: FOCUS ON HEALTH SERVICES AND HEALTH DISPARITIES SPRING 2010
NERI’s new Institute for
Health Services and Disparities
Research, co-directed by
Lisa Marceau and John McKinlay,
builds upon decades of research on the
organization and use of health services,
while expanding the focus to include
health care disparities.
NERI’s many pioneering factorial experi-
ments concerning physician decision
making reveal health care disparities to
be largely generated or amplified by
Getting to the Root of
Diabetes Disparities
IllnessSeverity
Age Differenceat Diagnosis
Difference inDisease Severity
at Diagnosis
PhysicianDiagnosis
Widening Race/EthnicDisparities
Following Diagnosis
Age
}M
etabolic
Syndrom
e
(Pre
diabetes)
Black
White
IllnessTrajectoryover Time
Figure 1. Theoretical model depicting the progression of diabetes and the
way race/ethnic inequalities are created/amplified following diagnosis.
continued on page 11
E X P LO R I N G H E A LT H C A R E D I S PA R I T I E S
continued on page 11
patient interactions with the health
care system. That is, they are “socially
constructed” as a result of doctors’
decision making with certain categories
of patient.
This research approach has deep theo-
retical roots and important implications
for programs designed to reduce or
eliminate health disparities. Focusing on
individual at-risk behaviors and increasing
access to care is unlikely to attack some
root causes of health disparities.
Current efforts often overlook the
“upstream” sociopolitical and economic
determinants of “downstream” health
care disparities. NERI’s approach, often
termed “healthy public policy,” shifts
the focus away from “downstream”
behavior (health education to reduce
risk factors) and even “midstream”
organizational approaches (reengineering
health care and improving access) to
“upstream” socio-political interventions
to improve population-level health.
Ever-widening health disparities are a major publichealth concern in the U.S. and many other countries.
An important example of this trend is disparities seen in the
prevalence of type 2 Diabetes Mellitus (T2DM), which afflicts
about 21 million adults in the US alone. Disparities in T2DM
are often thought to be “caused” by race and ethnicity, which
has spurred a well-intentioned search for genetic and bio-
physiological explanations.
NERI researchers, however, have shown that socioeconomic
status (SES), a potentially modifiable influence, has a much
stronger impact on the disparities in T2DM prevalence than
race or ethnicity. This suggests that the continuing focus on
New England Research Institutes9 Galen StreetWatertown, MA 02472(617) 923-7747www.neriscience.com
No research without therapeutic or policy benefit
• Institute for Clinical Trials and Registries
• Institute for Studies on Aging
• Institute for Health Services and Disparities Research
• Institute for Community Health Studies
• Institute for Epidemiology
• Institute for New Media andCommunications Research
• Center for Scientific Integrity
• Center for Data Systems Technology
• Center for Statistical Analysis and Research
• Center for Qualitative Research
• Center for Patient-ProviderRelationships
• Survey Research Center
Editor: Stephen BraunDesigner: Carol Dirga
This issue’s contributors:Andre AraujoDavid BrazierJoanne GormleySuzanne GrangerJay KaufmanVarant KupelianRebecca LiKaren LutfeyLisa MarceauMichael MauraoJohn McKinlaySonja McKinlayPatti NashRay RosenLauren SmithKristin SnowSharon TennstedtLisa Virzi
To order additional copies, or obtain further information on NERI projects and scientists, please contact [email protected].
The content of this newsletter is solelythe responsibility of the authors and doesnot necessarily represent the officialviews of any funding source or sponsor.
NERI continues to
GROW
Despite the recession, NERI has continued to thrive and expand in new ways.
NERI has not cut or frozen salaries, it has granted a number of promotions,
and has maintained its merit increase program.
NERI is currently in the midst of a recruitment boom with about 12 positions open. In part,
this is because NERI is expanding the types of services it offers and the types of “customers”
it can work with. In addition, NERI was awarded a multi-million dollar grant for expanding
the Pediatric Heart Network Study. This unique project has allowed for internal
promotions and an expansion of current employee capabilities, while creating new positions
for external candidates, particularly those from the private sector who have experience and
capabilities in industry-sponsored research.
NERI’s Survey Research Center is experiencing an uptick in project work and is rapidly
hiring experienced field and telephone interviewers as it services a wide range of research
projects. The Data Management group, supervised by Patti Nash, has also expanded rapidly.
Six data managers have completed certification from the Society for Clinical Data
Management. Several also attended the annual data manager conference, which was held
in Seattle this year.
NERI has also seen significant growth in several other areas. Three PhD epidemiologists
were awarded funding for proposals submitted to the NIH. Karen Lutfey has created a new
center for Patient-Provider Relationships. The Institute for Epidemiology, directed
by Andre Araujo, has seen an increase in funding for on-going projects in collaboration with
several private companies.
This brief review and other research synopses in this newsletter provide a flavor of the exciting
new work getting underway at NERI.
3
Many aspects to these questions could
be explored, but here I want to consider
one simple, yet critically important,
aspect of this question: the common
confusion between the distribution of
a measure in the data and the sampling
distribution of its mean. These are
elements of every introductory statis-
tics class, and yet much confusion
arises simply because this distinction
is too often neglected.
First let’s quickly review the statistical
ideas. A measure of interest, such as
systolic blood pressure (SBP), has a
distribution in the population. We
rarely get to measure every individual’s
value, however, so we instead collect a
representative sample. This sample has
a mean, which is estimated as the sum
of the individual values divided by the
size (“n”) of the sample. The sample
also has a variance, which is defined as
the expected squared deviation of any
randomly chosen observation from the
sample mean. The square root of the
variance is known as the “standard
deviation,” and is a common measure
of the spread of the data around the
mean. If we took many independent
samples of size n, then the observed
sample mean values would have a
distribution of their own.
As long as the sample size n is not very
small, this sampling distribution will
be “normally” distributed, regardless
of the distribution of the original data.
(A “normal” distribution has the shape
of the familiar “bell-shaped curve.”)
The sampling distribution of the mean
also has a variance, usually referred to
as the “standard error of the mean.”
For a sample size n of any reasonable
size, this is much smaller than the
standard deviation of the original data.
In order to show using a statistical test
that one population mean is “signifi-
cantly” different from another, it is
necessary that the difference in the
two means be large in comparison with
their standard errors. Since the stan-
dard error gets smaller as the sample
size n gets larger, one can almost
always find a difference between two
means with a large enough sample size.
A “significant” difference in this sense,
however, does not correspond to a
difference that is large with respect to
the distribution of the actual data. This
is the point that is often overlooked in
the consideration of evidence of race
differences to medical treatments.
Let’s take the example of ACE
inhibitors — a class of medications
that lower blood pressure. It is widely
believed that ACE inhibition is less
effective for black patients than for
white patients, and this disparity in
therapeutic efficacy is mentioned in
most hypertension textbooks and
clinical guidelines. The British
Hypertension Society Guidelines even
continued on page 16
When Should be a Factor in Determining Medical Treatment?
| G U E S T C O M M E N TA RY | J AY S . K A U F M A N , P H D |
In 2005, the FDA approved the first “race-specific” drug, BiDil, a medication for heart failure targeted to blacks.
More race-targeted therapies are apparently in the development pipeline. But is it really true that medicine should
be practiced differently for one race of patient than another? Is race really more than skin-deep?
Race
4
“Junk Sleep” and itsEffects on ChildrenSleep is an underappreciated health
habit…We all know that junk food is
unhealthy for our children, but so is junk
sleep. Healthy sleep is to the brain what
healthy food is to the body.
— Marc Weissbluth, MD
Poor sleep is an underappreciated
health habit and an unmet pub-
lic health problem. We all stay
up later than we should, get up earlier
than we’d like, and are awoken more
times than we care to admit in the
middle of the night. Research clearly
demonstrates that the cumulative
effects of poor sleep have significant
negative health impacts. Growing
evidence supports the fact that sleep
is an essential healthy behavior and a
key factor in disease prevention —
particularly in pediatric populations.
The importance of good sleep, however,
is continually under-appreciated by both
parents and health care professionals.
Unhealthy sleep habits in children
often impact negatively on mood,
behavior, attention, cognitive out-
comes, and on overall quality of life.
These apparent deficits may not always
be recognized by parents and may be
overlooked by providers as resulting
from inadequate sleep. A number of
factors give this issue particular
urgency, including:
• Inadequate sleep is increasingly preva-
lent in children, particularly in socio -
economically disadvantaged groups
• Poor sleep quality is linked to
impaired physical and mental health
and other unhealthy behaviors in
children
• Sleep habits are learned behaviors,
which are amenable to behavioral
change
• Healthy sleep behaviors adopted in
childhood may help prevent lifelong
problems
• Sleep disorders may be missed or
misidentified in the pediatric popula-
tion, which has important implica-
tions for subsequent clinical treat-
ment and management
To improve awareness of sleep problems
in children, NERI is collaborating
with pediatric physician Judith Owens
at the Alpert Medical School at Brown
University to produce a CME-accredited
web-based training program for primary
care providers and ultimately an
accompanying web site for parents.
Funded through a Small Business
Innovation Research (SBIR) grant from
the National Institutes of Health, the
project aims to raise awareness of sleep.
Culturally Appropriate Messages
The new Sleep Habits project will:
• Identify existing systems for
recognizing age and culturally
appropriate screening and surveil-
lance of pediatric populations
• Emphasize the importance of early
detection of sleep problems in
children and the role of cultural
differences in infant sleep.
• Present strategies aimed at prevention
of sleep problems, with consideration
of culturally relevant differences
• Emphasize the importance of
culturally sensitive education for
both parents and providers
ILLU
STRA
TIO
N: D
AN
FRE
Y
NEW RESEARCH
5
• Review the basic biology of sleep
and its relationship to one’s cultural
environment, beliefs, and values
A companion web site will target parents
with the goal of educating them about
the importance of good sleep habits for
their children. Importantly, this program
will include culturally and racially
diverse populations, recognizing that
the manifestations of unhealthy sleep
practices, sleep health promotion, and
“anticipatory guidance” during well
child visits must be presented within
diverse cultural contexts.
This work is supported by National Instituteof Child Health and Human Developmentgrant #HD062038.
Blood Diseases a Focus of NERI Research Efforts
Thalassemia and sickle cell
disease are two common
diseases of the blood. Both
diseases produce a range of serious
symptoms and can shorten life span
and impair quality of life. Both also
can be treated with regular blood
transfusions, and yet this life-saving
treatment can damage the body by
causing iron overload in the heart,
liver and endocrine glands.
NERI is involved in a large number of
studies aimed to improve the diagnosis
and treatment of these two serious
diseases. Understanding the molecular
biology and genetics of thalassemia
and sickle cell disease as well as
gaining an understanding of standards
of care, patient clinical characteristics,
and life style attributes may ultimately
improve the quality of life for millions
of people around the world.
Thalassemia Research
Thalassemia is actually a group of
disorders that is caused by a wide
range of mutations in the genes that
code for hemoglobin, the molecule
in red blood cells that carries oxygen.
(Different kinds of mutations cause
sickle-cell disease, which is explored
later in this article.)
In July, 2000, the National Heart,
Lung, and Blood Institute (NHLBI)
led the founding of the Thalassemia
Clinical Research Network (TCRN),
a global network of clinical centers,
with NERI serving as the Data
Coordinating Center. The network
includes sites in Lebanon, Turkey,
England, Canada, and the United
States all of which have a high density
of people with thalassemias.
In addition to support from NHLBI,
the Thalassemia Clinical Research
Network gets important aid from
the Cooley’s Anemia Foundation
(CAF), a non-profit, privately-funded
organization named for Dr. Thomas
Benton Cooley, one of the early
pioneers in thalassemia research.
The CAF supports patients involved
in the TCRN by providing funds for
travel for patients to make hospital
visits to TCRN sites, for patient educa-
tion and patient training.
NEW RESEARCH
6
Four studies conducted by the
Thalassemia Clinical Research Network
will contribute to the scientific body
of knowledge for this set of diseases:
• Thalassemia Longitudinal Cohort
Registry will provide a long-term
understanding of standards of care,
quality of life, and detailed genotypic
and phenotypic characterizations.
• Low Bone Mass Observational
Study in Thalassemia will estimate
the prevalence of low bone mass in
thalassemia patients and will evaluate
the interaction of factors such as
endocrine and genetic influences
on bone metabolism in hopes of
identifying preventive strategies and
effective treatments.
• Pulmonary Hypertension in
Thalassemia Pilot Interventional
Drug Study with Comparison
to Controls will evaluate the safety
and efficacy of sildenafil to treat
pulmonary hypertension (PHT).
Thalassemia patients frequently
have undetected PHT, and this study
will compare how thalassemia
patients and those without PHT
respond to treatment.
• Pain in Thalassemia Descriptive
Studies will assess, using a survey,
the prevalence of pain in subjects
purpose of this study is to find out if
one treatment plan is better than the
other in controlling sickle cell pain.
NERI is also the Data Coordinating
Center for a second NHLBI study of
sickle cell disease. The primary purpose
of the PROACTIVE feasibility study is
to determine if it is possible to design
and complete a randomized trial to
assess the effectiveness of a transfusion
in preventing a pneumonia-like disorder
called acute chest syndrome (ACS).
The study will determine if patients
at high risk of ACS can be reliably
identified using specific values of a
special substance (sPLA2) in sickle cell
patients hospitalized with pain. This
preliminary study will also ascertain if
high risk patients can be enrolled in
a complex Phase III trial in sufficient
numbers to answer the question of
transfusion effectiveness.
Because of its involvement in many
studies of thalassemia and sickle cell
disease over the last two decades,
including the most recent ones high-
lighted here, NERI has become a
world leader in both fundamental and
clinical research into these diseases,
and is playing a pivotal role in the
effort to increase quality life expectancy
in these populations.
The studies mentioned in this article are supported by Thalassemia ClinicalResearch Network Cooperative Grant#U01 HL065238 and the Sickle Cell DiseaseClinical Research Network CooperativeGrant #U10 HL083721.
with transfusion and non-transfusion
dependent thalassemia. The Pain
in Transfusion sub-study will assess
whether reports of pain vary over
the transfusion cycle.
Sickle Cell Disease
Sickle cell disease is a group of inherited
disorders of red blood cells that affect
millions of people worldwide. Healthy
red blood cells are round, and carry
oxygen to all parts of the body. In sickle
cell disease, genetic mutations cause
the red blood cells to become hard and
sticky and look like a C-shaped farm
tool called a “sickle.” The sickle cells
die early, which causes a constant
shortage of red blood cells. Also, when
they travel through small blood vessels,
they get stuck and clog the blood flow.
This results in impaired circulation,
chronic ill health, and premature death.
The disease cannot be cured, but
treatments exist for the symptoms
and some of the complications of the
disease. Bone marrow transplants may
offer a cure in a small number of cases.
NERI serves as a Data Coordinating
Center for the IMPROVE trial,
sponsored by the NHLBI. This trial
is investigating the use of patient-
controlled analgesia (PCA), which is
where the patient is in control of his or
her pain medicine. In this study, two
different treatment PCA plans will be
used to treat people with sickle cell
disease who are admitted to the hospital
for a pain crisis, which is an attack of
pain caused by the clumping of blood
cells in some part of the body. The
Because of its involvement in manystudies of thalassemia and sickle cell disease, NERI has become a world leader in both fundamental andclinical research into these diseases.
NEW RESEARCH
7
the population-based prevalence of ED
and is still the only major longitudinal
study of ED.
Two recent papers from the MMAS
have added significant weight to the
contention that ED does, in fact,
predict CVD (see Figure 1) and CVD
death, even when statistically adjusted
for known cardiovascular risk factors.
Indeed, ED is as strongly related to
CVD as known high-risk conditions
such as hypertension or diabetes.
Data from these papers indicate that
the risk of CVD is about 40% higher
in men with ED.
The evidence linking ED and CVD
implies a common systemic vascular
etiology. This is based on the premise
Linking ErectileDysfunction andCardiovascular Disease
Erectile dysfunction (ED) is a
common condition estimated to
affect 10-20 million men in the
U.S. Increasing evidence suggests that
ED may be caused by changes to the
blood vessels in the penis. Half of all
ED cases in men over the age of 50 are
attributed to atherosclerosis or plaque
build-up in the blood vessels.
Scientists have speculated for years that
the onset of ED, insofar as it represents
damage to the arteries in the penis,
may provide an early warning sign of
impending coronary events. This has
important implications from a public
health standpoint, because sometimes
men die from a sudden cardiac event
who have had no signs of cardiovas-
cular disease (CVD).
Recent and ongoing research conducted
at NERI using data from the Massachusetts
Male Aging Study (MMAS) and the
Boston Area Community Health
(BACH) Survey has provided informa-
tion addressing the potentially impor-
tant issue of whether ED might serve
as a barometer for CVD.
The MMAS, which enrolled 1,709 men
between 40-79 years of age, is widely
considered a landmark study in the
fields of aging and endocrinology. Men
from the MMAS have been followed
over a period of about 15 years.
MMAS was the first study to report
that the early functional consequence of
atherosclerosis — loss of the capacity
of blood vessels to open up manifests
symptomatically earlier in the small
blood vessels of the penis than in larger
(e.g., heart) vessels. This is known as
the “artery-size” hypothesis.
Furthermore, there is strong evidence
that a dysfunction in the endothelial
cells of blood vessels, which is charac-
terized by reduced levels of nitric
oxide, is the likely biologic mechanism
underlying both ED and CVD. NERI
recently received a grant from the
National Institutes of Health (Principal
Investigator: Varant Kupelian) to con-
duct an ancillary study of the Boston
Area Community Health (BACH)
Survey to investigate this hypothesis.
Surv
ival
Pro
bab
ility
Person-Years
Moderate/Complete ED
No. events:No. at risk:
681,057
86960
96654
11342
None/Minimal ED
0.0
0.3
0.5
0.8
1.0
0 5 10 15 20
yb
ilit
1.0
0.8
one/MN inimal ED
0
ob
abr
al P
viv
Sur
0.5
0.3
etaderoM e EDomplete/C
0
0.0
5ersoP
1510earson-YYears
20
..oN
..oN1,057
68isk:t r a.
ts:env e.96086
65496
34211
Figure 1. Men with ED had a significantly shorter time to CVD than men without ED.
NEW RESEARCH
8
The goal of the proposed research is to
provide the first systematic investigation
of the relationship between endothelial
dysfunction and ED in a large popula-
tion-based sample of men. About 400
subjects from the BACH Survey will
visit Dr. Joseph Vita’s Vascular Testing
Laboratory at the Boston University
School of Medicine for study assess-
ments. Endothelial function will be
measured in the brachial artery of the
forearm.
Erectile function will be assessed
using a validated self-report measure:
the International Index of Erectile
Function. The presence and extent
of endothelial dysfunction will be
compared to both severity of ED and
changes in erectile function over time.
The study will cost-efficiently draw on
the wealth of background demographic,
biomedical and psychosocial data on
the well-characterized cohort of the
parent BACH Survey.
NERI has a long and proud history of
making substantial contributions to
the field of urology, with MMAS and
BACH staff serving as the foundation.
The recent publications and recently-
awarded grant to NERI will add to
a growing literature on ways to
potentially identify men at risk for
the number one killer in the world:
cardiovascular disease.
This research is supported by Grant#DK080662 from the National Institute ofDiabetes and Digestive and Kidney Disorders.
Kids and Heart Disease:Speeding Clinical Discovery
It can take decades for the results
of basic laboratory research to be
translated into treatments available
to patients. This long delay is particu-
larly wrenching when the patients
are children. To speed the transfer of
laboratory (“bench”) research about
pediatric heart disease to clinical trials
and studies, the National Heart, Lung,
and Blood Institute has instituted a
translational research initiative called
the Bench to Bassinet Program. NERI
has been named the Coordinating
Center for the Program.
This multi-year, multi-million dollar
effort will establish two new research
consortia: the Cardiovascular
Development Consortium (CvDC)
and the Pediatric Cardiac Genomics
Consortium (PCGC). The CvDC aims
to generate and disseminate compre-
hensive data about the molecular
pathways that regulate cardiovascular
development. The goal of PCGC is to
identify genetic and epigenetic causes
of human congenital heart disease,
and relate genetic variants present in
the congenital heart disease patient
population to clinical outcomes.
The nine Research Centers in these
Consortia will align and interact with
the existing clinical research network,
the Pediatric Heart Network (PHN)
and its Data Coordinating Center,
which NERI has overseen and run for
the past 9 years. NERI will apply this
long-term experience to its new role
as organizer and manager of the
various facets of the Bench to Bassinet
Program. As part of its responsibilities,
NERI will provide information and
data systems support, administrative
and public websites, logistical and
meeting support, and contractual and
payment arrangements for selected core
research facilities. NERI’s work in the
Bench to Bassinet Program is led by
Sharon Tennstedt and Lynn Sleeper.
NERI has a unique understanding of
the challenges and solutions associated
with research in pediatric populations.
Fifty percent of NERI clinical trials and
registries include pediatric participants,
often with rare disorders, encompass-
ing over 22,000 subjects located in
roughly 500 national and international
research sites. NERI has served as the
coordinating center for the NHLBI
Pediatric Cardiomyopathy Registry
since 1994, and the Fall of 2009 began
in a similar role for an FDA-sponsored
Pediatric Cardiac Device Consortium.
In addition, NERI recently received a
grant from the federal Small Business
Innovation Research program to develop
a CME program prototype focused
on pediatric sleep. NERI’s pediatric
credentials also include the development
of the No More Hand-Me-Downs
campaign for the NHLBI. That program
is designed to raise awareness and
educate parents about pediatric clinical
research. For more information visit:
http://www.nhlbi.nih.gov/childrenand
clinicalstudies/index.php.
This research is supported by NHLBI grant#U01 HL098188.
NEW RESEARCH
9
The dictum “No good deed goes unpunished”
clearly applies to the ongoing controversy
surrounding recommendations of the US
Preventive Services Task Force (USPSTF), an independent
group of 16 private sector clinicians and scientists
appointed by the federal Department of Health and
The Mammogram Controversy
Human Services, which rigorously assesses ever-changing
evidence on medical care, and makes recommendations
based on explicit criteria.
Before reviewing the controversy that erupted from these
recommendations, here is some relevant statistical context.
According to the National Cancer Institute about
192,000 women in the U.S. will be diagnosed with breast
cancer and over 40,000 died of the disease in 2009.
Those sound like big numbers, but they translate to a
life-time risk of breast cancer of 2.86%. The risk that a
woman aged 40 will be diagnosed with invasive breast
cancer before her 50th birthday is 1.44%. And the risk
that a 40-year old woman will die of breast cancer before
her 50th birthday is tiny: 0.19%. And yet every year,
about 39 million women undergo mammograms in
the U.S., costing the health care system an estimated
$5 billion annually.
CA
RTO
ON
BY
MA
RK T
ON
RA
What Happened to Ev idence-Based Medic ine?
continued on page 10
HEALTH SERVICES AND HEALTH DISPARITIES
ON NOVEMBER 16, 2009, THE TASK FORCE:
• Reversed a recommendation made in 2002, and said
that women in their 40s should stop having annual
mammograms, except for a small group known to be
at high risk for breast cancer
• Recommended that women aged 50-74 should have
mammograms every 2 years rather than every year
• Said that breast self-examinations produce no
significant medical benefit and that doctors should
not teach women to perform them
HEALTH SERVICES AND HEALTH DISPARITIES
10
The new guidelines sparked immediate,
and heated, controversy from practically
every quarter. Patient advocacy groups
and some breast cancer experts and
scientists welcomed the new guide-
lines, noting that mammograms
produce false-positive results in about
10% of cases, causing anxiety and
prompting many women to undergo
follow-up testing, sometimes disfigur-
ing biopsies, unnecessary surgery,
harmful radiation and chemotherapy.
But many groups, such as The
American Cancer Society, vigorously
defended the old guidelines saying they
have reduced mastectomies and saved
thousands of lives annually. Physician’s
unions and professional societies, too,
reflexively denounced the new guide-
lines, as did many prestigious medical
centers. Cancer survivors and their
families presented personal moving
accounts of how mammography has
saved lives. Needless to say, the makers
of mammography machines were
apoplectic.
In due course, the current controversy
will die down, and the USPSTF recom-
mendations are likely to be viewed
as the gold standard and followed.
Medicare, for example, generally
adopts panel recommendations when
it makes coverage decisions for seniors,
and private insurers usually follow
suit. The new guidelines are expected
to alter the grading system for private
health plans. The National Committee
for Quality Assurance has already
announced the way in which it grades
private insurers will change as a result
of the new guidelines.
In the meantime, there are some
compelling lessons to be gleaned from
this episode.
Lesson OneThe acceptability of new guidelines
depends more on the preservation of
stakeholder interests and political
considerations than on the quality of
scientific evidence. While lip service is
given to the sanctity of evidence-based
medicine, the best new evidence will
be disparaged and dismissed if it runs
counter to established interests.
Lesson TwoThe development of clinical guidelines
needs to be completely overhauled.
Unlike every interest group either
opposed to or in support of the new
mammography guidelines, the USPSTF
has no dog in the hunt. The task force
is independent, nonpartisan, and
comprises well-intentioned respected
scientists who are prepared to under-
take public service for minimal reward,
often at considerable personal and
professional cost. This is not the case
for many other clinical guidelines
which are heavily influenced by the
pharmaceutical industry and special
interest groups.
Guidelines should be developed with
federal sponsorship by independent
scientists with no interest in a particular
outcome. The independent National
Institute for Health and Clinical
Excellence (NICE) in the
UK provides a model
for how things could
be done in the U.S.
Given public confusion
continued from page 9
and anxiety surrounding the release
of guidelines and results of other
federal initiatives, the means of their
effective dissemination is as important
as the method of their independent
development.
Lesson ThreeThe way in which guidelines are cur-
rently developed (with heavy influence
of various interests) and in many cases
disparaged (if challenging the status
quo and prevailing interests) makes
a mockery of the laudable goal of
evidence-based medicine. The success
or failure of clinical guidelines is
presently determined by political
processes, not by the quality of the
science dispassionately analyzed
by qualified independent experts.
Appropriate support from federal
sponsors is a sine quo non.
In an ironic postscript — on the same
day USPSTF members were being
interrogated by a congressional
committee, the results of a new Dutch
study revealed that mammographic
screening doubles the risk of breast
cancer among high-risk women and
the researchers urge avoidance of
repeated exposure, especially at younger
ages. If the USPSTF had included these
latest data from the Netherlands would
it have made any difference?
The Mammogram Controversy
11
race/ethnicity as the primary determi-
nants of T2DM disparities overempha-
sizes the importance of biomedical
factors and diverts efforts from more
important and potentially modifiable
social determinants.
Diabetes disparities likely result from
many different influences including:
• Structural (e.g., SES)
• Demographic (e.g., age and gender)
• Environmental (e.g., neighborhood
location and accessibility of
medical care)
• Behavioral (e.g., nutrition and
physical activity)
• Bio-physiologic (e.g., insulin resistance
and inflammatory processes)
• Genetic (e.g. family history)
Employing a multi-level approach,
NERI is beginning a large, community-
based epidemiologic study to disentan-
gle the relative contribution of these
different influences on T2DM disparities.
The research has several distinguishing
features. Because it is not clear when
in the natural progression of T2DM
disparities first becomes evident, our
study is uniquely focusing “upstream”
at the early pre-diabetes stage of the
condition. As illustrated in Figure 1
(on the cover), although there may be
some race/ethnic (or socio-economic)
differences in the pre-diabetes phase
of this disease (sometimes termed the
“Metabolic Syndrome”) these differ-
ences may be amplified by variations in
clinical decision making after patients
access the health care system.
Thanks in part to NERI research, it
is now known that widely-used race/
ethnic classifications do not accurately
characterize genetically distinct sub-
populations. The race label “African-
American” for example, does not
define a unique genotype, whereas
the geographical origin of a person’s
ancestors may.
With clinical colleagues at the
Massachusetts General Hospital
(Harvard Medical School) NERI
researchers are now able to identify
a set of genetic markers that align
with a person’s geographic ancestry.
These markers can then be used to
help characterize the genome of
people with mixed ancestries, which
will improve the accuracy of estimates
for the genetic component of a
person’s risk for T2DM. These are
continued from page 1
Getting to the Root of Diabetes Disparities
This effort requires broad multi disciplinary expertise and an ecumenical approach to research,
minimally including observational surveys, experimental studies and careful qualitative analyses.
NERI’s perspective is illustrated by two new NIH-supported studies — an experiment examining
clinical decision making when different types of patients, who have been activated by direct-
to-consumer advertising, request specific pain medications, and an epidemiologic study of the
multi-level contributions to race/ethnic disparities in pre-diabetes.
This newsletter features articles on these and other research efforts designed to improve thedelivery of effective and equitable health care and understand root causes of health disparities.
E X P LOR I NG H E A LTH C A R E D I S PA R I T I E Scontinued from page 1
Co-Directors: Lisa Marceau and John McKinlay
called ancestry-informative markers
(AIMs) and they allow researchers to
reliably estimate ancestry proportions
for an individual. They represent a
truly unique feature of NERI’s health
disparities research.
The potential implications of this study
are enormous. By focusing on risk
states preceding the onset of T2DM,
the study will contribute to the under-
standing of upstream disparities. In
addition, the study results may help
prioritize strategies for primary and
secondary prevention of T2DM.
By including neighborhood effects, it
will clarify the role of environmental
influences on the creation of T2DM
disparities, and with the inclusion of
bio-physiologic influences such as
AIMs, it will enhance understanding of
basic disease processes and pathways.
Gaining a multilevel understanding of
the development and amplification of
disparities in diabetes will arm health
care providers, researchers and policy
makers with a broad set of tools to
intervene at the appropriate level and
with the appropriate audience.
This research is funded with grant#DK080786 from the National Institute ofDiabetes and Digestive and Kidney Diseases.
12
The Center grows out of
ongoing work being done in
the Institute on Health Services
and Disparities Research. The patient-
provider relationship has changed a
great deal in recent decades, and as
a result has become increasingly
important for understanding health
services and disparities.
The importance of the patient-provider
relationship has long been recognized.
Fifty years ago, sociologist Talcott
Parsons developed the concept of the
“sick role” to explain patients’ roles
and social expectations when they were
sick. The sick role was a temporary
status taken in response to acute
symptoms. The patient was released
from social obligations while recovering,
but was also morally obligated to seek
help from an expert and follow medical
advice for how to get better. This por-
trait of a passive patient responding to
an authoritative medical doctor helped
set an agenda for research on related
topics such as health care utilization,
help-seeking, and treatment compliance
(later renamed “adherence” or
“concordance”).
These research agendas were driven in
part by modernist ideologies reflecting
the prominence of medical science and
emphasizing the importance of medical
intervention. The perspective was that
patients would experience desired
positive health outcomes if they would
just act rationally by seeking help and
follow the advice of their health care
providers. This emphasis on medical
authority was complemented by
homogeneity in the educational and
professional pipelines that produced
health care, including who trained to
be physicians (white men), their options
for types of professional positions
(physicians) and the types of environ-
ments in which they would work
(fee-for-service, often solo practice).
Together, these ideologies and
professional systems contributed to
a “Marcus Welby” model of patient-
provider relationships in which the
physicians were the experts and
patients were expected to be passive
consumers of this expertise.
Today, however, many of these factors
have changed, and the patient-provider
relationship is no longer viewed as a
simple conduit for doctors to give
patient information. For starters,
the terminology has changed: “doctors”
have become “providers” and“patients”
have become “clients” or “consumers.”
The biology has also changed: the
epidemiologic transition observed in
western countries has led to increased
chronic illness and lower morbidity
and mortality associated with acute,
infectious disease.
As a result, public health and medical
efforts are increasingly focused on pre-
ventative and palliative care rather than
waiting to treat acute symptoms after
they appear. With advances in medical
knowledge and testing, definitions of
what it means to be sick have also
expanded. More conditions are medical-
ized (i.e. “shift work sleep disorder”),
and people who are not ill but are
at risk for a condition can become
“patients” in the health care system.
At the same time, patients now often
bring their own expertise and initiative
to the relationship. They have
New Center Examines the
Patient-Provider RelationshipNERI has launched a new research initiative called
the Center on Patient-Provider Relationships,
which will expand this long-standing scientific focus.
HEALTH SERVICES AND HEALTH DISPARITIES
13
increased access to health-related
information through the internet and
direct-to-consumer advertising, both of
which help shift the content of medical
knowledge from the physician’s head
and medical books to widely available
venues that patients can access and
use. Furthermore, consumerist atti-
tudes encourage patients to actively
use this information in their own best
interests.
These circumstances make “patient-
hood” a longer-term condition (poten-
tially life-long), and more expansive
insofar as it includes a wider range of
indicators (rather than just “symptoms”
that make a person feel sick), and
requires more self-care and more sur-
veillance for potential developments.
Under such conditions, it is less possible
for patients to be temporarily dismissed
from their daily responsibilities —
instead, sickness (or potential sickness)
become integrated into everyday life.
To the extent that these broader defini-
tions reach all members of society,
this vigilance against potential sickness
requires increased mutual support
and cooperation from family members
and friends.
Large-scale organizational changes
in the health care system also have
implications for the patient-provider
relationship. The rise of managed care
in the US was accompanied by increased
emphasis on evidence-based medicine
and the emergence of Bayesian decision
making as the dominant approach to
medical statistics in the 1970s. These
changes further contributed to a sense
that outcomes and actions were no
longer defined by providers based on
their professional expertise, but rather
by managed care incentive structures,
reimbursement mechanisms, and
practice guidelines derived from
evidence-based medicine. These
changes led to changes in thinking
about how to measure variations,
mistakes, and health care disparities.
Given these conditions, more attention
has been paid to exactly what happens
in the allotted time patients and
providers have together. Bias in physi-
cian decision making, including
intended and subconscious overreliance
on patient demographics in making
diagnostic and treatment decisions,
make up an increasing portion of
research in patient-provider relation-
ships. Results consistently show
variations by patient characteristics,
provider attributes, health care systems,
and country, even when patients’
presenting symptoms are identical.
Topics such as miscommunication,
discrimination, diagnostic uncertainty,
and responses to stigma are all consid-
ered potential keys to understanding
sources of health disparities stemming
from within the medical encounter.
The new Center is already actively
engaged in exactly this type of
research. The National Institute on
Mental Health has funded a major
study of how physician decisions
regarding the diagnosis and treatment
of diabetes varies when the patient has
a stigmatizing comorbidity such as
schizophrenia or depression. But this
is just a start. In the years to come,
the Center on Patient-Provider
Relationships expects to play a major
scientific role in this critical aspect
of the overall health care system.
This research is supported by grant#MH081824 from the National Institute of Mental Health.
Patients now often bring their own expertise and initiative to the relationship.
IL
LUST
RATI
ON
: DA
N F
REY
HEALTH SERVICES AND HEALTH DISPARITIES
Effective Primary Health Care (PHC) appears
essential to both individual and population
health. An ongoing relationship with a specially
trained generalist physician, who is accessible
and provides comprehensive care, is something
everyone prefers, once it is experienced.
For many different reasons, primary health care is under
serious threat in the US, perhaps even heading towards
extinction. The term “crisis” has been used to capture the
present situation. Recognizing the important contribution
of PHC for both individual and population health, can we
“Save Dr. Ryan”?
First, let’s consider what will almost certainly not save
“Dr. Ryan”. Simply rewrapping traditional PHC in well-
intentioned concepts and calling it something else is unlikely
to work. In the past few decades concepts such as a “Medical
Home,” or a “Patient-Centered Medical Home” and later
“An Advanced Medical Home” were developed as “innovative”
approaches to the organization and delivery of PHC.
14
HOW DO WE SAVE DR.RYAN ?“ ”Important stakeholders including legislators, private
foundations, large employers, patient groups, and certainly
organized medicine, have championed the “Medical Home”
as the centerpiece of a “new” approach to the delivery of
health care, and more recently even health care reform.
A medical home is not a place, like a house or a hospital,
but rather an approach to providing PHC. Ideally, and at a
minimum, PHC delivered through the medium of a Medical
Home should be: accessible, continuous, comprehensive,
family centered, coordinated, compassionate, and culturally
appropriate.
There are claims that widespread implementation of medical
homes would decrease health care costs by 5.6% annually
(approximately $67 billion), with substantial improvement
in the quality of care provided and reductions in health
disparities. We certainly hope these things will happen.
A limited evaluation of medical homes is presently underway,
however this does not include appropriate experimentation
(e.g. cluster randomization of participating practices to
appropriate comparisons), hence it is unlikely to produce
results robust enough to inform evidence-based policy.
CA
RTO
ON
BY
MA
RK T
ON
RA
15
• Primary care physicians (PCPs) express high levels of workplace discontent
• Most medical students avoid PHC and instead choose careers in more lucrative medical specialties
• Non-physician health workers now venture on turf once the exclusive domain of PCPs
• The inaccessibility of PCPs is reported by patients and repeatedly confirmed by independent surveys
• Lacking any (or adequate) health insurance, millions of people have no PCP and seek care
from retail clinics or inappropriately use emergency departments for everyday medical needs
ROOTS OF THE CRISIS IN PRIMARY CARE
Newly empowered patients tell their PCPs what they have
and what treatment they expect. The inexorable increase in
medical information and resulting specialization continues
to threaten the basis of generalist medicine. Most PCPs are
now corporatized salaried employees who manifestly advance
organizational needs, resulting in some erosion of patient
trust. Primary care delivered by nurse practitioners in retail
clinics now offers an effective, cost efficient, and satisfying
alternative to traditional PHC for many routine medical
problems (which constitute the bulk of a highly trained and
costly doctor’s workload).
The recent health care reform debate in the US reveals the
modern state more responsive to macro economic interests
than the protection of well-established prerogatives of the
medical profession. With few notable exceptions, most
PCPs and PHC stakeholders appear, perhaps understandably,
“heads down” and focused on the more immediate features
of care inherent in the notion of a medical home, with their
backs to the underlying forces which threaten the future of
PHC in the US.
Improving access and continuity, payment reform, changes
to the medical curriculum, and practice-level improvements
like the introduction of electronic records, and introduction
of online tools to help patients manage information and make
more informed decisions are all worthwhile improvements.
But even if successfully introduced they are unlikely to save
“Dr. Ryan.”
While hoping PHC in the US may be reinvigorated by the
medical home initiative it is reasonable to ask if the medical
home represents any fundamental or structural change.
Many PCPs claim to have provided this type of care for
ages. And despite expressions of patient-centeredness, many
elements of medical homes appear designed to protect and
advance PCP interests — for example, they require “a personal
physician, physician-directed medical practice, and enhanced
access and adequate payment.” The physician remains the
captain of the team, despite its composition and the nature
of the patient’s illness.
Doubtless, the organization, financing, and delivery of PHC
in the US can be substantially improved, but the “changes”
presupposed by the notion of a medical home are unlikely
to bring this about. The medical home represents a repackag-
ing of traditional facets of PHC which preserve dominant
physician and organizational interests and actually represent
very little change at all. By itself, the medical home is unlikely
to save “Dr. Ryan.”
Any true solution to this complex issue must start with
recognition of the underlying causes and a deep understanding
of the magnitude of the problem. The more important origins
of the demise of PHC are social and political. Health and
medical care are now considered to be like other commodities,
to be bought and sold. Medical information and increasingly
medical care itself is available from the internet.
• Some PHC is increasingly available online
• PCPs appear relegated to a gate-keeping function
• The inflation-adjusted income of PCPs continues to decline
NERI’S WORK ON THE FUTURE OF PRIMARY CARE DOCTORING, OUR SAVING DR. RYAN PROJECT, HAS TWO ESSENTIAL FEATURES:• Recognition that PHC is essential to the health of both individuals and the general population• Identification of the upstream social, political and economic factors, which constitute both the greatest threats
to PHC and also offer promise for policy-level interventions to save PCPs
16
go so far as to state that blacks should
have first line treatment with calcium-
channel blockers or thiazide diuretics,
whereas Whites should be treated first
with ACE-inhibitors, angiotensin
receptor blockers, or b-blockers. The
authors of these guidelines justify the
recommendation by citing the “signifi-
cant” differences in the mean blood
pressure responses between these two
race groups that have been published
in the scientific literature. But let’s
examine this “difference” a little bit
more carefully.
Meta-analysis of randomized trials
including US blacks and whites who
were given monotherapy with ACE
inhibitors shows that the mean systolic
blood pressure (SBP) response for
blacks is about 4 millimeters of
mercury (mmHg) less than for whites.
Nonetheless, while this difference in
population means is highly statistically
significant, it is a small difference
compared to observed within racial-
group variability. Whites have a mean
SBP decline in response to treatment
of nearly 11 mmHg, but the standard
deviation is more than 12 mmHg. Since
these mean responses have “normal”
distributions, this latter number
indicates that about two-thirds of SBP
change values for whites obtained
from a random sample will fall between
-1 and 23 mmHg (i.e. ± 1 standard
deviation). For blacks, the mean SBP
response is 7 mmHg, while the stan-
dard deviation is 15 mmHg. Thus,
racial differences are quite small com-
pared with the variation within each
race group (See Figure 1). This implies
that knowing which group a patient
belongs to tells a clinician little about
their individual response to treatment.
Based on this simple example, there-
fore, statistical reasoning would not
support race-based clinical decision
making when it comes to treating
hypertension. This is consistent with
other lines of evidence that strongly
suggest problems with a race-based
approach. To begin with, racial groups
are defined in terms of social and
cultural affiliations, and therefore are
naturally imbued with the associations
gleaned from everyday life in American
society. This makes them a poor choice
for serving as biomedical quantities
because they naturally suggest to the
clinician the patterns of traits and
characteristics that are linked in the
popular imagination to the group,
even when these are inaccurate.
Various experimental trials have docu-
mented under controlled conditions
the irrational and inappropriate use
of racial identity in medical decision-
making. For example, a 1988 experi-
ment by Loring and Powell provided
dummy psychiatric case presentations
that were intended to represent
undifferentiated schizophrenia, and
labeled these as coming from patients
who were black or white and male or
female. The profiles were then assigned
continued from page 3
When Should Race be a Factor in Determining Medical Treatment?
a diagnosis by psychiatrists who
returned questionnaires through the
mail. Black patients, especially black
men, were much more likely to be
assigned the diagnosis of paranoid
schizophrenia, indicating that clinicians
perceived in these descriptions greater
degrees of violence, suspiciousness and
dangerousness than for the identical
white patients.
More fundamentally, it is well known
that racial classification is only trivially
correlated with genetic variability. It
is therefore unsurprising that biologic
traits relevant for medical decision-
making tend to be largely overlapping
across racial groups, and that race is
thus largely uninformative in diagnosis,
prognosis and treatment. In the simple
example of antihypertensive treatment
with ACE-inhibition, we saw that
although there is a “significant” differ-
ence in blood pressure response to
the medication between race groups,
this difference is too small (relative to
within-group variability) to be applied
clinically to decisions involving an
individual patient.
Figure 1: Racial differences in mean response to anti-hypertensive medication.
continued on page 20
Num
ber o
f Pat
ient
s
Response to treatment (in mm/Hg)
Blackpatients
Whitepatients
7 110-50 50
17
Many people know that they
ought to think ahead and
create documents that clearly
express their values and preferences
about medical care in the event they
cannot do so themselves. But this is
often easier said than done. For one
thing, decisions must be made about
diseases (e.g. dementia) about which
people may be unclear.
In addition, choices must be made
about medical treatments, such as
mechanical ventilation, which may also
be unfamiliar. Finally, it can be difficult
to find the right forms to fill out and
to know how those forms need to be
tailored for particular states.
A project recently undertaken by NERI
is aimed at overcoming these barriers
in order to make advance care planning
easier. A prototype interactive video
decision aid has been developed that
presents documentary films of patients
with several end-stage health condi-
tions and various types of end-of-life
“I didn’t realize thatyou could make all of these decisions. If I had a stroke likemy mother and lost my speech, I would wantothers to know my wishes.”
— 82 year o ld female prototype user
“This gives patients a better idea ofadvance directivesthan the two minutesI discuss it with them.”
— Phys ic ian prototype user
care or treatments. These films are
complemented by dramatic films that
model effective communication with
health providers and family about
preferences for end-of-life care. The
decision aid is presented on a tablet
computer to facilitate use in a busy
health care setting. Users are also able
to complete an advance care document
that can be uploaded electronically to
their medical record and printed out.
The decision aid has been developed
by Sharon Tennstedt and Angelo
Volandes, MD, at Massachusetts
General Hospital.
Feasibility testing of the prototype in
a primary care setting shows that this
interactive decision aid is likely to help
people make more informed choices
in advance care planning, and offers
some significant benefits above and
beyond that offered by traditional
print materials or verbal discussions
held with health care providers.
This project is funded by NIH grant#NR010825.
Making Better DecisionsAbout End-of-Life Care
Completed: Online Training Course About PTSDAs reported in NERI’s 2009 newsletter, there is a tremendous and continuing
need for high-quality mental health services. This is particularly true for
individuals suffering from Post-Traumatic Stress Disorder (PTSD). Cognitive
Behavioral Therapy (CBT), which is a well-known and effective form of
psychotherapy, is not as widely used with PTSD patients, perhaps because of
the intensity of the training required.
To address this need, NERI has recently completed a comprehensive online
training course on CBT as it is used for patients with PTSD. The goal is to
remove the well-known barriers to learning the skills needed for using CBT
with these clients. Development of the course has been successfully completed,
and evaluation of the program has begun, with the enrollment of participants
who work within the Veterans Affairs (VA) system. After completion of the
study, the online training course is planned to be opened for broader access.
This study is funded by Department of Defense grant #W81XWH-08-2-0089.
ONGOING RESEARCH
18
The Boston Area Community
Health/Bone (BACH/Bone)
Survey is an observational
research study of musculoskeletal
health conducted among 1,219 racially
and ethnically diverse men aged 29-80
years. Subjects for this study were
recruited from the parent study, BACH.
The baseline BACH/Bone examinations
occurred between 2002 and 2005.
NERI recently received a grant from
the National Institute on Aging
(Principal Investigator: Andre Araujo)
to conduct a second examination of the
BACH/Bone Survey cohort. These
examinations are scheduled to begin
early in 2010.
The BACH/Bone Survey represents a
comprehensive effort to understand
the fundamental causes of racial and
ethnic differences in markers of the
two primary ‘upstream’ determinants
of fracture: loads applied to bone and
bone fragility. This is particularly
important for the study of osteoporosis,
since persons with the disease often
feel no symptoms until a fracture occurs.
Furthermore, it recognizes the fact that
fractures have two main determinants
which may interact with one another:
events that apply extreme force to the
bone (e.g., falls) and weakness of the
bone material itself (see Figure 1 for
the conceptual model that informs the
research).
Therefore, to understand racial and
ethnic differences in fracture rates,
it is critical to consider factors that
influence loads that are applied to bone
(e.g., fall risk, body composition and
physical function) as well as factors that
influence bone strength and quality
(e.g., the bone’s tissue density, material
arrangement, and microstructure).
In the second examination, subjects
will once again visit the General
Clinical Research Unit at the Boston
University School of Medicine (BUSM),
where they will have bone density
tests performed. This will therefore
represent one of the few studies with
the ability to compare longitudinal
rates of bone loss among men of
different racial and ethnic groups.
While at the Research Unit, subjects
will also be scanned with a machine
that was recently acquired through the
NIH grant that uses high-resolution
peripheral quantitative computed
tomography (HR-pQCT) to estimate
bone quality on a microscopic level.
The use of this device is one of the
unique aspects of the BACH/Bone
Survey. There are very limited data on
bone microarchitecture in population-
based studies and no data that examine
racial and ethnic differences in bone
microarchitecture.
In addition, during the second exami-
nation, the portion of the protocol
assessing loads applied to bone will be
greatly expanded to include a compre-
hensive assessment of balance, muscle
strength, walking speed, and other
tests of physical function. These
measurements will be performed at
the Laboratory of Exercise Physiology
and Physical Performance at BUSM.
The BACH/Bone study is poised to
make substantial contributions to our
understanding of the elusive mechanisms
underlying racial and ethnic differences
in bone fragility. Ultimately, the study
could provide insights that will inform
the development of fracture prevention
strategies as well as rational approaches
to resource allocation.
The BACH/Bone Survey is funded by grant#AG020727 from the National Institute on Aging.
A Closer Look at Bone Loss in Men
Loads Applied to BoneFall kinematics
Height and weightMuscle strength
CoordinationBody composition
Load-Bearing Capacity of the Bone
Bone massBone geometry
Bone microarchitecture
Factor of Risk
Φ FRACTURE
Figure 1. Conceptual Model for Fracture Risk
ONGOING RESEARCH
19
Chronic pain is a costly, debili-
tating condition that ripples
through all aspects of a
patient’s life. Work and family roles
can change, and overall physical and
emotional health can be impaired.
There has been growing interest by
health care organizations to encourage
providers to better monitor and treat
intractable pain in the face of mounting
pressures to do more in less time.
Allowing patients to monitor and
record their pain levels with electronic
diaries (EDs) has been recognized as
one possible solution to better pain
management and treatment. The focus
of these efforts has been on improving
how pain is documented so that
providers can better manage the
patient’s pain. Little research, however,
has looked at how the use of EDs
might directly impact the patient’s own
attitude and perception of their pain.
NERI, in collaboration with Robert
Jamison of the Brigham and Women’s
Pain Management Center, recently
conducted a study to explore this
question — and found surprising
results. Qualitative interviews with
patients who took part in a larger
randomized trial, uncovered some
key findings that suggest previously-
unrecognized benefits of using EDs:
• Use of electronic diaries
improved patient understanding
and acceptance of their pain
• Improved self-management
• EDs reduced patient reliance
on medical treatments
• EDs were easy to use and
• Patients reported changing their
behavior
These findings challenge the notion
that electronic tracking will necessarily
result in improving medical treatments.
Instead, the findings suggest that
patients who track their pain using
EDs may better understand how to
cope with their condition through
increased awareness of their pain.
This greater understanding can have
positive benefits such as improved
patient-doctor communication, and
a greater tolerance for the way pain
affects daily life. In essence, appropriate
treatment may be better supported
when patients better understand their
pain. These results provide a new
perspective on the utility of electronic
tools for reducing health care costs
and improving patient quality of life.
This work is supported by National Instituteof Dental and Craniofacial Research Grant#DE014797.
Surprising ResultsFrom TrackingChronic Pain
Using an Electronic Pain Diary: Voices of Patients
“It helped me face my pain a little bit more.”
“A lot of times I have trouble accepting my pain. This makes me stop and at least
be happy that I can do what I can do.”
“I’m getting better at handling this… what used to be a 9, I now consider a 6…”
20
NERI has been at the forefront
of research into the ways that
patient characteristics influ-
ence diagnoses and clinical decision
making. Such things as a patient’s
gender, race, age, and perceived socio-
economic status can produce variations
in treatment that are unrelated to the
actual symptoms presented.
The Veteran’s Administration (VA)
realized several years ago that gender-
based variations in treatment might
be a significant issue since VA patients
have, until recently, typically been
male.
To improve gender-awareness, the
VA worked with NERI to develop a
CD-based training program called
Caring for Women Veterans. The
program’s efficacy was assessed through
a carefully designed two-group
When Should Race be a Factor in Determining Medical Treatment?
These considerations do not necessarily
rule out the possibility of a thoughtful
and appropriate use of race in medical
care. If a disease is etiologically related
to social affiliations and environments,
then race could be treated as a real
and consequential part of a patient’s
history and circumstances, with
important implications for a wide
range of experiences and exposures.
The existing track record for appropri-
ate consideration of race in medicine
is not very encouraging thus far,
however, and one may doubt whether
a social variable with such profound
historical connotations can ever be
used dispassionately, without invoking
all the irrational debris of its sordid use
continued from page 16 as an instrument of social oppression.
Nonetheless, the standard for modern
medicine should be clear. Medical
uses of racial classification should be
viewed suspiciously until justified by
compelling evidence. The traditional
practice of using racial descriptive
labels reflexively for all patients,
for example, should be reconsidered.
Just as race-specific newborn screening
for sickle cell trait in the US was
examined and ultimately abandoned
as unwarranted, so too should racial-
ized guidelines for treatment, such
as those of the British Hypertension
Society, unless or until it can be shown
that such recommendations provide a
real benefit for patients and clinicians.
The Times They Are a Changin’: Women in the VApretest-posttest equivalent control
group evaluation at the VA. A key
study outcome demonstrated that
this training increased sensitivity and
knowledge of gender issues within
VA staff. Because of the importance of
addressing this need, the VA is once
again working with NERI to transfer
the CD-based training to a web-based
application. The new Caring for
Women Veterans training program
will greatly expand access to this
important information within the VA
and is an example of NERI’s commit-
ment to translating basic research
into real-world actions that make a
difference in people’s lives.
For information about the Gender
Aware Health Care study contact Dawne
S. Vogt, Women’s Health Sciences
Division, National Center for PTSD,
VA Boston Healthcare System and
Boston University School of Medicine,
Department of Psychiatry. For informa-
tion about developing state-of-the-art
health care training programs, contact
This research was supported by aDepartment of Veterans Affairs HealthServices Research and Development ServiceAward (Project GEN 20-057-3) and theNational Center for PTSD, Department ofVeterans Affairs, grant #VA241-P-1366.
Jay S. Kaufman is an associate professor
in the Department of Epidemiology,
Biostatistics, and Occupational Health
at McGill University.
ONGOING RESEARCH
21
NERI Gives Back to the CommunityOne man and his car came to pick up the presents that had
been bought and wrapped by NERI employees for the 2009
Snow Kids Gift Drive. He took one look at the massive pile
and reached for his cell phone. One car was clearly not going
to be enough!
In the end, it took 4 cars to transport the more than 150 gifts
donated by NERI staff. As in the past, NERI worked with the
local Department of Social Services, which identified families
in need and detailed how NERI staff could help. This year
NERI provided five area families with gifts for 22 children,
ages 2 to 15. Gifts included toys, musical instruments,
clothes, household items, and gift cards.
Ensuring High-Quality Clinical Data Management
Averitable Amazon of clinical data pass through
NERI computers every year. Managing these data,
analyzing them, and presenting them for external
use is a massive challenge that NERI has consistently
met over the years. One way NERI does this is by adhering
to a set of principles known as Good Clinical Data
Management Practices (CGDMP) which are maintained
by The Society for Clinical Data Management (SCDM).
The SCDM is dedicated to advancing the discipline
through education and a commitment to the highest
standards of clinical data management practices.
The SCDM has established a certification exam to enhance
the credibility of its guidelines and clinical data managers
who pass the exams. The exams are rigorous and test
a manager’s knowledge in a variety of areas including
protocol review, case report form (CRF) design, external
data quality, metrics and adverse event review and
reconciliation. Once an eligible data manager has passed
the exam and been accredited, he or she is recognized
in the clinical research world as trained, qualified, and
committed to the clinical data management profession.
All NERI clinical data managers are members of the
SCDM and take advantage of training opportunities offered
by the organization. To date, seven NERI clinical data
managers have passed the SCDM exam and are Certified
Clinical Data Managers.
Opening New Career Paths at NERIIn its ongoing efforts to
create a dynamic workplace
that can respond to the
energy and talents of moti-
vated staff members, NERI
has recently implemented a
series of changes to the way
staff can advance profession-
ally. For example, a dual
career “ladder” has been created, which can help staff who
are currently on scientific or research career paths take
positions in management. In addition, job descriptions and
some job titles have been revised so that they conform to
industry and government standards. Staff members who do
not currently have a PhD can now progress on the manage-
ment side of the “ladder” with existing MS or BS degrees. By
opening up new career paths and new opportunities, NERI
will be able to retain and support staff members who want to
broaden their experience or grow into new responsibilities.
life at neri
22
NERI: Committed to Leading-Edge Computer Training
Computer hardware and software continually evolve, and NERI has
long been committed to helping its staff keep pace with an in-house
computer training program. This program has played a vital role in
keeping NERI employees well-versed in current technology and practices,
helping to keep staff at the top of the class when competing for research and
scientific business opportunities.
For the past decade, NERI’s computer training program has been led by
Michael Maurao. An example of the program’s strengths is its support of
NERI’s industry-leading data management system software, ADEPT. Maurao
and his team have developed a series of courses aimed at those people who
use the system the most: NERI’s data managers. Each new data manager
participates in a Data Management Certification Program composed of various
classes taught by several different employees with past or present experience
with ADEPT.
Many of the courses are interactive and require class participants to immerse
themselves in the role of a data manager and they thus experience ADEPT
on a first-hand basis. Because those teaching the courses have had such deep
experience with the system, new data managers are presented with living
resources to help guide them on the path of certification.
Many other types of courses are available as well, some required, others
available as options to any staff member interested in honing existing skills or
learning new software tools and programs. NERI’s commitment to computer
training is one reason it is so highly-regarded in the research community, and
a reason its staff retention rates are so high.
NERI a Major Presence at AUA MeetingStaff from NERI’s Institute forEpidemiology will give seven presen-tations at the 2010 AmericanUrological Association (AUA) AnnualMeeting, to be held in San Franciscothis year. The Annual Meeting isbilled as “the world’s largest gather-ing of urologists and researchers.” It is a key part of the AUA’s ongoingmission to further urological healthcare through continuing educationprograms and presentation of the latest research to its over 16,000members.
The seven presentations draw on threeimportant research studies developedand led by NERI investigators: theMassachusetts Male Aging Study; the Boston Area Community HealthSurvey; and the HypogonadismScreener Development Project.
In addition, one of the presentationswill feature an analysis of the Third National Health and NutritionExamination Survey. Three of theseven presentations were selected as podium presentations and coverthe following topics: erectile dysfunc-tion as a predictor of cardiovascular disease; nocturia as a marker ofincreased mortality risk; and urologicpain symptoms.
NERI Leads in SBIR GrantsA recent ranking of companies mostsuccessful in being awarded SmallBusiness Innovation Research (SBIR)Phase II grants from the NationalInstitutes of Health reveals that NERIwas #2 in the nation for the period1992-2005, a testament to NERI’scommitment to high-quality researchand dissemination of research findings.
life at neri
NERI welcomes new staff
Data Managers and Data Collection StaffFrom left: Paul Lithotomos, Senior Clinical Data Manager; Olivia Brown, Data Manager I; Chad Morin, Data Manager II. Not pictured:Olga Estevez, Data Collector/Field Interviewer;Suzeth Dunn, Bilingual Data Collector.
Administrative and Support StaffLeft, standing: Katey Falvey, Research Assistant;(center seated): Elizabeth Suarez, ResearchAdministrative Coordinator; (right): MatthewGrace, Research Assistant.
Kerstin Allen joins NERI as a Senior Research Scientist.With an MA in Biostatistics from Boston University,Kerstin rejoins NERI after spending about 16 years working in clinical research as a Biostatistician and Senior Biostatistician.
David Brazier has been made Associate Director ofClinical Operations. David served in the Air Force for 8 years, and has over 20 years of experience in biotech-nology/pharmaceutical companies. He has a BS in Biologyfrom Salem State College and is currently enrolled in anMS program in Management of Projects and Programs atBrandeis University.
Julia Dixon is now working at NERI as a Senior Research Associate. She has a BS in Neuroscience from the College of William and Mary, and an MPH from Yale School of Public Health.
Margaret (Maggie) Gates joins NERI as a ResearchScientist in Epidemiology. She has a doctorate inEpidemiology from Harvard School of Public Health, and two years of postdoctoral experience working withdata from the Nurses’ Health Study cohorts at HarvardUniversity and Brigham and Women’s Hospital.
Michael Greeley has been hired as a Clinical ResearchAssociate. He has a BS in Microbiology from AuburnUniversity and is currently enrolled in an MS program in Clinical Research Organization and Management atDrexel University.
Courtney Jackson joins NERI as Research Scientist.Courtney has an MA and PhD in Sociology from Rutgers University and served as Director of Research and Evaluation at The Abortion Access Project.
Rania Mekary was recently hired as a Research Scientist.She has a masters in nutrition from the AmericanUniversity of Beirut, and another masters in applied statistics as well as a PhD in nutrition from LouisianaState University. She just completed a post-doctoratetraining in epidemiology at the Harvard School of PublicHealth.
Haggar Nicholson joins NERI as a Senior Clinical Data Manager. She has a BS in Biological Sciences from University of Science and Technology, Ghana, West Africa and is currently enrolled in a MS programin Health Communications at Boston University.
life at neri
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PERMIT #56435WATERTOWN, MA
02472
9 Galen StreetWatertown, MA 02472
www.neriscience.com
Please send all address corrections to [email protected]
NERI recently launched an interactive, online anthologyof research methods and tools for researchers engagingin behavioral and social science research on health-related topics.
Called e-Source: Behavioral and Social Sciences Research
Interactive Textbook, this novel educational tool was created
through a contract from the Office of Behavioral and Social
Science Research. Recognized international experts in their
fields were enlisted to author the 14 chapters for the site.
This website aims to:
• Demonstrate the potential of BSS research to enhance
biomedical research
• Serve as a resource center for the most current and
high-quality BSS research methods
• Reveal how to easily and efficiently obtain authoritative
answers to methodological questions
• Identify consistent and rigorous quality standards
for the research community
Visit the e-Source site and experience it for yourself at
www.esourceresearch.org. No login is necessary to access
the digital anthology.
This work is supported by OBSSR contract #HHSN27620070003C.
A Behavioral and Social Science Text for the 21st Century
