Sutter Institute for Medical Research 2008 Annual Report

Sutter Institute for Medical Research
2008 Annual Report
Our Volunteers’ Perspectives
sutterresearch.org

About SIMR
Dedication
Like most annual reports, ours
typically focuses on Sutter Institute for
Medical Research (SIMR) activities
and accomplishments. In this annual
report, we have expanded the focus
to include the reasons behind that
work and what it has meant to a
few of the many Sutter patients who
have contributed the most critical
element of the research equation
by volunteering as clinical trial
participants.
No matter how hard any research team
works, we could not advance medical
care a single step without the trust and
faith of clinical trial participants. By
voluntarily contributing to improve
medical care, participants touch
the lives of people around the world
and those yet to be born. And so it is
with honor and appreciation that we
dedicate this annual report to the
research volunteers who work with
us to further our mission “to integrate
research into clinical care.”
Sutter Institute for Medical Research (SIMR)
provides a stable framework linking medical
research with patient care. Through SIMR, Sutteraffiliated
physicians receive the administrative
support and safety oversight needed to conduct
prudent, successful research. SIMR was founded in
1959 at Sacramento’s Sutter Memorial Hospital and
now offers research opportunities throughout the
Sutter Health Sacramento Sierra Region’s acutecare
hospitals, and outpatient facilities involving
both primary-care and specialty physicians.
Our Mission
To integrate research into clinical care.

Letter from the Medical and Operations Directors
We’re delighted that this year’s annual report treats
readers to the stories of four volunteers who have
taken part in clinical trials through SIMR. Stories like
these fuel the passion of our dedicated investigators
and staff, and it’s that passion that drives SIMR
forward. Our volunteers’ journeys illustrate the value
of providing research in a community hospital setting
in a way nothing else could, so we thank Rael, Sharon,
Kenneth and Jared’s families for agreeing to share their
experiences.
We also want to thank our investigators who spend long
hours caring for patients, yet willingly increase their
load by making medical research an important priority.
As clinical practitioners, our investigators are not
motivated by demands to publish or perish. They get
involved in research for the same reason they entered
the medical profession — to help people live longer,
healthier lives. While SIMR staff does its utmost to
remove the administrative work from the investigators,
adding research to already busy lives requires a special
dedication that we and their patients applaud.
SIMR researchers presented at several national and
international conferences.
Even closer to home, our own SIMR research
coordinators Tammy Donnel, Mary Hyland and Dorothy
Wullenwaber became poster presenters at the 17th
Annual Society of Clinical Research Associates. Their
poster entitled “Implementation of Patient Recruitment
Services Department in a Community Hospital Clinical
Research Institute” was met with great interest. Patient
recruitment is often the most difficult part of creating a
successful clinical trial, so many attendees were anxious
to find out more about SIMR’s successful recruitment
system.
With all systems running well, an exceptional staff and
enthusiastic investigators, we have all the ingredients
assembled to grow and strengthen the bond between
research and clinical care.
Sincerely,
In addition to investigators involved in clinical trials,
SIMR supports a special group of researchers who take
a ground-up approach by designing and implementing
research projects through SIMR’s Research Committee,
led by Harvey Wolkov, M.D., with financial support
from the Sutter Medical Center Foundation (SMCF).
Over the years, the Research Committee and SMCF
have enabled dozens of investigator-initiated studies
to come to fruition, with many presenting findings
through conference posters and presentations, as
well as peer-reviewed publications. This year alone,
Andrew Hudnut, M.D.
Medical Director
Linda D. Marks, MPA, CCRP
Director, SIMR Operations
John Mesic, M.D., CMO of
Sutter Health Sacramento
Sierra Region; Linda
Marks, Director of SIMR
Operations; Andrew
Hudnut, M.D., SIMR
Medical Director

Grant Enables SIMR to Pursue Key Goal
We have long believed that SIMR’s uncommon
position as a research entity within a community
hospital system would make it possible to employ
research to address issues that affect patients being
cared for in several settings over an extended period
of time. While most clinical research focuses on
one aspect of diagnosis or treatment, patient care
in the real world is a mixture of people, processes,
medications and medical devices that each affects the
patient’s outcome. In addition, conditions typically
begin long before hospital admission and seldom
completely resolve before hospital discharge. To
determine the most effective diagnosis and treatment
strategies, researchers must analyze the full care
continuum, provide statistically meaningful results
and translate those results into best practice models
other health care providers can replicate.
In 2008, SIMR, the Sutter Health Institute for
Research and Education (SHIRE) and SHSSR Clinical
Integrations received an unrestricted grant from
sanofi-aventis to study the process of care for patients
with or at risk of venous thromboembolism (VTE).
Though sanofi-aventis produces drugs used to treat
both conditions, this study is not tied in any way
to any products, and the decision to publish lies
solely with us. The study combines clinical research
and business process engineering, working with
key stakeholders to identify the ideal model of care,
interviewing patients and conducting literature
reviews. By analyzing each step along the care
continuum and quantifying findings, the research
team will develop a practical model shown to
deliver the best outcomes in patients with a deep
vein thrombosis or a pulmonary embolism. Once the
model has been verified, the study includes funding to
produce educational materials that will enable Sutter to
disseminate the model across the system.
According to Tom Leonard, grant manager for the study,
“The study allows us to expand the nature, scope and
purpose of research beyond clinical trials by examining
the processes related to care. While businesses
commonly develop and share best practices, health
care providers only do so in segments that have been
validated through research. In a sense, this takes the best
of both disciplines by extending the rigors of research
to all aspects of care, which will link the validated
segments into a sequence of best practices.”
Leonard adds, “This is very much a patient-centered
study. We’ll look critically at our current practices and
explore any blind spots so that the model we develop
and disseminate raises the standard of care across our
entire system. Of course, we’ll freely share the model
through peer-reviewed publications and conference
presentations so that other health care providers and
their patients will also benefit from what we learn.”
“The study allows
us to expand the
nature, scope and
purpose of research
beyond clinical trials
by examining the
processes related to
care.”

Research and Training Laboratory
SIMR Laboratory Staff
Back row, left to right: Dr. Richard Marshall, Jim Steel.
Front row, left to right: Alyson Iwamura, Liz Taylor, Todd Iwamura.
The Sutter Institute for Medical Research (SIMR) has
its origins in the research and training laboratory. In
1957, Dr. Edward Smeloff founded the laboratory where
he pioneered many early advances in cardiovascular
surgery. Since that time, the laboratory department has
kept Sutter on the cutting edge of developing and using
new medical devices and techniques, maintaining a
reputation for research excellence.
Ed Smeloff, M.D., and Jimmy
Durante visiting with the first ever
pediatric recipient of the Smeloff-
Cutter heart valve in 1963.
In 2008, the department conducted 204 research and
training laboratories. In collaboration with 32 medical
companies, the SIMR laboratory developed several
cardiovascular devices to treat congestive heart failure,
diseased valves, arrhythmias, arterial blockage,
and strokes. In addition, three Sutter physicians are
conducting independent orthopedic research: two are
developing new spinal fixation devices and techniques,
while the third is the inventor of the ROBODOC ® , the
first device in medical history to combine surgery,
imagery, and robotics. Other research ranges from
developing new endosurgical instruments and
techniques to treatments for sleep apnea and morbid
obesity.
To keep Sutter at the forefront of health care, the
laboratory attracts the most progressive physicians,
and continually trains its medical staff to use new
technology and life-saving procedures. Sutter boasts
one of the lowest infant mortality rates in the state
of California, partially because of the laboratory’s
continual training in advanced life-support techniques.
Other ongoing training sessions include minimally
invasive surgery techniques, circulatory assist devices,
and many others.
The laboratory’s work in developing new medical
devices and techniques improves patient safety
and care, which result in shorter hospital stays and
better outcomes, making health care better and more
affordable.

Less Invasive Surgery Synchronizes a Heart and Restarts a Life
“Bring it on,” said Kenneth, a recently retired 62 year old
who swims for 50 minutes several times a week. While
that fitness level may be uncommon for men Kenneth’s
age, it’s especially surprising for a man who had to rest
after climbing a flight of stairs not long ago.
It was during the holidays in 2001 that atrial fibrillation
began causing Kenneth’s heart to erratically beat. The
first serious bout sent him to the hospital, but he learned
over time that sleeping usually restored the rhythm and
he grudgingly adjusted his lifestyle to accommodate the
breathlessness. He also started taking medications to
control the symptoms and prevent the atrial fibrillation
from causing a stroke, but he didn’t like relying on the
medications to work without causing other problems.
“I was getting ready to retire,” said Kenneth, “but my
activity level had changed so dramatically that I wasn’t
looking forward to it.”
Because the medications were not providing the relief
Kenneth needed, electrophysiologist Larry Wolff, M.D.,
talked to him about volunteering as a study participant
for a minimally invasive surgery that cardiovascular
surgeon James Longoria, M.D., was pioneering. He
explained that instead of a traditional open heart
“It took me
four days to do
what now
takes four
hours.”
Cox Maze III surgery used to correct atrial fibrillation,
Dr. Longoria would use probes placed through small
incisions. Dr. Wolff would take part in the surgery,
as well, doing interoperative mapping and testing to
identify ganglionic plexi or areas of nerve tissue that
innervate the heart and are felt to be responsible for the
initiation and perpetuation of atrial fibrillation. Though
Dr. Wolff thought Kenneth was an excellent candidate
for the new procedure, which would involve smaller
incisions and less scarring, less postoperative pain, and
faster return to normal living than open heart surgery,
Kenneth wasn’t ready to undergo any heart surgery.
After another year of feeling that his life was on hold,
Kenneth celebrated his 60th birthday and decided it was
time for a tuneup.
“About a week before my surgery, I was rototilling my
yard,” said Kenneth. “I’d work for 10 minutes then rest,
work for 10 minutes, then rest. It took me four days to do
what now takes four hours.”
Kenneth volunteered to be among the first to undergo
the minimally invasive procedure with newly designed
probes. During the three-hour surgery, Dr. Wolff and
Dr. Longoria discovered that 13 of 26 areas needed to
be ablated. Dr. Longoria ablated these areas, as well as
performed the pulmonary vein isolation. Two and half
days after surgery, Kenneth went home to recover for
several weeks.
While certainly less invasive than open-heart surgery,
getting to the well-protected heart still requires that the
ribs, muscles and nerves to be separated for the probes
to pass through. Kenneth’s heart stopped misfiring
immediately, and has remained steady since, but he
had a bad reaction to the painkillers and the nerves
and muscles took longer to heal than he hoped. As the
procedure has continued to be perfected, recovery times
have shortened, but Kenneth knows his recovery was still
nothing compared to a friend who underwent open heart
surgery about the same time.
“Most important is how I feel,” Kenneth said.
“Comparing my life before the surgery to after is like
comparing night to day. I’m active again and in good
shape — with absolutely no heart arrhythmia.”

Artificial Disc Puts Skier Back on the Slopes
Rael was putting a piece of stone on a high shelf when
she felt a twinge in her neck. An active 40-something
woman who loved to ski, Rael was used to strained
muscles and didn’t think much about the soreness in
her neck that evening. When the pain increased instead
of going away, Rael thought she had pinched a nerve
and went to see her doctor, who sent her to a physical
therapist.
“Physical therapy only made the pain worse,” said Rael.
“I also practiced breathing, relaxation and focusing
exercises — anything I thought might help me deal with
the pain.”
In spite of everything she tried, the pain persisted and
her once-active life slowed to an agonizing crawl. Three
months after that first twinge, Rael underwent an MRI.
The scan revealed a bulging disc pressing directly
against the nerve roots of her spinal cord. Though glad
to understand what was causing the pain, Rael also
knew the most likely medical treatment would be to
remove the disc and fuse her neck vertebrae, which
would increase the risks of disease at other levels and
potentially mean the end of skiing and many other
activities she loved.
That December, Rael went to neurosurgeon Cully Cobb,
M.D., and immediately knew she’d found the right
patient-doctor fit. “Dr. Cobb doesn’t think of surgery as
the first option, which made me feel good,” said Rael,
“and he really understood how important mobility
is to me. When he told me about the possibility of
volunteering to be part of a study for a new artificial
cervical disc, I knew he wouldn’t have suggested it
unless he felt confident that it was the best solution for
me. Even though I would be one of the first patients in
the U.S. to get the device, Dr. Cobb, research coordinator
Kimberly Olsen-Wilson and the device manufacturer
were so thorough about making sure I was a good
candidate that I never felt apprehensive.”
Getting through the eight months it took to lay the
groundwork for surgery proved to be much more
difficult than the surgery. Rael went into surgery
at eleven, woke up in recovery around two, and
was standing up and walking by four o’clock. She
went home the following morning and saw a daily
“I feel as
though I was
never injured.”
improvement over the next three weeks. The mental
exercises that helped her manage the pre-surgery pain
also enabled Rael to manage the post-surgery pain with
nothing more than ibuprofen.
“I hit a wall at three weeks,” Rael said, “but Dr. Cobb
said that was part of the natural healing process my
body was going through, so I just kept pushing through.
By December I felt ready to ski again, but the doctors
made me wait six months to ensure the new disc was
firmly in place.” By the spring, six months after the
surgery, Rael felt she had regained her pre-injury
strength and stamina. The snow was gone for the year,
but she was ready to go the following season.
“I feel as though I was never injured,” she said, adding,
“I have no loss of mobility, no pain, no lingering issues
— none at all.”
The five-year study requires Rael to get a yearly CT scan
and X-rays to track her long-term healing, but it’s a sure
bet that she’ll schedule those appointments before or
after the ski season.

“I wasn’t the last one in line!”
“Jared was 19 1/4 inches at birth and he seemed to
get big fast,” said Allison, Jared’s mom. “But around a
year, we started wondering if everything was okay. We
noticed he wasn’t as big as his cousins and his clothes’
sizes were always a year behind his age. The
pediatrician said his size was normal, but when he
started school, I heard a lot of comments about how
small he was, and I noticed there were things he couldn’t
do, like reach the sink to wash his hands. He noticed,
too, and started asking what was wrong with him. By
the time he turned five, Jared’s worry was apparent, so
we decided to take him to see Dr. Prakasam.”
Pediatric endocrinologist G. Prakasam, M.D., one of
SIMR’s most dedicated research investigators, works
with children and families dealing with all types of
endocrine disorders. He knows that early detection and
treatment of endocrine-related issues is important, but
understands that children’s endocrine disorders are not
always easy to diagnose and there’s a wider range of
“normal” in children than adults. Clear-cut diagnostic
tests are not always available for every disorder either,
so it’s sometimes necessary to watch children over time
and see how they develop. In Jared’s case, Dr. Prakasam
performed blood tests, took periodic hand X-rays to
check growth, and followed Jared closely for more than
two years before determining growth hormones were
the best course of treatment.
Unfortunately, even with health insurance, the cost of
growth hormone treatment remains high. Dr. Prakasam
offered Allison and her husband Kevin, the chance
to enroll Jared as a volunteer in a clinical research
trial. Though the drug was not yet FDA approved,
Dr. Prakasam felt it showed good promise with few
drawbacks.
Best of all, Jared
grew two and
a half inches
in the first six
months of the
study.
“Enrolling Jared as a research volunteer was a very,
very tough decision for us,” said Allison, “but we
couldn’t afford treatment otherwise. We also trusted Dr.
Prakasam and knew he was very cautious, so we felt
fortunate that this door had been opened for us. Jared
has received such great care and been monitored so
closely since he joined the study in May 2008, that we
know he’s getting excellent care and being seen more
often than if we had chosen to do this on our own.”
Best of all, Jared grew two and a half inches in the first
six months of the study. “We’re ecstatic for him. It’s
such a weight off his shoulders,” said Allison. “I don’t
think I fully realized how much his size bothered him
until I picked him up after school the day they took
second grade pictures. Jared came running out to the car
yelling, ‘I wasn’t last in line! I wasn’t last in line! I was
second to last, but I wasn’t last!’”

“The results were
everything I had
hoped for.”
Robotic-Assisted Hip Surgery Restores the Spring in Her Step
While there’s no discounting the many benefits of
aerobic exercise, teaching aerobics classes for countless
years eventually took its toll on Sharon’s left hip. “In
the type of aerobic dancing I taught, every step began
on the left side,” said Sharon. “Over time, the constant
pressure on my left hip gradually wore down the joint
cartilage until it was bone on bone. It got to the point
that I couldn’t even walk without limping.”
Sharon talked to people who had undergone hip
replacement surgery and heard Dr. Bargar’s name
mentioned so often that she decided he was the one she
wanted to perform her surgery. In February 2008, she
went to see William Bargar, M.D., for the first time and
heard that the latest generation of the robotic surgical
assistant Dr. Bargar had helped develop many years
before would soon be tested in a clinical trial.
Dr. Bargar explained that the system would allow him
to use diagnostic images to assess Sharon’s hip anatomy
and condition, select the best hip implant type and size,
and determine its optimal placement. During surgery,
the system would assist him again, this time in carrying
out the plan and preparing the femur for implant
placement to ensure the implant was set at the correct
angle. Dr. Bargar’s experience in hip replacement,
combined with his confidence in the improved accuracy
the system would provide over manual surgery
techniques, convinced Sharon to enroll in the clinical
trial.
“The results were everything I had hoped for,” said
Sharon. “I didn’t even have to take pain medication
after the surgery. Eight or nine days after the surgery, I
was able to walk up and down the stairs at home. My
physical therapist said I could go down once in the
morning and up again at night, and I was very careful
to follow all instructions exactly, which I’m sure helped
contribute to my results. My greatest fear was that the
hip would pop out, but it settled right in and healed
beautifully.”
Today Sharon does not enjoy pain-free hips, however.
“I do a lot of walking, and I can honestly say that I’ve
never felt any pain in my left hip,” Sharon said, “but I
have arthritis in my right hip now — and that’s the only
hip that ever hurts.”

“There are a lot of unknowns in
pediatric neurology and a great
deal that can be learned by turning
clinical observations into research
studies that prove or disprove those
observations. When I started seeing
children with Down’s syndrome
exhibiting signs of autism, I
wondered if epileptic episodes might
be occurring in these children.
Working with SIMR allowed me to
pursue that idea and verify that there
may indeed be a connection. In fact,
the opportunity to do research is one
of the things that drew me to Sutter.
There is a large patient population
and ample support from SIMR to
initiate, conduct and complete a
research project.”
Michael Chez, M.D.
Medical Director, Pediatric Neurology
Symposium Highlights
One of the lesser-known opportunities SIMR
provides is the chance for investigators to pursue
research interests that lie outside clinical trials.
Since 1989, dozens of physicians and other Sutter
practitioners have initiated research projects. In most
instances, these researchers apply for and receive a
grant funded by donations and other philanthropic
gifts made by Sutter Medical Center Foundation.
Over the years, many SIMR researchers have received
national and international recognition for their work.
In October 2008, we gathered a few together for a
local symposium presented to Sutter colleagues and
members of the Greater Sacramento community. Research
scientist Carol Parise and SIMR staff members
Bobbie Benabides, Dorothy Wullenwaber, Tammy
Donnel, and Marilyn Dela Cruz, organized the symposium.
Presentations were made by six researchers
who recently completed studies with SIMR support:
Nate Hitzeman, M.D.
Affect of Personalized Annual Health Reminder Cards
(PAHRC) on Completion of Age-Appropriate Health
Maintenance Projective Objective
A study to determine if personalized reminders of
health maintenance items sent to patients on their
birthdays would improve their completion of patient
specific health maintenance requirements within six
months. Results showed no increase from this lowcost
intervention.
Vincent Caggiano, M.D.
Age, Race/Ethnicity, and Breast Cancer Subtypes in
California
A series of studies conducted by analyzing 6,370
records within the California Cancer Registry
database showing an invasive breast cancer
subtype featuring negative receptors for estrogen,
progesterone and human epidermal growth factor
receptor 2 (triple negative). The widely published
and presented studies conclusively showed that
the subtype is more prevalent and deadly in
young African American and Hispanic women, a
finding that can help doctors look for and treat this
challenging subtype.

Investigator-Initiated Research
Rosanna Hannum, R.N.
Using Telemedicine to Manage Children Starting Insulin
Pump Therapy
A study to determine if telemedicine (medical care at
a distance using technology) would improve access
to care and affect the care standard in children with
diabetes. The study showed telemedicine improved
access to care, produced comparable treatment
effectiveness and patient satisfaction. Current
equipment costs and quality, maintenance costs, and
lack of insurance reimbursement limit telemedicine’s
feasibility at present. This is saying that telemedicine
isn’t used because of the cost and insurance won’t
reimburse for telemedicine visits.
Michael Chez, M.D.
Frequency of Abnormal Overnight EEG in Downs
Syndrome Patients with Co-Morbid Diagnosis of Autism
A study that grew out of Dr. Chez’s observation
of an apparent link between Down’s syndrome
children who developed autistic behavior and
sleep abnormalities brought about by an epileptic
process. The study of seven patients using a 24-hour
electroencephalogram (EEG) showed brain wave
disruption in four of the six who completed the
test. Treatment with epilepsy medication created
significant improvements in all four patients.
Steve Weber, M.D.
Pain Scores in the Management of Postoperative Pain in
Shoulder Surgery
An outcome study that tested the correlation between
pain scores and patient outcomes. The study found that
high pain scores did correlate to longer recovery times,
but also found high pain scores were more common
in certain patient populations and did not correlate
with the magnitude of the operation or with heart rate,
respiratory rate, or level of consciousness.
William Bargar, M.D.
Validation of Computer Navigation for Acetabular
Component Placement in Total Hip Arthroplasty
A study to determine the precision and accuracy of
an imageless navigation system for correct placement
during insertion of the acetabular cup in total hip
replacement. The study showed high placement
accuracy in patients with BMI scores of less that 35.
The symposium drew a standing-room only crowd and
a great deal of positive feedback from the audience.
Supporting SIMR: We’re All in This Together
Sutter Medical Center Foundation, the philanthropic arm of not-for-profit
Sutter Medical Center, Sacramento, provides grants that enable Sutter
researchers to initiate and conduct quality research in a community
hospital setting. By giving to the foundation, everyone in the community
can take part in the excitement of advancing medical care through
research.
“Research funding is a critical investment in our future. The returns are
immeasurable: new drugs, improved technology, and most important,
better survival and quality of life for our patients and for people
everywhere,” says Katherine Keeney, executive director of Sutter Medical
Center Foundation. “Safe, effective medical research requires more than
the dedication of doctors, support staff and participants. The financial
support we receive from our community through charitable donations
to Sutter Medical Center Foundation helps SIMR to efficiently conduct
research in a well-organized atmosphere that ably supports research
participants, investigators and staff.”
To contribute to the work Sutter Institute for Medical Research is to
improve patient care in our community and beyond. Please contact the
Sutter Medical Center Foundation at (916) 733-3863. You can find out
more about the foundation at www.suttermedicalcenter.org/philanthopy.

2801 Capitol Ave., Suite 400
Sacramento, CA 95816
(916) 733-8930
sutterresearch.org
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