d e c e m b e r / J a n ua ry 2 017
Steve Struble, M.D. What You Need to Know About Cary and Holly Spring’s “Hip” Orthopedic Joint Surgeon
T H E M A G A Z I N E F O R H E A LT H C A R E P R O F E S S I O N A L S
Also in This Issue Closing the Outcomes Gap Face-to-Face with the AMA
“A Degenerated Hip Joint Sidelined Me
From Playing Football With My Grandson. Thankfully, Johnston Health’s Joint Center And Rehab Got Me Back In The Game!” Jimmy Marler & Grandson Payton Pine Level, NC
One of the main reasons Jimmy Marler retired was to have more time to enjoy activities with his grandson Payton. But when hip pain reached a level that he could no longer enjoy their routine of playing football, Jimmy turned to the experts at Johnston Health’s Joint Center.
SMITHFIELD
Hip replacement surgery and therapy at the Joint Center, followed by our Home Care support and therapy at our Rehab Center, got him back on his feet quickly, and back to his and Payton’s favorite pastime in just a few months. For his full story, visit www.johnstonhealth.org.
Expert Care - Close To Home! www.johnstonhealth.org
CLAYTON
T
From the Editor
Health and Happiness T H E M A G A Z I N E F O R H E A LT H C A R E P R O F E S S I O N A L S
Orthopedic surgeon Steve Struble of Total Joint Care may have created a model in which a small, independent practice can thrive. As he describes it, enhanced personal attention and a number of efficiencies create happier, more satisfied patients. Our returning contributors this month share insights for improved health care outcomes. Gynecologist Andrea Lukes discusses the underdiagnosed polycystic ovary syndrome, or PCOS. Practice management consultant Margie Satinsky gives tips for using performance management to improve practice quality.
Editor Heidi Ketler, APR heidi@trianglephysician.com Contributing Editors Marni Jameson Carey Andrea Lukes, M.D., M.H.Sc., F.A.C.O.G. Margie Satinsky Creative Director Joseph Dally jdally13@gmail.com
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Physician advocate Marni Jameson Carey reports on a meeting between the American Medical Association president and several leaders of
info@trianglephysician.com News and Columns Please send to info@trianglephysician.com
physician organizations to clarify issues. Together, the physicians and other professionals noted in this issue of The Triangle Physician represent a snapshot of the ongoing efforts to advance health care in our region and beyond. My colleagues and I are proud to be in the position of reporting on some of these great strides. We hope you will consider sharing your news and insights with our more than 9,000 readers in 2017. Contact us at info@trianglephysician.com to learn about the opportunities for coverage, in addition to our competitive advertising rates. We wish you and yours health and happiness in the New Year! With gratitude for all you do,
Heidi Ketler Editor
The Triangle Physician is published by: New Dally Design Subscription Rates: $48.00 per year $6.95 per issue Advertising rates on request Bulk rate postage paid Greensboro, NC 27401
Every precaution is taken to insure the accuracy of the articles published. The Triangle Physician can not be held responsible for the opinions expressed or facts supplied by its authors. Opinions expressed or facts supplied by its authors are not the responsibility of The Triangle Physician. The Triangle Physician makes no warrant to the accuracy or reliability of this information. All advertiser and manufacturer supplied photography will receive no compensation for the use of submitted photography. Any copyrights are waived by the advertiser. No part of this publication can be reproduced or transmitted in any form or by any means without the written permission from The Triangle Physician.
2
The Triangle Physician
Table of Contents
4
COVER STORY
Steve Struble, M.D.
What You Need to Know About Cary and Holly Spring’s “Hip” Orthopedic Joint Surgeon d e c e m b e r / J a n u a r y 2 0 17
FEATURES
8
Practice Management
Performance Measurement Tips that Help Improve Quality of Care
Vol. 8, Issue 1
DEPARTMENTS 12 Community Service
GiGi’s Playhouse Raleigh Wins National Rising Star Award
13 Women’s Health
Irregular Menstrual Bleeding and Prediabetes: Think PCOS
Margie Satinsky explains the goal-oriented process for closing
14 Research News
the gap between desired and actual outcomes.
10
Combination of Drugs Shuts Down Certain Breast Cancer Cells
15 Research News Physician Advocacy
On the Record with AMA President Andy Gurman, M.D. Marni Jameson Carey reports on a meeting for clarification on actions that have impacted independent physicians.
Peripheral Artery Disease Treatment Clarification Underscores Unmet Need
16 Research News Interdisciplinary Approach Leads to Drug-Delivery Modification that Sidesteps Allergic Response
17 News
Welcome to the Area
december/January 2017
3
Cover Story
Steve Struble, M.D.
What You Need to Know About Cary and Holly Spring’s “Hip” Orthopedic Joint Surgeon Orthopedic surgeon Stephen G. Struble,
none, in a relaxed atmosphere, with an of-
spine problems. He has staff privileges at
M.D., started Total Joint Care in 2009
fice staff that is friendly and upbeat.
WakeMed Cary hospital and Rex Ambulatory Surgery Center.
with offices in Cary and Holly Springs to address what he saw as a flaw of larger
“Whether you have a child with a broken
groups. “I started out practicing with a
bone, are a weekend warrior with a sports-
“Most orthopedic problems don’t require
large group. I felt patients had too many
related injury, an older patient with more
an expensive emergency department or
twists and turns to see me and often felt
complex musculoskeletal issues or even
urgent care visit, much less surgery.” Total
lost and frustrated before sitting down with
someone who needs a second or third
Joint Care is equipped with fluoroscopy
me in the exam room. Referring practices
opinion – we’ll see you expeditiously.
for onsite X-ray and pediatric and adult
also got tired of the hoops and barrels.”
Same-day appointments are the rule, not
casting for more cost-efficient, compre-
the exception.”
hensive care.
to endless telephone trees, unreturned
A board-certified orthopedic surgeon, Dr.
Dr. Struble is one of the few orthopedists
phone messages and long waits to be
Struble provides the full complement of
with optional fellowship training in joint
seen by an anonymous provider. “We of-
services, including the latest non-operative
reconstruction. This expertise is sought by
fer quick access for patients and referring
and operative treatments for degenerative
patients, many of whom have debilitating
doctors to quality care that is second to
diseases, sports injuries and trauma and
hip and knee problems – hence the prac-
Dr. Struble’s practice style is an antidote
tice name. His wheelhouse lies in hip and knee replacements and arthroscopies. Results speak for themselves. Dr. Struble’s hip and knee reconstruction patients typically spend a night in the hospital, are walking assistance-free at two weeks and oftentimes need no more than several weeks of formal physical therapy. This is a significant improvement over previous years, when patients could expect a full week in the hospital, followed by several months of therapy. Starting out at an orthopedic mega-practice demonstrated to Dr. Struble that bigger isn’t necessarily better. Higher overhead puts greater demands on the physicians to see more patients – spending less time with each. “Feeling like a ‘cattle call,’ such an office environment results in increased stress and dissatisfaction among patients and physicians alike,” Dr. Struble says.
4
The Triangle Physician
This experience helped shaped Dr. Struble’s patient-first paradigm and led him to his somewhat risky decision to go solo in 2009. “I created this practice to improve the patient-physician experience by keeping the practice small and operating efficiently. This allows me to work closely with patients – from initial consultation to subsequent appointments – to target their diagnoses and determine the most rapid path to recovery. Our practice model keeps costs down, which makes patients happy and keeps me busy.” “To me, the biggest compliment is having a patient refer a friend to me for help. I see our practice as that cozy restaurant you’re excited to tell your friends about.” exact precision to the millimeter. Jam-
He earned his medical degree from UCLA
Dr. Struble helps control costs with an eye
ming my surgery schedule a little less and
and continued general and orthopedic
on convenience by prescribing ancillary
spending a little extra time in the operat-
residency there.
services only when needed and close to
ing room has undoubtedly yielded better
where the patient lives.
outcomes.”
“I own no ancillary services. If a patient
At age 10, Dr. Struble became Ohio’s
in various orthopedic journals and pre-
needs physical therapy, I find an indepen-
youngest published author, with To See or
sented papers at the American Academy
dent therapy group that’s easy for them to
Not to See, a story about the adventures of
of Orthopedic Surgeons annual confer-
access. Expensive exams, such as MRIs,
a young boy as told by his eyeglasses. How
ence.
are kept to a minimum, and again or-
did this color his approach to medicine?
dered at facilities easily accessible to the
After publication, he kept up a busy book-
Dr. Struble completed an additional year
patient.” Dr. Struble believes this practice
tour schedule, visiting schools across the
of fellowship training in joint reconstruc-
puts him in “good position ahead of the
country and talking to large audiences.
tion at OrthoCarolina in Charlotte. “I want
During his training, he conducted research, co-authored several publications
to be the best trained at anything I do,” he
coming era of cost and quality metrics.” “I talked to hundreds of kids about writing.
says.
Bedside Manner Matches Expertise
Through the experience I became com-
Dr. Struble’s cutting-edge techniques and
fortable relating to people about some-
As one of the few orthopedic surgeons
innate technical understanding are com-
thing I’m passionate about,” he recalls.
with specialized fellowship training, Dr.
plemented by his bedside manner and
“The connectivity of life really hit home
Struble is skilled in performing the range
active interest in educating patients about
when a few years ago a patient brought
of advanced surgical procedures, includ-
their condition.
in a used copy of my book she’d gotten
ing arthroscopic, partial and complete
online. I’d signed it at a bookfair 30 years
joint replacement, using optimally inva-
ago!”
sive and computer-assisted techniques.
his dad’s workshop.“I was always taking
Dr. Struble graduated first in his class
Dr. Struble is an active member of the
things apart and sometimes putting them
from high school with a near-perfect SAT
American Academy of Orthopaedic Sur-
back together again.”
score and a National Merit Scholarship. He
geons and the North Carolina Medical So-
headed to Duke University, where he grad-
ciety, which keeps him current on medical
“Working with precision tools still fasci-
uated magna cum laude with a bachelor
advances and connected with the nation’s
nates me. Joint reconstruction requires
of science degree in molecular biology.
leading experts.
He remembers himself as a curious, bespectacled kid, who loved working in
december/January 2017
5
them involved in their care. Of course, the cool factor is a bonus,” says Dr. Struble. Personal Care from Your Surgeon? “If you call in the morning, we’ll see the patient that day most times. For the referring practice, we will schedule your patients first and ask questions later.” Dr. Struble has even been known to field calls from worried parents on the weekends and open his office to examine their injured child. “We really pride ourselves in providing streamlined, efficient, friendly care. Getting to see us should never be a problem.” Patient care starts when stepping into a Long-time Total Joint Care office staff members are, from left, Karen Fey, Debbie Bartrom and Cindy McGowan.
Total Joint Care office and being greeted by staff members, who have been with the practice since the start.
Optimally Invasive Procedures and
Technological Side of Patient Care
Holistic, Conservative Treatment
Dr. Struble is a self-admitted computer
Debbie Bartrom is the original pillar of
Dr. Struble recommends that all patients
geek, and his practice is a reflection of
the TJC front desk. She’s the go-to for ev-
consider surgery only as the last step in a
this.
erything and anything, whether it’s ques-
continuum of treatment.
tions about insurance or surgery schedulHe’s found ways to enable technology to
ing.
He explains that oftentimes an injury oc-
enhance the patient-physician relation-
curs due to weak joints that are not stable
ship. His exam rooms are equipped with
Karen Fey has been with TJC for almost
by themselves. They require extra help
large-screen monitors for reviewing X-rays
five years and warms everyone’s heart.
from muscles that surround them. “When
and magnetic resonance imaging scans.
She helps coordinate the front desk, jug-
sitting at work during the week, the mus-
“Many times patients will come to me for
gles scheduling and more.
cles weaken and are not up to the week-
a second opinion, and I’ll review their MRI
end tasks,” says Dr. Struble.
with them. They inevitably thank me for
Cindy McGowan is a registered radio-
explaining what was going on, something
logic technologist who has worked with
the previous doc hadn’t bothered to do.”
Dr. Struble for more than six years. As the
As such, his typical first prescription is for a sound, daily regimen of low-impact
practice X-ray tech/medical assistant, she
muscle strengthening. “Consistency is key
He uses a new, iPad-based program to
uses a C-arm fluoroscope to ensure accu-
to success.” Oftentimes he adds physical
customize treatment plans for patients
rate, convenient onsite X-rays. In addition,
therapy for the first month for guidance.
in real-time during their visit. Before
her duties include patient education, post-
“It’s like playing golf. It’s best to set a good
even leaving the exam room, patients
surgical care, casting and brace fitting. She
foundation with a pro.”
can receive exam results, along with
is always there for patients, offering a kind
diagnoses and treatment plans, by email.
smile and gentle hands.
During his training on the West Coast he
Treatment plans are accompanied by
learned the holistic side of medicine. “It’s
physical therapy videos that are easy for
Dr. Struble has regular office hours at Total
important to understand the joint holisti-
patients to follow at home, as well as 3-D
Joint Care in Cary and in Holly Springs.
cally. It’s more than articular cartilage. It’s
models of their pathology.
For information or to make an appoint-
a part of the whole.” This means that in
ment, call (919) 277-0427. The practice
addition to physical therapy, he may incor-
“This personalization and immediacy of
porate other therapeutic modalities, such
the treatment plan help patients retain
as dry needling, yoga and biofeedback.
what’s discussed in the office and get
6
The Triangle Physician
web address is totaljointcare.net.
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december/January 2017
7
Practice Management
Performance Measurement Tips that Help Improve Quality of Care By Margie Satinsky, M.B.A.
Given the many existing national and state
Definitions
laws and regulations that impact the health
The Institute of Medicine (IOM) defines
care environment, as well as anticipated
quality as “the degree to which health
future changes, there’s a tendency to lump
services for individuals and populations
all aspects of performance measurement
increase the likelihood of desired health
into the broad category of “governmental
outcomes
nuisance.” We prefer a positive approach
current professional knowledge” (Lohr,
where medical practices take a hard look
1990). Going a step further, in 2001 the
at quality of care, establish both clear
IOM said, “Americans should be able to
goals and indicators and use performance
count on receiving care that meets their
measurement to close the gap between
needs and is based on the best scientific
desired and actual outcomes.
knowledge”
and
are
consistent
(Crossing
the
with
Quality
Chasm. A New Health System for the practice
21st Century). Quality is the difference
management consultancy, four obstacles
between care that is given now and the
deter
care that could be delivered given what
In
our
experience practices
as
from
a
embracing
performance measurement. The first
we already know.
Margie Satinsky is president of Satinsky Consulting L.L.C., a Durham consulting firm that specializes in medical practice management. She has helped many physicians start new practices, assess the wisdom of affiliating with a larger health care system and improve their current practices. Ms. Satinsky is the author of numerous books and articles, including Medical Practice Management in the 21st Century. For more information, visit www.satinskyconsulting.com.
1) Service: patient satisfaction, telephone service, patient and other provider complaints
is absence of goals. The second is
2) People: physician staffing
lack of insight on what to measure to
Where does quality improvement fit into
achieve stated goals. The third is lack
the picture? It’s the method by which we
appropriate to practice growth; formal
of information about the current state
close the gap between the current and
processes for employee recruitment,
of affairs, not necessarily because the
desirable state(s), using measurement
retention and termination; and
data isn’t available, but because of
before, during and after to track changes
lack of knowledge regarding accessing
and results.
employee utilization 3) Operational components of quality: charting completion on a
the information. The fourth obstacle is practice size. In small practice
Measurement and Quality
timely basis; percentage of providers
settings, the individual responsible for
Improvement
meeting meaningful-use targets; and
performance measurement usually has
If measurement is the key to understand-
service recovery effectiveness and
multiple responsibilities, while larger
ing current status and improvements,
incident-related problem resolution
organizations have entire departments.
what should you measure? A good place
4) Practice Growth: growth of total
to start is the five pillars of excellence
organizational workload, new patient
Our goal in this article is to increase
identified by Quint Studor, author of Hard-
revenue and net revenue from all
awareness
use
wiring Excellence: (1) service; (2) people;
performance measurement to improve
(3) operational components of quality;
quality of care. We’ll define both quality
(4) growth and (5) finance.
and
of
quality
opportunities
improvement,
to
sources 5) Finance: pre-provider cost-to-revenue ratio compared with specialtyspecific standards; effectiveness of
provide
suggestions on topics to be measured
Here are suggested measurements for
net accounts receivable; self-pay net
and list action steps that your practice can
each.
collection rate; and claims denial rate
take to get started.
8
The Triangle Physician
Practice Management Action Steps If you are ready to move forward, here are seven steps to take in the suggested order. 1) Make an organizational commitment to excellence, using performance measurement
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to improve quality of care. Commitment starts at the top with practice ownership. 2) Designate a qualified individual with responsibility: Depending on the size of the practice, identify one or more individuals within or outside the organization to lead the effort. 3) Take an objective look at your practice, using a structured practice assessment questionnaire. 4) Identify the aspects of your practice that you plan to measure. Use the suggestions in the previous section as a starting point. 5) Establish quantitative measures as well as the sources of information. 6) Collect the data, analyze it and organize the results into a format that is comprehensible to all. 7) Develop a scoring system that works for you. There’s no
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levels of achievement. For example, if you were measuring patient satisfaction, you might have score ranges that correlate with 50, 75, 90 and 100 percent achievement of the goal. 8) Organize the findings and share them with the workforce. 9) Bring ownership of the effort to the entire workforce by incorporating financial incentives into a bonus system. 10) Keep a close eye on the project once it’s up and running.
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december/January 2017
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Physician Advocacy
On the Record with AMA President Andy Gurman, M.D. By Marni Jameson Carey
Last month, I joined six other leaders of
The face-to-face meeting was called to
physician organizations for a seat at the
cut through the rumor and speculation
table with American Medical Association
surrounding the relevance or irrelevance
President Andrew W. “Andy” Gurman, M.D.
of the 169-year-old medical association
Together, we asked the questions that are
and get some clarity on where the AMA
on a lot of doctors’ minds.
stands regarding the future of independent doctors.
During the past two years as executive
Marni Jameson Carey is the executive director of the Association of Independent Doctors. You may reach her at (407) 571-9316 or marni@aid-us.org. Visit www.aid-us.org for more information.
director for the Association of Independent
The meeting was during a general AMA
Doctors (AID), I have heard many members
conference in Orlando, Nov. 12. Dr.
Montgomery County Medical Society of
complain about the fact that the American
Gurman attended with two other AMA
Pennsylvania; Lee S. Gross, M.D., founder
Medical Association (AMA) simply no
representatives, Richard A. Deem, AMA
of Doctors 4 Patient Care; Beth Haynes,
longer represents them.
senior vice president for advocacy; and
M.D., executive director of the Benjamin Rush Institute; Kimberly Jackson, M.D., founder of Physicians Working Together; and Michael “Mike” Strickland, M.D., and Venu Julapalli, M.D., both of Let My Doctor Practice. Dr. Lopatin, who had organized the meeting,
opened
it
by
stating
the
meeting’s purpose, which was essentially to answer this question: Given that all our organizations share the AMA’s stated goal “to preserve the patient-physician relationship,” how can we find areas where we can collaborate. Even if we don’t agree on all issues, involvement from our respective organizations could help bolster the AMA’s waning membership. Dr. Lopatin added that he recognized that this meeting might put the AMA president in a difficult spot, given that the organizations at the table each felt
Andrew W. “Andy” Gurman, M.D.
compelled to form because the AMA As one member told me, “The AMA is
Jon Burkhart, chief of staff for the AMA
why organizations like AID exist.” Indeed,
medical advisory committee.
wasn’t speaking for its members. After each physician group leader spent
many reports indicate that membership in the association has fallen to below 15
Along with me were Mark Lopatin, M.D.,
a few minutes introducing his or her
percent of the total number of United States
F.A.C.P, F.A.C.R, a member of the board
organization, Dr. Gurman dispatched the
physicians.
of directors and past president of the
issue of a conflict among our groups. “First
10
The Triangle Physician
Physician Advocacy of all, this is not a difficult discussion at all,”
someone would need to do it, and who
What should we keep in mind going
he said. “This is exactly what I should be
better than doctors? The response should
forward?
doing.”
be, “Thank God the AMA is doing this,
AG: If you walk away with anything from
because it is a code written by doctors for
this meeting, I hope it is an understanding
Then he addressed a range of questions.
doctors.” Yes, it is a revenue stream for us,
that there is some credence to the
Here is a summary:
but not as big a percent of our revenues as
possibility that we do get it.
Fewer than 15 percent of America’s
you might think. While Dr. Gurman did not endear himself
physicians are AMA members, per reports. Why do you think the
Do you agree that electronic medical
to the group leaders when he referred to
numbers are declining?
records are a big problem for today’s
their organizations as “dinghies,” they did
Dr. Andy Gurman: That’s just not
practitioner?
believe the meeting served as a starting
correct. (He did not say what percent of
AG: The government has managed to find
point for a potentially productive dialogue,
physicians were AMA members.) When
the world’s most expensive data entry
an open line of communication and a
we go and talk to the legislature, we are
clerks.
greater awareness and recognition that
the nation’s voice for doctors. Congress
RADAR: BAY15001 What do you make of the fact that all calls on us when they want to know what Version 1 doctors are thinking.Ad: Thus, the AMA Date: 6/15 represents 100 percent of all doctors.
many physicians feel abandoned by the AMA and are finding a separate voice.
these groups have formed outside of the AMA to help doctors?
Although we may not ever get in the big
AG: The disparate voices are not a threat.
AMA boat, perhaps we could all row in the
Why did the AMA support the
To these doctors and small groups, I ask,
same direction.
Affordable Care Act when so many
“Do you want to get in the big boat that is
doctors didn’t?
heading to shore, and that will get there, or
AG: If I knew then what I know now, I
stay paddling in your little dinghies?”
would still support the Affordable Care Act… The ACA is complicated and heavily nuanced. But this we know for sure: People without health insurance get sicker and die younger. Why doesn’t the AMA support independent doctors? AG: We do support them. We have resources to help doctors evaluate whether to go into employment or not…. The AMA advocates on behalf of all physicians all the time in many ways. The AMA is in no way abandoning advocacy for physicians in all forms of practice. Why are doctors so ineffective in influencing policy? AG: Doctors are not politicians. They don’t vote. They don’t lobby. Why does the AMA focus on selling CPT (current procedural terminology) codes, a primary source of AMA revenue, rather than spend more time on member issues?
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Community Service
GiGi’s Playhouse Raleigh Wins
National Rising Star Award The Raleigh location of GiGi’s
Playhouse won the Rising Star award at the GiGi’s Playhouse National
Conference
this
November. The Rising Star award is presented to the playhouse that has had an outstanding start. “Raleigh has an uncanny ability to bring fund-raising dollars in the door and build community relationships. Raleigh is also an innovator and an outstanding partner on countless initiatives that have already been shared with other playhouses across the network,” says Kim Hanna, chief growth officer for GiGi’s Playhouse Inc.
Celebrating their Rising Star award are GiGi’s Playhouse Raleigh board members: From left, Maria Romano; Michelle Schwab; Denise Lloyd; Caroline Moor, site coordinator; Sam Choi; Rachel Geer; Jeanhee Hoffman and Michelle Pfeiffer.
GiGi’s Playhouse Raleigh opened on June 18 and is the first Down
GiGi’s Playhouse Raleigh is located at 2887 Jones Franklin Road
syndrome achievement center in North Carolina. The community
in Raleigh. For more information on how to support GiGi’s
has embraced GiGi’s philosophy of a kinder, more accepting world
Playhouse, visit gigisplayhouse.org/raleigh or call (919) 307-3952.
and belief in helping others, according to an official press advisory.
NEWSOURCE-JUN10:Heidi
8/5/10
12:57 PM
Page 1
Since the June opening, GiGi’s has served over 250 participants with Down syndrome, and community members have volunteered over 900 hours.
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The Triangle Physician
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Women’s Health
Irregular Menstrual Bleeding and Prediabetes:
Think PCOS By Andrea Lukes, M.D., M.H.Sc., F.A.C.O.G.
Polycystic ovary syndrome impacts up to
Pre-diabetes
8 percent of women, yet it is often missed
Women with PCOS are at increased risk
by providers1. The condition can cause
for insulin resistance, and this can occur
abnormal uterine bleeding and issues re-
regardless of whether she is lean, over-
lating to androgen excess, as well as pre-
weight or obese. Some estimates are that
diabetes.
30 percent of lean women with PCOS have prediabetes and that 70 percent of
There is not a consensus on the diagnostic
obese women with PCOS have prediabe-
criteria, but the clinical features are well
tes1. It is important to evaluate this, ide-
documented. In my opinion, the Rotter-
ally using a a glycated hemoglobin (A1c)
dam criteria are reliable in diagnosis and
test
require at least two of the following: oligomenorrhea, hyperandrogenism and poly-
Additionally, women with PCOS who are
cystic ovaries on ultrasound.
obese with insulin resistance (or prediabetes) are at increased risk for high choles-
Menstrual Irregularities
terol and coronary heart disease. Following
Abnormal bleeding can occur in adoles-
body mass indec (BMI), fasting lipid pro-
cents – and often women with polycystic
files and other tests may be necessary.
ovary syndrome (PCOS) have oligomenor-
After earning her bachelor’s degree in religion from Duke University (1988), Dr. Andrea Lukes pursued a combined medical degree and master’s degree in statistics from Duke (1994). Then, she completed her ob/gyn residency at the University of North Carolina (1998). During her 10 years on faculty at Duke University, she cofounded and served as the director of gynecology for the Women’s Hemostasis and Thrombosis Clinic. She left her academic position (2007) to begin Carolina Women’s Research and Wellness Center. She and partner Amy Stanfield, M.D., F.A.C.O.G., head the Women’s Wellness Clinic, the private practice associated with Carolina Women’s Research and Wellness Clinic. Women’s Wellness Clinic welcomes referrals. Call (919) 251-9223 or visit www.cwrwc.com.
rhea (fewer than nine menses per year).
The management of PCOS depends on
When menses occur, often they can be
a woman’s symptoms and her desire to
prolonged past eight days. This occurs
become pregnant or prevent pregnancy.
can be managed with change in diet and
because the female hormones, estrogen
Often combined oral contraception (pills
exercise versus medications.
and progestin, do not follow the expected
with estrogen and progestin) can improve
ovulatory pattern.
bleeding versus medications that can in-
We recommend that health care provid-
duce ovulation (letrozole and clomiphene
ers consider the diagnosis of PCOS when
Androgen Excess
citrate). Hair removal can improve hirsut-
confronted with a patient who has men-
Issues relating to the hyperandrogenism
ism, or excessive hair growth. Prediabetes
strual irregularities or evidence of hyper-
include acne, hirsutism and
androgenism. PCOS is
male-pattern baldness. This
common and can have a
does not mean that all women
strong impact on a wom-
with PCOS will have these is-
an’s long-term health.
sues, but it is important to consider PCOS in a woman
Resource
with these problems. It is
1
worth evaluating blood work,
of polycystic ovary
specifically total testosterone
syndrome in adults,
and
updated March 24, 2015.
serum
dehydroepian-
UpToDate Diagnosis
drosterone sulfate (DHEA-S).
december/January 2017
13
Research News
Combination of Drugs Shuts Down Certain Breast Cancer Cells Breast cancer cells that carry a certain
He
lead
This set of breast cancer cells all carry
gene mutation can be induced to die using
author Grace R. Anderson, began their
a mutation in the PIK3CA gene, which
a combination of an existing targeted
investigation with a medical contradiction:
is found in about 35 percent of newly
therapy along with an investigational
Breast tumors proliferate in part because
diagnosed breast cancer tumors. The
molecule tested by Duke Cancer Institute
the regulatory processes that control cell
PIK3CA gene encodes a protein called
researchers.
growth and death go awry. Several drugs
PI3K, which directly activates the mTOR
inhibit these regulatory pathways, but
pathway. Previous studies have shown
they have shown modest results in solid
that breast cancers with PIK3CA gene
tumors, including breast cancers.
mutations fail to respond well to drugs
When
used
together
in
preclinical
experiments, the drugs shut down two of
and
colleagues,
including
either targeting PI3K or mTOR for reasons
the key survival strategies these types of cancer cells use to evade treatment.
In their study, the Duke researchers began
that are largely unknown.
by asking how to make one investigational mouse
Through further study, the
models and human tumor
researchers appear to have
cells has wide implications
solved
for advancing treatment if
They found that PIK3CA-
planned clinical trials prove
mutated tumors are uniquely
the approach successful,
able to compensate when
according to a Duke press
either of the test therapies
advisory. About 35 percent
– ABT-737 or an mTOR
of breast cancers have this
inhibitor – is used alone,
gene mutation when they
relying on the cell survival
are discovered, and even
pathway that isn’t targeted
more develop the mutation
by the drug to stay alive. But
after exposure to standard
when used in combination,
treatments,
The
finding
in
this
conundrum.
could
the drugs become lethal,
make them susceptible to
shutting down both cell
the combination approach.
survival
which
pathways
and
enabling the tumor cells to die.
“This work reflects several careful studies to not only
“One of the compelling
define the mechanism of action of the combination therapy, but
drug work more effectively. The drug,
results of the study is that we can use very
also to explore the therapy’s activity in
called ABT-737, inhibits a cellular pathway
low doses of both therapies to achieve
cellular and animal models,” said Kris C.
involved in programmed cell death.
strong results,” said Ms. Anderson. “At
Wood, Ph.D., assistant professor in the
Consistent with other studies, the agent
such low doses, the side effects could be
Department of Pharmacology & Cancer
had little effect on a variety of solid cancer
minimized.”
Biology at Duke and senior author of the
tumor cells the researchers tested. The researchers said studies are being
study published Dec. 14 in the journal But when the researchers added a second
planned to advance the findings in clinical
agent – this time a drug that inhibits
trials using currently approved therapies
“Our preliminarily findings suggest that
another cell survival pathway called the
or investigational drugs like Navitoclax, a
this therapy may be a safe and effective
mammalian target of rapamycin, or mTOR,
clinical analog of ABT-737.
approach in human breast cancer patients
pathway – a subset of breast cancer cells
who carry this mutation,” Dr. Wood said.
died at a substantial rate.
Science Translational Medicine.
14
The Triangle Physician
In addition to Dr. Wood and Ms. Anderson,
Research News study authors include Suzanne E. Wardell,
Alley, Alexander Yllanes, Victoria Haney,
(K12HD043446,
DK48807),
the
Merve Cakir, Lorin Crawford, Jim C.
Kimberly L. Blackwell, Shannon J. McCall,
Department of Defense (BC151664), and
Leeds, Daniel P. Nussbaum, Pallavi S.
and Donald P. McDonnell.
the National Science Foundation (DGE1106401, DGF-1106401). Full grant support
Shankar, Ryan S. Soderquist, Elizabeth M. Stein, Jennifer P. Tingley, Peter S. Winter,
The study received federal funding
Elizabeth K. Zieser-Misenheimer, Holly M.
from the National Institutes of Health
is listed in the publication.
Peripheral Artery Disease Treatment Clarification Underscores Unmet Need Manesh Patel, M.D.
The finding that the drug
Brilinta, against the current standard of
ticagrelor
with peripheral artery disease.”
no
care, clopidogrel, which is now generic
better than clopidogrel in
but also is marketed under the brand
Dr. Patel said the findings demonstrate
reducing
name Plavix. Both are anti-platelet drugs.
that ticagrelor could be considered a
proved
cardiovascular
reasonable alternative for patients who
events for patients with peripheral artery disease
Aside from clopidogrel, the only other
could not take clopidogrel, but that new
should
assure
anti-clotting agent that has been tested
treatments are needed to give patients
patients about current treatments and
as a single therapy for peripheral artery
more options.
demonstrate that new options are still
disease is aspirin, which showed only
needed, Duke Clinical Research Institute
a modest reduction in cardiovascular
“There is still a huge unmet need and
investigators say.
events compared with a placebo pill.
high event rates for people with this
The findings, reported Nov. 13 at the annu-
Ticagrelor is currently approved for use
therapies to address this disease burden.
al American Heart Association Scientific
in patients with acute coronary syndrome
Future trials should evaluate well-defined
Sessions meeting and in the New England
and post-myocardial infarction. In studies
peripheral artery disease populations and
Journal of Medicine, followed a four-year
of patients with those conditions, the
take into account the procedures, drugs
study of nearly 14,000 patients through-
drug in combination with aspirin showed
and devices used to treat symptomatic
out the world. It was the largest study of
evidence of benefitting peripheral artery
peripheral artery disease.”
patients with peripheral artery disease,
disease.
both
disease,” Dr. Patel said. “We need other
In addition to Dr. Patel, study authors
which is a narrowing of the vessels to the In the comparative study led by DCRI and
include principal investigator William
CPC Clinical Research at the University of
R. Hiatt from the University of Colorado
“This is a disease that affects a lot of people
Colorado, the researchers found that 10.8
School of Medicine and CPC Clinical
– more than eight million in the United
percent of the patients taking ticagrelor
Research, and co-principal investigator
States and millions more worldwide,”
had a heart attack, ischemic stroke or
F. Gerry R. Fowkes of Usher Institute
said corresponding author Manesh R.
cardiovascular death, compared to 10.6
of Population Health Sciences and
Patel, M.D., chief of Duke’s Division of
percent of clopidogrel-treated patients.
Informatics.
Cardiology and member of the Duke
Major bleeding occurred at the same rate
Gretchen Heizer, Jeffrey S. Berger, Iris
Clinical Research Institute (DCRI). “But
– 1.6 percent – of patients treated with
Baumgartner, Peter Held, Brian G. Katona,
there aren’t many therapies to treat the
either ticagrelor or clopidogrel.
Kenneth W. Mahaffey, Lars Norgren, W.
extremities.
They
were
joined
by
Schuyler Jones, Juuso Blomster, Marcus
condition, so it’s important to determine if new therapies offer any advantages but
“Given the initial evidence, ticagrelor was
Millegård and Craig Reist on behalf of
also if current therapies are sufficiently
considered a potent anti-platelet agent
the International Steering Committee
effective.”
with potential benefit also in patients
and Investigators of the EUCLID Trial
with peripheral artery disease,” Dr. Patel
(Examining Use of tiCagreLor In paD).
Dr. Patel said the study provided a head-
said. “Our trial demonstrates the hazards
to-head comparison of a potential new
of extrapolating evidence from coronary
The
therapy, ticagrelor, which is marketed as
artery disease populations to patients
AstraZeneca, which markets ticagrelor.
study
received
funding
december/January 2017
from
15
Research News
Interdisciplinary Approach Leads to Drug-Delivery Modification that Sidesteps Allergic Response Biomedical engineers at Duke University
“We started down a path to make PEG-like
opment of an otherwise very promising ap-
have reconfigured a popular drug-delivery
conjugates of protein drugs more efficiently
proach to control blood clotting while limit-
technology to evade immune responses that
and stumbled into the PEG antigenicity prob-
ing bleeding,” said Dr. Sullenger. “Because
have halted some clinical trials.
lem,” Dr. Chilkoti said. “We were lucky to
people with pre-existing PEG antibodies
find an expert close at hand in the school of
are now present in the population and such
Polyethylene glycol, known as PEG, is a poly-
medicine at Duke. This work was only pos-
antibodies can elicit life-threatening allergic
mer commonly found in commercial prod-
sible because of the incredible interdisciplin-
reactions, it has become critical for drug de-
ucts from toothpaste to cosmetics and also
ary research culture at Duke that recognizes
velopment to create alternative formulations
in pharmaceuticals. PEG is used as a thick-
no boundaries.”
of PEG.”
ener, solvent, softener and moisture carrier. They also can be attached to active drugs in
The new PEG-delivery system was initially
the bloodstream to slow the body’s clearing
developed by Dr. Chilkoti and Yizhi (Stacey)
of them, greatly lengthening the duration of
Qi, Ph.D., as a graduate student, to boost pro-
their effects.
duction efficiency. Conventional PEG drugdelivery polymers require labor-intensive
The pervasiveness of PEG in daily human life,
synthesis and purification, but the new poly-
however, is causing many people to develop
mers are grown directly from a defined site
antibodies to the polymer. This has led some
on a drug molecule. The new polymer looks
PEG-modified, or “PEGylated” drugs, to lose
a lot like a bottle-cleaning brush, with many
their longevity and caused allergic reactions,
short segments of ethylene glycol sticking
some of which have been life-threatening.
out from a primary backbone.
In a new paper, Duke researchers reveal an
“Growing the polymer directly on the drug is
altered version of PEG that seems to avoid
simpler and more efficient in terms of yield
recognition by PEG antibodies already pres-
than the conventional process,” said Dr. Qi,
ent in individuals. The new technology also
who successfully defended her thesis in Au-
shows excellent efficacy controlling glucose
gust. “The boost in efficiency varies from pro-
levels in diabetic mice for up to four days
tein to protein, but our yield is significantly
when used with a drug that, without PEG,
higher and produces more uniform results.”
An artistic rendering of a new drug-delivery system created by Stacey Qi, first author on the paper. The technology updates a popular delivery method that uses polyethylene glycol (PEG) to extend a drug’s life by creating a new, shorter version featuring many bristles to avoid PEG antibodies. The drawing depicts troublesome antibodies (purple Ys) attacking the conventional PEG technology while leaving the modified version alone.
Meanwhile, just a few hundred yards away, a
Dr. Chilkoti heard about this problem and
The results appeared online on Nov. 28,
different challenge was being faced by Bruce
thought that his lab’s new bottlebrush PEG
in the new journal Nature Biomedical
Sullenger, Ph.D., the Joseph W. and Dorothy
polymer might be a solution. Because each
Engineering.
W. Beard professor of experimental surgery
of the molecular chain “bristles” is so short,
and director of the Duke Translational Re-
existing PEG antibodies might not be able to
“This work has been an inter-
search Institute. During a late-stage clinical
recognize them.
esting journey with the unex-
trial for an anticoagulant that used PEG to
pected twists and turns that
extend its effectiveness, 10 patients had an
To find out, Drs. Chilkoti and Qi turned to
makes research so reward-
immediate, anaphylactic immune reaction
Michael Hershfield, M.D., professor of medi-
ing,” said Ashutosh Chilkoti,
because of pre-existing PEG antibodies. The
cine and biochemistry at the Duke University
Ph.D., the Alan L. Kaganov
clinical trials were immediately shut down.
School of Medicine. Dr. Hershfield has been
treats Type 2 diabetes for just six hours.
Ashutosh Chikoti, Ph.D.
professor of biomedical engineering and chair of the biomedical engineering department.
16
The Triangle Physician
involved with PEG technology ever since the “These allergic reactions stopped the devel-
clinical trials and United States Food and
Research News Drug Administration approval for the very
existing anti-PEG antibodies in the first three
plans to test for immunological responses in
first PEGylated drug in 1990. An immune re-
patients who had allergic reactions to Dr. Sul-
living animals with preexisting PEG antibod-
sponse to this drug has never been an issue,
lenger’s PEGylated anticoagulant. Professor
ies. They also need to determine whether
because its intended recipients are children
Chilkoti’s initial substitute for PEG still had a
antibodies will be created against the new
with deficient immune systems.
little bit of PEG on it, so we needed to see if
polymers.
anti-PEG antibodies could recognize it.” This work was supported by the National In-
A second drug he helped develop in the early 2000s to treat gout however, has encoun-
On their second try at designing a suitable
tered obstacles. About 40 percent of patients
PEG substitute, the team hit pay dirt. The an-
develop antibodies to the PEG portion of the
tibodies left the new compound alone.
drug after the first few doses, leading to allergic reactions and a loss of effectiveness.
stitutes of Health (R01-DK092665). CITATION: “A brush-polymer/exendin-4 conjugate reduces blood glucose levels for up to
Dr. Qi then attached her new polymer to a
five days and eliminates poly(ethylene glycol)
drug used to treat Type 2 diabetes and inject-
antigenicity.” Yizhi Qi, Antonina Simakova,
“Nancy Ganson, a scientist in my lab, and I
ed it into diabetic mice to see if the system
Nancy J. Ganson, Xinghai Li, Kelli M. Lugin-
got involved with Professor Chilkoti’s project,
still worked as well. To her delight, there was
buhl, Imran Ozer, Wenge Liu, Michael S. Her-
because we had discovered that anti-PEG
almost no loss of efficacy, extending the ef-
shfield, Krzysztof Matyjaszewski, Ashutosh
antibodies were induced by our PEGylated
fects of one drug 16-fold.
Chilkoti. Nature Biomedical Engineering. Nov.
gout drug during clinical trials,” said Dr. Hershfield. “We later identified high levels of pre-
28, 2016. DOI: 10.1038/s41551-016-0002 http:// With this success in hand, the team next
www.nature.com/articles/s41551-016-0002.
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