Colorectal Cancer Screening Quality and Benchmarks

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Aasma Shaukat • John I. Allen
Editors

Colorectal Cancer Screening

Quality and Benchmarks

1  3
Editors
Aasma Shaukat John I. Allen
Department of Gastroenterology Section of Digestive Disease
Minneapolis VA Medical Center Department of Medicine
Minneapolis Yale University School of Medicine
Minnesota New Haven
USA Connecticut
USA

ISBN 978-1-4939-2332-8     ISBN 978-1-4939-2333-5 (eBook)

DOI 10.1007/978-1-4939-2333-5

Library of Congress Control Number: 2014956665

Springer New York Heidelberg Dordrecht London

© Springer Science+Business Media New York 2015
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Dr. Shaukat: I would like to thank my
husband Dan for his love and endless
support, and my children Myra and Rayaan
for their patience
Dr. Allen: I would like to thank my wife
Carolyn, and my children Jennifer and
Joshua

v
Foreword

Colorectal cancer (CRC) screening originated from the work of Dukes at St. Marks
Hospital in London in the 1930s who developed a staging system for CRC and
observed that survival correlated with early stage diagnosis and treatment. He and
Lockhart-Mummery, unbeknownst to them at the time, also provided the basis for
today’s CRC screening goals of detecting both curable CRC and preexisting adeno-
mas by demonstrating the link between the two. These concepts were challenged for
decades until FOBT randomized trials showed that CRC screening reduced CRC
mortality, the colonoscope was introduced into clinical practice, colonoscopic pol-
ypectomy was shown to be feasible, and CRC incidence was observed to be reduced
by colonoscopic polypectomy.
This amazing series of developments, beginning in the 1970s, culminated in
2012 with the report of a reduced CRC mortality following colonoscopic polypec-
tomy, which proved the concept of the polyp-cancer sequence and the effectiveness
of screening for both CRC and adenomas. This resulted in the explosion of CRC
screening worldwide which we are seeing today. In the USA, CRC screening is
now being performed by about two thirds of the at-risk men and women, according
to a recent CDC report. Most (90 %) of those screened in the USA have been with
colonoscopy, while the majority of those screened elsewhere have been primarily
with FIT, and to a much lesser extent with flexible sigmoidoscopy. All roads lead
to colonoscopy, whether as a screening test or for diagnosis in those with a positive
first step screening test.
If screening is to be successful, it needs to be part of a multistep “package,”
which includes screening, timely diagnosis (pathology of polyps, cancer), timely
treatment (cancer surgery, polypectomy) and follow-up surveillance. If one step
in the process fails, the impact will be lessened or lost. At each step, quality in the
performance is a critical factor. For screening colonoscopy, quality benchmarks cor-
relate directly with the frequency of interval cancers. The good news is that inter-
val cancers following average risk screening colonoscopy occurs at a rate of about
1/1000 exams. The bad news is that 5 % of the cancers are missed. The interval
cancer rate is even greater in the high risk post-polypectomy patients (1/200), and
is related most often (70 %) to missed lesions and incomplete polypectomy. Clearly,
quality performance is required. When the “simple” FOBT card was introduced in

vii
viii Foreword

the 1970s, there was no quality control. A quality control window was added later
but interpretation was often inaccurate. Quality performance is also critical for FIT
since a false positive triggers off an unnecessary colonoscopy, and a false negative
has other consequences. Newer tests such as CTC and stool DNA testing have their
own unique quality performance considerations.
With the field of CRC screening moving dramatically from its early rudimentary
stage to the present widespread high technology stage, we need to be certain that
maximum effectiveness is achieved by high quality performance at each step. In
this book an experienced and thoughtful group of leaders in CRC screening have
identified the key issues in quality performance. The authors have cast a wide net in
this area, with comprehensive presentations for every screening modality. In addi-
tion, issues related to surveillance, sedation, pathology, medical-legal aspects, and
cost-effectiveness have been addressed. Concrete examples of various programs
and initiatives provide excellent “nuts and bolts” tools for guidance in this increas-
ingly complex field.
It has become clear that we need to step back and take stock of how we are to
move forward in CRC screening. The latest data indicates that there has been a
progressively downward trend in CRC incidence and mortality in recent decades.
The annual “Report to the Nation” demonstrated that a major factor in this trend is
screening. In the USA it is “opportunistic” rather than within the framework of a
nationally organized program, which makes quality performance programs more
compelling. The US screening rate is the highest in the world and the incidence/
mortality reduction is also the highest worldwide. A campaign has been initiated
nationally by the ACS and CDC to further increase the US screening rate to 80 %
by 2018 and to help eliminate the current racial disparities. This accelerated screen-
ing needs to be accompanied by quality performance in order to achieve maximum
effectiveness. Each man and woman who accepts screening should be offered a test
of the highest quality that provides the greatest probability to have CRC diagnosed
at an early stage, or even to have CRC prevented altogether. Everyone who has
been touched by cancer in a loved one understands the human tragedy that can be
averted. We need to screen. Any test is better than none, and the best test is the one
that gets done, and done well! This book tells us how to do it and what gaps there
are to be filled in the future. It is a state-of-the-art treatise on quality performance
of the entire range of screening and surveillance and their related issues. It is a must
read for everyone engaged in this effort.

Sidney J. Winawer, MD
Paul Sherlock Chair in Medicine Gastroenterology and Nutrition Service
Department of Medicine Memorial Sloan-Kettering Cancer Center
Professor of Medicine, Weill Medical College
Cornell University
Preface

Colorectal cancer (CRC) is the third most common cancer in men and women, and
the second leading cause of cancer-related death in the USA. Screening is highly
effective in reducing the risk of developing and dying from CRC. There is a menu of
screening options that includes tests that detect cancers (stool-based tests, imaging)
and tests that detect both cancers and precancerous lesions with the option of con-
current removal and thus cancer prevention (colonoscopy). Regardless of modality,
the most effective screening program is one that is high quality, safe, cost-effective,
readily accessible, highly acceptable, and actually performed. Establishing quality
metrics and benchmarks for all types of CRC screening and surveillance tests is
important for delivering high value care.
This textbook will provide a comprehensive overview of quality metrics and
methods used to improve quality for all major modalities of CRC screening. It will
introduce the readers to the evidence of effectiveness behind various CRC screen-
ing modalities: stool-based tests (Fecal Occult Blood, Fecal Immunochemical and
Fecal DNA tests), flexible sigmoidoscopy, colonoscopy, and CT colonography. It
will review the latest guidelines for CRC screening, compare differences among
the five major national guidelines and highlight the need for valid quality and cost
indicators. The main focus will be colonoscopy since most quality indicators and
analyses have focused on this modality of screening and surveillance, but one chap-
ter will be devoted to quality indicators of other screening modalities. Differences
between process and outcome measures will be highlighted and a small but valid set
of recommended national measures will be listed.

ix
Contents

1 History and Overview of the National Quality Strategy����������������������   1

John I. Allen

2 Current Screening and Surveillance Guidelines�����������������������������������   13

Swati G. Patel and Dennis J. Ahnen

3 Comparative Effectiveness and Cost-Effectiveness of

Current CRC Screening Modalities�������������������������������������������������������   45
Ann G. Zauber

4 Quality Indicators and Benchmarks for Guideline-

Recommended Fecal Occult Blood Tests�����������������������������������������������   65
James E. Allison, Callum G. Fraser, Stephen
P. Halloran and Graeme P. Young

5 Quality Indicators for CT Colonography����������������������������������������������   81

Elizabeth G. McFarland, Judy Yee, Abraham
H. Dachman and Paul M. Knechtges

6 Stool DNA for Colorectal Cancer Screening: From Concepts

to Quality Care�����������������������������������������������������������������������������������������   97
David A. Ahlquist and John B. Kisiel

7 Quality Indicators for Colonoscopy������������������������������������������������������� 113

Victoria Gómez and Michael Bradley Wallace

8 Toward a Learning Health-Care System:Use of Colorectal

Cancer Quality Measures for Physician Evaluation����������������������������� 123
Ziad F. Gellad and Joel V. Brill

9 Sedation Issues in Colonoscopy: Quality and

Economic Considerations������������������������������������������������������������������������ 141
Karen J Wernli and John M Inadomi
xi
xii Contents

10 Role of Pathology in Quality of Colonoscopy���������������������������������������� 153

Lawrence J. Burgart, Patrick M. O’Reilly, Kenneth
P. Batts, Jason A. Daniels, H. Parry Dilworth and Schuyler O. Sanderson

11 Managing Quality in Ancillary Services������������������������������������������������ 163

Michael Frist, Marc Sonenshine and Steven J. Morris

12 Medical Legal Aspects of Quality Improvement����������������������������������� 173

Kayla Allison Feld, Sarah Faye Blankstein and Andrew D. Feld

13 Areas for Future Research���������������������������������������������������������������������� 193

Douglas K. Rex and Ashish K. Tiwari

Index���������������������������������������������������������������������������������������������������������������� 203
Contributors

David A. Ahlquist Division of Gastroenterology and Hepatology, Mayo Clinic,

Rochester, MN, USA
Dennis J. Ahnen Department of Medicine, University of Colorado School of
Medicine, Denver, CO, USA
John I. Allen Department of Medicine, Yale University School of Medicine,
New Haven, CT, USA
James E. Allison Department of Internal Medicine/Gastroenterology, University
of California San Francisco, San Francisco, CA, USA
Kenneth P. Batts Minnesota Gastroenterology, Minneapolis, MN, USA
Sarah Faye Blankstein Seattle, WA, USA
Joel V. Brill Predictive Health LLC, Paradise Valley, AZ, USA
Lawrence J. Burgart Minnesota Gastroenterology, University of Minnesota
College of Medicine, Minneapolis, MN, USA
Abraham H. Dachman Department of Radiology, The University of Chicago
Medical Center, Chicago, IL, USA
Jason A. Daniels Minnesota Gastroenterology, Minneapolis, MN, USA
H. Parry Dilworth Department of Pathology, Hospital Pathology Associates,
Allina Health, Minnesota Gastroenterology, Minneapolis, MN, USA
Andrew D. Feld Department of Gastroenterology, University of Washington,
Group Health Cooperative, Seattle, WA, USA
Kayla Allison Feld Seattle, WA, USA
Callum G. Fraser Centre for Research into Cancer Prevention and Screening,
University of Dundee, Dundee, Scotland
Michael Frist Atlanta Gastroenterology Associates, LLC, Atlanta, GA, USA

xiii
xiv Contributors

Ziad F. Gellad Division of Gastroenterology, Duke University Medical Center &

Durham Veterans Affairs Medical Center, Durham, NC, USA
Victoria Gómez Department of Gastroenterology, Mayo Clinic, Jacksonville,
FL, USA
Stephen P. Halloran Clinical Biochemistry, Royal Surrey County Hospital,
University of Surrey, Guildford, Surrey, UK
John M Inadomi Department of Medicine, University of Washington School of
Medicine, Seattle, WA, USA
John B. Kisiel Department of Internal Medicine, Division of Gastroenterology
and Hepatology, Mayo Clinic, Rochester, MN, USA
Paul Martin Knechtges Department of Radiology, Medical College of Wisconsin,
Milwaukee, WI, USA
Elizabeth G. McFarland Department of Radiology, SSM St. Joseph West
Medical Center, Lake St. Louis, MO, USA
Steven J. Morris Atlanta Gastroenterology Associates, LLC, Atlanta, GA, USA
Patrick M. O’Reilly Minnesota Gastroenterology, PA, St. Paul, MN, USA
Swati G. Patel Department of Internal Medicine, Division of Gastroenterology,
University of Michigan, Ann Arbor, MI, USA
Douglas K. Rex Department of Gastroenterology/Hepatology, Indiana School of
Medicine, IU Hospital, Indianapolis, IN, USA
chuyler O. Sanderson Minnesota Gastroenterology, Minneapolis, MN, USA
Marc Sonenshine Atlanta Gastroenterology Associates, LLC, Atlanta, GA, USA
Ashish K. Tiwari Department of Internal Medicine, Michigan State University
(MSU), East Lansing, MI, USA
Michael Bradley Wallace Department of Gastroenterology and Hepatology,
Mayo Clinic Florida, Jacksonville, FL, USA
Karen J Wernli Group Health Research Institute, Seattle, WA, USA
Judy Yee Department of Radiology and Biomedical Imaging, University of
California, San Francisco, CA, USA
Graeme P. Young Flinders Centre for Innovation in Cancer, Flinders University,
Adelaide, SA, Australia
Ann G. Zauber Department of Epidemiology and Biostatistics, Memorial Sloan
Kettering Cancer Center, New York, NY, USA
About the Editors

Dr. Shaukat is a gastroenterologist and a clinical researcher. She received her

medical degree at The Aga Khan University Medical College in Pakistan. She
then matriculated to Johns Hopkins School of Public Health where she received an
M.P.H. in International Health and Epidemiology. She conducted a gastroenterol-
ogy fellowship at Emory University School of Medicine. She is currently Associ-
ate Professor in the Department of Medicine, Division of Gastroenterology at the
University of Minnesota and Section Chief of Gastroenterology at the Minneapolis
Veterans Affairs Healthcare system.
Dr. Shaukat has numerous publications on epidemiology, molecular markers and
outcomes of colorectal cancer, quality of colonoscopy and colon cancer screening.
She is an invited speaker at national and international scientific meetings on qual-
ity of colonoscopy and benefits of colon cancer screening. Dr. Shaukat has an ac-
tive research program through federal funding, and continues to study colon cancer
screening and prevention.

Dr. Allen grew up in New Jersey, upstate New York and Albuquerque, New Mexi-
co. He graduated from Rice University in 1973 and the University Of New Mexico
School Of Medicine 1977. He completed internship, residency in Internal Medi-
cine and Gastroenterology Specialty training at the University of Minnesota (Min-
neapolis). He then spent 10 years on the Academic Faculty in the Department of
Medicine in Minnesota attaining the rank of Associate Professor of Medicine while
conducting clinical and laboratory research in the fields of alcoholic hepatitis and
colon cancer. In 1991 he was recruited to be Associate Director of the Virginia Piper
Cancer Center at Abbott Northwestern Hospital (Minneapolis) and joined a private
gastroenterology practice. From 1991–2013 Dr. Allen helped build this single spe-
cialty GI practice into Minnesota Gastroenterology, one of the largest GI practices
in the country and helped develop their nationally known Quality Improvement
program. He also worked closely with leadership in Allina Health, a large Integrated
Delivery System in the Twin Cities. He currently Chairs the Quality Committee of
Allina Health and is on their Board of Directors. In April 2013, he left community
practice to become Clinical Chief of Digestive Diseases and Professor of Medicine
at Yale University School of Medicine.

xv
xvi About the Editors

For the last decade, Dr. Allen has worked in a leadership position with the Amer-
ican Gastroenterological Association (AGA). He was selected to Chair the Clinical
Practice and Quality Management Committee of the AGA and led development of
clinical quality measures for gastroenterology. He has written extensively on qual-
ity improvement in GI and has chaired or co-chaired Task Forces that created many
of the GI measures currently in Medicare’s Physician Quality Reporting System.
He has published and spoken widely about the impact of health care reform on the
specialty of gastroenterology and continues to publish about evaluation and man-
agement of inherited colon cancer syndromes. In 2014 he became President of the
AGA Institute.
Chapter 1
History and Overview of the National
Quality Strategy

John I. Allen

Introduction

In March 2011, the Agency for Health Care Research and Quality (AHRQ) pub-
lished a report detailing a “National Quality Strategy” (NQS) for US health care, as
mandated by the Patient Protection and Affordable Care Act (ACA). NQS provides
an official blueprint for achieving a high-value health-care system. This blueprint
has profound implications for all medical providers and health-care systems in this
country and physicians need to understand the basic elements of the strategy and
their role in the evolving world of health-care delivery. This chapter provides a
background on the history of quality improvement (QI) efforts in medicine, the
development of the NQS, and elements that impact the practice of gastroenterology,
especially colonoscopy and colorectal cancer (CRC) prevention.
Some of the best medical care in the world is available in USA, yet there is a
growing body of evidence that our commitment to deliver coordinated, effective
health care to all citizens is below the standards of many other developed countries.
The USA spends more per capita than all other countries, yet we lack universal
health care and we lag behind other developed countries in terms of life expectancy
and many major health outcome measures [1]. Our “healthy life expectancy” (a
measure of overall population health accounting for both length of life and levels
of ill health) places us 26th among developed countries, a testament to our lack of a
national coordinated system of disease and preventive care [1].
To enhance national discussions about coordinating USA’s health-care delivery,
the Commonwealth Fund established a Commission on High Performance Health
Systems in 2005. The commission [2–4], composed of 16 nationally recognized
health-care leaders, issued a series of reports beginning in 2006 that defined a

J. I. Allen ()
Section of Digestive Disease, Department of Medicine, Yale University School of Medicine,
40 Temple Street, Suite1A, New Haven, CT 06510, USA
e-mail: [email protected]
© Springer Science+Business Media New York 2015 1
A. Shaukat, J. I. Allen (eds.), Colorectal Cancer Screening,
DOI 10.1007/978-1-4939-2333-5_1
2 J. I. Allen

framework for a high-performing health-care system, a series of organizing prin-

ciples and finally a “roadmap” for reforming health insurance to achieve universal
medical coverage.
In their initial report, the commissioners provided background on how we misal-
locate resources, fail to provide universal medical care, and fall short of delivering
maximum value (defined as health outcomes per unit cost). The overarching recom-
mendations from this report include (1) a commitment to a defined national strategy
for achieving highest value, (2) a process to implement and refine that strategy, (3)
proposals for care delivery through systems that emphasize clinical coordination,
and (4) a movement to value-based reimbursement based on metrics that reflect
health outcomes, quality of care, access to care, population-based disparities, and
efficiency [2–4].
These reports, among many others, provided a foundation for discussions about
restructuring health-care delivery in the USA and accelerated the commitment to-
ward a “National Quality Strategy” that was ultimately codified within the ACA
signed into law by President Barack Obama in March 2010. With passage of the
ACA, the demand for providers and health systems to produce performance and
health outcomes measures that are understandable to the lay public, readily avail-
able and tied to reimbursement has finally been woven into the core fabric of US
medicine.

History of QI in Medicine

A brief history of the QI movement within US medicine is instructive and will help
the reader understand current initiatives contained within the ACA, especially the
NQS and the “value-based modifier” (VBM) that will form the basis of reimburse-
ment by the Centers for Medicare and Medicaid (CMS), State Medicaid agencies,
and many commercial health plans. While innumerable individual initiatives have
provided a basis for this QI movement, five key events are highlighted in this chap-
ter.

Ernest Amory Codman

Ernest Codman (1869–1940) was a surgeon at the Massachusetts General Hospital

(MGH), a prolific author and the first vocal advocate of the “End Result” system
of measuring the quality of medical care (in 1910). His colleagues described him
as “maniacally obsessed” with the simple idea that every hospital should follow
every patient long enough to determine whether or not their treatment was suc-
cessful and if not why not [5]. He became so disliked because of his insistence on
end result analysis that he resigned from MGH and opened the Codman Hospital
(literally down the street). He also advocated analysis of treatment effectiveness
(clinical effectiveness analysis or CEA) and recommended tying a surgeon’s pay