AJCM Summer 2010

American Journal of Clinical Medicine® Owned and Published by the American Association of Physician Specialists, Inc.

Special issue 2010 COLORECTAL CANCER prevention Some Highlights in This Issue 105 Extended Flexible Sigmoidoscopy

vs. Colonoscopy: A Family Medicine Perspective 109 Patient Time Burden and Sedation-Related Complications in Screening and

Surveillance Colonoscopy 113 Comparative Effectiveness of Water vs.

Air Methods in Minimal Sedation Colonoscopy Performed by Supervised Trainees in the US Randomized Controlled Trial 119 Hidden Cost of Sedation for Screening and

Surveillance by Optical Colonoscopy 121 More Polyps Are Seen on Screening Colonoscopy With Water Infusion in Lieu of Air Insufflation (Water Method) Compared

With Usual Air Insufflation 124 Minimizing the Burden of Colorectal Cancer Screening – An Approach in Rural Areas

2010 • Volume Seven, Number Three

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The American Journal of Clinical Medicine® (AJCM®) is the official, peer-reviewed journal of the American Association of Physician Specialists, Inc. (AAPS), an organization dedicated to promoting the highest intellectual, moral, and ethical standards of its members. Its diversity incorporates physicians that represent a broad spectrum of specialties including anesthesiology, dermatology, diagnostic radiology, disaster medicine, emergency medicine, family medicine/OB, family practice, geriatric medicine, hospital medicine, internal medicine, obstetrics and gynecology, ophthalmology, orthopedic surgery, plastic and reconstructive surgery, psychiatry, radiation oncology, general surgery, and urgent care medicine.

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To further the goals of AAPS, which include providing education for its members and promoting the study, research, and improvement of its various specialties, the AJCM® invites submissions of high-quality review articles, clinical reports, case reports, or original research on any topic which has potential to impact the daily practice of medicine.

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Special Issue 2010 • Volume Seven, Number Three 124

Minimizing the Burden of Colorectal Cancer Screening – An Approach in Rural Areas Robert J. Newman, MD

127

Hypnosis to Manage Anxiety and Pain Associated with Colonoscopy Gary Elkins, PhD

In This Issue Extended Flexible Sigmoidoscopy vs. Colonoscopy: A Family Medicine Perspective

130 105

Felix W. Leung, MD, FACG

Wm. MacMillan Rodney, MD Ricardo G Hahn, MD

Patient Time Burden and Sedation-Related Complications in Screening and Surveillance Colonoscopy

134 109

Hidden Cost of Sedation for Screening and Surveillance by Optical Colonoscopy

140

Medical Ethics: Civil But Disobedient

144

How I Teach My Trainees “Water Navigation Colonoscopy”

Joseph W. Leung, MD, FRCP, FACG, FACP, FASGE Surinder K. Mann, MD, FACP, FACG, AGAF Lynne Do, MD Rodelei Siao-Salera, BSN, CGRN Felix W. Leung, MD, FACG

Mark Pastin, PhD

Takeshi Mizukami, MD, PhD Toshifumi Hibi, MD, PhD

147 119

Cost Benefit Analysis and Cost Estimating Sedated vs.

Unsedated Colonoscopy: An Organizational Perspective Laura Granados-Savatgy, MPA Douglas D. Bradham, DrPH Liz Blohm Rodelei Siao-Salera, BSN, CGRN Joseph W. Leung, MD Felix W. Leung, MD, FACG

Cynthia W. Ko, MD, MS

More Polyps Are Seen on Screening Colonoscopy With Water Infusion in Lieu of Air Insufflation (Water Method) Compared With Usual Air Insufflation

Adopting the Water Method: Lessons, Tips, and Pitfalls Learned Francisco C. Ramirez, MD Felix W. Leung, MD, FACG

113

Kanat Ransibrahmanakul, MD Joseph W. Leung, MD, FRCP, FACG, FACP, FASGE Surinder K. Mann, MD, FACG Rodelei Siao-Salera, BSN, CGRN Brian S. Lim, MD Chhaya Hasyagar, MD Danny Yen, MD Igor Nastaskin, MD Felix W. Leung, MD, FACG

On Demand Sedation in Community Practice John L. Petrini, MD, FASGE

137

Felix W. Leung, MD, FACG

Comparative Effectiveness of Water vs.

Air Methods in Minimal Sedation Colonoscopy Performed by Supervised Trainees in the US Randomized Controlled Trial

Scheduled, Unsedated Colonoscopy Provides Access to Colonoscopy in a VA Setting With Unexpected, Unplanned Discoveries

121 151

Effect of Music on Patients Undergoing Colonoscopy John B. Marshall, MD Matthew L. Bechtold, MD

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elcome to the American Journal of Clinical Medicine® (AJCM®) Special Issue on Colorectal Cancer 2010. The Journal is dedicated to improving the practice of clinical medicine by providing up-to-date information for today’s practitioners.

The AJCM is the official journal of the American Association of Physician Specialists, Inc. (AAPS), an organization dedicated to promoting the highest intellectual, moral, and ethical standards of its members, and whose diversity incorporates physicians that represent a broad spectrum of specialties including anesthesiology, dermatology, diagnostic radiology, disaster medicine, emergency medicine, family medicine obstetrics, family practice, geriatric medicine, hospital medicine, internal medicine, obstetrics and gynecology, ophthalmology, orthopedic surgery, plastic and reconstructive surgery, psychiatry, radiation oncology, general surgery, and urgent care medicine.

Part of the mission of the AAPS is to provide education for its members and to promote study, research, and improvement of its various specialties. In order to further these goals, the AJCM invites submissions of high-quality review articles, clinical reports, case reports, or original research on any topic that has potential to impact the daily practice of medicine. Publication of a peer-reviewed article in the AJCM is one of the criteria needed to qualify for the prestigious Degree of Fellow in the Academies of Medicine of the AAPS. Articles that appear in the AJCM are peer reviewed by members with expertise in their respective specialties. Manuscripts submitted for publication should follow the guidelines in The International Committee of Medical Journal Editors: “Uniform requirements for manuscripts submitted to biomedical journals” (JAMA, 1997; 277:927-934). Studies involving human subjects must adhere to the ethical principals of the Declaration of Helsinki, developed by the World Medical Association. By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of their article that might create any potential conflict of interest.

More detailed information is included in the AJCM Manuscript Criteria and Information on pages 142 and 143.

All articles published, including editorials, letters, and book reviews, represent the opinions of the authors and do not reflect the official policy of the American Association of Physician Specialists, Inc., or the institution with which the author is affiliated, unless this is clearly specified. ©2010 American Journal of Clinical Medicine® is published by the American Association of Physician Specialists, Inc. All rights reserved. Reproduction without permission is prohibited. Although all advertising material is expected to conform to ethical standards, acceptance does not imply endorsement by the American Journal of Clinical Medicine® and the American Association of Physician Specialists, Inc.

William J. Carbone Chief Executive Officer Nadine B. Simone Executive Assistant Arrie A. Potter Manager of Certification Andrea N. Balboa Manager of Certification

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Daniel M. Avery, MD Harold M. Bacchus, Jr., MD, FAAFP Gilbert Daniel, MD, FAAR Michael K. Garey, MD Robert J. Geller, DO, FAAEP Thomas A. Gionis, MD, JD Beverly R. Goode-Kanawati, DO Jeff Hersh, MD, PhD, FAAEP Thomas G. Pelz, DO, FAAIM Cyril H. Wecht, MD, JD

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Dear Editorial Board, Staff, and Readers: We have an opportunity to participate in building a bridge between gastroenterology and family medicine.

As you know, there are few who continue to offer colonoscopy and EGD in private family practice, general internal medicine, and general surgery. One of our editorial missions is to document improved patient care through and on behalf of the unique contributions of the AAPS and its member specialties. The AAPS differs from the ABMS and AOBMS in its willingness to consider multiple pathways to certified competence.

For example, only the AAPS endorses multiple pathways of primary care for certification in emergency medicine. This is particularly important for the American public, because training cartels have created economic monopolies and downstream problems in access to care. One important area is colorectal cancer prevention through colonoscopy.

As an AAPS member and long-time advocate of colonoscopy by qualified internists, family physicians, surgeons, and others, it was an honor to be invited to participate in the colorectal cancer screening symposium sponsored by the Sacramento Veterans Affairs Medical Center, VANCHCS, and The University of California at Davis Division of Gastroenterology, March 20, 2010.

This conference demonstrated a technique for a more painless colonoscopy. In some states office-based physicians are forbidden from doing IV sedation analgesia. In other states hospital bylaws outright forbid recognition of family physicians and internists. The water immersion technique may help restart office-based colonoscopy, which removes one barrier to care for underserved patients.

Physicians dedicated to the prevention of premature death from colorectal cancer will benefit from this research, and it may help more physicians to learn how to do colonoscopy in their offices. In collaboration with distinguished Professor Felix Leung, MD, and Professor Joseph Leung, MD, the American Journal of Clinical Medicine速 is proud to cosponsor the publication of these proceedings.

Wm. MacMillan Rodney MD, FAAFP, FACEP

Editor, American Journal of Clinical Medicine Member, American Board of Family Medicine Obstetrics

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Letters to the Editor The following letters were written in response to Sounding Board, Volume 7, Number One, Winter 2010, “Why Are Very Few Autopsies Performed Today?” by Daniel M. Avery, MD Dear Editor: Dr./Counselor Wecht’s comments (“Letters to the Editor,” AJCM 2010:7(2)) regarding Dr Avery’s article (“Why Are There Very Few Autopsies Performed Today”, AJCM 2010:7(1)) deserve rebuttal. To suggest that physicians are complicit in hiding a deceased patient’s actual diagnosis by not pursuing a post-mortem examination should insult all of us who actively care for patients.

Many reasons contribute to the declining autopsy rate in this country (less deaths occurring in hospitals, family wishes, costs/ payment for the examination, more accurate diagnosis based on current anti-mortem ancillary studies, etc.), but physician ethical or moral dishonesty should not be purported without solid evidence. Conjecture without fact is harmful and is only inflammatory. There may be anecdotal information from some of Dr Wecht’s cases of high notoriety, but I am not aware of a proper study supporting such a conclusion.

I would suggest that it is the attitude portrayed in the above-cited letter that is harmful to the practice of medicine and only serves to further heighten our (already too sensitive) defensive postures. It is my fervent wish that the medical-legal community can make it our mutual goal to place medical error in proper context and eliminate the need to place individual blame whenever it is possible. Sadly, the current concept of medical reform makes no provision for such egalitarianism.

Fraternally, Dennis E Hughes, DO, FAAFP, FACEP

Dear Editor: I appreciate the thoughts and responses to my Sounding Board paper, “Why Are There Very Few Autopsies Performed Today.”

The design of the Sounding Board is such that it will stimulate thought and ideas from the readers. I appreciate the letters from both Dr. Wecht and Dr. Hughes. The point of my paper is that the request for most autopsies centers around what the physician may have missed and fear of subsequent litigation. As Dr. Hughes points out, cost and payment for autopsies is one of the reasons that limits the actual performance of an autopsy.

As an OB/GYN, I am in the highest risk class for malpractice in my state. An older OB/GYN physician once said about opening his mail, the first pass through the mail each day is looking for subpoenas and requests for records from attorneys, the second pass is looking for the pink reimbursement notices from Medicare to see if one is going to get paid, and the third pass, like everyone else, is just looking at what came in the mail that day. Fear of malpractice and litigation is a big concern in the practice of medicine today.

Having worked in the field of forensic sciences and received training in forensic pathology, the name Dr. Cyril Wecht is a prominent name I have been familiar with for four decades. He is one of the most prominent forensic pathologists alive, and I certainly value his opinions. Dr. Wecht describes the declining numbers of autopsies in hospitals and the subsequent loss of information both from the patient care perspective as well as medical education as a whole.

I equally appreciate Dr. Hughes’ rebuttal, which addresses Dr. Wecht’s statement in his last paragraph, suggesting that some physicians may not pursue postmortem examination to hide correct diagnoses, which may be the case in a small number of autopsies. While I know of no studies on the subject, it would be worthy of more information from Dr. Wecht’s vast experience. I do know that it is not unusual to question autopsy results with second opinions and exhumation with re-autopsying remains, even after some period of time. Prominent forensic pathologists are often retained to give opinions on other forensic pathologists’ original autopsies after studying reports and reviewing evidence, pictures, diagrams, trace evidence, toxicology results, and tissue slides. Sometimes consulting pathologists come to different conclusions from the original pathologist.

Thoughts are welcomed.

Daniel M. Avery, Jr, MD, FAASS Tuscaloosa, AL

Letters to the Editor

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Proceedings of the Colorectal Cancer Screening Symposium March 20, 2010 Sacramento Veterans Affairs (VA) Medical Center Mather, California Co-Directed by Felix W. Leung, MD, FACG Professor of Medicine David Geffen School of Medicine at UCLA Chief of Gastroenterology Sepulveda Ambulatory Care Center Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS) Joseph Leung, MD, FRCP, MACG, FACP, FASGE Mr. & Mrs. C. W. Law Professor of Medicine Division of Gastroenterology and Hepatology University of California, Davis School of Medicine Sacramento, CA Chief of Gastroenterology Veterans Affairs Northern California Health Care System (VANCHCS)

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Opening Address Brian J. O’Neill, MD

Good morning Ladies and Gentlemen: I would like to begin by welcoming you to the Sacramento VA Medical Center for the 2010 Colorectal Cancer Screening Symposium.

I am thrilled to see so much interest from our community in this really important area of preventive medicine. I was told the attendees would be made up of both VA and non-VA attendees, which is great, because it will permit us to have spirited dialogue and an exchange of ideas. VA is really fortunate in that we have a genuine alignment of financial incentives in the way that we deliver our care, since our veteran patients are with us longitudinally for many years. While our primary goal is to prevent cancer, we also realize a financial benefit in so doing; and, of course, colorectal cancer is a huge target.

I would like to begin by talking about the “perfect storm” of colorectal cancer screening, and then we can move on to hear various strategies that deal with the challenges of comprehensive screening. I have been working with Dr. Leung since 1994, which is an interesting place to start from a hospital administrator’s perspective, because this was also the same year that Ken Kizer, MD, became the Under Secretary for the VA. When Dr. Kizer arrived, his lofty vision included a colossal transformation of VA health care with a paradigm shift to continuous improvement in quality and patient safety. In his first year, Dr. Kizer focused on establishing VHA’s nationwide electronic medical record system, known as CPRS, followed closely by the launching of quantifiable clinical outcomes and performance measures. From the very beginning, colorectal cancer screening was selected as one of the original inpatient/ outpatient clinical measures, and 15 years later it remains in this select group.

In 1995, the target for patient screening for colorectal cancer was 50%; however, over the years, this goal has been consistently raised.

To give a brief background, our system covers over 40,000 square miles from the San Francisco East Bay area, along the Highway 80 corridor into Sacramento, and north to the Oregon border. We provide care to our veterans in ten different locations and currently treat almost 70,000 patients, which is twice the number of patients we were treating in 1995. So herein lies the perfect storm for VANCHCS: the first part of the perfect storm is – our patient volume has doubled. Secondly, our veterans, who served during WWII, Korea and Viet Nam, have aged and in the last 15 years have moved into the high-risk years for colorectal cancer. Therefore, we have a higher portion of patients now requiring screening. Thirdly, the gold standard for colorectal cancer screening has drastically changed with the advancement of medicine. In 1995, most screening was done using FOBT cards, and, as clinicians, you know the limitations of that method. With the inception of preferential screening colonoscopy, we have increased the complexity level and time needed to provide care. Fourthly, we have had constraints on our resources during all of this time, and, lastly, the 1995 target of 50% has been increased to a current 2010 target that 67% of all patients within the defined age range shall be screened. Thus, these five factors: doubled population, aging population, FOBT versus colonoscopy, constrained resources, and a significantly higher performance target, have been our challenge.

As the Section Chief of GI Medicine, Dr. Leung is responsible for colorectal cancer screening at all ten of our locations and provides GI procedures at three of those sites. Today, you are going to hear how this is done. In brief, we have done it by: adding resources, changing our delivery model, introducing innovations, increasing our efficiency, using the electronic medical record system, and devising tools that allow for a better screening and tracking process. A point I want to leave you with is that you can face the perfect storm and actually achieve the outcome you are seeking. In our current environment, which is patient centric, forward thinking, and results driven, we have been able to improve our screening rate to 75% (which is a 50% improvement over the last 15 years) while experiencing a doubling of our workload. This 75% figure is inclusive of all patients contacted and includes patient refusals.

Other areas covered today will include our results of cancer detection, improved outcomes with earlier detection, and improved customer satisfaction. You will hear how our patients have responded to changes in the delivery model and to state-of-the-art innovations. The bottom line is – our quality is high and we have the data to show it.

I look forward to a very interesting and exciting meeting, and I want to welcome you again to our conference. Dr. Leung and his team and I want to emphasize the word “team,” which plays a critical role in our successes. They have done a fantastic job. Thank you, Dr. Leung, for inviting me.

Brian J. O’Neill, MD, is Director, VA Northern California Health Care System (VANCHCS).

Opening Address

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Extended Flexible Sigmoidoscopy vs.

Colonoscopy: A Family Medicine Perspective Wm. MacMillan Rodney, MD Ricardo G Hahn, MD

As family physicians, we are honored by the invitation to collaborate in the discussion to decrease death rates from colorectal cancer via earlier detection and treatment. Studies presented here share the common thread of increased access and improved compliance through a new colonoscopy technique, which is less painful and can be provided at a lower cost. This technique should allow decreased dependence on highly regulated and costly hospital-based services, which frequently generate charges of more than $3,000 per colonoscopy. In other words, more services might be provided to more people at a lower cost.

Although screening of asymptomatic patients is one issue, our early studies described the reality of communities where symptomatic patients could not or would not comply with recommendations for colonoscopy/flexible sigmoidoscopy.1,2

Figure 1: Physicians demographics for flexible sigmoidoscopy/ colonoscopy in the USA

The unkept promise of cancer prevention through colonoscopy is the visible tip of a larger iceberg calling for changes in the way physicians get the right test to the right patient for the right price. Family Medicine was designed to provide high quality continuing care unrestricted by age, gender, organ system, and location. Fewer than 30% of family physicians have maintained these skills, and that too is part of the unkept promise.

See Figure 1.

In the mid-1990s generalist physicians were relabeled as “primary care providers” which included nurse practitioners. Many primary care providers stopped participating in hospital care, which is where privileges and equipment for colorectal cancer screening existed.

Academic medical centers and the US government have worked to produce miraculously effective centers of excellence where the best doctors produce the best outcomes under the best conditions. But Boston, Massachusetts, is a lot different from Muddy Waters, Tennessee. Efficacy in the Mayo Clinic does not automatically translate into effectiveness in Mississippi.

The American miracle of JCAHO- approved hospital medicine



Over 900,000 physicians in USA.



Fewer than 150,000 general internists/family physicians.



Fewer than 75,000 have access to equipment for gastrointestinal [GI] endoscopy.



Training programs are not encouraged to teach basic endoscopy which is the gateway to early diagnosis and prevention.



Access for patients is affected, but revenues increase for the hospital. Misaligned incentives.

is too expensive and inaccessible to most uninsured patients everywhere. Even well insured patients will avoid examinations which are perceived as inconvenient, too distant, embarrassing, or lacking enthusiastic support by a trusted family physician.3,4 Fear and perceived pain are some of the psychosocial barriers preventing early detection of colorectal cancer by colonoscopy.

Fear of colonoscopy is exaggerated by language, travel, and financial barriers. Most of Memphis cannot read English at a high school level of comprehension. Rather than a melting pot, 21st century USA has become a salad bowl of distinct cultures.

Extended Flexible Sigmoidoscopy versus Colonoscopy . . .

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Psychiatric comorbidity affects over 35% of health care visits.

Usually these psychiatric issues are undetected or unmentioned.

Family Medicine physicians are more likely to deal with multicultural, multilingual, and broad comorbidities on a daily basis.

This includes the special issues of mental health and rural community medicine.5,6 These dimensions are not adequately addressed by the cocoon environment of most academic medical centers where fragmented care is the rule.

There are potential benefits from decentralizing services back into the community if quality can be maintained. The water immersion method of colonoscopy may be part of this solution.

The blending of high tech services, such as colonoscopy, with high touch primary care in the community was published in Family Medicine journals 1981-2000.7-9 The technology had improved to allow simple and low cost video documentation of normal and abnormal findings. For the first time there was objective evidence available to resolve differences ofopinion.10 See Figure 2.

Figure 2: Photodocumentation improves specificity of diagnosis

In a phrase, we underestimated the geopolitical and economic incentives for preservation of the status quo in the medical schools. Family Medicine and general Internal Medicine were not viewed as essential power players, and, to this day, are not major requirements for the accreditation of a medical school.

Literally every mention of colonoscopy success by a family physician was countered by criticism on the grounds of FP going beyond the scope of their training.16,17 After a promising collaboration in flexible sigmoidoscopy with the American Society for Gastrointestinal Endoscopy[ASGE],18 requests for support of colonoscopy were denied. Family Medicine academics were instructed by Deans that GI endoscopy would be off limits. The enthusiasm for office-based endoscopy examination reached its highest level in the mid 1990s. See Figure 3.

Hospital committees looked to gastroenterology for credentialing rules, and a credentialing arms race ensued.19 Family physicians and general internists were slowly removed from eligibility in hospital settings. Office overhead crept upward while reimbursement remained flat. Incentives were not aligned.

New studies confirmed the need and technical feasibility of colonoscopy in the office,20.21 but a substantial percentage of family medicine programs began to abandon colonoscopy and flexible sigmoidoscopy. The tree of family medicine was obscured by a forest of generic primary care where “providers” Figure 3: Interest in office screening reaches its peak

AAFP 1994 Survey Availability of Training

This is a second generation of an image. It was digitalized using a $120 camera in the office. The adenomatous surface characteristics of this lesion and its size are now a matter of recorded fact versus a vaguely remembered opinion. Interobserver agreement for interpretation of the photo is 100%.

Table 1 describes the flexible sigmoidoscopy rationale as presented at a meeting of Family Medicine educators in 1986. In that year, a family physician published findings that unsedated extended flexible sigmoidoscopy to 105 cm could reach the cecum in a substantial percentage of cases.11 Family physicians moved on to using colonoscopy and published their results.12-14 Yet, none of these data are mentioned in the literature of gastroenterology. This is the first and only conference bringing members of both specialties together.

What happened to the push for colonoscopy in the community where access is better, costs are lower, and compliance seemed to be enhanced by advice from a continuity physician? We had predicted that diagnostic endoscopy of the gastrointestinal tract would become “despecialized” and available to communitybased physicians in family medicine and internal medicine.15 Similar to other technical innovations, there would be a diffusion curve and eventually the technology would be improved to the point where these skills could be incorporated into residency training. At that time few had even dreamed of owning a smart phone, a digital camera, and a personal computer. But time marched on, except for colonoscopy.

RIGID SIGMO

HOSPITAL

OFFICE

PLAN TO ENHANCE THE TRAINING

21%

27%

13%

FLEX SIGMO

70%

97%

46%

COLONOSCOPY

22%

27%

24%

EGD

18%

13%

34%

The American Academy of Family Physicians [AAFP] started providing CME annually with registration requests from 200 physicians each year 1984-1998.

Figure 4: Family medicine enthusiasm for colorectal cancer screening 2004 —What changed?

2004: Interest Declines: Why? HOSPITAL

OFFICE

PLAN TO ENHANCE THE TRAINING

RIGID SIGMO

OBSOLETE

OBSOLETE

OBSOLETE

FLEX SIGMO

AVAILABLE BUT RARELY ACCOUNTABLE

40% - 60% TRY TO ATTAIN 25 PROCEDURES

DYING OUT IN 50% OF PROGRAMS

COLONOSCOPY

15%

35%

0%

EGD

15%

35%

0%

A variety of political, economic, and psychosocial vectors affected those who viewed themselves as family physicians. General internal medicine began its decline with increasing desire among students to subspecialize and have limited ownership of their own practice. In this year registration for the AAFP course was less than 80.

Extended Flexible Sigmoidoscopy versus Colonoscopy . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Table 1: The Environmental Impact of Technology Transfers on Medical Practice

I. Assumptions

II. Predictions

A. In health care, accurate and early diagnosis is of public value.

A. Some offices will evolve into health centers offering urgent care, preventive care, team care, patient education, counseling, resource management, procedures, and office surgery. Colonoscopy is one example.

B. Dissemination of diagnostic and therapeutic skill to a broader base of physicians is desirable, if the costs are acceptable. This improves access.

B. New diagnostic and therapeutic skills will gradually blend the technical power of the hospital with the high touch environment of the office (community health center).

C. Training resources are limited, costs are significant, and tax support for medical education has been deflected away from the training of generalist physicians in the community.

C. For example, the power of diagnostic imaging will return to the office.

Defragmentation of health care will enhance continuity and patient satisfaction.

D. Technology is quietly transforming the biomedical model and the psychosocial model. A new paradigm is evolving, but political resistance is substantial.

D. Digitized images, computerization, and other advances will create electronic information management systems linking offices into efficient primary care research networks. Outcomes will be measured, analyzed, and published.

D. Digitized images, computerization, and other advances will create electronic information management systems linking offices into efficient primary care research networks. Outcomes will be measured, analyzed, and published.

F. Parallel health care systems will persist and compete. Without painful reconfiguration, parallel systems of medical education will persist and compete.

G. The absolute numbers of general physicians will grow slowly. Generic “primary care” will compete with procedurally enhanced generalists for training resources. Comprehensive care physicians (much needed in rural and underserved communities) will constitute less than 10% of practicing physicians until a sustained crisis precipitates change or until economic and technologic events shape evolutionary change.

were interchangeable. The interchangeability was largely due to an emphasis on ambulatory skills with immediate referral to specialized clinics for all procedures. The cutting edge of technical innovation was viewed by some as the lunatic fringe.22 The controversy over the professional identity of family medicine23,24 has temporarily obscured this important opportunity for community physicians to provide new methods, such as the water immersion colonoscopy method presented at this conference. This renewed collaboration between the two specialties fosters improved public health. Virtual colonoscopy has not provided a realistic alternative,25 and the unkept promise of flexible sigmoidoscopy has been given new life.26 My compliments to the Doctors Leung who conceptualized and administrated this conference on research into making colorectal cancer prevention more available to everyone.

“Everyone is in favor of progress, it’s the changes that they don’t like.”

– Anonymous Source: Mary MacMillan Rodney, MD 1882-1968

Acknowledgements Sponsored by the University of California Davis, Division of Gastroenterology, Sacramento California Wm. MacMillan Rodney, MD, Medicos para la Familia, Meharry Department of Family Medicine, Nashville.

Ricardo G. Hahn, MD, is Professor of Family Medicine, Alfred E. Mann Institute for Biomedical Engineering, University of Southern California.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

References 1.

Rodney WM, Felmar E. Why flexible sigmoidoscopy instead of rigid sigmoidoscopy. J Fam Pract. 1984;19:471-476.

2.

Rodney WM, Beaber RJ, Johnson RA, Quan M. Physician compliance with colorectal cancer screening (1978-1983): The impact of flexible sigmoidoscopy. J Fam Pract. 1985;20:265-269.

Extended Flexible Sigmoidoscopy versus Colonoscopy . . .

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3.

Felmar E, Rodney WM. Who should do gastrointestinal endoscopy?

JAMA. 1981;246:1301 [LETTER].

15. Rodney WM. Flexible sigmoidoscopy and the despecialization of endoscopy: An environmental impact report. Cancer. 1992;70S[5]:1266-1271.

4.

Rodney WM. High tech is most effective when blended with high touch and vise versa: Office technology in the 21st century. Fam Pract Res J. 1991;11:235-238.

16. Rex DK, Rodney WM. Colonoscopy. J Fam Pract. 1994;38:456-7.

5.

Newman RJ, Nichols DB, Cummings DM. Outpatient colonoscopy by rural family physicians. Ann Fam Med. 2005;3:122-125.

6.

Carr K, Worthington JM, Rodney WM. Advancing from flexible sigmoidoscopy to colonoscopy in rural family practice. J Tenn Med Assoc.

1998 (Jan):32-34.

7.

Rodney WM. Procedural skills in flexible sigmoidoscopy and colonoscopy for the family physician. Primary Care - Gastrointestinal Disease. WB Saunders, Philadelphia. March 1988; 15(1):79-91.

8.

Johnson RA, Quan M, Rodney WM. Flexible sigmoidoscopy outcomes in a family practice residency. J Fam Pract. 1982;14:757-770.

9.

Hocutt JE, Jaffe R, Owen GM, et al. Flexible sigmoidoscopy in family practice. Am Fam Physician. 1984;29:131-138.

10. Rodney WM, Ounanian LL, Werblun MN. Second-generation video sigmoidoscopy. Am Fam Phys. 1985;31:127-132.

11. Dervin JV. Feasibility of 105 cm flexible sigmoidoscopy in family practice.

J FamPract. 1986;23:341-344.

12. Rodney WM, Dabov G, Orientale E, Reeves WP. Sedation associated with a more complete colonoscopy. J Fam Pract. 1993;36(4):394-400.

13. Hopper W., Kyker KA, Rodney WM. Colonoscopy by a family physician: a 9-year experience of 1048 procedures. J Fam Pract. 1996;43(6):561-566.

14. Pierzchajlo RPJ, Ackermann RJ, Vogel RL. Colonoscopy performed by a family physician: a case series of 751 procedures. J Fam Pract. May 1997;44(5):473-479.

17. Rex DK, Erickson RL, Rodney WM. Who should do colonoscopy? Fam Pract J. 1994;14:109-113.

18. Rodney WM, Felmar E, Auslander M. AAFP-ASGE Conjoint course on flexible sigmoidoscopy. Fam Pract Res J. 1986;5:209-215.

19. Rodney WM. Will virtual reality simulators end the credentialing arms race in gastrointestinal endoscopy or the need for family physician faculty with endoscopic skills? JABFP. 1998;11(6):492-495.

20. Wilkins T, Gillies RZ. Office based unsedated ultrathin esophagoscopy in a primary care setting. Ann Fam Med. 2005;3:126-130.

21. Knox L, Hahn RG, Lane C. A comparison of unsedated colonoscopy and flexible sigmoidoscopy in the family medicine setting: An LA net study. J Am Board Fam Med. 2007;20;444-450.

22. Rodney WM, Deutchman ME, Hahn RG. Advanced Procedures in Family Medicine: The Cutting Edge or the Lunatic Fringe? J Fam Pract.

2004;53:209-212.

23. Rodney WM. Should any hospital-based training for family physicians persist? Fam Med. 1998;30:398-399.

24. Rodney WM. The dilemma of emerging technologies as required curriculum in primary care. Fam Med. 1997;29:584-5.

25. Rodney WM, Richter R. Virtual colonoscopy: Can we screen for cancer of the colon? Curr Surg. 2003;60(2):130-134.

26. Rodney WM. Flexible sigmoidoscopy: The unkept promise of cancer prevention. Am Fam Phys. 1999;59:270-273.

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Extended Flexible Sigmoidoscopy versus Colonoscopy . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Patient Time Burden and Sedation-Related Complications in Screening and Surveillance Colonoscopy Felix W. Leung, MD, FACG

Abstract Optical colonoscopy is the final common pathway for all other positive screening tests as well as having been recommended as a screening modality. Because of costs, it is generally considered underutilized for screening, especially among subgroups of patients who have limited resources. These costs arise as a consequence of sedation being used for screening colonoscopy – escort costs, post-colonoscopy recovery and activity restriction costs, and a low risk of sedation-related complications. A framework for consideration of the scheduled and unscheduled sedation is described to set the stage for further discussions of these sedated and unsedated alternatives.

Narrative The objectives of this introductory discussion are to review the components of patient time costs, to tabulate the extent and significance of sedation-related complications in screening colonoscopy, and to discuss how various options impact these events.

Colon cancer is the second leading cause of cancer deaths in the United States and worldwide. In the United States, estimated new cases and deaths from colon and rectal cancer in 2009 are as follows: new cases - 106,100 (colon); 40,870 (rectal); deaths 49,920 (colon and rectal combined).1 One out of three people diagnosed dies from colon cancer. Professional Gastroenterology, Endoscopy, and Cancer Societies have recommended colorectal cancer (CRC) screening for healthy, asymptomatic individuals.

In 2004, the Center for Disease Control estimated that there were 43 million Americans eligible for CRC screening.2

Optical colonoscopy has been reported to discover 1% cancer and 9% advanced adenomas in the setting of CRC screening.3 Observational studies have shown that optical colonoscopy is effective in detecting colon cancer and removal of polyps. It is the final common pathway for all patients with positive CRC screening tests such as fecal occult blood test (FOBT), fecal immunochemical testing (FIT), barium enema (BE), computerized tomographic colonoscopy (CTC), and flexible sigmoidoscopy (FS). In recent years, it has even been recommended as a first-line CRC screening tool for healthy asymptomatic individuals. Because of costs, it is generally considered underutilized for screening, especially among subgroups of patients with limited resources.4-7 The most obvious cost is due to the fact that sedation is routinely used, mandating the need for an escort, nursing staff for monitoring and recovery of the patient, and post-sedation activity restrictions. One study reported that the total time occupied by preparation, undergoing and recovering from a sedated colonoscopy amounts to 40 hours.8 This subject will be covered in detail in paper by Dr. Ko in this issue.9 An accounting approach to evaluate burden is micro-costing, using time and motion recording.10,11 For example, a colonoscopy broken down to the individual components will reveal those related to a patient’s direct and indirect costs.

Patient costs include time for bowel preparation, transport to hospital or endoscopy center, check in time, on site preparation (insert intravenous line, complete consent form, undergo induction of sedation), undergo the colonoscopy, spend time in the recovery room, receive post-procedure counseling, transport to

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home, and recovery time at home before going back to normal activities. Patient costs in time and inconvenience go up when sedation is administered. For example, the post-procedure counseling done verbally with a patient immediately after sedation is a likely waste of time because of the amnesic effect of the sedation medication.12 On the other hand, counseling can be done readily after an unsedated examination.

Micro-costing was applied to analyze sedated colonoscopy.

Costs included $391 for direct health care, $288 for direct nonhealth care costs, and $274 for patient time costs, when a colonoscopy was performed at one VAMC.11 Dr. Ko published a report on complications after screening or surveillance colonoscopy based on patients identified in the Clinical Outcomes Research Initiative database.13 Of 21,375 patients, the incidence of sedation-related complications during colonoscopy was 12.9 per 1000 patients. The most common was respiratory depression occurring in 7.5 per 1000. Immediate cardiovascular complications including hypotension and bradycardia occurred in 4.9 per 1000. Most were self-limited.

Some did require sedation reversal with atropine, flumazenil, or naloxone, occurring in 2.9 per 1000. Five were hospitalized for observation for abdominal pain or prolonged sedation.

Screening colonoscopy is offered to healthy, asymptomatic individuals between the ages of 50 and 75. Patient time costs, escort costs, and sedation complications are an integral part of the screening procedure. While these are all acceptable when a patient undergoes a diagnostic examination, some of these costs should be minimized for the healthy, asymptomatic individuals undergoing screening.

Scheduled unsedated colonoscopy is not standard practice in the US. Unscheduled, unsedated colonoscopy has been offered to the 1-2% of patients without an escort.14,15 Scheduled, unsedated colonoscopy has been requested by 6-7% of colonoscopy patients at one university practice by professionals with independent knowledge of the option16 as a way to reduce cost of activity restriction. Interestingly, when the colonoscopist actively presents the pros and cons of such an option, it has been consistently accepted by about one-third of the patients at one VA facility without the capability to provide on-site sedation17,18 and by about one-quarter of the patients at another VA facility with the capability to provide on-site sedation.19 Even in sedated patients, there are the options of deep sedation on the one hand and minimal (less than full dose) on the other.

Escort cost is unavoidable. Sedation as needed is based on assessment by the colonoscopist.20 However, this may carry a risk of coercion, as assessment of patient pain at colonoscopy by nursing staff is better than by endoscopists, who tend to underestimate patient discomfort.21 Escort cost is unavoidable.

Sedation on demand is requested by the patient. It is less likely to be coercive. For research studies we have proposed the following routine for on-demand sedation. To eliminate colonoscopist bias21 the nurse recorded patient reported pain scores (0=none, 10=most severe) every two to three minutes. For scores ≥2, maneuvers to minimize pain22 were implemented for both methods. Immediately thereafter the nurse offered medications, which the patients could accept or decline as previously described.22 Escort cost is unavoidable. Completion without sedation obviates the costs of sedation complications and costs of on-site and at-home recovery times.

Table 1: Attributes of scheduled options Sedated

Unsedated

Routine in US

Not routine in US

Very small

None

~ 90%

80 to 90%

Yes

Yes

Escort

Mandatory

Not required

Drive a car after colonoscopy

Not allowed

Allowed

Likely

Not applicable

Remember discomfort

No due to amnesia

Yes

Remember discussion

No due to amnesia

Yes

Need monitoring after colonoscopy

Yes

No

Activity restriction after colonoscopy

Yes

No

May require repeat with sedation

NA

If colonoscopy is incomplete

Availability Risks: hypotension, hypoxia, etc.

Success rate Purge preparation

Discomfort reduced by medication

Patient Time Burden and Sedation-Related Complications . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Table 2: Summary of options Scheduled

Unscheduled

Conscious sedation D E E P

S E D A T I O N

As needed

S E D A T I O N

On demand

U N S E D A T E D

U N S E D A T E D

S E D A T I O N

The pros and cons of (or differences between) scheduled options with and without sedation are summarized in Table 1. If a patient completes a colonoscopy without sedation in the context of either sedation as needed or on demand, all of the benefits of no sedation are maintained except for the issue of an escort.

Since the question as to which patients can complete without sedation cannot be predicted in advance, an escort is required.

To summarize, Table 2 displays the various options of sedation or no sedation. The options can be scheduled or unscheduled.

The only unscheduled one is unsedated colonoscopy. This is offered to patients who drank the purge solution and arrive without an escort and do not mind having the colonoscopy done without sedation. Scheduled options include deep sedation, conscious sedation, and unsedated colonoscopy. A debate on deep sedation has been ongoing for several years. Should an anesthesiologist be involved? Obviously, if one is involved, the cost for the entire colonoscopy goes up.

Conscious sedation can be divided into as needed or on demand sedation. As needed is controlled by the colonoscopist, and on demand is controlled by the patient. In both instance, the sedation medication can be given before the start of the colonoscopy as dictated by the colonoscopist (as needed) or requested by the patient (on demand). The as needed option may suffer the drawback of coercion because data in the literature indicate the colonoscopist underestimates patient discomfort.21 Sedation on demand is based on patient request. The procedure starts without sedation, the nurse monitors the pain scores, offers the patient sedation medications when a certain level of pain is reported, the patient can accept or decline the medications. The likelihood of coercion is smaller.

In both instances a proportion of the patients will complete the colonoscopy without actually receiving medications. If the colonoscopist is motivated to complete the colonoscopy without giving the patient medications, this framework predicts a higher proportion of patient completing without sedation in the as needed option.

U N S E D A T E D

U N S E D A T E D

The scheduled unsedated option is usually requested by the patient. Studies have shown that these individuals tend to be educated professionals. The vast majority of Americans undergoing colonoscopy do receive sedation.

These proceedings assess the various options so that physicians can be more responsive to the needs of the patients. The goal is to enhance adherence to recommended screening procedures and, ultimately, to decrease morbidity and mortality related to colorectal cancers.

Acknowledgements Grant support: Supported in part by ACG Research Award (FWL 2009), VA Clinical Merit Medical Research Funds and the ASGE Career Development Award (FWL 1985).

Felix W. Leung, MD, FACG, is Professor of Medicine, David Geffen School of Medicine at UCLA, and Chief of Gastroenterology, Sepulveda ACC, VA Greater Los Angeles Health System.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The author has stated that no such relationships exist. ®

References 1.

Colon & Rectal Cancer Home Page - http://www.cancer.gov/cancertopics/ types/colon-and-rectal (accessed 03122010).

2.

Seeff LC, Richards TB, Shapiro JA, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC’s survey of endoscopic capacitty. Gastroenterology. 2004;127(6):1670-7.

3.

Lieberman DA, Weiss DG, Bond JH, et al. Use of colonoscopy to screen asymptomatic adults for colorectal cancer. New Engl J Med. 2000;343:162-8.

4.

Yepes-Rios M, Reimann JO, Talavera AC, et al. Colorectal cancer screening among Mexican Americans at a community clinic. Am J Preventive Medicine. 2006;30(3):204-10.

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5.

Diggs JC, Xu F, Diaz M, et al. Failure to screen: predictors and burden of emergency colorectal cancer resection. Am J Managed Care.

2007;13(3):157-64.

6.

Fenton JJ, Tancredi DJ, Green P, et al. Persistent racial and ethnic disparities in up-to-date colorectal cancer testing in Medicare enrollees. J Am Geriatrics Soc. 2009;57(3):412-8.

7.

Maxwell AE, Crespi CM. Trends in colorectal cancer screening utilization among ethnic groups in California: are we closing the gap? Cancer Epidemiology, Biomarkers & Prevention. 2009;18(3):752-9.

8.

Jonas DE, Russell LB, Sandler RS, et al. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007;102:2401-2410.

9.

Ko C. Hidden cost of sedation for screening and surveillance by optical colonoscopy. American Journal Clinical Medicine. In press.

10. Sharara N, Adam V, Crott R, et al. The costs of colonoscopy in a Canadian hospital using a microcosting approach. Can J Gastroenterol.

2008;22(6):565-70.

11. Henry SG, Ness RM, Stiles RA, et al. A cost analysis of colonoscopy using microcosting and time-and-motion techniques. J Gen Int Med. 2007;22(10):1415-21.

12. Hayes A. Buffum M. Educating patients after conscious sedation for gastrointestinal procedures. Gastroenterol Nurs. 2001;24(2):54-7.

13. Ko CW, Riffle S, Michaels L, et al. Serious Complications Within 30 Days of Screening and Surveillance Colonoscopy Are Uncommon. Clin Gastro Hepatol. 2010;8(2):166-173.

14. Aslinia F, Uradomo L, Steele A, et al. Quality assessment of colonoscopic

cecal intubation: an analysis of 6 years of continuous practice at a University Hospital. Am J Gastroenterol. 2006;101:721-731.

15. Nelson DB, McQuaid KR, Bond JH, et al. Procedural success and complications of large-scale screening colonoscopy. Gastrointest Endosc.

2002;55(3):307-314.

16. Subramanian S, Liangpunsakul S, Rex D. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol. 2005;39(6):516519.

17. Leung FW. Unsedated colonoscopy introduced as a routine option to ensure access is acceptable to a subgroup of US veterans. Dig Dis Sci. 2008;53(10):2719-2722.

18. Leung FW. Promoting informed choice of unsedated colonoscopy patient-centered care for a subgroup of U.S. veterans. Dig Dis Sci. 2008;53(11):2955-2959.

19. Leung FW, Mann SK, Salera R, et al. Options for screening colonoscopy without sedation – sequel to a pilot study in United States veterans.

Gastrointestinal Endoscopy. 2008;67(4):712-717.

20. Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999;49(5):554-559.

21. Ramakrishnan S, Yiannakou JY, Ellis WR, et al. Assessment of patient pain at colonoscopy: are nurses better than endoscopists? J R Soc Med. Sep 2004;97:432-433.

22. Leung JW, Mann S, Leung FW. Option for screening colonoscopy without sedation – a pilot study in United States veterans. Alimen Pharmacol Ther.

2007;26(4):627-631.

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Patient Time Burden and Sedation-Related Complications . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Comparative Effectiveness of Water vs. Air Methods in Minimal Sedation Colonoscopy Performed by Supervised Trainees in the US - Randomized Controlled Trial Kanat Ransibrahmanakul, MD Joseph W. Leung, MD, FRCP, FACG, FACP, FASGE Surinder K. Mann, MD, FACG Rodelei Siao-Salera, BSN, CGRN Brian S. Lim, MD Chhaya Hasyagar, MD Danny Yen, MD Igor Nastaskin, MD Felix W. Leung, MD, FACG

Abstract

Introduction

Concern over the complexity of the water method of colonoscopy insertion has dampened enthusiasm for its adoption. To compare the water method vs. air method in the hands of supervised trainees, a randomized, controlled trial was performed.

Screening and surveillance colonoscopy patients consented to randomization. They all received minimal sedation for premedication. Colonoscopy was performed by supervised trainees. The primary outcome was pain during colonoscopy. During insertion the following parameters were significantly lower with the water method: pain scores and total doses or increments (fentanyl and midazolam) of medications. The above were accomplished without compromising unassisted or total cecal intubation rates, patient satisfaction scores at discharge and at 24 hours, patient willingness to repeat colonoscopy, or yield of adenomas. Predominance of male veterans was the main limitation. Supervised trainees replicated the superior performance of the water method reported for the attending staff confirming the water method is not difficult to learn.

In the US, training in sedated colonoscopy involves insertion of the colonoscope aided by air insufflations (air method).1-4a,4b Overseas variations of a water method have been described5-7 to facilitate insertion in unsedated patients. There is a current push towards deep sedation for colonoscopy based on practice efficiency and economics in the US.8,9 Publications by US clinicians10 and investigators11 documenting the use of water infusion in enhancing colonoscopy performance10 and reduced patient discomfort11 received relatively minor attention until recently. In the past seven years we found ourselves in a unique position to provide scheduled, unsedated colonoscopy in the US.12-14 The search for a more comfortable approach15 resulted in the description of a water infusion in lieu of air insufflation technique (water method) to aid colonoscope insertion in the unsedated patients in the US.16-18 Concern over the complexity of the method requiring the acquisition of an entirely new set of skills dampened enthusiasm for its adoption by other investigators (personal communications). Recently, we reported an

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observational19 as well as a randomized controlled trial (RCT)20 by attending endoscopists showing that the water method was superior to the air method – producing less discomfort and engendering a reduced need for sedation medications. In the current RCT, we assessed the comparative effectiveness of the water vs. air methods in the hands of supervised trainees. We tested the hypothesis that the water method can be learned by supervised trainees who can replicate the superior impact of the water method in minimally sedated patients.20

Methods This study, approved by the Institutional Review Board of Sacramento VA Medical Center, is registered with ClinicalTrials. gov (NCT00841282). Patients received instructions in a class setting. Those who reside at a distance were contacted by telephone and given a comparable narrative description. The research consent form was given to the patient during class or sent to the patient by mail. Patients received written instructions for standard bowel preparation.20 Those who signed the research consent form on the day of colonoscopy were randomized. Consecutive screening or surveillance colonoscopy patients examined by the participating trainees were enrolled in the study. There were no exclusion criteria.

Patients were placed in the left lateral position. For pre-medication each patient received minimal sedation consisting of inFigure 1: All the trainees were instructed on the water method in ~20 cases each before commencement of the trial.

Figure 1A

Figure 1C

Figure 1B

Figure 1D

Trainees were shown how to recognize diverticular opening to be avoided (A), infusion of water to produce local distension to permit advancement of the colonoscope (B), the slit-like appearance of the collapsed lumen (C), simultaneous suction of dirty water due to residual fecal matter and infusion of clean water to clear the suboptimally prepared colon (D).

travenous fentanyl (25 μg or 0.5 increment) and midazolam (1 mg or 0.5 increment) plus a single dose of 50 mg diphenhydramine,20 a routine adjunct since 2006.21 Blood pressure, pulse, EKG, and oximetry were monitored. A sealed envelope was opened to reveal the method (air vs. water). Five supervised second- or third-year gastroenterology trainees participated.

First-year trainees were not included because none rotated at the VA during the study period. Each trainee had experience in ~400 cases of supervised sedated colonoscopy using the air method. All the trainees were instructed on the water method in ~20 cases each before commencement of the trial. They were shown how to recognize and avoid diverticular openings (Figure 1A), infusion of water to produce local distension to permit advancement of the colonoscope (Figure 1B), the slit-like appearance of the collapsed lumen (Figure 1C), simultaneous suction of dirty water due to residual fecal matter, and infusion of clean water to clear the sub-optimally prepared colon (Figure 1D) and appearance of the appendix opening under water (published in references 18 and 20). Application of abdominal compression and change in position were employed when repeated attempts to advance the colonoscope failed. The usual sites, e.g., sigmoid or transverse colon, were used for application of abdominal compression in both methods. Unassisted cecal intubation was defined as no hands-on involvement by the attending. The trainees were supervised by experienced endoscopists (JWL and SKM). Verbal instructions were allowed for both methods.

With the air method, air was used during insertion, and water at room temperature administered by a 20 ml syringe was used for washing. With the water method, the air pump on the light source generator (CLV 180, Olympus, Tokyo, Japan) was turned off before scope insertion. Water in one liter bottles (maintained at 37oC using a water bath [Cardinal Health, McGraw Park, IL]) was infused intermittently using a peristaltic pump (Endolav EL-100C, Cooper Surgical, Trumbull, CT) with a blunt needle adaptor through the biopsy channel. If turbid water (due to residual fecal matter) obscured the view, the dirty water was suctioned and clean water was infused to improve the view and to facilitate advancement or visualization of the appendix opening.16-20 Prior to insertion, the nurse provided guidance regarding reporting of pain score, i.e., pain or discomfort experienced in the abdomen exclusive of other painful conditions, such as hemorrhoids, back pain, or joint pain. At regular intervals of two to three minutes, the minimally sedated patients were asked to report their pain score (0=none, 10=most severe). For pain score ≥2, maneuvers to minimize pain (e.g., suction of colonic content, shortening of the length of the colonoscope inside the patient) were implemented in the same manner for both methods. To eliminate bias by the endoscopists,22 nurses assessed the pain score as described above and offered additional medications, which the patients could either accept or decline. Since control of pain was the primary indication for additional medications, fentanyl (25 μg) was given first, then alternating with midazolam (1 mg).20

Comparative Effectiveness of Water vs. Air Methods . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Figure 2: CONSORT flow chart

63 patients were examined by attending staff in the absence of trainees

125 patients referred for screening or surveillance colonoscopy during study period

62 patients enrolled in the study

order to replicate such a magnitude of reduction in pain score, with a power of 90% and an alpha of 0.05 (two-sided), a sample size of 36 participants was needed, or 18 in each group.23 With five trainee-endoscopists performing procedures, the cluster design to account for possible variation in skills was adopted.

Based on the cluster design, calculations with intra-class correlation of 0.05 suggested by preliminary data, the sample size had to be inflated by a factor of 1.7 giving a total of 62 subjects to be enrolled in the study. Pain scores, willingness to repeat future colonoscopy, satisfaction scores, total procedure time, and recovery time were compared using two-sample t test. The mean doses of fentanyl and midazolam and medication increments were analyzed by the Wilcoxon rank-sum test. Cecal intubation rate was compared using the c2 test. All tests were two-sided with p<0.05 considered significant. Data analysis was performed using Stata version 10 (College Station, Texas).

Randomization

Air method N = 31

Results

Water method N = 31

To blind the patient to the method, a towel was used to cover the patient’s eyes. If the trainee failed to achieve cecal intubation, the attending would continue with the same method to complete cecal intubation. Upon confirmation of cecal intubation by visualization of the ileocecal valve, the appendix opening and touching the cecal floor, the towel was removed. The patient could observe the withdrawal phase and engage in dialogue with the endoscopist or nurse if they were not too sedated.

For both methods, residual colonic content was suctioned and sufficient air was insufflated to distend the lumen for inspection on withdrawal; biopsy and polypectomy were performed. The amount of water used and time taken for insertion and withdrawal (inclusive of time for biopsy and polypectomy) were recorded. Upon completion of withdrawal the patient was asked by the endoscopy nurse (not blinded to colonoscopy method) regarding pain before transfer to recovery. When vital signs returned to baseline at 30 minutes from the last dose of medication, the patient would be fit for discharge. The time spent in recovery was documented. The recovery nurse (blinded to colonoscopy method) queried the patient about willingness to repeat future colonoscopy (0=no, 1=yes) and satisfaction with the experience (0=not satisfied, 10=very satisfied) at the time of discharge. At a telephone follow-up call after 24 hours, the question regarding satisfaction score was repeated.

Statistics In a study involving attending endoscopists,20 the maximum pain scores during insertion were 1.3 (1.8) (water method) and 4.1 (3.4) (air method). The mean difference of 2.9 in pain score in SD units was 1.61 using SD of 1.8 or 0.85 using SD of 3.4. In

From 11/05/2008 to 02/09/2009, 125 patients underwent screening or surveillance colonoscopy. Sixty-three were examined by attending staff in the absence of trainees. Sixty-two consented to be randomized (figure 2). The mean age (years) 61 (7.9) and 61 (7.8); the male to female ratio 31:0 and 30:1; the ratio of screening to surveillance colonoscopy 23:8 and 21:10 and the ratio of colonoscopy class attendance to non-attendance 23:8 and 22:9, for the air and water method group, respectively, were comparable.

Tables 1 and 2 tabulate data comparable to the published data of the attending staff (20). Table 1 shows the trainees reproduced Table 1: Medication requirement and pain scores

Supervised Trainee Performance Water (n=31)

Air (n=31)

P*

To cecum

2.4 (1.7)

3.3 (1.5)

<0.05

During withdrawal

0.1(0.4)

0.1 (0.3)

NS

Total

2.5 (1.9)

3.4 (1.6)

<0.05

Pain score before procedure

0.1 (0.4)

0.6 (1.3)

NS

3.1 (2.9)

4.8 (3.3)

<0.05

1.9 (2.4)

2.1 (2.9)

NS

0.4 (0.8)

1.1 (1.6)

<0.05

Medication increments

Ascending Pain score colon (0 = none; 10 = max) Cecum Pain score at discharge

Data are expressed as mean (SD). *One increment is equivalent to 25 μg of fentanyl or 1 mg of midazolam; **Wilcoxon rank-sum test; NS, not significant.

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Table 2: Procedure characteristics

Supervised Trainee Performance Water (n=31)

Air (n=31)

P

Unassisted intubation rate

94%

94%

NS

Cecal intubation rate

100%

100%

-

Cecal time (min)

11 (7.3)

10 (5.5)

NS

Total procedure time (min)

21 (8.5)

24 (11.6)

NS

Compression/position change

No 22, yes 9

No 12, yes 19

<0.05*

1006 (429)

3 (18)

<0.05**

Water used (ml)

Discussion

Total recovery (from last meds) (min)

34 (8.8) 37 (10.4)

NS

In recovery room time (min)

18 (8.3)

21 (6.5)

NS

Cardiopulmonary unplanned events

0/31

1/31

NS

Willingness to repeat (same method)

29/31

25/31

NS

Satisfaction (0 = not satisfied, 10 = very satisfied)

the lower pain score in the ascending colon but not in the cecum; but the patients did have less pain at the time of discharge with the water method. Expressed as increments of medications used during insertion, significantly fewer increments [2.4 (1.7) vs. 3.3 (1.5), p<0.05] were needed for the water method, again reproducing the findings of the attending staff. Table 2 shows data similar to the attending, less abdominal compression/position change was required with the water method. Unassisted (94%) and total (100%) cecal intubation rates were similar for both methods. By design, the volume of water used was significantly larger in the water than the air method. The insertion and withdrawal times were also comparable. One subject in the air group had a transient episode of bradycardia.

At the time of completion of the colonoscopy, more patients in the water group were willing to repeat 29 of 31 vs. 25 of 31, but the difference was not significant. Satisfaction scores were comparable between the two methods at the time of discharge and at 24 hours after colonoscopy. Unlike the attending data, more medications were administered to both groups resulting in no shortening of the time spent in the recovery room. Table 3 shows there was no difference in the yield of adenomas.

After exam

9.0 (1.7) 9.4 (1.3)

NS

1 day later

8.7 (2.2) 9.3 (1.3)

NS

Data are expressed as mean (SD). *Fisher’s exact test; ** t test

This RCT shows that, during insertion, the pain scores and the medication requirements were significantly lower with the water method (Table 1). Not surprisingly, compared with the data generated by the attending endoscopists,20 both the maximum pain scores and medication requirement were higher in the current study performed by the supervised trainees (Table 1), attesting to the fact that experience does impact performance.

Unassisted and total cecal intubation rates, willingness to repeat, and satisfaction scores were comparable between the air and water groups in this trainee study (Table 2). The current results support the hypothesis that, compared with the air method, patients examined by supervised trainees using the water method have diminished discomfort and require less sedation medications, without compromising cecal intubation rate and patient satisfaction scores.

Cecal intubation rate of supervised trainees was enhanced by the addition of sedation,24 but sedation in the hands of supervised trainees had also been associated with more frequent sedation-related complications.25 The techniques of minimal air insufflation, loop reduction and abdominal compression are well-described adjuncts to reduce colonoscopy discomfort and

Table 3: Number of patients with at least one adenoma (ADR) and number of patients whose adenomas are in the proximal colon

Number of patients with at least one adenoma (ADR)

Number of patients whose adenomas are in the proximal colon

Water (n=31)

Air (n=31)

P

Water (n=9)

Air (n=10)

P*

9 (29%)

10 (32%)

NS

7 (78%)

8 (80%)

NS

*Fisher’s exact tes

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

to enhance cecal intubation with the air method.1-4 However, lengthening of the colon by air insufflation has been well-documented by one study comparing computerized tomographic colonography with optical colonoscopy measurements.26 Lengthening of the colon increases difficulty in reaching the cecum. Initial findings of the water method to aid insertion permitted 52% of patients accepting on-demand sedation to complete without medications.16 The water method significantly increased cecal intubation from 76% to 97% in patients accepting scheduled, unsedated colonoscopy.18 Both reports suggested that the water method increased tolerance for colonoscopy without sedation in US patients. These observations are particularly important in the context of sedation being the usual practice in the US because of the widely held viewpoint that colonoscopy is a painful experience.27-29 The volume of water used was dependent on the quantity of residual fecal matter, which, when suspended by the infused water, decreased visibility in the lumen. The discolored water was removed by suction followed by infusion of clean water in order for the lumen to be visualized again to allow further insertion. While the exchange was developed initially to facilitate passage of the colonoscope, the net result was additional cleansing of the lumen. Suction removal of the dirty water also meant that most of the water was collected in the suction bottle even during insertion. When the bowel preparation was excellent, only a small amount of water was necessary to produce local distension of the colonic lumen to provide the clear view for advancement. When the patient is in the left lateral position, the water in the left colon weighs that segment down to straighten the sigmoid colon5,6,30 minimizing the need for sigmoid compression,16,18-20 which was confirmed by the data in the present study.

method was used to ascertain adequacy of blinding. Reported unassisted cecal intubation rates using the air method for trainees who have performed at least 100 supervised colonoscopies range from 62%-84%34-36 in the sedated patients and 81% in unsedated patients.31 The unassisted cecal intubation rate of 94% in this study reflected the considerable experience of the participant trainees.

We concur with the calls to assess efficacy of the water method

by RCT.37,38 This study reveals the water method to be simple and relatively easy to learn. Successful transfer of skills to trainees will expand the pool of colonoscopists needed to address questions that require large number of patients and varied practice settings, e.g., impact on sedation-related complications, cost-effectiveness, and applicability of the method to non-VA settings, female and younger patients, and those with prior abdominal surgery, as these are factors associated with difficult colonoscopy.39 Finally, the impact of the water method on less experienced supervised trainees also deserves to be assessed.

Acknowledgements The study is supported by the C.W. Law Research Fund (JWL), the Research and Medical Services of the VANCHCS and VAGLAHS and statistical support from the Clinical and Translational Science Center, UC Davis, and in part by the American College of Gastroenterology Clinical Research Award (FWL).

The study was accepted for poster presentation at the ACG Annual Meeting in San Diego, CA, 10/25/2009.

Kanat Ransibrahmanaku, MD, Gastroenterology Medical Clinic, Folsom, CA.

The need to improve cecal intubation in the scheduled, unsedated patients31 prompted us to review methods for reducing discomfort during colonoscopy.15 In contrast to reports of water as an adjunct to air insufflation found on review of Medlineindexed literature,5,7,10,11,30 we described the method of water infusion in lieu of air insufflation during insertion.16,17 We added the feature of turning off the air pump until the cecum is reached,16,18-20 in anticipation of involvement of trainees who might “accidentally” trigger air insufflations causing elongation of the colon. Subsequently in 2008, we discovered similar methods described in the Japanese literature32,33 and in journals not indexed in MEDLINE.6 In retrospect, it is remarkable to observe that independent clinicians came to the recognition that a paradigm shift, namely, exclusion of air and inclusion of water only, is critical to enhance success of cecal intubation,18 minimize patient discomfort,20 and facilitate trainee education.6 Table 3 shows that adenomas detection was not affected. Taken together, these features of the water method should reassure even experienced colonoscopists that the acquisition of the novel skill set may be worthwhile.

Joseph W. Leung, MD, FRCP, FACG, FACP, FASGE, C.W. Law Professor of Medicine, University of California Davis School of Medicine, and Chief of Gastroenterology, Veterans Affairs Northern California Health Care System.

Limitations include the recruitment of predominant male patients at a single VA site. We did not determine whether the patients were able to guess more correctly than by chance what

Danny Yen, MD, Sutter Auburn Faith Hospital, Auburn CA.

Surinder K. Mann, MD, FACP, FACG, AGAF, is Clinical Associate Professor of Medicine, University of California Davis Medical Center, Associate Chief of Gastroenterology, Veterans Affairs Northern California Healthcare System, Director of Endoscopy, Sacramento VA Medical Center, Mather, CA. Rodelei Siao-Salera, BSN, CGRN, Department of Medicine, Veterans Affairs Northern California Health Care System (VANCHCS) Brian S. Lim, MD, MCR, Kaiser Permanente Riverside Medical Center, Riverside, CA. Chhaya Hasyagar, MD, North Kaiser Permanente Medical Center, Sacramento, CA.

Igor Nastaskin, MD, Santa Maria, CA.

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Felix W. Leung, MD, FACG, is Professor of Medicine, David Geffen School of Medicine at UCLA, and Chief of Gastroenterology, Sepulveda ACC, VA Greater Los Angeles Health System.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

References 1.

Cotton PB. Colonoscopy. In: Cotton PB, Williams CB, editors. Practical gastrointestinal endoscopy, 3rd ed. Oxford: Blackwell Scientific Publications. 1990;160-223.

2.

Rex, DK. Colonoscopy. Gastrointest Endosc Clin N Am. 2000;10:135-60.

3.

Leslie A, Steele RJ. Colonoscopy. J Royal College Surgeons of Edinburgh.

2002;47:502-9.

4a. Waye J, Rex DK, Williams CB. Insertion Techniques. Colonoscopy Principles and Practice. 2003:318-338.

4b. Pope, JB. Colonoscopy. In Pfenniger JL, Fowler BE, eds. Procedures for Primary Care. 2nd ed. Philadelphia, PA. 2003. Third edition in press, Capter 100, 2010.

5.

Hamamoto N, Nakanishi Y, Morimoto N, et al. A new water instillation method for colonoscopy without sedation as performed by endoscopistsin-training. Gastrointest Endosc. 2002;56:825-828.

6.

Mizukami T, Yokoyama A, Imaeda H, et al. Collapse-submergence method: simple colonoscopic technique combining water infusion with complete air removal from the rectosigmoid colon. Dig Endosc.

2007;19:43-47.

7.

Brocchi E, Pezzilli R, Tomassetti P, et al. Warm water or oil assisted colonoscopy: towards simpler examinations? Am J Gastroenterol.

2008;103:581–587.

8.

SedationFacts.org – Comprehensive Information on GI Sedation. http:// www.sedationfacts.org/ (accessed 02202010).

9.

Vargo JJ, Bramley T, Meyer K, et al. Practice efficiency and economics: the case for rapid recovery sedation agents for colonoscopy in a screening population. J Clin Gastroenterol. 2007;41(6):591-598.

10. Falchuk ZM, Griffin PH. A technique to facilitate colonoscopy in areas of severe diverticular disease. N Engl J Med. 1984;310(9):598.

11. Church JM. Warm water irrigation for dealing with spasm during colonoscopy: simple, inexpensive, and effective. Gastrointest Endosc.

2002;56(5):672-674.

12. Leung FW. Unsedated colonoscopy introduced as a routine option to ensure access is acceptable to a subgroup of US veterans. Dig Dis Sci. 2008;53(10):2719-2722.

13. Leung FW. Promoting informed choice of unsedated colonoscopy patient-centered care for a subgroup of U.S. veterans. Dig Dis Sci. 2008;53(11):2955-9.

14. Leung FW, Aharonian HS, Guth PH, et al. Unsedated colonoscopy: Time to revisit this option? J Family Practice. 2008;57(12):E1-E4.

15. Leung FW. Methods of reducing discomfort during colonoscopy. Dig Dis Sci. 2008;53:1462-1467.

16. Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther.

2007;26(4):627-631.

19. Leung JW, Salera R, Toomsen L, et al. Pilot feasibility study of the method of water infusion without air insufflation in sedated colonoscopy. Dig Dis Sci. 2009;54:1997-2001.

20. Leung JW, Mann SK, Siao-Salera R, et al. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009;70:505-10.

21. Tu RH, Grewall P, Leung JW, et al. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc. 2006;63:87-94.

22. Ramakrishnan S, Yiannakou JY, Ellis WR, et al. Assessment of patient pain at colonoscopy: are nurses better than endoscopists? J R Soc Med. Sep 2004;97:432-433.

23. McCance I. The number of animals. In News in Physiological Science.

1989;4:172-176.

24. Rodney WM, Dabov G, Orientale E, et al. Sedation associated with a more complete colonoscopy. J Fam Pract. 1993;36:394-400.

25. Sharma VK, Nguyen CC, Crowell MD, et al. A national study of cardiopulmonary unplanned events after GI endoscopy. Gastrointest Endosc. 2007;66:27-34.

26. Duncan JE, McNally MP, Sweeney WB, et al. CT colonography predictably overestimates colonic length and distance to polyps compared with optical colonoscopy. AJR. 2009;193:1291-1295.

27. Leo RA. Unsedated endoscopy: you don’t get a medal for it! South Med J. 2004;97:797-798.

28. Levenson D. Health quality organization criticizes colonoscopies given without pain medication. Rep Med Guidel Outcomes Res. 2001;12:910,12.

29. Madan A, Minocha A. Who is willing to undergo endoscopy without sedation: patients, nurses, or the physicians? South Med J. 2004;97:800805.

30. Baumann UA. Water intubation of the sigmoid colon: water instillation speeds up left-sided colonoscopy. Endoscopy. 1999;31:314-317.

31. Leung FW, Aharonian HS, Guth PH, et al. Involvement of trainees in routine unsedated colonoscopy - review of pilot experience. Gastrointest Endosc. 2008;67:718-722.

32. Abe K, Hara S, Takada Y, et al. A trial on water pouring method during colonoscopic insertion. Yakuri-to-Chiryou. 1986;14:108-112 (In Japanese).

33. Mizukami T, Maruyama K, Iwao T, et al. ‘Collapse-submergence method’ and ‘Self-abdominal manipulation’ are useful in the technically difficult case of colonoscopy. Gastroenterol Endosc. 2004;46:610 (In Japanese).

34. Cass OW, Freeman ML, Peine CJ, et al. Objective evaluation of endoscopy skills during training. Ann Intern Med. 1993;118:40-44.

35. Chak A, Cooper GS, Blades EW, et al. Prospective assessment of colonoscopic intubation skills in trainees. Gastrointest Endosc.

1996;44:54-57.

36. Church J, Oakley J, Milsom J, et al. Colonoscopy training: the need for patience (patients). ANZ J Surg. 2002;72:89-91.

37. Davila ML, Davila RE. The demise of air insufflation and the rise of the warm water infusion method. Gastrointest Endosc. 2009;70:511-514.

38. Wasan SK, Schroy PC. Water-assisted unsedated colonoscopy: does the end justify the means? Gastrointest Endosc. 2009;69:551-553.

39. Witte TN, Enns R. The difficult colonoscopy. Can J Gastroenterol.

2007;21:487–490.

17. Leung FW. Water-related techniques for performance of colonoscopy. Dig Dis Sci. 2008;53:2847-2850.

18. Leung FW, Aharonian HS, Leung JW, et al. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009;9:546-550.

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Hidden Cost of Sedation for Screening and Surveillance by Optical Colonoscopy Cynthia W. Ko, MD, MS

Abstract The majority of colonoscopies for performed under sedation.

Patient recovery time and activity restrictions have social and economic costs. A shortage of facilities, trained personnel, and equipment limits physicians’ ability to perform colonoscopy.

In one study, patients spent a median of 37.2 hours from bowel preparation until resumption of routine activities. If there were no sedation used, patients could save as much as 18 hours. In one study, examining non-adherence to screening colonoscopy, 14% of patients reported transportation difficulties as a significant barrier. Further research might describe the effect of sedation-free colonoscopy on access, economic costs, and social costs as they relate to patients and their caregivers.

Introduction In the United States, roughly 14 million colonoscopies were performed in 2003.1 Colonoscopy is recommended for early polyps and for follow-up of other abnormal screening tests, such as fecal occult blood. Endoscopic screening programs may reduce the risk of colorectal cancer mortality by 90%.2-5 In addition, colonoscopy is useful for investigation of gastrointestinal tract symptoms. Most colonoscopies are performed under moderate or deep sedation, the latter usually managed by an anesthesiologist or certified nurse-anesthetist.

Although sedation improves patient comfort, the associated side effects of sedation may prevent patients from having the procedure. Sedation increases recovery time in the endoscopy unit and later at home. Sedated patients usually require transportation home and are advised not to return to work until the following day. These time constraints may cause poorer patients to forego screening or a therapeutic intervention. This

paper reviews the opportunity cost of colonoscopy as it relates to colorectal cancer screening and posits that sedation-free colonoscopy may decrease these costs.

Opportunity Cost Preparation and recovery require far more time than colonoscopy itself. At an academic medical center,6 110 patients undergoing screening or surveillance colonoscopy completed a time diary from the beginning of bowel preparation until the resumption of normal activities. Jonas et al. found that these patients spent a median of 37.2 hours for colonoscopy from commencing bowel preparation until the resumption of routine activities.

Polyethylene glycol-based bowel preparation required a median 16.7 hours. The average time spent traveling from home to the endoscopy suite and returning home was 3.7 hours. At home, recovery required a median of 15.8 hours until normal activities were resumed. These patients required an average of 1.8 additional hours to achieve self-reported normalcy.

This study also examined time lost from other activities because of the colonoscopy. Forty-three percent of patients gave up work although 42% of the patients were retired or disabled.

Twenty-four percent of patients lost only one day from work; approximately 10% lost more. Forty-seven percent lost leisure time and time for household chores. Twenty-nine percent lost time normally used for the care of others.

Similar to flexible sigmoidoscopy, colonoscopy without sedation minimizes time spent in the recovery unit of the endoscopy facility. Furthermore, patients usually do not require an escort home and may even return to work the day of the procedure.

Based on the above data, patients could save up to 17.6 hours in recovery time.

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Need for Escort Home

Summary and Conclusion

Sedated patients usually require transportation home after colonoscopy. Indeed, in one study examining reasons for nonadherence to screening colonoscopy, 14% of patients reported transportation difficulties as a significant barrier.7 Few studies address the opportunity cost for caregivers of patients undergoing colonoscopy. In a study of 502 patients undergoing screening or surveillance colonoscopy, 75% of caregivers did not report losing any days from work, 22.7% reported losing one day of work, and 1.9% lost more than one day of work. To our knowledge, no study has addressed the issue of caregiver time for patients who undergo colonoscopy without sedation.

The process of colonoscopy requires time, with preparation and recovery at home accounting for the majority. Sedation increased costs by prolonging the recovery process, which delays the return to normal activity. These costs may impede colonoscopy adherence. Colonoscopy without sedation may decrease economic and social costs to patients and their caregivers.

The Fiscal Cost of Sedation Using questionnaires, Heitman et al. compared the time lost and economic costs for 604 patients undergoing screening fecal occult blood tests and 723 patients undergoing screening colonoscopy in Canada.8 For colonoscopy, the time was measured from the departure to the endoscopy facility until the patient arrived home after the procedure. Time spent on bowel preparation and post-procedural recovery was not surveyed. Patients spent a median of 4.0 hours for colonoscopy compared to a median of 0.9 hours for fecal occult blood testing. Caregivers spent a median of 3.7 hours for colonoscopy patients, while no patients undergoing fecal occult blood testing reported caregivers giving time. Patients undergoing colonoscopy also reported a median of 4.1 hours off work, with caregivers reporting 1.8 hours (IQR 0-4.7). Total patient costs, including time for travel, time receiving care, and any other additional time, were $36 Canadian for fecal occult blood testing, compared to $308 Canadian for colonoscopy. Importantly, colonoscopy patients reported median lost wages of $76.4 (IQR $63.7-95.5) for travel and clinic time and $78.60 (IQR $52.5-108.2) for additional time, including time off work for recovery. Caregivers for colonoscopy patients reported total costs, including lost wages, of $70.0 (IQR $46.1-85.6) for travel and clinic time, and $86.4 (IQR $56.3-$124.0) for additional time caring for the patient.

Time devoted to colonoscopy may have significant impact on the cost-effectiveness of screening. Jonas, et al. used data on patient time requirements discussed earlier to estimate total costs from lost time associated with colonoscopy.9 They found a median of $1,341 (IQR $596-$6,405) of lost wages from the beginning of bowel preparation until the return to normal activities. The estimated lost wages for caregivers was $73 (IQR $23-258) for the time spent accompanying the patient to and from colonoscopy. These costs, in addition to the QALY published in a previous analysis,10 increased the cost per life-year saved for screening colonoscopy from $24,500 to $36,000. The incremental cost per life-year saved compared with no screening increased from $13,100 to $22,400.

Cynthia W. Ko, MD MS, is Associate Professor of Medicine, Division of Gastroenterology, University of Washington, Seattle.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The author has stated that no such relationships exist. ®

References 1.

Seeff LC, Richards TB, Shapiro JA, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC’s survey of endoscopic capacity. Gastroenterology. 2004;127(6):1670-7.

2.

Baxter NN, Goldwasser MA, Paszat LF, et al. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009;150(1):1-8.

3.

Winawer SJ, Zauber AG, Ho MN, et al. Prevention of colorectal cancer by colonoscopic polypectomy. N Engl J Med. 1993;329(27):1933-1981.

4.

Muller AD, Sonnenberg A. Prevention of colorectal cancer by flexible endoscopy and polypectomy: a case-control study of 32,702 veterans. Ann Intern Med. 1995;123(12):904-910.

5.

Muller AD, Sonnenberg A. Protection by endoscopy against death from colorectal cancer: a case-control study among veterans. Arch Intern Med. 1995;155(16):1741-1748.

6.

Jonas DE, Russell LB, Sandler RS, et al. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007;102(11):2401-10.

7.

Denberg TD, Melhado TV, Coombes JM, et al. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005;20(11):989-95.

8.

Heitman SJ, Au F, Manns BJ, et al. Nonmedical costs of colorectal cancer screening with the fecal occult blood test and colonoscopy. Clin Gastroenterol Hepatol. 2008;6(8):912-917.

9.

Jonas DE, Russell LB, Sandler RS, et al. Value of patient time invested in the colonoscopy screening process: time requirements for colonoscopy study. Med Decis Making. 2008;28(1):56-65.

10. Sonnenberg A, Delco F, Bauerfeind P. Is virtual colonoscopy a costeffective option to screen for colorectal cancer? Am J Gastroenterol.

1999;94(8):2268-74.

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

More Polyps Are Seen on Screening Colonoscopy With Water Infusion in Lieu of Air Insufflation (Water Method) Compared With Usual Air Insufflation Joseph W. Leung, MD, FRCP, FACG, FACP, FASGE Surinder K. Mann, MD, FACP, FACG, AGAF Lynne Do, MD Rodelei Siao-Salera, BSN, CGRN Felix W. Leung, MD, FACG

Abstract This paper is a retrospective, uni-institutional analysis that compares the polyp detection rate of water infusion versus conventional air insufflation colonoscopy. The queried database consisted of two groups based on the method of endoscopy used. There were 683 patients in the air group (1/2000-6/2006) and 495 in the water group (6/2006-6/2009). There were significantly more patients with at least one polyp in the water group compared to the air group. Similarly, there were more >9mm polyps. Overall adenoma detection rate was significantly higher in the water group. Water colonoscopy improves bowel preparation, which may contribute to higher polyp/adenoma detection.

Narrative An effective colonoscopy should have a high cecal intubation rate to detect the presence of colonic polyps. Different methods may increase the adenoma detection rate (ADR) of screening and surveillance colonoscopy. These include tandem examination,1 narrow band imaging,2 high definition white light endoscopy,3 and chromoendoscopy.4 Current literature suggests that colonoscopy is effective in preventing left-sided colon cancer but does not offer significant

benefits in protection against right-sided colon cancer.5 Presumptive biological differences of the different portions of the colon may explain this failure. Currently, missed lesions account for 4% of missed cases.6 This paper describes warm water infusion in lieu of air insufflation for screening/surveillance colonoscopy and compares the polyp detection rate of water infusion to that of conventional air insufflation.

With conventional colonoscopy, insufflated air distends the colon to facilitate insertion. Water at room temperature irrigates and removes adherent and residual stool in the lumen to improve visualization. With the water method, the air button is turned off at insertion, warm water (37oC) is infused using a blunt needle adaptor inserted into the biopsy channel and an irrigation pump to distend the colon and facilitate scope insertion until the cecum is reached.7 When air pockets or dirty water are encountered, suction is performed before more clean water is infused to facilitate scope advancement. For both air and water techniques, residual water and stool are suctioned on scope withdrawal, air is insufflated to distend the colon for proper examination and removal of lesions or biopsies. In contrast to air insufflation, water infusion only distends the colon locally and the infused water tends to pool with gravity and, therefore, does not lengthen the entire colon. Gentle finger pal-

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pation of the right lower quadrant may be seen as a gentle bulge of the water-filled colon and can confirm cecal intubation. With adequate distension of the cecum, the appendix opening can be seen under water, which is subsequently confirmed by air insufflation and suctioning of the residual fluid. On withdrawal, all of the residual water is suctioned to facilitate examination of the mucosa. Even for poor bowel preparation, repeat exchange of dirty water with clean water improves visualization. The amount of water used varies between 200 ml for excellent bowel prep to two liters for patients with poor bowel prep. Indeed, water infusion method is the only technique that is directly controlled by the colonoscopist, which can improve bowel preparation, which may improve outcomes.

One of the goals of screening/surveillance colonoscopy is the detection and removal of precancerous lesions in the colon. The US Multi-Society Task Force on colorectal cancer screening recommended a minimum ADR of 25% in male patients and 15% in female patients8.

Several controlled randomized trials (RCT) evaluate the water technique in colonoscopy. In patients undergoing screening/ surveillance colonoscopy with minimal sedation, the authors showed that the water method has a high cecal intubation rate and is associated with better patient tolerance and lower medication requirement.9 When offered sedation on-demand, significantly more patients completed the colonoscopy without sedation using the water method.10 One abstract suggests an increased polyp detection rate with deep sedation compared to routine conscious sedation, presumptively owing to improved patient comfort and, therefore, a more thorough exam.11 Historically, most reports based on database analysis focus on polyp detection rather than adenoma detection because the final pathology reports are not incorporated into endoscopic databases.

The authors retrospectively reviewed uni-institutional data collected over ten years from a single endoscopist to determine if water colonoscopy improves polyp/adenoma detection compared with air colonoscopy in screening/surveillance patients.

The results of colonoscopy were entered onto a database (GI Trac, Akron Systems). Conventional air insufflation colonoscopy was used for screening colonoscopy between January 2000 to June 2006, and the water method was used from June 2006 to June 2009. The information extracted included the total number, the size, and the location – proximal included the cecum to the transverse colon and distal the splenic flexure to the rectum. Pathology data were retrieved from another VA database (Computerized Patient Record System or CPRS).

A total of 1189 patients underwent screening/surveillance colonoscopy during this period; 11 patients with incomplete pathology data were excluded from the analysis. In the remaining 1178 patients, 683 patients had air colonoscopy and 495 patients had water colonoscopy. There were no significant differences between the age, gender, and the Body Mass Index (BMI) of the patients between the two groups. There was a significant difference in the percentage of patients found to have at

least one polyp (45.1% for air and 62.4% for the water group, p<0.0001). In addition, there was also a significant difference in the number of polyps >9 mm (8.6% vs. 17.2 % respectively).

In a subsequent analysis, pathology of the removed polyps was compared. There were 183 patients (26.8%) in the air group and the 173 patients (34.9%) in the water group with proven adenomas. The difference was significant, p<0.0031.

The limitations of this study are the retrospective nature and being a non-randomized study. Other confounding factors, such as change to better endoscopic equipment over the past years and an improvement in the bowel preparation, could have influenced the polyp/adenoma detection rate. A number of factors may have contributed to missed lesions at the time of colonoscopy secondary to poor visualization, such as incomplete clearance of stool, colon spasm limiting colonic distension, difficult polyp location, etc.

In conclusion, the water method may improve polyp detection in screening colonoscopy. In patients with good bowel preparation the magnification through water in a less distended colon aids in identifying small polyps. Decreased distension shortens the colon and facilitates cecal intubation. RCTs have shown that the water method is associated with less abdominal pain and discomfort during examination, which minimizes sedation requirements. In patients with poor bowel preparation, irrigation and suction remove residual stool, improving polyp detection.

Appendix The following commentary was provided by Dr. Surinder K. Mann during a live demonstration of water colonoscopy at the Colorectal Cancer Symposium.

A discussion of the option about availability of unsedated water infusion colonoscopy was carried out in a pre-colonoscopy setting. When the patient arrived today, time out procedures confirmed the patient’s identity using a wrist band with name, date of birth, and social security number. Before colonoscope insertion, the air was turned to the off position. The colonoscope tip was inserted into the rectum, and water was infused into the rectum. The lumen was found, and the scope was advanced in a spiral fashion. The colon preparation was poor in this patient; clean water was exchanged for dirty water, and residual air was suctioned at the rectosigmoid junction and descending colon. Diverticula were more clearly seen with water infusion as a diverticulum is filled and dilated with water. At the splenic flexure, a soft loop was formed and advanced into the transverse colon. Air was encountered in the proximal transverse colon and mid-ascending colon, which must be suctioned and replaced with water. On average the left colon will be infused with 300 cc to 500 cc of water. Reaching the cecum usually requires roughly 1000 cc of water. For redundant colon, the application of transabdominal pressure or repositioning the patient may aid scope advancement. At the cecum, the appendix will be visualized with good preparation. Right lower quadrant finger pressure protrudes into the colon and indicates cecal proximity. In this patient, the colon preparation was poor, but

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cecal intubation was achieved using right lower quadrant finger pressure as an aid. Subsequently, the air was engaged and the dirty water was removed. Visualization of the appendix reconfirmed cecal intubation, which required roughly 1500 cc of water in this case. The scope was withdrawn while residual water was suctioned. Colonic insufflations revealed good preparation – the direct result of this unsedated water infusion colonoscopy, which changed a poor colon preparation into a good one.

References 1.

Rex D, Cutler C, Lemmel G, et al. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology.

1997;112(1):24-28.

2.

Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008;57(10):1406-12.

3.

Kahi CJ, Anderson JC, Waxman I, et al. High-definition chromocolonoscopy vs. high-definition white light colonoscopy for average-risk colorectal cancer screening. Am J Gastroenterol. Advance online publication, February 23, 2010; doi:10.1038/ajg.2010.51.

4.

Stoffel EM, Turgeon DK, Stockwell DH, et al. Chromoendoscopy detects more using intensive inspection without dye spraying. Cancer Prev Res. 2008;1:507-513.

Joseph W. Leung, MD, FRCP, FACG, FACP, FASGE, C.W. Law Professor of Medicine, University of California Davis School of Medicine, and Chief of Gastroenterology, Veterans Affairs Northern California Health Care System.

5.

Baxter NN, Goldwasser MA, Paszat LF, et al. Association of colonoscopy and death from colorectal cancer: a population-based, case-control study.

Ann Intern Med. 2009;150(1):1-8.

6.

Bressler B. Colonoscopic miss rates for right-sided colon cancer: A population-based analysis. Gastroenterology. 2004;127(2):452-456.

Surinder K. Mann, MD, FACP, FACG, AGAF, is Clinical Associate Professor of Medicine, University of California Davis Medical Center, Associate Chief of Gastroenterology, Veterans Affairs Northern California Healthcare System, Director of Endoscopy, Sacramento VA Medical Center, Mather, CA.

7.

Leung JW, Mann S, Leung FW. Option for screening colonoscopy without sedation – a pilot study in United States veterans. Aliment Pharmacol Therap. 2007;26(4):627-631.

8.

Rex DK, Bond JH, Winawer S, et al. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2002;97:1296-1308.

9.

Leung JW, Mann SK, Rodelei SS, et al. Randomized controlled comparison of warm water infusion in lieu of air insufflation vs. air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer (CRC) screening and surveillance. Gastrointest Endosc.

2009;70:505-510.

Acknowledgements The study is supported in part by the C.W. Law Research Fund (JWL), Research support from the VANCHCS.

Lynne Do, MD. Rodelei Siao-Salera, BSN, CGRN, Department of Medicine, Veterans Affairs Northern California Health Care System (VANCHCS) Felix W. Leung, MD, FACG, is Professor of Medicine, David Geffen School of Medicine at UCLA, and Chief of Gastroenterology, Sepulveda ACC, VA Greater Los Angeles Health System.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

10. Leung JW, Mann SK, Siao-Salera R, et al. A randomized controlled comparison of warm water infusion in lieu of air insufflation (water method) vs. air insufflation (air method) during insertion in patients accepting sedation on-demand for screening and surveillance colonoscopy.

2010 DDW abstract (accepted).

11. Hoda K, Holub J, Eisen G. More large polyps are seen on screening colonoscopy with deep sedation compared with moderate conscious sedation. Gastrointest Endosc. 2009;69(5):AB119-AB120.

12. Leung FW, Aharonian HS, Leung JW, et al. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009;69(3):546-550.

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Minimizing the Burden of Colorectal Cancer Screening – An Approach in Rural Areas Robert J. Newman, MD

Abstract There are many barriers to screening colonoscopy including cost and access to the procedure in rural and underserved areas.

Methods A previously published case series of colonoscopy performed by rural family physicians is reviewed.

Results There were a total of 731 colonoscopies performed by two family physicians in a rural outpatient office from 1996-2001.

The adenoma detection rate was 21.3%, with villous adenomas found in 3.1% of cases and adenocarcinomas in 0.8%. There was a low incidence (0.54%) of minor conscious sedation complications and no major complications. Patient satisfaction with the office-performed colonoscopy was high.

Discussion Numerous studies have now shown that properly trained family physicians can perform colonoscopy safely and effectively, meeting standard quality benchmarks. Colonoscopy credentialing barriers for family physicians persist in some regions.

Training more family physicians to perform colonoscopy will provide much needed access to these procedures, especially in rural and underserved areas.

Background Less than half of the US population is currently being screened for colorectal cancer by any method.1 The barriers to screen-

ing are many but include inadequate access to colonoscopy, especially in rural areas. In one meta-analysis, which included 264 studies, laxative preparation was described as the biggest barrier.2 Anxiety, anticipation of pain, embarrassment, a sense of vulnerability, inadequate knowledge of the importance of screening, and fear of cancer diagnosis were additional barriers. Practical barriers included inconvenience, transportation, scheduling, and cost. On the other hand, incentives to have a colonoscopy include physician endorsement, a family history of colon cancer, knowing someone with colon cancer, and perceived accuracy of the test.

Cost barriers can be substantial. The cost of colonoscopy ranges from $450 to $5000. Office exams usually eliminate the expense of a facility fee. The author obtained grant funding from 2008-2009, which permitted screening of 31 uninsured patients at our institution. Thirty-five percent of those screened were diagnosed to have adenomatous polyps, much higher than the typical average. In one report of a study in China, 87% were willing to get colonoscopy if it was free, but only 53% were willing if they had to pay for the exam.3 We present our experience in outpatient colonoscopy performed by rural family physicians. In the US, five percent of family physicians offer colonoscopy, mostly in rural and underserved areas, according to survey results from the American Academy of Family Physicians (AAFP).4 Two previous large studies have demonstrated the ability of trained family physicians to perform colonoscopy safely and competently.5,6 Since 1984, this has been a core skill taught annually at the AAFP scientific assembly,7 and the mission of colonoscopy in underserved areas has been supported by family medicine.8 My original study was published to verify these findings in an outpatient setting.9

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Since then new data by family medicine10 and the water navigation method have emerged. To support this renewed direction in colorectal screening in the community, the previously published study is reviewed here, and some additional perspective is given.

Methods This was a retrospective case review of 731 colonoscopies. All of the procedures were performed by the rural physician authors. Institutional Review Board approval for the study was granted at East Carolina University. Cold biopsy removal of polyps only was used. Polyps >1 cm or those requiring snare polypectomy were referred to gastroenterology or surgery for removal.

After the examination, patients participated in a satisfaction survey. The physician authors were both trained to do flexible sigmoidoscopy during residency and attended AAFP and University of Maryland-sponsored training courses in colonoscopy. Both were proctored initially by a gastroenterologist colleague in a city 45 miles away from the office where the exams were performed.

Results Conscious sedation was used. The drug dose averages were diazepam 4.6mg, meperidine 43.4mg, and midazolam 2.6mg.

Table 1 shows the indications and the adenoma yield. Table 2 shows the cecal intubation rate over time. The pathology yield Table 1: Adenomatous Polyp Yield by Indication Most Common Indication

Percent of Patients

Adenoma Yield

Previous polyps

22.2%

32.3%

Rectal bleeding

19.8%

16.7%

FH of colon cancer

10.5%

18.5%

Abdominal pain

10.0%

15.5%

Screening

9.3%

17.7%

Guaiac positive stool

6.5%

25.4%

Iron deficiency anemia

4.2%

14.0%

Table 2: Cecal Intubation Rates 1996-1998

89%

229/256

1999-2001

94.6%

442/467

Overall

92.8%

671/723

included a total of 215 adenomatous polyps in 156/731 procedures, with a 21.3% overall incidence of adenomas. Villous adenomas were present in 3.1% (23/731). There were six adenocarcinomas (0.8%). Among male patients greater than 50 years of age, there was a 27.2% incidence of adenomas, and among female patients, the incidence was 21.4%. Fifty-six percent of polyps were in the transverse or ascending colon beyond the reach of the flexible sigmoidoscope. Only 24% of patients with proximal polyps had concurrent left-sided polyps.

The complications were quite low in this series. Four patients (0.54%) had bradycardia and hypotension responding to intravenous saline and atropine. One patient with atrial fibrillation had a good outcome with resolution within 24 hours. One patient with post-polypectomy bleeding required an overnight hospital observation without transfusion. There were no colon perforations. Nineteen patients (2.6%) were referred to a gastroenterologist for removal of polyps > 1 cm. Ten patients (1.4%) were referred to colorectal surgery for removal of large villous adenomas or adenocarcinomas. There was excellent correlation of specialty findings with the original examination.

Patient satisfaction was documented with 90% of patients rating the experience as a 7 to 10 on a 10-point scale. The mean patient satisfaction score was 8.8. Ninety-two percent reported they would have a repeat exam in the family medicine office.

Discussion These results indicate that family physicians that are properly trained perform colonoscopy safely and effectively with high patient satisfaction. The standard benchmarks for cecal intubation >90% and adenoma detection of >20% were achieved.11 A substantial percentage of family physicians can and should be trained to perform colonoscopy to improve access to screening in rural areas. In 2004, only 46% of Family Medicine training programs offered colonoscopy training.12 A recent meta-analysis by Wilkins et al.13 included >18,000 cases from 12 studies of primary care physician (PCP) performed screening colonoscopies. The adenoma detection rate was 29%, and cancer detection rate was 1.7%. The major complication rate was 0.04%, and there were no deaths. The outcomes met parameters for quality and safety outlined by the American Society for Gastrointestinal Endoscopy, the American College of Gastroenterology, and the Society of American Gastrointestinal Endoscopic Surgeons.11 The study concluded that PCP performed screening colonoscopy was safe and effective.

There are significant credentialing barriers for primary care physicians. After performing more than 300 colonoscopies in private practice and moving to an academic practice in North Carolina, the author was advised not to apply for privileges to perform colonoscopy at the local hospital in 2002. Shortly after the application was made, by-laws were passed by the hospital that allowed only surgeons and gastroenterologists to perform colonoscopy, thus barring primary care physicians from doing these procedures. This occurred despite the recommendation

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by the Joint Commission for Accreditation of Hospitals that privileges for procedures should be based on demonstrated competence and not specialty training.

References 1.

Walsh JME, Terdiman JP. Colorectal cancer screening – scientific review.

JAMA. 2003;289(10):1228-1296.

2.

McLachlan S, Clements A, Austoker J. Patients’ experiences and reported barriers to screening colonoscopy: A systematic review. J Clin Oncol.

27:15s, 2009:1537.

3.

Cai SR, Zhang SZ, Zhu HH, et al. Barriers to colorectal cancer screening: A case-control study. World J Gastroenterol. 2009 May;15(20):25312536.

4.

American Academy of Family Physicians Practice Profile I and II survey, May 2002. Leawood, Kan: American Academy of Family Physicians.

2002.

5.

Hopper W, Kyker KA, Rodney WM. Colonoscopy by a family physician: a 9 year experience of 1048 procedures. J Fam Pract. 1996; 43(6):561 – 566.

6.

Pierzchajlo RPJ, Ackerman RJ, Vogel RL. Colonoscopy performed by a family physician. A case series of 751 procedures. J Fam Pract.

1997;44(5):473-480.

7.

Rodney WM. Editor’s Foreward and Disclaimer. p.9 In Flexible Sigmoidoscopy/Colonoscopy 5th Edition [Ed. Rodney WM]. American Academy of Family Physicians. Kansas City, Mo. 2004.

8.

Carr K, Worthington JM, Rodney WM. Advancing from flexible sigmoidoscopy to colonoscopy in rural family practice. J Tenn Med Assoc.

1998 (Jan):32-34.

Fortunately, collaboration has been formed with our general surgery group that will allow training of our interested family medicine residents in the endoscopy center. Extended flexible sigmoidoscopy continues to be performed in our outpatient center by our own faculty. The addition of the water method offers promise to make this more acceptable to patients and to expand access for the uninsured. The author’s goal remains that of training motivated family medicine residents who will provide much needed access to these procedures in rural and underserved areas.

9.

Newman RJ, Nichols D, Cummings D. Colonoscopy by rural family physicians. Ann Fam Med. 2005;(3):122-125.

Robert J. Newman, MD, is Director of Clinical Services, East Carolina University, Family Medicine, Greenville, NC.

13. Wilkins T, LeClair B, Smolkin M, et al. Screening colonoscopies by primary care physicians-a meta-analysis. Ann Family Med. 2009;7:56-62.

The author continued to perform colonoscopy in the outpatient clinic setting between 2002-2004 after being proctored by both a staff gastroenterologist and a general surgeon with endoscopic training. Both proctoring physicians wrote letters of support for credentialing. A total of 89 additional colonoscopies were performed during and after this proctoring, some including snare polypectomy. Adenomas were detected in 25% of cases, and a >95% cecal intubation rate was achieved. There were no complications.

Despite this, the author was asked to stop performing officebased colonoscopy in 2004, secondary to a letter received from one of the local gastroenterologists expressing his outrage over these procedures being done by a family physician. Others have commented on this as a credentialing “arms race.”14 It may have been well intentioned, but failure to achieve meritbased credentialing in the American medical system has been to the detriment of our underserved communities.15 Medical subspecialists do not and will not settle there.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The author has stated that no such relationships exist. ®

10. Knox L, Hahn RG, Lane C. A comparison of unsedated colonoscopy and flexible sigmoidoscopy in the family medicine setting. J Am Board Fam Med. 2007;20:444-450.

11. Rex DK, Bond JH, Winawer S, et al. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on colorectal cancer. Am J Gastroenterol. 2002;97(6):1296-1308.

12. Wilkins T, Jester D, Kemrick J, Dahl J. The current state of colonoscopy training in family medicine residency programs. Fam Med. 2004;36(6):407-411.

14. Rodney WM. Will virtual reality simulators end the credentialing arms race in gastrointestinal endoscopy or the need for family physician faculty with endoscopic skills? JABFP. 1998;11(6):492-495.

15. Rodney WM. Flexible sigmoidoscopy: The unkept promise of cancer prevention. Am Fam Phys. 1999;59:270-273.

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Hypnosis to Manage Anxiety and Pain Associated with Colonoscopy Gary Elkins, PhD

Abstract Hypnosis is a mind-body intervention that has been used to manage pain and anxiety with reduced sedation during medical procedures. In a clinical study six patients received a hypnotic induction and instruction in self-hypnosis on the day of their colonoscopy. Patients’ levels of anxiety, pain, and satisfaction were obtained using Visual Analogue Scales (VAS). Results revealed most of the patients experienced very minimal anxiety and pain during colonoscopy, and satisfaction with hypnosis was very positive. The techniques of self-hypnosis for relaxation can be easily learned by patients and has the potential to decrease the requirement for sedation during colonoscopy.

Narrative The learning objectives of this presentation are to discuss a hypnosis protocol for pain and anxiety during colonoscopy and identify directions for future research. Hypnosis is a mindbody intervention that may be of benefit in reducing patient anxiety and discomfort during colonoscopy. Hypnosis involves a focus of attention, inducing a deeply relaxed state and mental imagery combined with therapeutic suggestions.1-3 Hypnosis for pain and distress has been well-described in the literature.4 For example, a number of articles have dealt with hypnosis in the setting of chronic pain,5-7 in the performance of excisional breast biopsy,8 and invasive radiological procedures.9 In a clinical pilot study of hypnotic relaxation for colonoscopy, six patients scheduled for colonoscopy for colorectal cancer screening were evaluated.10 The patients were referred from family practice, five male and one female. Their ages ranged from 53-68 years; mean age was 58 years (SD = 6.2 years).

There were five Caucasians and one African-American. Anxiety was assessed by the Visual Analog Scale (from not anxious at all to as anxious as I could be) pre- and post-hypnosis and during procedure. Pain was assessed by the Visual Analog Scale (from no pain at all to as much pain as I could have) during colonoscopy. Satisfaction was assessed by the Visual Analog Scale (completely unsatisfied to completely satisfied).

Hypnotic ability was assessed by the Stanford Hypnotic Susceptibility Scale – Form C.11 The standard care comparison group included 10 patients. Measures recorded included colonoscopy procedure time, recovery time, and vasovagal events.

Patients receiving the hypnosis intervention arrived approximately one hour before their appointment for colonoscopy and completed demographic questionnaires and the baseline measures of anxiety. The patients then participated in a standardized hypnotic induction provided by a psychologist trained in hypnosis.12 The hypnotic induction followed a transcript that lasted approximately 20 minutes. It included suggestions for relaxation, suggestions to deepen the relaxed state, suggestions to imagine (dissociate to) a “special place,” instructions for how to use self-hypnosis, and for feelings of control. In addition, suggestions for control of pain and anxiety (e.g., you will feel very little pain; most of the pain will be under control most of the time; and very little anxiety; you will feel calm and relaxed; you will notice a peaceful feeling and perhaps a numbness) were provided. Patients receiving hypnosis were then provided with an audio-cassette tape player, a tape recording of a hypnotic induction for relaxation, and instructions in the use of the tape recording for hypnosis during their colonoscopy.

Results indicated a reduction in anxiety post-hypnosis and during colonoscopy. Figure 1 shows the pre- and post-hypnosis Visual Analog Scale Anxiety Ratings for all the patients. Aver-

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Figure 1: Anxiety pre- and post-hypnosis and during colonosocopy

Figure 2: Length of Colonscopy Procedure Time

Procedure Time (minutes)

30

20

during colonoscopy was 2.47 (SD = 3.05). Stanford Hypnotizability Scale – Form C score average was 7.17 (SD = 3.49).

Figure 2 shows there is no significant difference in the length of colonoscopy procedure time in the group receiving hypnosis and the group receiving standard care. Figure 3 shows that the recovery time following colonoscopy was shorter for the hypnosis intervention group. Figure 4 shows that the number of vasovagal events was fewer for the hypnosis intervention group. All of these patients began colonoscopy without sedation and completed the examination without sedation, although they all knew that they could have access to sedation medications should they need them.

Results provide persuasive evidence for the potential of hypnosis management of anxiety and pain during colonoscopy. For example, one of the participants in this study was a 63-year-old Caucasian male that was referred for colonoscopy for colorectal cancer screening. The patient was diabetic and was allowed fluids during preparation. Procedure time was ten minutes as no mucosal abnormalities were detected other than scattered left-sided diverticulae. The patient rated his anxiety as 7.9 before hypnosis and 0.9 after the hypnotic induction. Anxiety rating during colonoscopy was 0.9. Pain rating during colonoscopy was 0.7. The patient rated effectiveness of self-hypnosis in controlling anxiety and pain during colonoscopy as 9.2 and 9.2 respectively. Satisfaction with medical care was rated as 9.3 on a 0-10 scale.

The directions for future clinical research include setting up the standard transcript and its integration into clinical care. A multi-site study is desirable for determination of the requirements of training of medical teams, ratings of patient satisfaction, and cost-benefit analysis.

10

0 N=

6

Hypnosis Intervention

9

Acknowledgements

Standard Care

Figure 3: Recovery Time Following Colonoscopy 80

Procedure Time (minutes)

128

Supported in part by NCCAM grant 5U01AT004634 and NCI grant R21CA131795 to Dr. Elkins.

Gary Elkins, PhD, ABPP, is Professor and Director, Mind-Body Medicine Research Laboratory, Department of Psychology and Neuroscience, at Baylor University.

60

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The author has stated that no such relationships exist. ®

40

20

References 0 N=

5

Hypnosis Intervention

9

Standard Care

age pre-hypnosis anxiety was 3.8 (SD = 2.62), average posthypnosis anxiety was 0.50 (SD = 0.37), and average anxiety during colonoscopy was 2.50 (SD = 2.81). Corresponding to this, the average pre-hypnosis pain was 1.38 (SD = 2.53), average post-hypnosis pain was 0.18 (SD = 0.25), and average pain

1.

Elkins GR, Handel DH. Clinical Hypnosis. An Essential in the “Tool Kit” for Family Practice. Fam Practice Clin North America. 2001;3(1):113-126.

2.

Cadranel JF, Benhamou Y, Zylberberg P, et al. Hypnotic relaxation: A new sedative tool for colonoscopy? J Clin Gastroenterol. 1994;18:127-129.

3.

Woody EZ, Bowers KS,and Oakman JM. A conceptual analysis of hypnotic responsiveness: Experience individual differences and context.

In Contemporary Hypnosis Research. Fromm E and Nash MR,Eds. New York: Guilford Press; 1992.

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

4.

Hilgard ER, Hilgard JR. Hypnosis in the relief of pain. 2nd ed. Los Altos, CA: William Kaufmann; 1983.

5.

Elkins GR, Jensen M, Patterson D. Hypnotherapy for the management of chronic pain. Internat JClin Exp Hypnosis. 2007;55(3):275-287.

6.

Patterson DR, Jensen MP. Hypnosis and clinical pain. Psychological Bull.

2003;129:495-521.

7.

Elkins GR, Cheung A, Marcus J, et al.

Hypnosis to reduce pain in cancer survivors with advanced disease: A prospective study. J Cancer Integrative Med. 2004;2(4):167-172.

8.

Montgomery GH, Weltz CR, Seltz M, et al. Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. Internat J Clin Exp Hypnosis. 2002:50:17-32.

9.

Lang EV, Benotsch EG, Fick LJ, et al. Adjunctive non-pharmacological analgesia for invasive medical procedures: A randomised trial. Lancet.

2000,355, 1486-1490.

10. Elkins G, White J, Patel P, et al. Hypnosis to manage anxiety and pain associated with colonoscopy for colorectal cancer screening: Case studies and possible benefits. Internat J Clin Exp Hypnosis. 2006;54(4):416-31.

11. Hilgard ER. Hypnotic susceptibility. New York: Harcourt, Brace & World; 1965.

12. Elkins GR, Hammond DC. Standards of Training in Clinical Hypnosis: Preparing Professionals for the 21st Century. Am J Clin Hypnosis.

1998;41(1):55-64.

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Diplomates may purchase a color-copy, reduced size (5x7) ABPS certificate inserted into the crystal frame and a full-size, unframed ABPS certificate for $125.00. Additional crystal frames with inserted certificates may be purchased for $50.00 each. Please note that framing for full-size ABPS certificates can be ordered through Framing Success at www.framingsuccess.com Order Form Please allow four weeks for delivery since these are individually special order Yes, I would like to order ______ Crystal frame with inserted reduced-size certificate, includes one full-size, unframed certificate ($125.00) ______ Additional crystal frames with inserted reduced-size certificate ($50.00 each) ______ Full-size, unframed certificate(s) ($85.00) Shipping Address: Name:_____________________________________ Address:___________________________________________________ City:____________________________________ State:__________ Zip:______________ Country:_ ___________________ Method of Payment: (Make checks payable to ABPS)

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Scheduled, Unsedated Colonoscopy Provides Access to Colonoscopy in a VA Setting With Unexpected, Unplanned Discoveries Felix W. Leung, MD, FACG

Abstract When a nursing shortage necessitated discontinuation of our conscious sedation program for colonoscopy, scheduled, unsedated colonoscopy was offered to restore local access to colonoscopy. The option was accepted by one-third of the patients after the pros and cons of unsedated and sedated colonoscopy were explained. Interest in communication with the colonoscopist and lack of an escort were the most frequently cited reason for acceptance of the unsedated option. Initial cecal intubation rate was <80%, limited by discomfort. A search of the literature for methods to minimize discomfort led to the discovery of several water-related techniques. Based on these techniques, a water infusion in lieu of air insufflation (water method) for aiding colonoscope insertion was developed. In a consecutive group non-randomized observational study, the water method significant improved cecal intubation rate to 97%.

Narrative This essay chronicles the evolution of a scheduled, unsedated colonoscopy program at one VA ambulatory care facility. At each step, the issues that challenged the clinician investigator, the approaches adopted to deal with these issues, the results, and the lessons learned are described. The emphasis is on providing feasibility data to support the use of scheduled, unsedated colonoscopy to provide access to colonoscopy without the need for registered nurse support and with minimal discomfort.1-2 In 2002 a nursing shortage at the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS) led to discontinuation

of sedated colonoscopy practice at the VA Sepulveda Ambulatory Care Center. At patients’ requests to have an alternative to being sent to another facility, the literature was reviewed. The result of the review established the feasibility of the option of scheduled, unsedated colonoscopy. With institutional approval, we offered scheduled, unsedated colonoscopy as an option to restore local access to colonoscopy1 with emphasis on patientcentered care.2 During a pre-colonoscopy clinic visit, the pros and cons (based initially on literature review) of the scheduled, unsedated option were reviewed with each patient.

The features of no escort requirement and the possibility of communication with the colonoscopist during the examination were the two most common reasons (Table 1)3 motivating veterans to choose the scheduled, unsedated option. From 2002 Table 1: The stated reasons why this group of patients (N=123) chose to undergo unsedated colonoscopy -- answers given immediately prior to examination.

Reasons* for choosing unsedated

n (% total)

Able to communicate

107 (87%)

No escort

98 (80%)

Familiarity with doctors

84 (68%)

Short distance to facility

84 (68%)

Able to return to work on the same day

41 (33%)

* Patients can check more than one reason.

Scheduled, Unsedated Colonoscopy Provides Access to . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

to 2009, consistently ~1/3 (n = 50 to 60 per year) of the veterans embraced the option. Eight patients examined in 2002 to 2003 and eligible for three-year surveillance completed repeat unsedated surveillance examination in 2006 - 2007.3 The patient-centered nature of the option has been quite convincingly dramatized by the veterans who pointed out that the scheduled, unsedated option (without escort requirement) enabled them to participate in screening.4 In order to minimize coercion, an agreement was made with each patient that the unsedated examination should stop if there was excessive discomfort. During unsedated colonoscopy the colonoscopist implemented maneuvers (minimal air insufflation, removal of looping) to diminish discomfort. The next challenge for the clinician investigator was the recognition that discomfort was indeed the major factor limiting the success of cecal intubation in over 20% of the patients. The cecal intubation rate of almost 80%,1,3 though comparable to the success rate reported overseas,5 was far below the 90 to 95% recommended for quality performance.6 To overcome this problem, another review of the literature was undertaken to identify ways to decrease colonoscopy discomfort. The literature survey led to the discovery of several water-related techniques, which we summarized in one review.8 These techniques, as adjuncts to air insufflation, facilitated passage through difficult segments with severe diverticulosis or spasm, minimized discomfort without reducing the dose of sedation medication, and decreased discomfort in unsedated patients. Since air insufflation can elongate the colon, accentuate angulations at the flexures, and increase the difficulty of cecal intubation in the unsedated patients, we decided to omit air insufflation altogether during insertion of the colonoscope.

Based on information in the literature and subsequent “trial and error” attempts to modify or “perfect” the techniques to minimize colonoscopy discomfort, the water method (water infusion in lieu of air insufflation method)8-11 was developed. Details of this method are described in other articles in this issue of the Journal.11,12 The data in an observational study10 comparing the air and water method in scheduled, unsedated patients are described below. In a consecutive group observational study, 62 patients were examined with the air method; a subsequent group was examined with the water method. The water method significantly improved cecal intubation rate from 76% to 97% and the proportion of patients who reported willingness to repeat from 69% to 90%. Failure due to poor bowel prep was 13% in the air group but only 1.5% in the water group. Similarly, failure due to abdominal discomfort was 13% in the air group but only 1.6% in the water group. A numerically higher adenoma detection rate in the water group – 37% vs. 26% –was also observed.10 The finding of a numerically higher adenoma detection rate prompted us to perform a review of an endoscopic database to evaluate the impact of the water method on polyp detection.11 Indeed, the water method appeared to have increased the proportion of patients with at least one polyp of any size.

Discussion The importance of the data or the importance of the concept of unsedated colonoscopy in the US is as follows: In the US, unsedated colonoscopy has been offered to 1-2% of patients who present for colonoscopy without escorts after purging themselves.13,14 Unsedated colonoscopy has also been requested by 7% of patients who are educated professionals with independent knowledge of the option.15 When we actively discussed the option with the patients about one third accepted the option, a rate that is much higher than any previous reports in the US. The data suggest there are patients who will accept the unsedated option if it is actively discussed and offered. We speculate that when endoscopists make the assumption that most patients in the US want sedation and, therefore, omit the mention of the unsedated option, the result is a low rate of unsedated colonoscopy in this country. An alternative explanation is that most colonoscopists in the US have not received formal training in performing unsedated colonoscopy and do not offer what they have not been trained to do. A recent survey16 (28% response rate) in Germany, a country where unsedated colonoscopy has been common, reported an increasing proportion of colonoscopies there were performed with sedation, including use of propofol. To proponents of sedation this indicates that when individuals are given the option of sedation vs. no sedation, they choose sedation; and since sedation has become an option in Germany, the proportion of individuals willing to undergo screening colonoscopy has increased. An alternative interpretation is that, even in places where unsedated colonoscopy is acceptable, there is a real need to develop methods to minimize the discomfort of the unsedated procedure. Unsedated colonoscopy is not a concept. It is real practice and can be uncomfortable. The importance of our work has been in developing a less uncomfortable way to perform unsedated colonoscopy by using water infusion in lieu of air insufflation.

More studies in this area are warranted, because the data we reported have significant limitations. The studies reporting beneficial effects of the water method have been small and limited to evaluations of elderly, male veterans. Whether the results are applicable to non-veterans or other practice settings is not known. Studies in community practice, university medical practice, and health maintenance organizations will be important to determine whether the unsedated colonoscopy performed with the aid of the water method has a place in these settings. Other settings, such as rural or inner city communities where screening colonoscopy is not available in part due to lack of resources to support sedation, are appropriate for evaluating the unsedated option performed with the aid of the water method. If practitioners in these settings can learn to apply the techniques described in the articles in this issue of the Journal, then screening colonoscopy can potentially be available where there has been obvious disparity in colonoscopy service.

A number of potential patient-centered benefits deserves mention. With scheduled, unsedated colonoscopy aided by the water method achieving a successful cecal intubation rate of over 95%, patients participating in screening can be assured a qual-

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ity cecal intubation rate. There is no need to bring an escort.

As soon as the examination is completed, they can almost immediately resume usual activities. There is no need to spend time on site or at home to recover from the effects of sedation medications. The very small risk of sedation medication-related complications can be obviated.

The answer to the question whether unsedated colonoscopy performed with the water method would improve access to an important cancer-screening tool is unknown but deserves to be sought in formal studies. The limited experience that we have derived from the veterans who do not possess escort resources suggested that the answer to this question is “yes.” Veterans have informed us that had it not been for the unsedated option (without escort requirement), they would not have participated in screening.

The documentation we have provided is focused on demonstrating the restoration of access to colonoscopy service by using the option of unsedated colonoscopy when nursing shortage curtailed the continued provision of the original sedation-based colonoscopy program. There was no intention to demonstrate any savings or a less costly approach. If readers would recognize that the unsedated option, by obviating the need for registered nurses (required if conscious sedation is administered) and the patients can avoid recovery time cost, escort cost, side effects, and complications of medications, then they can pass value judgment as to whether the approach is less costly or not than the one relying on sedation.

Physicians in primary care and family medicine in the US have long embraced the practice of unsedated extended flexible sigmoidoscopy.17,18 Gastroenterologists have reported a higher cecal intubation rate with extended flexible sigmoidoscopy.19 It is conceivable that with proper training of the water method, even endoscopists in primary care and family medicine practice can achieve a higher cecal intubation rate with less discomfort experienced by the patients. This is a priority for those interested in clinical research in this area. Practically, an extended flexible sigmoidoscopy is the same as an unsedated colonoscopy. The former has a better appeal because any portion of the colon examined proximal to the splenic flexure, even without achieving cecal intubation, provides added yield. In the latter, not reaching the cecum is a failed unsedated colonoscopy.

Finally, a RCT published in the Lancet recently20 shows that flexible sigmoidoscopy is a safe and practical test and, when offered only once between ages 55 and 64 years, confers a substantial and long- lasting benefit. The control group had 113,195 people assigned to it, and 57,237 were assigned to the intervention group, of whom 112,939 and 57,099, respectively, were included in the final analyses. Seventy-one percent, or 40,674 people, underwent flexible sigmoidoscopy. During screening and median follow-up of 11·2 years (IQR 10·7-11·9), 2524 participants were diagnosed with colorectal cancer (1818 in control group vs 706 in intervention group) and 20,543 died (13,768 vs 6775; 727 certified from colorectal cancer [538 vs 189]). In intention-to-treat analyses, colorectal cancer inci-

dence in the intervention group was reduced by 23% (hazard ratio 0·77, 95% CI 0·70-0·84) and mortality by 31% (0·69, 0·59—0·82). In per-protocol analyses, adjusting for self-selection bias in the intervention group, incidence of colorectal cancer in people attending screening was reduced by 33% (0·67, 0·60-0·76) and mortality by 43% (0·57, 0·45-0·72). Incidence of distal colorectal cancer (rectum and sigmoid colon) was reduced by 50% (0·50, 0·42-0·59; secondary outcome). The numbers needed to be screened to prevent one colorectal cancer diagnosis or death by the end of the study period were 191 (95% CI 145-277) and 489 (343-852), respectively.

Conclusion To meet the challenge of finding a less burdensome approach for patients in colorectal cancer screening, scheduled, unsedated colonoscopy (or extended flexible sigmoidoscopy) is an option.

The option avoids all sedation-related complications, which are relevant in preventive screening for healthy asymptomatic individuals. The water method enhances success of cecal intubation and willingness to repeat. Whether the approach can enhance utilization of screening in patients with limited resources (e.g., no escort) in settings other than a VA ambulatory care facility experiencing a nursing shortage remains to be confirmed.

Acknowledgements Grant support: Supported in part by ACG Research Award (FWL 2009), VA Clinical Merit Medical Research Funds and the ASGE Career Development Award (FWL 1985).

Felix W. Leung, MD, FACG, is Professor of Medicine, David Geffen School of Medicine at UCLA, and Chief of Gastroenterology, Sepulveda ACC, VA Greater Los Angeles Health System.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

References 1.

Leung FW. Unsedated colonoscopy introduced as a routine option to ensure access is acceptable to a subgroup of US veterans. Dig Dis Sci. 2008;53(10):2719-2722.

2.

Leung FW. Promoting informed choice of unsedated colonoscopy patient-centered care for a subgroup of U.S. veterans. Dig Dis Sci. 2008;53(11):2955-2959.

3.

Leung FW, Aharonian HS, Guth PH, et al. Involvement of trainees in routine unsedated colonoscopy - review of pilot experience. Gastrointest Endosc. 2008;67(4):718-722.

4.

Leung FW. Thinking outside the box – the case of unsedated screening colonoscopy in the U.S. Gastrointest Endosc. 2009;69(7):1354-1356.

5.

Thiis-Evensen E, Hoff GS, Sauar J, et al. Patient tolerance of colonoscopy without sedation during screening examination for colorectal polyps.

Gastrointest Endosc. 2000;52(2):606-610.

6.

Rex DK, Bond JH, Winawer S, et al. Quality in the technical performance of colonoscopy and the continuous quality improvement process for

Scheduled, Unsedated Colonoscopy Provides Access to . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2002;97:1296-1308.

TK. Procedural success and complications of large-scale screening colonoscopy. Gastrointest Endosc. 2002;55(3):307-314.

7.

Leung FW. Methods of reducing discomfort during colonoscopy. Dig Dis Sci. 2008;53(6):1462-1467.

8.

Leung FW. Water-related method for performance of colonoscopy. Dig Dis Sci. 2008;53 (11):2847-2850.

15. Subramanian S, Liangpunsakul S, Rex D. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol.

2005;39(6):516-519.

9.

Leung JW, Mann S, Leung FW. Option for screening colonoscopy without sedation – a pilot study in United States veterans. Alimen Pharmacol Ther.

2007;26(4):627-631.

10. Leung FW, Aharonian HS, Leung JW, et al. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009;69(3):546-550.

11. Leung JW, Do L, Siao-Salera R, et al. More polyps are seen on screening colonoscopy with water infusion in lieu of air insufflation (water method) compared with usual air insufflation. Am J Clin Med. In press.

12. Mann SK, Leung JW, Leung FW. Water infusion unsedated colonoscopy procedure – comments during a live demonstration. Am J Clin Med. In press.

13. Aslinia F, Uradomo L, Steele A, Greenwald BD, Raufman JP. Quality assessment of colonoscopic cecal intubation: an analysis of 6 years of continuous practice at a University Hospital. Am J Gastroenterol.

2006;101:721-731.

14. Nelson DB, McQuaid KR, Bond JH, Lieberman DA, Weiss DG, Johnston

16. Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey.

Z Gastroenterol. 2010;48(3):392-7.

17. Carr KW, Worthington JM, Rodney WM, et al. Advancing from flexible sigmoidoscopy to colonoscopy in rural family practice. Tenn Med. 1998;91(1):21-6.

18. Knox L, Hahn RG, Lane C. A comparison of unsedated colonoscopy and flexible sigmoidoscopy in the family medicine setting: An LA Net Study.

J Am Board Fam Med. 2007;20(5):444-450.

19. Lee JG, Lum D, Urayama S, et al. Unsedated extended flexible sigmoidoscopy for colorectal cancer screening: a pilot study. Alimen Pharmacol Ther. 2006;23:945-951.

20. Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW MSc b, Cuzick J, UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. The Lancet. Early Online Publication, 28 April 2010. doi:10.1016/S0140-6736(10)60551-X.

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Scheduled, Unsedated Colonoscopy Provides Access to . . .

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On Demand Sedation in Community Practice John L. Petrini, MD, FASGE

Abstract Sedation-free colonoscopy in the US is feasibility. We conducted a prospective IRB-approved trial in patients willing to begin without sedation. Two thousand ninety-one consecutive patients were eligible. Our data reveal that sedation on demand colonoscopy was successful in 99.2% of all patients; 99.3%, 99.4% and 99.1% of those medicated at start of colonoscopy; unsedated throughout; and medicated during colonoscopy, respectively. There was a reduction in complications, 0.43% vs.

6.67%, unsedated versus sedated. Ninety-seven point five percent of unsedated patients were willing to repeat without sedation. The adenoma detection rate was 32% in men and 22% in women. Thus, unsedated colonoscopy is possible in a large percentage of patients, particularly if the patient had previous colostomy or left hemicolectomy. Patients who present for their procedure without a driver and patients in whom the completeness of the bowel preparation was uncertain are good candidates to start unsedated as are patients who have had previous unsedated examination.

Narrative The purpose of this presentation is to review experience of one community practice in providing colonoscopy with seda-

tion on demand. We will recognize the factor related to successful or difficult unsedated colonoscopy and review tips for performing successful unsedated colonoscopy. Sedation-free colonoscopy in the US (Table 1) is feasible but has no universal acceptance.1-4 The benefits for the patients include reduced complications, less need for companion, ability to resume activities immediately, less loss of productivity, and greater participation in the procedure.

At the Sansum Clinic we have offered unsedated colonoscopy for years with 20-25% of the patients able to tolerate a full, unmedicated procedure. Pressure from propofol proponents prompted us to perform a prospective trial. All gastroenterologists participated in the study (including those not previously using unsedated colonoscopy). This was a non-randomized trial of unsedated colonoscopy in an outpatient ambulatory surgery center. The results of this study have previously been reported.5 We conducted a prospective IRB-approved trial in patients willing to begin without sedation from June 7, 2006, to Dec. 7, 2006.

2091 consecutive patients were eligible; one refused and was excluded. Inpatients, those <18 years of age or those who had combined procedures, were also excluded. Four gastroenterologists with between 14 and 36 years experience participated. No attempt was made to coerce patients into unsedated examination. Post-procedure assessment of pain and satisfaction was performed by nurses not involved in the procedure.

Table 1: Previous studies on unsedated colonoscopy in US References

No. of patients

Randomized

Cecal intubation

1

173

No

95%

2

70

Yes

94%

91%

3

258

No

97%

84%

4

63 water, 62 air

No

97%, 76%

90%, 69%

On Demand Sedation in Community Practice

Willingness to repeat

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Table 2: Patient characteristics

No. of patients

First exam

Prior abdominal surgery

Weight (lbs) (Mean±SD)

>High School

Sedated at start of procedure Men

599

300 (50.1)

272 (45.4)

192.3±33.6

429 (71.6)

Women

913

521 (57.1)

658 (72.1)

155.0±36.2

533 (58.4)

Unsedated throughout procedure Men

353

203 (57.5)

142 (40.2)*

193.4±35.5

244 (69.1)

Women

117

68 (58.1)

62 (53.0)

162.1±40.9***

84 (71.8)**

Sedated during procedure Men

50

28 (56.0)

26 (52.0)

183.3±34.3

35 (70.0)

Women

58

34 (58.6)

39 (67.2)

148.7±27.1

34 (58.6)

Percentages in parenthesis, SD=standard deviation. *p<0.001 vs. sedated at start of procedure; **p<0.002 vs. sedated at start of procedure and sedated during; ***p<0.05 vs. sedated at start of procedure and p<0.01 vs. sedated during

Medications were offered at any time during the procedure for patients who experienced discomfort, with further medication on demand. The average dose of meperidine was 48 mg; and the average dose of midazolam was 0.97 mg. To minimize discomfort, attempts were made to straighten the colon continuously and reduced air insufflation was adhered to during insertion. Variables assessed included age, sex, weight, previous abdominal surgery, level of education, and previous colonoscopy experience. Variables measured included time to cecum, quality of preparation, total time of procedure, biopsies and polyps removed, depth of insertion at end of procedure, length of instrument used, instrument type, ease of procedure, and complications. End of procedure variables measured included postprocedure assessment of level of pain (maximum pain level at any point during procedure), satisfaction with level of sedation, and willingness to have procedure performed with less, more, or the same amount of medication in the future. Ninety-seven percent of cases were examined using the pediatric instrument [PCF-140L (55%), PCF-160AL, PCF-Q180AL]. Cecal or terminal ileal intubation was verified by the nurse in the examination room. Time to cecum and total time were recorded by the nurse. Withdrawal time was not independently measured.

Table 2 shows the patient outcome. Figure 1 shows the percentages of men at each pain score. Figure 2 shows the percentage of women at each pain score. Our data reveal that sedation on demand colonoscopy was successful in 99.2% of all patients; 99.3% of those medicated at start of colonoscopy; 99.4% of those who were unsedated throughout; and 99.1% of those medicated during colonoscopy. There was a marked reduction in complications (0.43% vs. 6.67%). There were 97.5% of unsedated patients willing to repeat without sedation. The adenoma detection rate was 32% in men and 22% in women.

Men who started unsedated were more likely to complete the exam unsedated, 88% vs. 67%. Women who completed without medication had higher body weight and education level.

who present for their procedure without a driver and patients in whom the completeness of the prep was uncertain are good candidates to start unsedated, as are patients who have had previous unsedated examination. Whether the water infusion method makes unsedated colonoscopy easier is uncertain. In the unsedated patients, complete exam depends on the level of anxiety/expectation, previous surgery/anatomy, education level, Figure 1: Men (percentages at each pain score)

Figure 2: Women (percentages at each pain score)

Our experience indicates that unsedated colonoscopy is possible in a large percentage of patients, particularly if the patient had previous colostomy or left hemicolectomy. Patients On Demand Sedation in Community Practice

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BMI, skill of colonoscopist, use of adjuvant materials (e.g., water infusion, caps), type of colonoscope, and desire of patient to have unsedated examination. Several useful tips include the use of minimal air through the sigmoid colon, if any, and use of water through sigmoid colon, reposition patient early on the back at first turn of the sigmoid colon and use of the right lateral decubitus position to negotiate the splenic flexure. Several pressure points include the left lower quadrant when the colonoscope is making the transition from the sigmoid to descending colon, mid-transverse pressure to assist with passage through the splenic flexure, and the hepatic flexure when the colonoscope passes from the hepatic flexure into ascending colon.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist.

For future consideration, it is necessary to recognize that most US trainees have not been given adequate training in the proper techniques of colonoscopy. Many centers use propofol routinely to eliminate patient discomfort and reduce total time patient spent in ambulatory surgical centers. The pressure to increase through-put and less emphasis on technique needs to be addressed.

®

References 1.

Herman FN. Avoidance of sedation during total colonoscopy. Dis Col Rect. 1990;33(1):70-72.

2.

Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999;49(5):554-559.

3.

Cataldo PA. Colonoscopy without sedation: a viable alternative. Dis Col Rect. 1996;39:257-261.

4.

Leung FW, Aharonian HS, Leung JW, et al. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009;69:546-550.

5.

Petrini J, Egan J, Hahn W. Unsedated colonoscopy: patient characteristics and satisfaction in a community-based endoscopy unit. Gastrointest Endosc. 2009;69:567-572.

John L. Petrini, MD, FASGE, is Clinical Associate Professor of Medicine, University of Southern California, and Chairman of the Department of Gastroenterology, Sansum Clinic, Santa Barbara, CA.

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On Demand Sedation in Community Practice

American Journal of Clinical MedicineÂŽ â&#x20AC;˘ Special Issue 2010 â&#x20AC;˘ Volume Seven, Number Three

Adopting the Water Method: Lessons, Tips, and Pitfalls Learned Francisco C. Ramirez, MD Felix W. Leung, MD, FACG

Abstract After studying the literature, an experienced traditional colonoscopist achieved proficiency using the water method and documented his progress with two groups: the first 20 patients and a subsequent group of the next 25 patients. Cecal intubation rates and procedure-related outcomes were compared with a retrospective, control group consisting of 100 consecutive patients who had undergone traditional colonoscopy. Cecal intubation for the first 20 patients averaged almost 10 minutes.

The average time for the next 25 patients was 7.8 minutes. The air insufflation group required an average of 5.8 minutes for cecal intubation. In the second, fewer patients required change in their position (8% vs. 30%) and external pressure (12% vs.

30%) as an aid to insertion. In sedated patients examined by an experienced traditional colonoscopist, the water method can be learned quickly.

Introduction Water-related colonoscopy techniques have been described1-10 and reviewed.2 Water infusion causes local distension and facilitates passage through segments with significant diverticulosis.5 With the patient in the left lateral position, the water infused into the sigmoid colon opens a passage6 and the water weighs down the left colon straightening the sigmoid segment.6,7,9 The use of warm water minimizes spasm.8 Suction of residual air in the colonic lumen minimizes angulations at the flexures, which facilitates advancement.3,9 The absence of air insufflation avoids colon elongation, which increases difficulty in reaching the cecum. The water method has been found to allow 52% of patients who were willing to start the colonoscopy

without pre-medications to complete the exam without any sedation.1 In addition, this method increases adenoma detection rate (ADR). Since the learning curve for competency for water infusion is not described, we relay our experience with the water method using cecal intubation rates as a surrogate for successful colonoscopy.

Methods In June of 2009, an experienced endoscopist at a VA Medical Center in Phoenix performed consecutive water infusion colonoscopies procedures using only the published literature as training.7-9 Data recorded included: patient demographics, procedure indication, cecal intubation, and total procedure time. Drug usage, dosage, as well as body position change and external pressure to facilitate visualization of the cecum were also recorded. Patients were placed in the left lateral decubitus position with the air feature on the light generator turned off immediately after inserting the scope into the rectum. Water at room temperature was infused through the colonoscope using a pedal pump to distend and find the lumen. Contaminated water was also exchanged for clean water to facilitate scope advancement and visualization.3,4 When the presumed cecum was reached, the air feature was used to confirm the location.

If the cecum had not been reached, colonoscopy was deemed unsuccessful and was continued aiming to reach the cecum.

Cecal intubation was confirmed upon identifying the appendix opening and ileocecal valve. Air was used for the withdrawal portion in all patients. All colonoscopies were performed using video-colonoscopes (160/180 series, Olympus Corporation).

The measured outcomes were cecal intubation rates, cecal intubation and withdrawal time, and the need for external pressure

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Table 1: The learning curve of the water method in screening colonoscopy patients Air (Retrospective)

Water (Prospective)

100 Reference Cases

Case 1-20

Case 21-45

Age (years)

61.3±0.9

60.5±1.0

59.3±1.0

Cecal intubaton rate (ITT)*

98%

70%

92%

Final cecal intubation rate

98%

100%

100%

Cecal intubation time

5.8±0.4

9.7±1.2a

7.8±0.6a

Total time

18.9±0.7

21.8±1.2

20.4±1.4

Fentanyl dose (μg)

76.5±2.8

77.6±3.3

76.0±3.2

Midazolam dose (mg)

3.1±0.1

3.1±0.1

3.0±0.1

Abdominal compression

Not recorded

6 (30%)

3 (12%)

Position change

25/97 (25.8%)

6 (30%)

2 (8%)

*ITT: intent-to-treat; Data are mean SEM; a versus air, p<0.05 (t-test).

and patient position change. Patient tolerance was defined as excellent, good, fair, fair adequate, fair compromised, and poor, based on the endoscopist’s judgment and drove the decision to give additional sedation (fentanyl and/or midazolam). All detected polyps were removed and sent for histopathologic examination. Adenoma detection rate (ADR) was defined as the percent of patients with at least one adenoma on histology. A historical cohort of 100 consecutive, traditional colonoscopies using the same equipment and immediately prior to the adoption of the water method was used for comparison purposes.

With the traditional method, air was used during scope insertion and water at room temperature used via a pedal pump for washing purposes only.

Results This report is based on the analysis of 45 patients who were presented at the ACG Meeting in October 2009. The mean age of this group was 59 years; their indications included screening in 29 patients (64%), surveillance in 10 (22%), four (9%) with occult/overt bleeding, and two (4%) patients with symptoms.

The traditional group of 100 had a mean age of 61 years with indications as follows: screening in 51%, surveillance in 27%, and presumed occult bleeding in 22% of patients.

We arbitrarily divided the 45 study patients into the “first” 20 and “second” 25 cases for comparison. The ultimate cecal inTable 2: Adenoma detection rates Air (Retrospective)

Water (Prospective)

100 Reference Cases

Case 1-20

Case 21-45

Patients with Adenomas

46 (46%)

9 (45%)

9 (36%)

Total # Adenomas

90

17

15

# Adenomas per patient

0.90

0.85

0.6

Data are frequency (% total).

tubation rate was 100%. The cecal intubation rate increased from 70% (14/20) to 92% (23/25) for the first 20 and second 25 cases, respectively. For the first 20 cases, average cecal intubation time was roughly eight minutes and the second group had an average cecal intubation time of eight minutes. The withdrawal times were similar. The total study group patients had an average cecal intubation time of roughly eight minutes thirty seconds, while the historic group had an average cecal intubation time of roughly six minutes. Eight percent of patients in the second group required position changes compared to 30% in the first group. Moreover, 12% of patients in the second group required external pressure compared to 30% in the first group. Of the total group 17.8% required position change versus 25.8% of the traditional group.

The adenoma detection rate in the first 20 cases (45%) was similar to the second 25 cases (36%), and as a group the ADR was also similar (40%) to the historic control (46%).

Failure to reach the cecum using the water method occurred in eight cases and was attributed to misidentification (four cases), prolonged procedure time secondary to technical difficulty (three cases lasting more than 12 minutes), and inadequate bowel preparation.

Discussion In the hands of an experienced colonoscopist, the water infusion method can be rapidly incorporated and learned. Cecal intubation time is expected to be longer than the endoscopist’s average for conventional colonoscopy but improves over time. Whether or not the cecal intubation time ultimately approaches the time seen during conventional colonoscopy needs to be tested with a larger sample size. Furthermore, assistant involvement may be obviated since fewer patients required position changes and external pressure. The polyp detection rates were similar throughout the study and were similar to historical controls.

Misidentification of the cecum was common at the beginning of the study. Suctioning the suspected cecal wall often left a

Adopting the Water Method: Lessons, Tips, and Pitfalls Learned

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Table 3: Reasons for “failed” ITT cecal intubation during the water method Case

Reason for “failure”

Location where air switched on

Time at which air switched on

#6

Prep

Recto-sigmoid

Not recorded

#7

Prolonged/tortuosity

Not recorded

10 min

# 11

Misidentification cecum

Hepatic flexure

12 min

# 15

Prolonged

Hepatic flexure

12 min

# 19

Misidentification cecum

Hepatic flexure

8 min

# 20

Misidentification cecum

Transverse colon

11 min

# 38

Misidentification cecum

Hepatic flexure

6 min

# 44

Unable to get into ascending colon

Hepatic flexure

18 min

ITT: intent-to-treat

“suction mark” (Figure 1), which in turn could be used as a landmark. The time spent to reach the cecum as well as the distance traveled was a reliable indicator of arrival at the cecum.

For example, if an expected cecal time had elapsed, especially at a distance of about 60 cm or less, it was unlikely the cecum had been reached. Initially, an estimated additional two minutes will be required for cecal intubation when compared to traditional colonoscopy.

Figure 1: Endoscopic picture depicting a characteristic suction mark next to appendix opening (crescent-shaped structure in the left side) for aiding to identify the cecum

In conclusion, in sedated patients examined by an experienced colonoscopist, the water method has a learning curve that may be easily achievable, has lower rates of changes in patient’s position, and has similar polyp detection rates when compared to historical controls.

Acknowledgements Supported in part by VA Clinical Merit Research Funds and an American College of Gastroenterology Clinical Research Award (FWL).

Francisco C. Ramirez, MD, is Professor of Clinical Medicine, University of Arizona, College of Medicine, Phoenix, and Division of Gastroenterology, Carl T. Hayden VAMC, Phoenix, AZ.

Felix W. Leung, MD, FACG, is Professor of Medicine, David Geffen School of Medicine at UCLA, and Chief of Gastroenterology, Sepulveda ACC, VA Greater Los Angeles Health System.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

References 1.

Leung JW, Mann S, Leung FW. Option for screening colonoscopy without sedation – a pilot study in United States veterans. Aliment Pharmacol Ther. 2007;26(4):627-631.

2.

Leung FW. Water-related method for performance of colonoscopy. Dig Dis Sci. 2008;53(11):2847-2850.

3.

Leung FW, Aharonian HS, Leung JW, et al. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009;69:546-550.

4.

Leung JW, Mann SK, Siao-Salera R, et al. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009;70(3):505-10.

5.

Falchuk ZM, Griffin PH. A technique to facilitate colonoscopy in areas of severe diverticular disesase (letter). NEJM. 1984;310:598.

6.

Baumann UA. Water intubation of the sigmoid colon: water instillation speeds up left-sided colonoscopy. Endoscopy. 1999;31:314-7.

7.

Hamamoto N, Nakanishi Y, Morimoto N, et al. A new water instillation method for colonoscopy without sedation as performed by endoscopistsin-training. Gastrointest Endosc. 2002;56:825-8.

8.

Church JM. Warm water irrigation for dealing with spasm during colonoscopy: simple, inexpensive, and effective. Gastrointest Endosc.

2002;56:672-4.

9.

Mizukami T, Yokoyama A, Imaeda H, et al. Collapse-submergence method: simple colonoscopic technique combining water infusion with complete air removal from the rectosigmoid colon. Digestive Endoscopy.

2007;19:43-47.

10. Brocchi E, Pezzilli R, Tomassetti P, et al. Warm water or oil colonoscopy: towards simpler examinations? Am J Gastroenterol. 2008;102:1-7.

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M e d i c a l E t h i c s Without the Rhetoric Cases presented here involve real physicians and patients. Unlike the cases in medical ethics textbooks, these cases seldom involve cloning, bizarre treatments, or stem cell research. We emphasize cases common to the practice of medicine.

Most cases are circumstantially unique and require the viewpoints of the practitioners and patients involved. For this reason, I solicit your input on the cases discussed here at councile@aol.com. Reader perspectives along with my own viewpoint are published in the issue following each case presentation.

We are also interested in cases that readers submit. The following case is particularly relevant in these days when healthcare reform – and who is going to pay for it - is on everyone’s mind.

Mark Pastin, PhD Mark Pastin, PhD, is president and CEO of the Council of Ethical Organizations, Alexandria, VA. The Council, a non-profit, nonpartisan organization, is dedicated to promoting ethical and legal conduct in business, government, and the professions.

case Se ven

C i v i l B u t D i s o b e d i e n t

A fourteen-year-old girl was a victim of a disfiguring fire when she was in kindergarten. Since that time, the girl has been through dozens of surgeries intended to address her disfigurements – and there has been progress. Her physician is now recommending another surgery, but the girl makes it clear to her parents and to the physician that she does not want the surgery. She says she is tired of living in the hospital, experiencing pain, and can live without the promised potential benefit of the surgery. The physician makes the argument that the surgery is likely to be more successful now than later in the girl’s life and that she will be glad she had the surgery as her teen years progress. The parents are in agreement with the physician, but the girl insists that she does not want the surgery and will accept the consequences of not proceeding with it. The physician feels that he would not be in the position of ordering an unwilling patient to be anesthetized. In other words, if the girl’s parents order the girl to have the surgery, she would probably obey them. But it is clear that she is unmovable in her desire not to have the surgery. While the physician is reasonably confident that it would be legal to perform the surgery, he wonders if he should proceed against the wishes of his patient.

Medical Ethics Without the Rhetoric

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

M e d i c a l E t h i c s Without the Rhetoric CASE SI X ANALYSIS

In our case from the last issue, a terminal patient in great pain refuses, for religious reasons, to allow the plug (on further therapeutic treatment) to be pulled. However, the patient requests that everything be done to reduce the pain to the maximum possible extent. The patient’s physicians explain that the pain can be reduced and almost eliminated, but at the expense of the patient’s consciousness and, imminently, his/her life. The patient and the patient’s family find this consequence acceptable. The physicians, however, wonder if they are participating in an assisted suicide. Should the patient’s wish be granted?

Reader opinion on this case was divided. Some thought that the patient’s wish could be granted so long as no effort was made to shorten the patient’s life by administering the pain medication and life support continued. Others felt that the patient was seeking “total anesthesia” or even assisted suicide while avoiding responsibility for making this decision – or even placing responsibility on the physicians. The viewpoint was expressed that in some states the actions the patient seeks might be illegal or border on being illegal.

It can be argued that whether or not an action constitutes total anesthesia, or even assisted suicide, it depends on the intentions with which the action was performed. Evaluating the intentions of the various stakeholders in a complex ethical situation often occurs in a court of law and is subject to the whims of a justice system often ill equipped to address such issues.

My advice to the physicians in this case is to point out to the patient that continuing treatment, or even life support, while maximizing pain remediation are inconsistent actions since pain remediation may nullify the effects of treatment or life support. Since the patient wants treatment to continue, there may be a limit to the extent to which the pain can be controlled.

In short, the right answer is for the patient to make the choice no matter how uncomfortable that may be for the patient. The temptation to “blink” in a case in which treatment is likely to have little or no effect is great, but ethical decision-making always focuses responsibility for a decision on the party primarily affected, even if he or she does not want that responsibility.

This is an actual case. Of course, there are any number of complicating circumstances and additional details; but please address the case on the basis of the information provided.

There will be an analysis of this case and a new case in the next issue.

Your input is requested. Email your responses to: councile@aol.com.

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

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How I Teach My Trainees “Water Navigation Colonoscopy” Takeshi Mizukami, MD, PhD Toshifumi Hibi, MD, PhD

Abstract Colonoscopy is a difficult examination for inexperienced examiners, often due to over-insufflation of air, causing elongation of the colon and patient pain. Sedation medications relieve pain, which is a warning sign of perforation. We describe the water navigation method. With the patients in the left lateral position, air removal from recto-sigmoid allows the injected water to flow into the descending colon through the ‘collapsed’ lumen, improving the view. The “cork-screw twist” maneuver facilitates the passage of the colonoscope through the “straightened” sigmoid colon without pain. Under supervision by the author, six novices were allowed to insert the colonoscope within ten minutes by this method in one patient per week, as long as the patients did not complain of pain. The average number of attempts for the first cecal intubation within ten minutes was 3.3, and the average success rate during the first three months was 58.6%.

Introduction Colonoscopy is a difficult examination to conduct for inexperienced examiners. To improve the view, there is often a tendency to over-insufflate air, which makes passage of the scope difficult and causes patients to experience pain and discomfort.

Sedatives and analgesics relieve this pain or discomfort during colonoscopy but also mask the warning signs of colon perforation. In addition, sedative use requires a patient to be accompanied by an escort, time for recovery, and activity restrictions.

Sedative-free painless colonoscopy is the best way, if possible.

retroperitoneum. It is mobile, and, in the left lateral position, infused air collects in the sigmoid colon and pulls it up to the right side of the body. So a larger amount of air is needed for keeping the view to pass through the sigmoid-descending junction (SDJ) (the left side of body), and it stretches the mesentery and causes patient pain (Figure 1).

Sakai was the first to describe the “Water Pouring Method,”1-3 a simple colonoscopic technique using water infusion instead of air insufflation. The method allows easier negotiation of the scope and does not cause so much pain to the patients, but in this method, complete air suction in the recto-sigmoid colon was not mentioned. The debris in the recto-sigmoid colon and the boundary can partially or completely obscure the view.

We have modified this technique by combining water infusion with complete air suction from the rectum to the descending colon as “Water Navigation Colonoscopy”4 (Figure 2). With the paFigure 1: 200 ml of water is sufficient to improve the view by water infusion

Most of the pain during colonoscopy insertion is felt at the passage of the sigmoid colon. The sigmoid colon suspended in the abdominal cavity by mesentery is not fixed directly to the How I Teach My Trainees “Water Navigation Colonoscopy”

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

tients in the left lateral position, complete air removal from rectosigmoid allows the injected clear water to flow straight down into the descending colon through the ‘collapsed’ lumen (Figure 3).

This improves the view during passage through the recto-sigmoid by “shortening and straightening” the sigmoid colon.

The sigmoid colon is a helical structure. The “cork-screw twist” maneuver facilitates the passage of the colonoscope through the “SHORTENED and STRAIGHTENED” helical sigmoid colon (Figure 4).

Figure 2: Technical procedures of “Water Navigation Colonoscopy”

The change in colonic volume during colonoscopy with this method was measured and had been shown not to increase.4 Patients self-reported pain showed that they hardly experienced any pain during this sedative-risk free “Water Navigation Colonoscopy.4

Training Program in our Hospital Training target: The beginner house officer and gastroenterology residents.

Previous training of gastroscopy is not necessary in my hospital. In most cases, the training of colonoscopy and gastroscopy proceeds in parallel.

Training principle: • • •

The main purpose of colonoscopy is detection of neoplasms. Insertion of colonoscopy is just a way to do that.

Training program should not cause any inconvenience to patients.

Training program should not disturb the medical routine.

Training program (once a week):

Figure 3: Complete air suction from the recto-sigmoid makes the sigmoid colon “short" and "straight”

1. Before the training program starts, the trainees observe five cases of colonoscopy.

2. Learn how to manipulate the colonoscope with the help of the colon model (one hour for the first training day and 10 minutes for every training day thereafter).

3. Training to recognize the colon as a helical structure based on appearance of the colonic folds during observation of the colonoscopies performed by the supervisor.

4. Under supervision, trainees are allowed to insert the colonoscope within 10 minutes in one patient per week, as long as the patients do not complain of pain.

5. After five months of training, examination during withdrawal of the colonoscope is permitted.

Training with colon model:

Figure 4: “Cork-screw twist” realizes the intubation without forming any loops in SDJ

First, proper endoscope manipulation is essential for colonoscopy. In training with the colon model, trainees learn the functions and capabilities of the colonoscope. Practice with the colon model is more difficult than the human colon for colonoscope insertion, because “water navigation” cannot be used.

Training to recognize the helical structure of the colon: The folds of colon mucosa show the way. The sigmoid colon is a helical structure. “Cork-screw twist” inserts the scope as if it ascends the spiral stair. The view obtained during “cork-screw twist” insertion resembles the view that one sees looking up while ascending a spiral staircase. The bends of the colon folds show the direction of insertion (Figure 5), and “cork-screw twist” in this direction achieves the intubation without forming any loops. Training to recognize the helical structure of the colon from the colon folds is essential to this “cork-screw twist” insertion.

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Figure 5: The bend of the colon folds shows the direction of insertion

Training outcome4 (training parallel with gastroscopy): Six trainees from 2002 to 2005: • The average trial number for the first passage of SDJ was 1.4.

• The average trial number for the first cecal intubation within 10 min was 3.3.

• The average success rate of cecal intubation during the first three months was 58.6%.

Latest two trainees (without training of gastroscopy) (from November 2009 to March 2010) Trainee No. 1: A 26-year-old resident of surgery • At the first trial, she passed through SDJ without pain • At the second trial, she intubated to the cecum • The success rate of the passage of SDJ was 91.6% (11/12) • The success rate of Total Colonoscopy was 50% (6/12) Trainee No. 2: A 25-year-old house officer • At the first trial, he passed through SDJ without pain • At the second trial, he intubated to the cecum • The success rate of the passage of SDJ was 100% (14/14) • The success rate of total colonoscopy was 66.7% (8/14)

Discussion The insertion of the colonoscope without sedatives and analgesics by Japanese masters does not cause any pain. I myself have experienced the sedative-free colonoscopy twice. The first one was performed by the famous Japanese colonoscopist Dr. Mitsushima with conventional method. I felt a very slight different feeling at the passage of the sigmoid colon but did not feel any pain. The second one was performed by my second-year trainee with “water navigation colonoscopy.” I did not feel any pain at all compared with the first time.

Most of the pain during colonoscope insertion occurs during the passage of the SDJ, due to over-distension of the sigmoid colon and stretching of the sigmoid mesentery. Over-insufflation of air for keeping the view by beginners causes excessive distention. Japanese masters of colonoscopy can insert the colonoscope with minimal insufflation of air without stretching the sigmoid colon. “Water navigation colonoscopy,” a colonoscope insertion technique with water infusion and complete air removal from recto-sigmoid, hardly changes the volume of the colon. The “cork-screw twist” technique does not stretch the

sigmoid colon and does not cause any pain or discomfort to the patients, even when performed by the beginner.4 This “cork-screw twist” technique means the continuous application of “RIGHT OR LEFT TURN AND SHORTENING”5 during insertion, following the helical structure of the colon.

The technique enables the scope to pass through the SDJ without forming any loops. The essential points in teaching the technique are the manipulation of colonoscope and the recognition of the colon helical structure from the colon folds. Insertion without touching the wall at the tip of the colonoscope is also necessary for this technique. If the tip touches the wall, the colon stretches during the “cork-screw twist” maneuver.

Training outcome shows that the passage of SDJ is very easy in “water navigation colonoscopy.” The latest two trainees passed through SDJ at the first trial and succeeded at almost every trial, without causing any pain to the unsedated patients. This means “water navigation colonoscopy” can facilitate the success of training.

Acknowledgements Figures 1-3 Mizukami T, Yokoyama A, Imaeda H, et al. Collapse-submergence method: simple colonoscopic technique combining water infusion with complete air removal from the rectosigmoid colon. Dig Endosc. 2007;19:43-48. Permission to republish these has been requested from the publisher. Dr. Felix Leung provided assistance in revising drafts of this manuscript.

Takeshi Mizukami, MD, PhD, is head doctor, Endoscopy Center, Yokohama Municipal Citizens Hospital, Yokohama, Japan.

Toshifumi Hibi, MD, PhD, Professor, Gastroenterology, Keio University, Japan.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

References 1.

Sakai Y. Colon examination and diagnosis with colonoscopy.

Gastroenterological Endoscopy. 1988;30(Suppl.1):2925-7 (in Japanese).

2.

Abe K, Hara S, Takada Y, et al. A Trial on water pouring method during colonoscopic insertion. Yakuri to Chiryo. 1986;14 (Suppl.1):108-12 (in Japanese with English abstract).

3.

Sekioka T, Kosuga T, Endou K, et al. A new insertion technique of the colonoscopy: The submarine method. Gastroenterol Endosc.

1990;32:1461-8 (in Japanese with English abstract).

4.

Mizukami T, Yokoyama A, Imaeda H, et al. Collapse-submergence method: simple colonoscopic technique combining water infusion with complete air removal from the rectosigmoid colon. Dig Endosc.

2007;19:43-48.

5.

Shinya H, Wolff WI. Colonoscopy Surg Annu. 1976;8:257-95.

How I Teach My Trainees “Water Navigation Colonoscopy”

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Cost Benefit Analysis and Cost Estimating: Sedated vs. Unsedated Colonoscopy at One VAMC Laura Granados-Savatgy, MPA Douglas D. Bradham, DrPH Liz Blohm Rodelei Siao-Salera, BSN, CGRN Joseph W. Leung, MD Felix W. Leung, MD, FACG

Abstract A Cost Benefit Analysis of sedated vs. unsedated colonoscopy based on the VA perspective and a 24- hour time horizon is presented. Study data came from the NCHCS Sacramento VA, GI Clinic on demand sedation study, a RCT comparing air vs. water techniques. Data were also used from the VA Allocation Resource Center (ARC) Web, VA DSS Costing Data; workload data, as well as reports from the Veterans Support Service Center (VSSC) Web. VA’s direct costs are primarily personnel and medications. Since both procedures use the same space, that direct cost is ignored when examining the difference between the procedures. Fixed costs are costs that do not vary with level of output. The VA perspective obtains a difference of approximately $58 per procedure, favoring the unsedated alternative, regardless of whether the air or the water technique was used.

Narrative This paper reviews an examination of changes to delivering colonoscopy through Cost Benefit Analysis (CBA), which is a group of economic comparisons to help decision makers. All CBA studies must first identify the costs and the outcomes (benefits) for the alternative approaches used to deliver the service.

In this case, we are focused on: sedated vs. unsedated colonoscopy procedures at the VA Northern California Health Care System (NCHCS). When we began this pilot evaluation, a decision was required about the perspective – whether cost is defined from the VA’s view, the patient’s, or both (which would be

society’s view). The view proposed in this paper is the VA’s, but we have highlighted the patient’s view for completeness. Then, the study period, or “horizon,” was selected. To simplify the problem for this case, the 24 hours around the colonoscopy was selected. Finally, the focus had to be determined, which was to narrow the scope to only the direct costs to the VA. These decisions frame the analysis and the question being asked.

This framing determines the cost difference of the two procedures for the VA organization. This paper will review CBA cost definitions and terminology and describe the collection and evaluation of local VA data for this specific situation. Practical cost estimation will be applied to illustrate the type of information that can be derived in the VA for this pilot evaluation. The methods are described as: Before collecting any data, it is important to do the following: 1. Recall your objective. In this case, “Is it less costly to the VA to perform unsedated colonoscopies?” This is a simple cost comparison.

2. Document the activities of the procedure carefully, including items that can be valued with a “typical cost value.”

3. Estimate future requirements and their values, which may require assumptions.

4. Determine where there is “no difference” between the options being compared to eliminate those costs from your comparison.

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procedures were not part of the analysis but are shown in the final tables for completeness.

5. Estimate a value or make tangible even those activities that seem intangible, if used in your comparison.

Table 1 shows seven activities that might have costs. In both the sedated (usual care) and in the unsedated (innovative care) approach, we see that many of these costs are the same and, therefore, can be ignored, since we are looking for the direct cost differences. Since sedation time and recovery time can be different depending on whether air or water is used, these are included.

Data Sources The data used for this comparison were collected from a number of sources. Study results came from the NCHCS Sacramento VA, GI Clinic on demand sedation study.1 Data were also used from the VA Allocation Resource Center (ARC) Web,2 VA DSS Costing Data,3 workload data,4 as well as reports from the Veterans Support Service Center (VSSC) Web.5

In the comparison of Table 2, developed from a study of scheduled, on demand sedation at the Sacramento GI Clinic,1 the two center columns represent the assumptions of time. An average sedation time of 12 minutes was made. If the right-most column, or more extreme option, of “scheduled, unsedated” procedure, was accepted by a facility and their staff, and/or the patient as the “innovative care,” then some of the “VA’s direct costs” could completely disappear (e.g., medication and additional required staff).

The Application Cost identification requires that we examine all relevant and available costs or estimate what we need. Remember that the focus is on a 24-hour period and that the perspective is the VA’s view of costs to the VANCHCS. Costs can either be a onetime expense or a slice of an ongoing cost (e.g., depreciation of equipment). Direct costs are those directly related to the procedure. Thus, VA’s direct costs are: personnel and medication. (Note: since both procedures use the same space, that direct cost is ignored when examining the difference between the procedures). Fixed costs are costs that do not vary with level of output. Intangible costs are benefits or dis-benefits that are not easily quantified but might affect the use of the procedure or service. For instance, from the VA’s perspective, intangibles could cause negative or positive press.

Table 1: What are the Expected Cost Differences?

Usual Care - Sedated

Activity

Patient-Centered Innovative Care Unsedated

If VA’s Perspective is adopted:

The estimate takes into account the identified costs associated with each procedure. It uses only direct medical supplies and personnel costs. In order to simplify the costs, additional assumptions were developed, when needed. These assumptions included: 1. Each technician, nurse practitioner, registered nurse, and physician “typically” works a five-day/40 hour work week.

3. Pre-procedure time

Same

Same

4. Procedure time

Same

Could be longer

5. Sedation time

Required – varies by air or water

None

6. Recovery time

Required – varies by air or water

None

If Patient’s Perspective is adopted:

2. The VA salaries are not per procedure, so the staff would be present at the clinic, even when no procedures were being preformed.

3. Additional fixed costs that remained the same for both

1. Patient's family or driver

Same

Same

2. Patient's prep time

Same

Same

7. Patient's time to resume activity

~17 hr

Almost immediately8

Table 2: Assumptions Scheduled On Demand Sedation

Scheduled Sedated

Sedated

Scheduled Unsedated

Unsedated

If VA’s Perspective is adopted: Pre-procedure time

Same

Procedure time

Same

May be longer

Sedation time

Required

12 min

none

none

Recovery time (on site)

Required

Required

none

none

Required

Required

Required

No8

~17 hr

~17 hr

Almost immediately8

Almost immediately8

If Patient’s Perspective is adopted: Driver Prep time Resume activity

Same 7

7

Source: VA Sacramento GI Clinic On Demand Study 2006.

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Table 3 reflects estimated costs associated with sedated and unsedated colonoscopies. Within each type of procedure, the option whether air or water method was used is shown. This table summarizes the calculation for personnel involved in the procedures. These are VISN 21 salary estimates (without benefits). (Note: To get a more inclusive estimate one could add 28% for benefits.) Personnel Costs are from the Veterans Equitable Resource Allocation (VERA) 2009 Labor Index for VISN 21 detailed to our (NCHCS) facility and were computed using four pay periods from FY08; i.e., “Normal Pay.” The difference per procedure in personnel costs is a cost savings of

$56.40 for the unsedated care option over the sedated procedure. This impact is from VA salary costs alone.

There are different VISN 21 costs associated with the alternative medications used for sedation; benadryl 50 mg = $0.81 cents, fentanyl 100 mg = $1.38/vial, and versed 5 mg/5 ml = $0.91 cents/vial. Table 4 associates these costs with colonoscopies performed either with air or water techniques in the on-demand sedation study. Although these costs are small per procedure, they are VA costs and, over numerous procedures, would add up and should be captured for completeness.

Table 3: Personnel Costs Associated with Procedures VA Personnel Cost - Sedated Procedure ITEM

FTE

SALARY for each

$ Per Pay Period

$ Per Week

$ Per Day

Per 8 hr Shift

Cost

RN

2

$78,208

$3,008

$1,504

$300

$37

$75

Physician

1

$149,248

$5,740

$2,870

$574

$71

$71

Technician

1

$56,296

$2,165

$1,082

$216

$27

$27

TOTALS

4

$283,752

$10,913

$5,456

$1,091

$136

$174

VA Personnel Cost - Unsedated Procedure RN

0.5

$78,208

$3,008

$1,504

$300

$37

$18

Physician

1

$149,248

$5,740

$2,870

$574

$71

$71

Technician

1

$56,296

$2,165

$1,082

$216

$27

$27

TOTALS

2.5

$283,752

$10,913

$5,456

$1,091

$136

$117

Source: Veterans Equitable Resource Allocation (VERA) 2009 Labor Index for VISN 21.

Table 4: Medication Costs Associated with Procedures SEDATED WATER

SEDATED AIR

ITEM

Cost

ITEM

Cost

Benadryl

$0.81

Benadryl

$0.81

Fentanyl

$0.78

Fentanyl

$0.73

Versed

$0.21

Versed

$0.19

TOTALS

$1.80

TOTALS

$1.72

UNSEDATED - Water

UNSEDATED - AIR

ITEM

Cost

ITEM

Cost

Benadryl

$0.00

Benadryl

$0.00

Fentanyl

$0.00

Fentanyl

$0.00

Versed

$0.00

Versed

$0.00

TOTALS

$0.00

TOTALS

$0.00

Type

Total benadryl in mg. Prior to cecum

Total fentanyl in mcg.

Prior to cecum

Total Versed in mg.

Prior to cecum

SEDATION Air technique

50

52.7

2.04

NO SEDATION Air technique

0

0

0

SEDATION WATER technique

50

56.82

2.27

NO SEDATION WATER technique

0

0

0

TOTAL Sedated

$3.52

TOTAL Unsedated

$0.00

Sedation Cost Difference

$3.52

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Table 5: Cost Estimate of Both Procedures, given the Water and Air techniques Sedated Water N=11

Unsedated Water N=39

VA’s Perspective: Pre Op Procedure

Same

Procedure

Same

Medication

$2

$0

Personnel

$174

$118

Equipment

Same

TOTAL

$176

$118

Sedated Air N=23

Unsedated Air N=27

VA’s Perspective:

Pre Op Procedure

Same

Procedure

Same

Medication

$2

$0

Personnel

$174

$118

Equipment TOTAL

Same $176

$118

All of the VISN 21’s personnel and medication costs were used to calculate totals for each procedure in Table 5. Where there were “no differences,” the amounts were indicated as “same” for either procedure.

Variations on the Comparison Taken for VA’s Perspective If one were to look at this from the patient’s perspective, the benefit of the “new” approach is not being sedated, and the patient’s wages are not lost for the duration of arriving for the procedure, undergoing the procedure, and the following day. This would be the benefit to the patient. Our best estimate would be the value of that time at their expected wage, which we can estimate. It should be noted that estimating the patient’s benefit this way assumes an “opportunity cost,” because the patient could be working. Thus, recovery time and time until return to normal activity is “valued” at an estimated wage and fringe amount. Additionally, if unsedated patients can drive themselves home and can return to work either later that day and/ or the next morning, there is less of a “cost” than if sedated.

These are intangibles or societal costs that were not used in this VA perspective comparison but could be used in a patient’s perspective comparison.

Findings and Conclusion The VA perspective obtains a difference of approximately $58 per procedure, favoring the unsedated alternative, when the water technique is used. If the air technique is employed, the VA difference is again the $58 savings for the unsedated.

In conclusion, within this particular pilot study, given our assumptions, the unsedated procedure would be a definite cost savings (benefit) to the VA because the VA is allocated funding from a workload-driven perspective. With further research it could be determined that more patients could be seen, less staff could be utilized and, therefore, used in delivering more services to other veterans, while we would be providing a safe and efficient alternative procedure.

Laura Granados-Savatgy, MPA, is Chief, Performance Improvement Section, Benefits and Data Management, Department of Veterans Affairs, Northern California Health Care System, Martinez, CA. Douglas D. Bradham, DrPH, is Distinguished Professor of Public Health, Department of Preventive Medicine and Public Health, Kansas University, School of Medicine-Wichita, and Veterans Affairs Health Services Research & Development, Robert J Dole Veterans Affairs Medical Center, Wichita, KS Liz Blohm, Chief, Benefits and Data Management Service, Benefits and Data Management Service, Department of Veterans Affairs, Northern California Health Care System, Martinez, CA Rodelei Siao-Salera, BSN, CGRN, Department of Medicine, Veterans Affairs Northern California Health Care System (VANCHCS) Joseph W. Leung, MD, is Professor of Medicine, Department of Medicine, Veterans Affairs Northern California Health Care System, and UC Davis Medical Center.

Felix W. Leung, MD, FACG, is Professor of Medicine, David Geffen School of Medicine at UCLA, and Chief of Gastroenterology, Sepulveda ACC, VA Greater Los Angeles Health System.

Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

References 1.

Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim BS, Canete W, Samson L, Gutierrez R, Leung, FW. A RCT of warm water infusion in lieu of air insufflation (water method) vs. air insufflation (air method) for screening and surveillance colonoscopy with on demand sedation. Abstract presented at 2010 DDW, May 2010.

2.

http://vaww.arc.med.va.gov/reports/reports_v2.html#vera.

3.

http://vaww.dss.med.va.gov/.

4.

http://vaww.arc.med.va.gov/reports/reports_v2.html.

5.

http://vssc.med.va.gov/.

6.

Leung FW. The case of unsedated screening colonoscopy in the United States. Gastrointestinal Endoscopy. 2009;69(7):2009;69(7):1354-1356.

7.

Jonas DE, Russell LB, Sandler RS, et al. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007;102(11):2401-10.

8.

Leung FW. Promoting informed choice of unsedated colonoscopy patient-centered care for a subgroup of U.S. veterans. Dig Dis Sci. 2008;53(11):2955-9.

Cost Benefit Analysis . . .

American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Effect of Music on Patients Undergoing Colonoscopy John B. Marshall, MD Matthew L. Bechtold, MD

Introduction A survey of American College of Gastroenterology members published in 2006 showed that 98.8% of colonoscopies utilized intravenous sedation.1 Certainly, the vast majority of patients in the US want to be sedated for colonoscopy, and, in fact, many have the expectation “to be put out” or that at least they will feel no pain or discomfort during the procedure. Questionnaire studies in the US suggest that less than 5% to 20% of patients express even a willingness to consider unsedated colonoscopy.1-4 However, it is well know that sedation accounts for a substantial proportion of the costs and complications of the procedure.

The first author’s own interest in unsedated and light sedation colonoscopy dates back many years. For instance, he underwent an unsedated colonoscopy in the early 1990s after turning 40 years of age, primarily with the intent of seeing how uncomfortable it was so that it would help him to offer the service to patients. Our group also did a patient questionnaire study in the late 1990s of our three practice settings (university medical center, a cancer center, and a VA medical center) examining patient attitudes toward unsedated colonoscopy. 2 Also, until the last five years, the endoscopy units in which the first author practiced had minimal recovery room space. This meant that the endoscopist had to become technically proficient in colonoscopy (including loop prevention) so that just light conscious sedation could be used in an effort to shorten recovery time and improve room turnover. In various endoscope trials performed by the first author (prior to five years ago), the mean doses of meperidine ranged from just 50-60 mg and the mean doses of midazolam ranged from just 1.5 to 2.5 mg.5-7 A number of studies through the years have examined whether having patients listen to relaxing music decreases anxiety, pain,

and sedation requirements associated with invasive procedures.

These have included trials specifically examining upper GI endoscopy and colonoscopy. The purpose of this paper is to review the published experience examining the effect of music on patients undergoing outpatient colonoscopy.

The Music Study at the University of Missouri In 1999, our group performed a randomized controlled trial of 167 consecutive adult outpatients presenting for routine colonoscopy under low-dose conscious sedation utilizing meperidine and midazolam. It was published in 2006.7 In our study, which was approved by our Institutional Review Board, patients did not know that they were participating in a study examining the effects of music. They were only told that the investigators were collecting information to assess their attitudes regarding colonoscopy before and after the procedure. Patients were randomized to undergo their procedures either with music playing in the procedure room or no music played. The same music was played for all patients in the music group: “Watermark” by Enya (Reprise Records, a Time Warner Company, 1988), which contained 12 tracks (ranging from 1:59 to 4:25 in length). The CD player was set on repeat. The mean age of patients was mid-50s, and the gender makeup of participants in the study was 50% males and 50% females.

As shown in Table 1, there was no difference between the two groups in terms of doses of sedative medications, time to reach the cecum, total procedure time, perceived colonoscope insertion difficulty, or perceived adequacy of sedation. (The insertion difficulty I scale was a visual linear analog [VLA] scale where 0-mm represented “very easy” and 100-mm represented “very difficult.” The insertion difficulty II scale was a five-

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Table 1: Procedure outcomes and results of the questionnaire given to endoscopists Music (n = 85)

No music (n = 81)

P

Meperidine dose (mg)1

57.0

54.6

0.68

Midazolam dose (mg)1

1.92

1.85

0.46

Time to reach cecum (min)1

10.4

9.2

0.46

Total procedure time (min)1

20.7

21.0

0.84

Insertion difficulty I scale (mm)1

40.9

36.5

0.47

Insertion difficulty II scale (1-5)2

3

3

0.31

Adequacy of sedation scale (1-4)2

1

1

0.093

Outcome

Mean value; 2median value.

Adapted from: World J Gastroenterol. 2006;12:7309-7312

1

point scale which ranged from 1=very easy to 5=very difficult.

The adequacy of sedation was a four-point scale which ranged from 1=satisfactory to 4=combative.)

Table 2 shows the results of the post-procedure patient questionnaires. Patients reported a better overall experience on the three experience scales, though the difference only attained statistical significance on the experience I and III scales (P = 0.045 and P = 0.037 respectively, compared to P = 0.080 for the experience II scale). The perception of pain in the two groups was similar. Many more patients in the music group requested music at the next colonoscopy. (The experience I scale was a four-point scale which went from 1=pleasant to 4=unacceptable. The experience II scale was a five-point scale which went from 1=much better than I expected to 5=much worse than I Table 2: Post-procedure patient questionnaire results Music (n = 85)

No music (n = 81)

P

Experience I scale (1-4)2

2

2

0.045

Experience II scale (1-5)2

1

2

0.080

Experience III scale (mm)1

22.5

28.1

0.037

Pain experience (mm)1

25.3

25.4

0.8

Want music at next colonoscopy (%)

96.3

56.1

<0.0001

Outcome

Mean value; median value.

Adapted from: World J Gastroenterol. 2006;12:7309-7312

1

2

expected. The experience III scale was a 100-mm VLA scale where 0-mm represented pleasant and 100-mm represented the worst experience the patient ever had. The pain experience scale was a 100-mm VLA scale where 0-mm represented “not painful at all” and 100-mm represented “unbearable.”)

We concluded that, while music does not result in shortened procedure times, lower doses of sedative medications, or perceived patient pain, the patients who have music playing during their procedures at least report modestly greater satisfaction with their colonoscopies.

Meta-Analysis of Randomized Controlled Trials Looking at the Effect of Music on Patients Undergoing Colonoscopy Randomized controlled trials (RCTs), which have examined the benefits of music during colonoscopy, have shown varying results. Meta-analysis is a useful statistical technique that can help answer clinical questions where the results of multiple clinical trials have shown variable results. Our group recently conducted a meta-analysis to analyze the effect of music on patients undergoing colonoscopy.8 We only included RCTs on adult subjects that compared music versus no music during colonoscopy. Meta-analysis was analyzed for total procedure times, doses of sedative medications, patients’ pain scores, patients’ experience, and patients’ willingness to repeat the procedure in the future. Eight studies, involving 712 patients, met inclusion criteria.7,9-15 Table 3 lists the characteristics and Jadad scores for the eight trials. The Jadad score is a method to assess the quality of RCTs.16 Table 4 summarizes the results of our meta-analysis. Patients’ overall experience scores were significantly improved with music (P <0.01). However, no significant differences were found for mean doses of meperidine (P = 0.23), mean doses of midazolam (P = 0.10), total procedure time (P = 0.06), patients’ pain scores (P = 0.09), and patients’ willingness to repeat colonoscopy in the future (P = 0.10). No publication bias, evaluated by funnel plot, was identified.

Since the publication of our meta-analysis, there have been no other trials specifically evaluating the effects of music on colonoscopy. One trial evaluated the effect of music to reduce anxiety in patients undergoing GI endoscopy in general.17 They found significantly less anxiety in patients undergoing lower GI endoscopy who listened to music. However, the study did not separate colonoscopy procedures from flexible sigmoidoscopy procedures. This study also did not look at other outcomes, such as medication doses for procedures.

Discussion Results of our own RCT and our meta-analysis examining the RCTs which have studied the effects of music on colonoscopy demonstrate that music played during colonoscopy significant-

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American Journal of Clinical Medicine® • Special Issue 2010 • Volume Seven, Number Three

Table 3: Studies included in the meta-analysis7,9-15 Author

Publication year

Country

Number of patients

Type of study

Type of music

Jadad score

Schiemann

2002

Germany

119

RCT

Variety radio station

2

Lee

2002

China

110

RCT

Variety per patient

5

Smolen

2002

USA

32

RCT

Variety per patient

2

Andrada

2004

Spain

118

RCT

Classical

3

Uedo

2004

Japan

29

RCT

Easy listening

2

Bechtold

2006

USA

166

RCT

Relaxing-Enya

3

Harikumar

2006

India

78

RCT

Variety per patient

5

Ovayolu

2006

Turkey

60

RCT

Turkish classical music

3

* = Jadad score is a method to assess the quality of RCTs.; Adapted from: Dig Dis Sci. 2009;54:19-24

ly improves patients’ overall colonoscopy experience.7,8 This benefit is most likely the result of music’s role in decreasing anxiety and promoting patient relaxation during a stressful procedure.17 In our trial and meta-analysis, utilizing music during colonoscopy did not demonstrate a significant reduction in doses of sedative medications, patients’ pain, or increase the willingness of patients to repeat colonoscopy in the future. The meta-analysis had several weaknesses. For one thing, the music utilized in the study was highly variable in its type, timing, and mode of delivery. For instance, the type of music utilized ranged from relaxing classical music to patient-directed selections. The optimal type of music and its mode of delivery remain to be defined. Also, a majority of the studies were not blinded to the endoscopist, though it is unlikely that this would affect outcome variables such as doses of sedative medications and procedure times. The meta-analysis also included studies from many different countries and areas of the world, which may have influenced the results by increased heterogeneity.

Another meta-analysis has recently been published by Tam et al.,18 which showed somewhat different results from our metaanalysis.8 Whereas our meta-analysis demonstrated that music during colonoscopy did not significantly decrease sedation medication doses, Tam et al. demonstrated a small but significant decrease in sedation medication requirements (MD -0.46; CI: -0.91 – -0.01, p=0.05).18 However, our meta-analysis only used studies involving midazolam, whereas Tam et al. included a study in their analysis, which used propofol rather than midazolam for sedation.10 Given the differences between propofol and midazolam for sedation and that the other trials on the subject utilized midazolam, we believed that adding the propofol study to the analysis on sedative medicine doses could be misleading and potentially result in inaccurate results, particularly since the margin of significance was borderline at p=0.05 anyway. Both meta-analyses otherwise share similar limitations

related to the designs of the original RCTs. However, in view of the discussion above, we feel our study may be more accurate as regards the effect of music on sedative doses of medications during colonoscopy.

None of the music studies to date have specifically examined the benefit of music in patients undergoing unsedated colonoscopy. However, extrapolating the results of the available studies and of our meta-analysis suggests that the benefit would likely be modest at most. On the other hand, given the simplicity of permitting patients to listen to music in the endoscopy suite, its use should be encouraged in patients undergoing unsedated colonoscopy and colonoscopy utilizing low-dose conscious sedation. Further trials are needed to define the optimal type of music for patients and its mode of delivery.

Table 4: Summary of meta-analysis Improved with music Patients’ overall experience

p <0.01

No significant differences Mean doses of meperidine

p = 0.23

Mean doses of midazolam

p = 0.10

Total procedure time

p = 0.06

Patients’ pain scores

p = 0.09

Patients’ willingness to repeat

p = 0.10

No publication bias detected (evaluated by funnel plot).

Adapted from: Dig Dis Sci. 2009;54:19-24

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In conclusion, music is a useful adjunct for improving patients’ overall experience in centers that perform unsedated colonoscopy or that utilize low-dose conscious sedation.

John B. Marshall, MD, is Professor of Medicine, Division of Gastroenterology, University of Missouri School of Medicine, Columbia, MO. Matthew L. Bechtold, MD, is Assistant Professor of Clinical Medicine, Division of Gastroenterology, University of Missouri School of Medicine, Columbia, MO Potential Financial Conflicts of Interest: By AJCM policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. The authors have stated that no such relationships exist. ®

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Cohen LB, Wecsler JS, Gaetano JN, et al. Endoscopic sedation in the United States: Results from a nationwide survey. Am J Gastroenterol.

2006;101:967-974.

Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol.1999;94:1862-1865.

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Madan A, Minocha A. Who is willing to undergo endoscopy without sedation: patients, nurses or the physicians? South Med J. 2004;97:800805.

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Cohen LB, Aisenberg J. Sedation for colonoscopy. In Waye JD, Rex DK, Williams CB (eds). Colonoscopy: Principles and Practice (2nd edition).

Singapore; Wiley-Blackwell; 2009; pp.101-113.

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Marshall JB, Perez RA, Madsen RW. Usefulness of a pediatric colonoscope for routine colonoscopy in women who have undergone hysterectomy.

Gastrointest Endosc. 2002;55:838-841.

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Al-Shurieki SH, Marshall JB. Is the variable-stiffness paediatric colonoscope more effective than a standard adult colonoscope for outpatient adult colonoscopy? A randomised controlled trial. Digestive Liver Dis. 2005;37:698-704.

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Bechtold ML, Perez RA, Puli SR, Marshall JB. Effect of music on patients undergoing outpatient colonoscopy. World J Gastroenterol.

2006;12:7309-7312.

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Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: A meta-analysis of randomized controlled trials. Dig Dis Sci. 2009;54:19-24.

9.

Schiemann U, Gross M, Reuter R, Kellner H. Improved procedure of colonoscopy under accompanying music therapy. Eur J Med Res. 2002;7:131-134.

10. Lee DWH, Chan KW, Poon CM, Ko CW, Chan KH, Sin KS, Sze TS, Chan ACW. Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial.

Gastrointest Endosc. 2002;55:33-36.

11. Smolen D, Topp R, Singer L. The effect of self-selected music during colonoscopy on anxiety, heart rate, and blood pressure. Appl Nurs Res. 2002;15:126-136.

12. Lopez-Cepero Andrada JM, Amaya Vidal A, Castro Aguilar-Tablada T, et al. Anxiety during the performance of colonoscopies: modification using music therapy. Eur J Gastroenterol Hepatol. 2004;16:1381-1386.

13. Uedo N, Ishikawa H, Morimoto K, et al. Reduction in salivary cortisol level by music therapy during colonoscopic examination.

Hepatogastroenterology. 2004;51:451-453.

14. Harikumar R, Raj M, Paul A, et al. Listening to music decreases need for sedative medication during colonoscopy: a randomized, controlled trial.

Indian J Gastroenterol. 2006;25:3-5.

15. Ovayolu N, Ucan O, Pehlivan S, et al. Listening to Turkish classical music decreases patients’ anxiety, pain, dissatisfaction and the dose of sedative and analgesic drugs during colonoscopy: a prospective randomized controlled trial. World J Gastroenterol. 2006;12:7532-7536.

16. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials.

1996;17:1-12.

17. El-Hassan H, McKeown K, Muller AF. Clinical trial: music reduces anxiety levels in patients attending for endoscopy. Aliment Pharmacol Ther. 2009;30:718-724.

18. Tam WWS, Wong ELY, Twinn SF. Effect of music on procedure time and sedation during colonoscopy: A meta-analysis. World J Gastroenterol.

2008;14:5336-5343.

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