STANDING COMMITTEES
Education Committee:
Chairman: Jerome D Waye
650 Park Avenue
New York, NY 10021, USA
Fax: 1-212-2495349
Members: Daldiyono (Indonesia), R Fujita (Japan), Yesus Y Perez (Philippines), A Martin
(Italy), L.A. Simon (Hungary), C.B. Williams (UK), N Chopita (Argentina), H Espejo Romeo
(Peru), G Machado (Brazil)
Research Committee:
Chairman: Eamonn MM Quigley
University of Nebraska - Medical Ctr
Section of Gastroenterology & Hepatology
600 South 42nd Street
Box 982000
Omaha, NE 68198-2000, USA
Fax: 1-402-559 9004
Members: H.J. Choi (Korea), S Nakazawa (Japan), K Huibregtse (NL), R Lambert (France),
J.F. Riemann (Germany), T.H. Wang (ROC), Villa-Gomez (Bolivia), R.A. Kozarek, (USA), A
Abrao Neto, (Brazil)
Nominating Committee:
Chairman: T. Sakita (Japan)
Members: G Machado (Brazil), R Llanio (Cuba), H Niwa (Japan), M Crespi (Italy)
Financial Committee:
Chairman: A. Montori (Italy)
"AD HOC" COMMITTEES
Information Committee:
Chairman: Friedrich Hagenmüller
A.K. Altona
Paul-Ehrlich Str. 1
D-22763 Hamburg, GERMANY
Fax: 49-40-88224902
Members: B Krishna Rau (India), Y Oguro (Japan), J St. John (Australia), D Colin- Jones
(UK), A Nowak (Poland), W Roesch (Germany), A Celestino (Peru), M Paniagua (Cuba), A
Penaloza-Rosas (Colombia)
Terminology and Data Processing Committee:
Chairman: Zdenek Maratka
U5 baterie 40
16200 Praha 6, CZECH REPUBLIC
Fax: 4202-24314574
Members: WSC Chao (Hong Kong), MA Fujino (Japan), S Wilairatana (Thailand), S Brunati
(Italy), W Swobodnik (Germany), CW Venables (UK), LAG Juruena Mattos (Brazil), JE Segal
(Argentina), M Schapiro (USA)
Minimal Invasive Surgery Committee:
Chairman: Alberto Montori
III Dept. of Surgery
University La Sapienza
00161 Roma, ITALY
Fax: 39-06-44702412
Members: SC Sydney Chung (Hong Kong), Dayasiri Fernando (Sri Lanka), T Yamakawa (Japan), J
Perissat (France), A Cuschieri ( UK), G Buess (Germany), AL de Paula (Brazil), P Briceno
(Venezuela), J Ruiz (Cuba)
Electronic Communications Committee:
Chairman: J.R. Armengol-Mirò
Secretary: A. Grassi
National Cancer Institute Regina Elena
Viale Regina Elena 291 – 00161 Roma, ITALY
Fax: +39.06.44 57 086 e-mail: mc6512@mclink.it
Members: H.D. Allescher, M. Delvaux, M. Fujino, V. Tejedo Grafia, Cheng-Yi Wang
Ethics Committee (joint with the OMGE Ethics Committee):
Chairman: Jean Escourrou
Service de Gastroenterologie
Hopital de Rangueil
Avenue Jean Poulhes 1
31054 Toulouse Cedex, FRANCE
Fax:33-56132-2176
REPORTS OF STANDING COMMITTEE CHAIRMEN
Education Committee
Terminology and Data Processing Committee
Minimally Invasive Surgery Committee
Education Committee
Jerome D. Waye, Chairman (1994-1998)
OUTLINE OF THE ACTIVITIES OF THE OMED
EDUCATION COMMITTEE, MAY 1995
This Committee has set broad goals for
the next four years:
1. A set of teaching video tapes will be made available in each of the major endoscopic
specialties. OMED will maintain an up-to-date video library, and copies of tapes will be
presented to endoscopy societies, hospitals and chiefs of endoscopy training centers
throughout the world.
2. An attempt will be made to establish true "hands on" training programs for
beginner endoscopists and for learning advanced techniques. Intensive, short courses have
been successfully structured in upper intestinal endoscopy and colonoscopy by Dr. Charles
Swan in England. Although these provide only rudimentary entry-level knowledge and are not
acceptable in countries where full training programs exist, they will provide the concepts
of indications, contraindications and techniques to ensure a safe start in endoscopy.
3. OMED will collect from each national endoscopic society a copy of their constitution,
by-laws and guidelines to serve as an international reference source. Information can be
shared, and societies that are in the formative stages will no longer need to reinvent the
structure of their group anew, nor rewrite guidelines which have already been labored over
by other endoscopic societies.
All of these endeavors will need funding to be able to provide the services that are
necessary to introduce endoscopy to countries where it is undeveloped and underutilized,
to assist in continuing education and to ensure our patients of the safety of the
procedure.
ACTIONS BY THE OMED EDUCATION COMMITTEE, MAY 1997
Omed is embarking upon a two-part approach to teaching endoscopy in under developed countries. The overall plan is to present videotape demonstrations of endoscopic procedures to a national meeting at which all people who are interested in gastrointestinal endoscopy and gastroenterology will be invited. The group of people who express an interest in forming endoscopic centers will subsequently (within one year) be invited to attend a practical workshop on endoscopy in that country. Cases will be provided and experts will demonstrate various techniques of basic endoscopic procedures. Lectures and written material will be developed for those basic workshops. The first area contacted for this approach is Africa. Communication has been established with professor Simjee, president of the newly-formed African Federation of Gastroenterology. He has expressed an interest in this program and is currently contacting physicians who may be interested in this approach.
A cadre of teachers in endoscopy is being developed for purposes of teaching endoscopy in underdeveloped countries. If anyone would like to be nominated as a member of the Omed teaching faculty, please contact me with a brief resume detailing your endoscopic experience, the hospitals in which you were trained, a description of the level of expertise, and the types of endoscopy in which you are interested in teaching.
The education committee is attempting to act as a repository for the collection of constitution and by-laws of endoscopic societies throughout the world. This will allow us to know which organizations have established by-laws, and the languages in which they are written. Upon request from any group which is considering formation of an endoscopic society, or which would like further information on patterns which have been developed by other organizations, the names of the endoscopic societies and a specific contact person will be sent so that communications can be established between various endoscopic societies for the exchange of this information. At the present time, the education committee has received twelve responses. The committee has also requested information concerning teaching videotapes and guidelines which have been established for endoscopy. The American Society for Gastrointestinal Endoscopy, seems to have the best-developed set of guidelines. The British Society of Gastroenterology also has several endoscopic guidelines available.
In order to facilitate communication between endoscopic societies and endoscopists worldwide concerning items of interest, Omed is currently on the internet at: www.uni. net/omed. The E-mail address is OMED@uni.net.
Videotapes of the Post-graduate Courses of the last two World Congresses of Gastroenterology, held in Sydney and Los Angeles, are currently available at no cost for national organizations who request them from the Omed General Secretariat. The stipulation is that they will be shown at a National Congress of Gastroenterology within a year after their having been received by the national Society.
They will be also available to individual physicians by
request. They are in two formats, Pal and Ntsc. The price for the complete package of 13
videotapes is $ 100 US. This is to defray the cost of videotapes and mailing. The requests
should be addressed to Prof. Massimo Crespi, National Cancer Institute "Regina
Elena", Viale Regina Elena 291 - 00161 Roma, Italy
Fax: +39.06.4457086 E-mail: as stated above.
OMED EDUCATION COMMITTEE, OCTOBER 1997
The World Organization of Digestive Endoscopy represents
organized gastrointestinal endoscopy throughout the world. Many areas of the world are
well-served by endoscopic societies, endoscopic organizations, and gastroenterology
associations which have active endoscopic components. Each of the many endoscopic
organizations throughout the world are autonomous, and most endoscopic organizations or
groups of endoscopists develop their own rules, regulations, and organizational structures
to suit their particular needs, constituents, and geographic areas. For the most part,
rules, regulations, endoscopic guidelines, and organizational structures are developed
independently from any other endoscopic organizations. Associations which are well
established and have multitudes of members are the groups that characteristically take the
lead in the development of practice parameters, practice guidelines, and in the defining
of indications, techniques and contraindications for gastrointestinal endocopy. omed has
taken upon itself the collation of information from various sources throughout the world
and has redefined itself as being the stucture which scan knit the various worldwide
organizations into a cohesive array of societies. OMED is the link across all of endoscopy
and will disseminate knowledge and education to all of our members, from the highly
organized societies to te less-well-developed groups of endoscopists throughout the world.
In an attempt to transmit specific knowledge about endoscopy, OMED has made available the
endoscopy videotapes from the last two World Congress of Gastroenterology to any
member-constituent GI organization throughout the world. These are available in both PAL
and NTSC format, and merely have to be requested by the constituent societies. The intent
of OMED is to have these shown at any endoscopic congress held by the individual society,
or available to be loaned to any individual or group in that society. Any individual may
purchase the entire twelve-videotape packet of World Congress videotapes from the
endoscopy courses of the Australia World Congress of Gastroenterology (1990) as well as
from the Los Angeles World Congress of Gastroenterology (1994) for US$100 plus mailing.
These can be obtained by sending a check directly to: Massimo Crespi, MD - OMED acting
president.
The Education Committee has also requested information on constitutions and by-laws from
all of the constituent endoscopic organizations. Only a few of the many constituent
societies have submitted copies of their constitutions and by-laws, but a list of
countries which have sent printed by-laws, will be made available to any organizations who
request them.
Some of the larger and more advanced endoscopic societies have multiple guidelines and
practice parameters which are "state of the art" position papers. A list will be
sent upon request.
The education committee has made initiatives for the
"hands-on" teaching of endoscopy in areas in which endoscopy is underdeveloped
or under-served. A cadre of teachers is currently available for teaching endoscopy in
underdeveloped countries. If any member would like to add their names to the list of
available endoscopists who may be requested to travel to foreign countries to begin
endoscopic instructions, please contact me with names, addresses, and a curriculum vitae
listing hospital affiliations, endoscopic training, current affiliations, and an outline
of the endoscopic teaching that you have performed.
All the members of the Education Committee have committed to submitting to the OMED
bulletin articles concerning endoscopy in their particular countries. Other endoscopists
are encouraged to send in their own experiences in individual countries, unusual
endoscopic situations, et cetera. Please send manuscripts directly to: Alberto Montori, MD
- OMED News Letter Editor.
OMED is currently on the worldwide web, and can be reached at: "uni.net/omed".
This website will be further developed in the future, and is intended to be a bulletin
board of worldwide interest in endoscopy. It is hoped that a "chat page" can be
formulated to allow interchange between endoscopists throughout the world.
The OMED bulletin will be published twice yearly, and an attempt will be made to
disseminate these at all major endoscopic meetings throughout the world; OMED is committed
to disseminating knowledge about endoscopy and being the leader in worldwide endoscopy
education. Please send in suggestions and comments concerning educational endeavours in
the field of gastrointestinal endoscopy.
REPORT OF THE EDUCATION COMMITTEE OMED, APRIL 1998
The Education Committee consists of the following members:
Nestor A. Chopita, MD
Daldiyono, MD
Rikiya Fujita, MD
Glaciomar Machado, MD
Alessandro Martin, MD
Jesus Y. Perez, MD
Herman Espejo Romeo, MD
Laszlo A. Simon, MD
Jerome D. Waye, MD (Chairman)
Christopher B. Williams, MD.
The Education Committee has applied itself over the past four years to several areas with
the purpose of bringing information concerning various aspects of endoscopy to
endoscopists throughout the world. The major thrust of the Education Committee is not in
the training of endoscopists in a formal fellowship program, but rather is focused on
bringing information to physicians who already perform endoscopy and educating doctors
about endoscopy in countries where there is a need for further endoscopic expertise.
Videotapes from the past two World Congresses of Gastroenterology (Australia, 1990 and
USA, 1994) are now available as a package. The price for the entire package is US$100.
This is available in either PAL or NTSC format, and is available upon request form Prof.
Massimo Crespi, President of OMED. Constituent member societies of OMED may acquire a copy
of these videotapes free of charge providing that they agree to show these videotapes at
national meetings of their endoscopic societies.
The Education Committee has arranged for a live demonstration endoscopy course to be held
in Moscow on April 23-24, 1998. This course will be presented in conjunction with the
Olympus Corporation, who will supply equipment and arrange for video transmission.
The Education Committee currently has a list of constitutions and by-laws which is
available on request. These constitutions and by-laws had been submitted by member
endoscopic societies of OMED three years ago. The Education Committee is currently seeking
information from every constituent endoscopic society as to the availability of
educational aids for gastrointestinal endoscopy. The aids would include slide series,
brochures, written material, and videotapes. A letter has been sent to every president of
each constituent endoscopic society throughout the world seeking such information.If any
individual members have knowledge of educational material which contain information
concerning gastrointestinal endoscopy, please contact Dr. Waye with a listing of this
information.
The Education Committee is currently working on developing a brochure for the performance
of live courses in endoscopy. Live tele-endoscopic courses are of great benefit in the
education of large numbers of physicians in the performance of endoscopic procedures. A
section of this brochure will address small, focused endoscopy courses. OMED desires to
establish standards for patient safety, patient selection, the performance of such live
courses, and patient privacy. The Education Committee is also concerned with the selection
of "experts" in endoscopic procedures, and desires to eliminate any risk to the
patient from being a subject in a "live" endoscopic course. Most physicians who
agree to produce such a course, are, in general, not knowledgeable about the various forms
of transmission to a nearby or remote location, and would benefit by having a
"primer" on the conduct of these courses. Anybody with a special expertise in
the development or production of live courses or is knowledgeable about the video
requirements should contact Dr. Waye with such information.
Stimulated by an excellent response from the Research Committee on a previous
questionnaire, the Education Committee is collaborating with the Research Committee to
distribute a questionnaire worldwide to collect further information on endoscopic
practices. The questionnaire is currently in the development phase, and will be
distributed during 1998.
MINUTES OF THE MEETING OF THE OMED EDUCATION, MAY 1998
OMED conducted a live endoscopy demonstration
in Moscow on April 23-24, 1998. The meeting was sponsored by Olympus and Wilson-Cook. The
local organizers were Drs. Poddubny and Fedorov. Approximately 400 Russian physicians
attended the two-day workshop, where they saw a wide range of endoscopic procedures
including ERCP, stone extraction, endoscopic ultrasound, endoscopic mucosal resection and
colonoscopic polypectomy. Several lectures were also given by the faculty members, which
consisted of Dr. Massimo Crespi, MD (President, OMED), Dr. Alberto Montori, MD (Treasurer,
OMED), Dr. Melvin Schapiro, MD (Vice President, OMED), Dr. Aksel Kruse, MD (Denmark), Dr.
Paul Fockens, MD (Amsterdam), Dr. J.R. Armengol Mirò, MD (Barcelona) and Dr. Jerome Waye,
MD (New York).
The meeting was a great success and was considered a great benefit to all of the
registrants who had traveled from all different parts of Russia to attend the workshop. At
the present time various locations are being explored for future workshops.
The committee has developed a list of all the guidelines and brochures concerning
endoscopy, as well as the video-educational material available throughout the world. The
United States, Japan and Australia have the largest number of published guidelines and
instructional videotape material concerning endoscopy. The Education Committee will try to
adapt currently published guidelines in English for use by the international fraternity of
endoscopy. Permission must be obtained from countries which already have developed
guidelines. Once the guidelines have been reformulated for their international
applicability, the will be published in the OMED bulletin and on the internet site. We
thank the individual societies who responded to our request for information.
OMED had made available a 12-pack packet of videotapes from the Sidney World Congress of
Gastroenterology and the Los Angeles World Congresses of Gastroenterology.
These videotapes are available without charge upon request by any of the constituent
endoscopic societies, and are available for $100 for anyone else who is interested. If
interested, contact Dr. Massimo Crespi and specify whether the video format desired il PAL
or NTSC.
The Research Committee, in conjunction with the Education Committee, has distributed a
questionnaire about "endoscopic practice and priorities throughout the world".
We urge all of the constituent societies to answer the survey promptly so that information
can be gathered on several topics, including the availability of endoscopy in various
parts of the world, the types of endoscopy which are considered to be of greatest benefit
throughout the world, and the degree of training required for performing endoscopy. The
information from this survey will serve to focus the future thrusts of endoscopy for both
educational purposes and research needs.
The Education Committee is currently developing a brochure on the requirements for live
courses in endoscopy. This will consist of two parts, a technical portion concerning types
of transmission, number of cameras, and the adequacy of facilities. The second part will
consist of patient selection, patients safeguards, and the role of the nurse/assistant
during live demonstration.
OMED has its own web page, which is found at www.uni.net/omed.
The E-mail address is OMED@uni.net.
TEACHING ENDOSCOPY BY INTERACTIVE
VIDEOTAPES, MAY 1997
(Melvin Schapiro, MD)
Teaching endoscopy has evolved from artist’s
reproduction of endoscopic findings, through the direct capture of high quality still and
video images. The limitations of teaching were primarily related to the need for a one on
one or very small group experience. The electronic endoscope brought large screen T-V to
the teaching environment and a large number of remote transmissions from international
centers soon evolved via satellite or telephone lines. The two most important limiting
factors to the remote, live transmission technology are the down time during complicated
cases, and the costs involved for a one time use.
A radically different approach has been developed by Advance Medical Ventures, a Hollywood
based company that utilizes professional motion picture production and editing crews as
well as state-of-the-art presentations designed to capture the "live
atmosphere".
The format is the presentation of a wide range of pretaped video sequences of procedures
actually performed by experts in their individual endoscopy units. In addition to large
screen projection, a high quality sound reproduction system and multiple high resolution
video monitors are spaced through out the presentation center allowing close-up
demonstrations of the technical aspects of complicated therapeutic endoscopic techniques
that were performed under real practice situations.
The direct video reproductions are enhanced by split screen technology allowing the
audience to focus on many aspects of the procedures with simultaneous visualization of the
high resolution endoscopic images. The use of stop-start and rapid rewind methods have
been combined with both recorded and live voice-over explanations by the on-site faculty
presenters who were filmed in their own units
The audience is further involved in the sessions through the use of interactive
"touch-pad" questions and the presence of an expert endoscopic
"facilitator" who anticipates questions and the need to review special technical
aspects of the presentations. The facilitator is as well scripted with time code
associated material so that by watching a special monitor he can amplify certain teaching
points agreed with by the faculty in pre-presentation rehearsal sessions.
A special teaching technique is further provided by "telestrator" technology
that allows the expert presenter to draw over or provide diagramming to emphasize
particular concepts.
This teaching concept was developed over five years ago and has been utilized at the World
Congresses of Gastroenterology Post-graduate Endoscopy course in Los Angeles in 1994 and
at the American Society for Gastrointestinal Endoscopy’s annual Post -graduate
teaching course in San Francisco in 1996. Parts of the program have been reproduced
internationally at the UEGW, and at regional society meetings. New endoscopic material is
provided every two years so that the latest in technology is provided as well as the
opportunity for individuals who have attended previous presentations to return for new
material. The attendance evaluations have universally indicated that the program is
extremely well received.
The high quality video material has been reproduced on video cassettes for international
distribution, and lends itself to the new electronic formats such as DVD and CD-ROM. This
enables continued study outside of the presentation environment.
The teaching format has been used by small groups such as a hospital that invites 50
physicians to a meeting, or by large groups with attendance exceeding 2000. Further
information concerning presentations and materials are available on the AMV home page:
http:/www.amv.com.
" SURVEY ON ENDOSCOPIC PRACTICE AND
PRIORITIES THROUGHOUT THE WORLD"
All the member Societies already received the questionnaire.
Those which did not yet reply are invited to do so as soon as possible.
SURVEY ON ENDOSCOPIC PRACTICE AND PRIORITIES THROUGHOUT
THE WORLD DEVELOPED BY RESEARCH AND EDUCATION COMMITTEES OF OMED: CHAIRS EAMONN M.M.
QUIGLEY, M.D.,JEROME D. WAYE, M.D.
Please Submit Responses to: Eamonn M.M. Quigley, M.D. Gastroenterology and
Hepatology University of Nebraska Medical Center Omaha, NE 68198-2000, USA,
FAX.+001.402-559-9004, E-MAIL: equigley@mail.unmc.edu
1. Who performs endoscopy in your country? For each type of practitioner, please estimate the percentage of all endoscopy that is performed by these individuals.
A. Upper Gastrointestinal Endoscopy
------- % Family Practitioner
------- % General Internist/General Physician
------- % Gastroenterologist
------- % Surgeon
------- % Other (Please clarify)
B. Colonoscopy
------- % Family Practitioner
------- % General Internist/General Physician
------- % Gastroenterologist
------- % Surgeon
------- % Other (Please clarify)
C. ERCP and Other Interventional Procedures
------- % Family Practitioner
------- % General Internist/General Physician
------- % Gastroenterologist
--------% Surgeon
--------% Other (Please clarify)
2. In your country, please estimate the proportion (as %) of endoscopic examinations that are performed at the following sites:
% hospital inpatient
% hospital outpatient (ambulatory)
% private clinic, attached to a hospital
% free-standing private clinic, not associated with a hospitalSurgical Residency
Gastroenterology Fellowship
Fellowship training in endoscopy other than that provided in
Gastroenterology.
3. Which of the following endoscopic procedures are available in your country? For each, state whether they are
A. Not available
B. Available only at a few center
C. Available only at major referral hospitals or
D. Available widely in community-type hospitals or physician's offices.
A B C D
Esophago- gastroduodenoscopy/upper gastrointestinal endoscopy
Endoscopic therapy of gastrointestinal hemorrhage
Endoscopic therapy of esophageal/gastric varices
Endoscopic placement of gastrostomy/jejunostomy tubes
Colonoscopy
Colonoscopic Polypectomy
ERCP
ERCP with Sphincterotomy
ERCP with Sphincterotomy and placement of stents
Esophageal dilatation and placement of prosthesis
Enteroscopy
Endoscopic Ultrasound
Endoscopic laser therapy of tumors
4. What are the most common indications for the major endoscopic procedures in your country? For each procedure, list the top 3 indications:
A. Upper Gastrointestinal Endoscopy (diagnostic)
B. Upper Gastrointestinal Endoscopy (therapeutic)
C. ERCP
D. Colonoscopy (diagnostic)
E. Colonoscopy (therapeutic)
5. What is the prevailing practice of patient preparation/sedation/anesthesia in your country for:
A. Upper Gastrointestinal Endoscopy
No sedation
Conscious Sedation with Benzodizapine/Opiate/Other (please specify)
General Anesthesia
B. Colonoscopy
No sedation
Conscious Sedation with Benzodizapine/Opiate/Other (please specify)
General Anesthesia
If conscious sedation or anesthesia are employed, who administers these?
The endoscopist
An anesthesiologist
Other (please specify)
6. What are the guidelines for disinfection of endoscopes and accessories in your country?
No generally accepted guidelines - each institution has its own
National guidelines developed by national GI/endoscopic societies
National guidelines mandated by governmental agency
7. In general, would you regard the approach to the disinfection of endoscopes and accessories in your country as...
Adequate
Inadequate
8. What are the major problems in terms of the disinfection of endoscopes in your country?
A. Are there particular or unique infections or infectious agents that cause problems with disinfection in your country" Please specify
B. Do cost concerns limit the performance of disinfection of endoscopes and accessories? If so, please specify.
C. Is there access to adequately trained personnel for the disinfection of endoscopes and accessories?
9. What is the average time taken to clean and disinfect an instrument between uses in your country?
--------------- minutes.
10. What is the disinfectant most commonly used in your country?
11. What do you perceive to be the greatest unmet need in the area of endoscopy in your country? Please list
A. Clinical problems that you feel would benefit from additional endoscopic expertise or technology:
B. The endoscopic procedures that you would most like to see developed in
your country.
Research Committee
Eamonn M.M. Quigley, Chairman (1994-1996)
OMED RESEARCH COMMITTEE, SAPRIL 1997
Following the resignation of Dr. Stiel, it
was my great honor to be nominated to succeed him as Chair of the Research Committee,
which became effective in May 1996. I now have the pleasure of updating you on current and
planned activities of the Research Committee. Several activities are currently in hand.
A major priority for the Research Committee is the development of an international
database on endoscopic priorities. If the Research Committee is to serve as a voice for
endoscopic research in the future it is clear that we need data to indicate the important
priorities for the development of endoscopy in various parts of the world. Each member of
the Research Committee has, therefore, been charged with compiling a list of the most
important diagnostic and therapeutic uses of endoscopy in their part of the world. This
data will be collated and should be of considerable assistance in the development of
research and educational strategies appropriate to different parts of the world. It is my
impression that, contrary to popular belief, endoscopy may, in fact, be a very important
and almost basic medical tool in many parts of the world, including the developing world,
yet priorities may be quite different.
In the past, the Research Committee, Omed and the World Congress have addressed the issue
of endoscopic disinfection. I am pleased to announce that the Organizing Committee of the
Vienna World Congress have asked me to chair a working party on minimal standards for
endoscopic disinfection. While this will be performed within the auspices of a separate
working party, the results of this group should be of considerable value to Omed and its
Research Committee. Along similar lines, the Omed Research Committee is also working to
develop a consensus document on minimal standards for the performance of endoscopy. Our
goal here is to establish, through data generated by members of the Research Committee,
what are, indeed, the basic requirements for the performance of diagnostic and/or
therapeutic endoscopy in various parts of the world. This information should, again, help
to provide an appreciation of variations in endoscopic priorities throughout the world,
help delineate areas of mutual interest and also assist in developing specific protocols
for different parts of the world. Building on this, we also hope to address the
standardization of accessory equipment.
A proposal for a multicenter study of Barrett’s esophagus, intestinal metaplasia and
adenocarcinoma is under review and proposal in the area of endoscopic hemostasis and
laparoscopy will be considered.
The Research Committee will meet in Washington DC, at the time of Digestive Diseases Week
– we anticipate lively discussion, and I look forward to updating you of the
continuing activities of the Omed Research Committee.
ACTIVITIES OF RESEARCH COMMITTEE OF OMED, APRIL 1998
In association with Dr. Jerome Waye, Chair of the Education Committee of OMED, the Research Committee has been working over the past several months to develop a comprehensive questionnaire on endoscopic priorities throughout the world. This has now been finalized and is about to be distributed to the constituent national societies of OMED. This questionnaire will address several areas, including what endoscopic procedures are performed, who performs them and what has been their training. The purpose is to develop a database on endoscopic practice, training and facilities throughout the world, to provide a basis for further education, training and research initiative in this area. We look forward to the active participation of the constituent national societies in this process and we hope that all of you will complete this questionnaire and, also, that you will communicate with either Dr. Waye or Dr. Quigley regarding any comments or criticisms on the questionnaire. We believe that this is a vital prerequisite to developing short- and long-term strategies for OMED throughout the world.
SUMMARY OF THE SURVEY CONDUCTED BY THE RESEARCH COMMITTEE OF THE S.I.E.D.
During 1997, the Research Committee of the Interamerican
Society of Gastrointestinal Endoscopy (SIED), conducted a survey directed to all the
Societies of Gastrointestinal Endoscopy within the Latin-American area on "Endoscopic
equipment, Accessories, Disinfection and Endoscopy training". As illustrated by the
response rate, the survey was well received among constituent societies. A total of 58
endoscopy centers completed the survey: 19 from Brazil, 18 from Argentina, 9 from
Colombia, 5 from Uruguay, 4 from Bolivia, 2 from the Dominican Republic and 1 from Peru.
Endoscopic Examinations:
Regarding the frequency of the various endoscopic studies, there was only minor variation
between centers: the most frequent studies being esophagogastroduodenoscopy (comprising
65% to 70% of all studies), colonoscopy (20% to 23%) and duodenoscopy (10% to 15%).
Endoscopic Equipment:
Only four of the centers used videoendoscopes exclusively. Most (30) used both
videoendoscopes and fiberscopes; a significant number (20), also utilized videocameras,
i.e., an adaptor connection to transform a fiberoptic image into a video image. Only 3
centers did no possess video equipment. Fiberscopes are, therefore, still widely used in
Latin American countries, even though videoendoscopes are increasing in popularity.
Of those centers that use fiberscopes, 80% use immersible equipment. Of importance in
relation to disinfection, 13% of all centers continue to use non-immersible endoscopes and
7% use both immersible and non-immersible. Given the fact that non-immersible equipment
has not been manufactured for several years, it can be concluded that a significant number
of centers still use this outdated equipment. Of all videoendoscope systems, 60% were
housed in endoscopy centers and 40% in public hospitals. This distribuction was similar in
all countries with the exception of Argentina where 75% of videoendoscopes were in private
and 25% in public centers. This difference in distribution may be explained by the fact
that, in Argentina, videoendoscopy is frequently reimbursed at a higher rate than
fiberoscopy. In 75% of responses from centers in all other countries, it was stated that
both types of endoscopy were reimbursed at a similar rate. It should be noted that 28% of
centers responding to the questionnaire did not answer this question; these conclusions
are, therefore, drawn from an incomplete sample.
Costs of Endoscopy:
Inquiries regarding fees charged for endoscopic studies provided widely variable
responses: charges for diagnostic videoesophagogastro-duodenoscopy ranged from U.S.$ 150
to 600, in various countries. In those countries where there was a difference in fees
between video and fiberoscopy (notably Argentina), fiberoscopy was reimbursed at half, or
even less, of the rate for videoendoscopy. In general, the fee quoted included the use of
the equipment and accessories, as well as, nursing support and other ancillary services.
The fee for therapeutic endoscopy varied widely and it was very difficult to draw any
conclusions.
Cleaning and Disinfection:
All centers performed manual cleasing of endoscopes and accessories with a neutral
detergent or an enzymatic soap and then disinfected with 2% glutataldehyde. Six centers
used ethylene oxide for accessories and only 4 used automated "washing
machines". Seventy-five percent disinfected equipment after each examination; 25%
performed this, only at the end of the day or following cases with known infectious
diseases.
With regard to who performs cleaning and disinfection, 41 centers stated that disinfection
is performed by trained paramedical personnel; 28 stated that disinfection is carried out
by the physician (in several centers both of those options were operative) and only 3
centers use operating room personnel who do not have specific training in endoscopic
cleaning and disinfection.
With regard to protection of staff: 100% of responders use gloves, 53,5% protective
goggles, 48,3% chin straps, 39,6% disposable aprons and 15,5% boots. Some centers took
precautions only in those cases where they knew that the patient was HIV (+).
Accessories:
With regard to access to accessories, 40 centers responded that accessories can be easily
obtained in their own countries; 15 experienced some difficulties and 3 did not answer
this question. The reasons for such difficulties included the following: high price,
absence of hospital budget, lack of stock in the country and a bureaucracy that hinders
purchase of accessories. When asked about what accessories are used in the different
centers, most (50) use well-known international brands; 12 (from Argentina and Brazil),
use national brands (domestically manufactured) and 9 (in Argentina, Bolivia and Brazil)
use self-manufactured accessories. Accessory prices vary widely. For example, the price of
a papillotomy knife ranged from U.S. $200 to 700 and a polypectomy snare from U.S. $65 to
500. In Argentina and Brazil, domestic brands are, on average, half the price. In Latin
America, accessories are, onaverage, twice or three times more expensive than in USA or
Europe and this is a major problem for endoscopy centers. All centers stated that they
re-use accessories that have previously been disinfected with 2% glutaraldehyde or
ethylene oxide.
Endoscopy Training and Certification:
With regard to gastrointestinal endoscopy training, all countries responded that their
gastroenterology residencies include training in gastrointestinal endoscopy; both
diagnostic and therapeutic. The location of such gastroenterology training is as follows:
University Center 51, Private Institution 19, Public Hospital 18. Thirty-five centers
responded that specialized, concentrated, endoscopic training experiences were available
in their country; in addition to a standard gastroenterology residency. The duration of
this additional endoscopy training is variable, but they generally last between one years
and two. With regard to the administration of these specialized endoscopic training
portions, 27 responses stated that these were administered by Universities, 12 by
Scientific Societies, 10 by private and 5 by other hospitals. When asked about wherether a
higher qualification in gastroenterology enables a physician to perform endoscopies, all
countries answered affirmatively except for Brazil where 14 Centers answered positively an
5 negatively.
With regard to the granting of certification in
gastroenterology and endoscopy, 25 answered that such certification is granted by
Scientific Societies, 20 by Universities, 16 by Medical Colleges and 9 by a giverment
Ministry. In some countries more that one mechanism was operative. In Peru, the Dominican
Republic and Uruguay, certification does not require a practival demonstration of
endoscopic skills. In other countries requirements appeared to vary. In Brazil 18 Centers
stated that a practical demonstration is required; one stated that it is not. In Colombia,
4 answered positively and 5 negatively; in Argentina, 2 answered positively and 16
negatively and in Bolivia, 2 answered positively and 2 negatively.
The last question was whether centers were prepared to receive foreign doctors for
endoscopy training. To this, 45 answered affirmatively, 6 negatively and 7 did not answer.
Nevertheless, in all countries that responded to the survey there is at least one center
willing to receive foreign trainees.
COMMENTARY BY EAMONN M.M. QUINGLEY, CHAIRMAN RESEARCH COMMITTEE OMED
Dr. Rainoldi and his colleagues are to be congratulated on
this important survey. This report illustrates that meaningful surveys are feasible an
worthwhile. Several important findings deserve emphasis. These include the persistence of
non-immersible endoscopes in a minority of centers and significant variations in policies
for cleaning, disinfection ,and staff protection.
Reflecting high costs and difficulties with accessory cleaning, re-use of accessories
following disinfection seems universal and should be contrasted with emerging policies
regarding single-use in Europe an North America. While the basic components of
gastroenterology training appear similar, the details of endoscopic training and
certification, in particular, vary considerably both between and within various countries.
Surveys such as this provide "real" data on endoscopic practive and should serve
as the basis for future projects in endoscopic research, training and education.
WORLD CONGRESS OF GASTOENTEREOLOGY, WORKING
PARTY
ON "MINIMAL STANDARD FOR ENDOSCOPIC DISINFECTION", May 1998
Intermediate Report
Present: Eamonn Quigley, MD (USA-Chair), Habib Ben
Khelifa, MD (Tunisia), Nestor Chopita, MD (Argentina), Axel Kruse, MD (Denmark), Kazuei
Ogoshi, MD (Japan), Rakesh Tandon, MD, PhD (India)
Excused Absence: Walter Bond, MS (USA), Alistair Cowen, MD, FRACP (Australia), Richard
Kozarek, MD (USA)
I)The following interns were distributed:
A. Monograph "Clinical Risks of Infection Associated with Endoscopy" by Dr. Cowen
B. Correspondence to Dr. Quigley from Dr. Bond, draft monograph, "Standard practice for the reprocessing of reusable, heat-stable endoscopic accessory instruments (EAI) used with flexible fiberoptic and video gastrointestinal endoscopes, Correspondence to Dr. Cowen from Dr. Bond regarding his monograph, monograph on "Disinfection, Sterilization and Antisepsis in Health Care", published by the Association for Professionals Infection Control in Epidemiology and draft from CDC on "Creutzfeldt-Jakob disease. Current epidemiology, risk factors and decontamination.
C. Comments on the draft proposal by Dr. Ben Khelifa
D. Comments on the experience in Latin America with endoscopic disinfection from Dr. Chopita
II) Dr. Quigley summarized the format and the order of presentation for the Working Party in Vienna. The presentation for the Working Party is scheduled between 4-6 pm on Monday afternoon September 7, 1998. Following a brief introduction by Dr. Quigley, three-20-minute presentations will follow as follows:
A. Walter W. Bond, MS "Microbiological Considerations in Disinfection and Endoscopy.
B. Alistai Cowen, MD "Clinical Risk of Infection Associated with Endoscop
C. Rakesh Tandon, MD "Endoscopic Disinfection – Practices and Recommendations for Endoscopes and Accessories"
1. This will be followed by a discussion within the panel with particular emphasis on experience in different parts of the world and on controversial issues, in particular, the reuse of accessories.
2. This will be followed by an open discussion and concluding remarks by Dr. Quigley.
III) The remainder of the meeting was taken up with a
detailed discussion of Prof. Tandon’s presentation on "Endoscopic Disinfection
– Practices and Recommendations for Endoscopes and Accessories". The details of
this presentation will be circulated to the members of the committee following receipt of
the complete document from Prof. Tandon. The most extensive discussion has surrounded a
number of areas which remain controversial.
These are as follows:
A. The issue of reuse of accessories. While it was agreed that some accessories such as sclerotherapy needles should never be reused, there was some divergence of opinion with regard to the reuse of some common accessories such as biopsy forceps and sphinctertomes, The problems here appears to be in relation to the cleaning of these accessories rather than their disinfection.
B. The other contentious issue related to the "soaking time" in disinfectant. This is clearly a major issue which has enormous impact, particularly in the developing world. Again, there was divergence of opinion varying from the 10 minutes recommended by the Gastroenterological Nurses Society of Australia and Gastroenterological Nurses Society of Australia to the 20 minutes recommended in Britain and Europe. Indeed, times of up to two hours had been recommended in some reports.
C. The issued of cleaning, manual vs. machine was discussed in some detail. With regard to manual cleaning, the importance of adequate training of personnel, adequate protection and adequate ventilation were emphasized. Some discussion took place with regard to automated systems, their potential benefits an limitations.
D. There was consensus that non-immersible instruments should not be recommended.
E. While most data relates to 2% glutaraldahyde, there are problems with its use, in particular, with the issue of sensitivity in personnel, which apparently has led to its prohibition in Germany and Denmark. What should the Working Party recommended as an alternative? Should this be paracetic acid or are there other possibilities?
F. Are there some infectious agents that we cannot protect against, in particular, prions and MAI? What should be our statement with regard to these?
G. What should be our position on alternative methods of disinfection such as thermal, superoxide water, etc? Should these be mentioned if there is insufficient data or availability?
IV) Dr. Quigley undertook to distribute the three
draft documents to all of the Working Party once these have been received.
There being no further business, the meeting was adjourned.
REPORT OF "AD HOC" COMMITTEES CHAIRMEN
Terminology and Data Processing Committee
Zdnek Maratka, Chairman (1994-1998)
TERMINOLOGY COMMITTEE REPORT, July 1993
The Committee of Terminology in Digestive Endoscopy was founded in 1976 by the European Scociety for Gastrointestinal Endoscopy (ESGE) and was raised to a Committee of the World Society (OMED) in 1978. Its activity has included regular meetings at the European and World Congresses of ESGE and OMED and elaboration of a standard endoscopic terminology suitable for daily practice and computer-aided endoscopic reports. The collaboration within the Committees in the three zones of OMED as well as continuing discussions have resulted in a series of publications, especially the manual of standard endoscopic terminology: Terminology, Definitions and Diagnostic Criteria in Digestive Endoscopy, 1st ed. [Scan J Gastroenterol 1984, 19 (suppl 103): 1–74]. The 2nd revised edition appeared in English (1989), German (1989), Italian (1989), Czech (1989), French (1990); all published by Normed Verlag, Bod Homburg, Germany. The Spanish, Portuguese and Norwegian editions are in preparation as well as the 3rd English edition. This book has been complemented by an atlas of endoscopic pictures presenting the most common findings with a standard description and interpretation (by the same publisher). Five video films have been produced by F. Costentino) documenting standard terminology in upper and lower digestive endoscopy (so far published in English, Italian and German). The publications and video films have been included in the educational programmes of endoscopic and gastroenterological societies.
TWENTY YEAR ANNIVERSARY OF THE OMED
TERMINOLOGY COMMITTEE, April 1998
The evolution of endoscopic terminology and nomenclature has been mentioned in previcus reports (1) but a 20 years anniversary of the committee gives the opportunity to recall the story shortly.
In the seventies the need for a standardized endoscopic terminology became more and more apparent and with the advent of computers was urgent. One of the first innovations which I introduced after being elected President of the European Society for Gastrointestinal Endoscopy (ESGE) in 1976 was founding the Terminology Committee. A round table conference was organized at the IV World Congress of Digestive Endoscopy in Madrid (1978) which aroused unexpected interest and incited inviting representatives of the other zones to participate in future activities. Thus the ESGE Committee was raised to an OMED Committee and since then bore the name Committee for Terminology and Computerization in Digestive Fndoscopy of the World Society of Digestive Endoscopy (OMED).The achievements of this committee during its 20 years existence can be summarized as follows.
First it was necessary to establish basic rules for endoscopic terminology. Three essential requirements were put forward:
1) Endoscopic terminology must be based on visual
perception and denomination of macroscopic features as seen through the scope.
2) Accepted terms must be classified and arranged in a system according to the character
of the finding; OMED’s classification distinguished nine categories of findings
referring to lumen, contents, wall, peristalsis, mucosa,
hemorrhage, flat changes, protrusions and depressed/excavated lesions. The list of all
terms belonging to the discipline represents a comprehensive database: the OMED
nomenclature.
3) The endoscope findings designated by appropriate terms specific for the endoscopic
method are interpreted in terms of clinical diagnosis by means of accessory methods like
biopsy, if necessary.
Developing a consistent endoscopic terminology was
considered to be the primary goal of endeavor. A draft was prepared and repeatedly
circulated to the members of the Committee and relevant experts to insure the greatest
possible consensus. At all international Congresses symposia and round table conferences
were held and the present state of the document was discussed and comments respected.
In 1984 the first publication appeared and gained wide acceptance; it was quickly
translated in other languages and updated in further editions (2). At present the forth
English edition is ready-to-print. In addition to the book, an atlas (3) and videos (4)
were published. A CD-ROM in 5 languages presenting gastroenterology as a discipline viewed
by the eyes of the endoscopist and using the OMED nomenclature was published under the
name Normedia-Gastro (5). All this work was accomplished thanks to sponsoring by
pharmaceutical and endoscopic industry companies as well as by perfect collaboration with
Normed Verlag, Bad Homburg.
The OMED nomenclature aims at being a possibly complete list of terms used in digestive
endoscopy organized in a hierarchical system and provided by definitions and diagnostic
criteria. Being such it should represent a fundamental database. For practical purposes
this exhaustive list can be tailored to suit different computer programs, e.g. Minimal
Standards for a computerized endoscopic database (6) facilitating a correct formulation of
endoscopic records. Customized databases of this kind, however, should use the
standardized nomenclature and should not depart from agreed categorization and
terminology.
It has been a privilege to chair the OMED Terminology Committee for these 20 years and to see its achievements being accepted by the endoscopic community and further developed by the ESGE Committee for Minimal Standards for Tenninology and Documentation in Digestive Endoscopy.
REFERENCES
Minimally Invasive Surgery Committee
Alberto Montori, Chairman (1994-1998)
THE IMPACT OF ENDOSCOPY
ON DIGESTIVE SURGERY
Having been trained as a surgeon in the
so-called pre-endoscopic era, I have no doubt that the impact of endoscopy on digestive
surgery has been tremendous. In an attempt to identify and analyse the key points of such
tremendous impact, I draw my readers’ attention to three different aspects.
The importance of endoscopy in obtaining early diagnosis, its influence on clinical
judgement and its role in surgery, by suggesting the most
appropriate surgical approach and technique through a correct diagnosis of the lesion.
The contribution of digestive endoscopy to a better knowledge of the pathophysiology
of several gastrointestinal diseases with enormous consequent benefit in the surgical
decision-making process.
The host of therapeutic applications which have become more and more widespread and
sophisticated and which have arisen because of the direct visual inspection that endoscopy
allows.
Therapeutic endoscopy has perhaps had the most visible impact in terms of reducing
morbidity and mortality in the emergency as well as in the high-risk patient. Its
application and the consequent refinement of indications for surgery has also produced a
reduction in the number of surgical operations performed and has shortened hospitalization
periods, thus producing a reduction in the cost of management of surgical patients.
In my opinion, endoscopy has also had an impact on the evolution of digestive surgery. In
fact, the same principles of flexible endoscopy have inspired the diffusion of
"minimal access surgery" via laparoscopy, which represents a great progress in
gastrointestinal surgery.
On the basis of these brief observations, I recommend that gastrointestinal endoscopy be
considered a complementary aid to surgery and not a contrasting technique. It has led to a
multidisciplinary approach to the gastroenterological patient and to a better co-operation
between physicians and surgeons.
FIRST CLINICAL APPLICATIONS IN TELESURGERY
PRESENTED AT 6TH WORLD CONGRESS OF ENDOSCOPIC
SURGERY IN ROME, JUNE 1998
Based on recent scientific and clinical experience of the
first applications in telesurgery, the 6th World Congress of Endoscopic Surgery in Rome
added two special sessions to include presentations by Professor Guy-Bernard Cadiere, of
St. Pierre Hospital in Belgium, and Doctor Anno Diegeler, of the Leipzig Heart Center in
Germany. These two surgeons were invited to present their initial results and experience
using the Intuitive computer-enhanced surgery system.
Professor Cadiere performed the world’s first computer-enhanced Nissen Fundoplication
procedure and Doctor Diegeler and his team performed the world’s first videoscopic
coronary artery bypass surgery.
The World Congress of Endoscopic Surgery provides a scientific forum in which to debate
and exchange scientific experiences in the field of Minimally Invasive Surgery. While
moving toward the next millennium, technologies such as this system will be one of the
most significant advancements in endoscopy, helping to redefine minimally invasive surgery
as we know it today.
Intuitive is developing a computer-enhanced minimally invasive surgery system that uses
proprietary electronics, advanced robotics, and enhanced visualization to greatly improve
surgical technique and take surgical precision far beyond what is possible today.
The system is a new surgical technology intended to eliminate the major obstacles to
widespread adoption of Minimally Invasive Surgery. It is designed to transform a broad
range of open procedures to Minimally Invasive Procedures by making MIS more precise and
easier to perform.
Using state-of-the-art computing, sophisticated software and highly-specialized
micro-surgical instruments, this system combines the natural hand movements used in
traditional open surgery, with the less traumatic approach of Minimally Invasive Surgery
– thereby delivering the best of both techniques.
Using this system, surgeons will perform procedures seated at the console while viewing a
high-resolution 3-D video image of the surgical field.
The surgeon’s hands rest below the monitor and hold instruments that provide the
flexibility of those used in open surgery. Highly-specialized technology simultaneous
transfers the surgeon’s exact hand movements made at the console to precise
microsurgical movements of the instruments at the operative site.
With this remote control it is nowadays possible to operate with precision and these
surgical procedures can be done based on scientific and clinical experience of the
application in telesurgery.
ULTRACISION – THE ARMONIC SCALPEL
As we know, electrosurgical units are more often based on
monopolar energy sources which transmit the electrical power to the patient by means of a
metallic pad placed on the skin. Once the surgeon activates the unit, a flow of electrical
energy passes through the patient tissues and, according to the frequency and intensity,
cauterisation or cutting is obtained.
Complications from the diffusion of energy to healthy structures or skin burns are
frequently reported. Armonic dissection is a totally different approach to obtain
sectioning of tissue and simultaneous hemostasis with no risks of inadvertent injury to
the surrounding structures.
The Ultracision – Armonic Scalpel is composed by a current generator connected to a
piezoelectric transducer which is located inside the handle used by the surgeon. The
transducer transforms the electric power into mechanic energy, then transferred to a
blade. The blade vibrates linerly for a distance varying between 50 and 100 microns at a
frequency of about 55,000 times per second. The blade is incorporated in a mechanism in
the shape of scissors. Only tissues incorporated by the surgeons between the two blades
undergo the mechanical dissection energy. Low temperature heath is generated, which
contributes to vessel coagulation without carbonisation of tissue, a normal effect of most
monopolar electrosurgical units.
Therefore, Armonic Dissection and Ultracision guarantee one of the most precise and less
invasive dissection methods available today provided by Ethicon Endo-Surgery a Johnson
& Johnson Company.
OMED POSTGRADUATE COURSE ORGANIZED
WITHIN THE 6th WORLD CONGRESS OF ENDOSCOPIC SURGERY Rome, JUNE 1998
The Postgraduate Course was organized under
the auspices of the OMED, the EAES and the SAGES. The coordinators were J.R. Armengol
Mirò, M.D. and M. Crespi, M.D. for OMED, Sir A. Cuschieri, M.D. and J.J. Jakimowicz, M.D.
for EAES and J. Ponsky, M.D. and G. Van Stiegman, M.D. for SAGES
This interesting and successful Course was followed by 322 participants for 10 hours a
day.
This Postgraduate Course with live interactive demonstrations (16 patients operated in 2
days) with Satellite connection with the Auditoruim of Alitalia where the Nurses’
Seminar took place and with the Hospitals in Milan and Taranto.
The Postgraduate Course was dedicated to "Diagnostic and Interventional Flexible
Endoscopy; Interventional Radiology and Endoscopic Surgery: Competing, Complementary,
Combined?". The contribution and participation of about 40 specialists in the
different minimally invasive methods has brought up the possibility of managing patients
through a cooperative efforts. When involved in the management of patients, only the
knowledge of the possibilities and limits of each diagnostic and therapeutic approach
makes it possible to achieve the best outcome with the lowest morbidity and costs. The
Postgraduate Course has been focused mainly on all management options of digestive
diseases of surgical interest, including interventional radiology and flexible endoscopy,
with updating of all new-coming technologies, from the ultimate imaging technologies to
the future role of telerobotics and virtual reality. The technological evolution has been
indicated as the path for future wider and wider application of the principles of
Minimally Invasive Surgery.
Nonetheless, technology has not been the only commitment of the Course, where special regard has been given to the study and treatment of pre-cancerous lesions, early cancers and other malignancies. Therefore, at the end of the Course, the new profile for the Surgeons of the 3rd millennium has been drawn: an expert in sophisticated technology; good hand skills but also deep cultural roots.
Ethics Committee
Endoscopy and ethics, May 1996
ENDOSCOPY AND ETHICS, MAY 1996
Hippocrate’s Oath has been considered as the
physicians’ legal and moral code in the whole world for twenty two centuries.
The Code of Nuremberg defines the conditions in which experiments on human subjects may be
authorited. The difterent Ethics Committees, and more recently, Laws about Bio-Ethics
attest of the fundamental questions that science and medical technics improvements bring,
modifying continuously what gives the worth to life and death to Human being Endoscopy in
Gastroenterology, and the permanent development of its diagnostic and therapeutic
possibilities, raise new questioning about medical power and medical know how.
Concerning this invasive procedure, Ethics defines collective rules of "logic"
and "good practice" that can’t be limited in their dimensions by an
individual choice.
These measures allow to establish some rules of conduct we must respect to avoid drifts
regarding the patient and the technique.
Even if these basic principles seem obvious and established, to ensure patient’s security ancl cornfolt before, during and after intervention.
ETHICS COMMITTEE REPORT
Among the activities of the Committee, is the publication
of the book "Medical Ethics in Gastroenterology and Digestive Endoscopy: changing
concepts in a changing world" Editor J. Escourrou, with articles from N Antaki
(Syria), Ben Khelifa
- A. Kilani (Tunisie), M.A. Latorzeff - J. Escourrou (France), J. Campos (Colombia), F.
Villardell (Spain), M.C. Milano (Argentina), J.H. Solhaug (Norway), B.H. Novis (Israel),
C. Francesconi (Brazil) - C. Stanciu (Romania).
The passionate and competent work of Professor Escourrou during his chairmanship of the
OMED Ethics Committee has produced a booklet which will be, for several years, a reference
text for gastroenterologists and endoscopists. This book is distributed at the World
Congress in Vienna and is available through the OMED Secretariat.
In a changing medical world, characterized by an
increasing confrontation with administrative rules, budget restrictions, litigations, but
also with a decrease of compassion and distorted human relationships, the doctors are
confronted too often with difficult and sometimes painful decisions. This publication,
which faces these problems from different points of view, will refresh to all of us our
duties and obligations and give us the opportunity to stop for a while and ask ourselves:
where we are?
We may be proud that Professor Jean Escourrou and his co-authors, under the auspices of
OMED, were able to produce such a valuable reference work.
Medical Ethics, Gastroenterology and Digestive Endoscopy : changing concepts in a changing world
Editor Prof. Jean Escourrou, Chairman of the OMED Ethics
Committee
An OMED Newsletter Publication
Editor: Prof. Alberto Montori
Co-Editor: Prof. Massimo Crespi
Rome, Italy 1998
The passionate and competent work of Professor Escourrou
during his chairmanship of the OMED Ethics Committee has produced the present booklet
which will be, for several years, a reference text for gastroenterologists and
endoscopists.
In a changing medical world, characterized by an increasing confrontation with
administrative rules, budget restrictions, litigations, but also with a decrease of
compassion and distorted human relationships, the doctors are confronted too often with
difficult and sometimes painful decisions. This publication, which faces these problems
from different points of view, will refresh to all of us our duties and obligations and
give us the opportunity to stop for a while and ask ourselves: where we are?
I am proud that Professor Jean Escourrou and his co-authors, under the auspices of OMED, were able to produce such a valuable reference work. Thank you Jean, thank you all.
Professor Massimo Crespi President OMED
FOREWORD
Sir Thomas Percival was the first to recognize the necessity of collective thought on the
development of new medical procedures back in 1803. The first " Ethical
code " concerning research on human beings was developed after the Nuremberg
trial, and has since been completed at different meetings.
As Greenberger said, Ethics is a domain of truth or error,
where intelligent and sensitive people can sincerely differ. Indeed, countries can have a
different conception of Ethics according to the different social values and/or religions
in a given society. This concept is constantly questioned due to progress in the fields of
biology and medicine. It is not uniform or static, and doesn’t concern medicine
alone. Contrary to morals which are based on individual conscience, the notion of ethics
is decided on, is arbitrary and must correspond to a collectif consensus ;
In this work, the reader will find the reflections of authors from different countries on
existing ethical relationships in numerous fields. Thus, N. Antaki (Allepo, Syria) has
analysed particularly well the link between ethics - the goal of which is the common well
- being, and morals, which correspond to personal obligations. Habib Ben Khalifa (Tunis)
has developed the duties of the gastroenterologist, especially as regards the need to
follow the procedure according to the rules, yet respecting the ethical aspect. From this
point of view informed consent is the basis of the respect of the patient. The evolution
of means of communication and data-processing mean that new problems concerning the
respect of the medical secret have arisen. These two aspects have been particularly well
analysed by J. Campos (Bogota) and F. Villardell (Barcelona). The limitation of financial
means generates a real conflict when it comes to respecting ethics. The same is true for
ethics and scientific progress, dealt with by Claudia Milano (Buenos -Aires) and J.
Solhaug (Oslo) Numerous practical elements concerning Helicobacter Pylori are illustrated
in the chapter by B. Novis (Tel-Aviv). Finally I would like to thank C. Stanciu (Roumania)
President of the Ethical Committee of the WGO (World Gastoenterological Organization)
together with Carlos Francisconi (Porto Alegre, Brasil) for having dealt with the
responsibilities of Ethical Committees when faced with the different problems that
transgress this notion. This notion of ethics that requires each thing and every act to be
in the right place. This book should enable physicians in general, and gastroenterologists
in particular, to exerce their activity whilst respecting restraints and the four basic
principles which are the very backbone of Ethics : -the respect of the invidivual,
-the respect of knowledge, -the responsability of the researcher and -the refusal of
profit.
Jean Escourrou, France
AUTHORS
ANTAKI Nabil MD. President of the endoscopy section of the
Syrian Society of Gastroenterology,
PO BOX 6448 Aleppo - SYRIA
BEN KHELIFA Habib MD. Gastroenterology Unit – Hopital Habib Thameur Tunis - TUNISIA
CAMPOS Jaime M.D. Associate Professor, Dean,Faculty of
Medicine. National University of Colombia
Bogota - COLOMBIA
ESCOURROU Jean M.D. Professor of Hepatogastroenterology,
University Hospital Rangueil
31403 Toulouse - FRANCE
FRANCISCONI Carlos M.D., FACG, Chief, Gastroenterology
Division, Hospital de Clínicas de Porto Alegre,
BRAZIL
KILANI A. MD. Gastroenterology Unit – Hopital Habib Thameur, Tunis - TUNISIA
LATORZEFF Marie Ange MD. Hospital LA GRAVE,Toulouse - FRANCE
MILANO Claudia, M.D. Specialist in
Gastroenterology.Specialist in Clinical Oncology.
Hospital Nacional Profesor Alejandro Posadas, Buenos Aires - ARGENTINA.
NOVIS B.H. MD. Meir Hospital, Kfar Saba and the Sackler
School of Medicine, Tel Aviv University
ISRAEL
SOLHAUG Jan Helge M.D. Dept of Surgery, Diakonhjemmets Sykehus, Oslo - NORWAY
STANCIU Carol, MD. University Hospital " St. Spiridon " Iind Medical Clinic Gastroenterology B-dul Independentei 6600 Iasi - ROMANIA
VILLARDELL Francisco, MD DSc FRCP FACP Postgraduate School
of Gastroenterology,
Autonomous University, Hospital Sant Pau Barcelona - SPAIN
CONTENT |
|
| ETHICS AND RELIGION N. Antaki |
1 |
| DUTIES OF THE ENDOSCOPIST Ben Khelifa - A. Kilani |
6 |
| DOCTRINE OF INFORMED CONSENT M.A. Latorzeff - J. Escourrou |
18 |
| ETHICS AND MEDIA Campos |
23 |
| ETHICS, ENDOSCOPY AND COMPUTERS Villardell |
29 |
| ETHICS AND MONEY A view of ethics, money and collective resources. M.C. Milano |
40 |
| ENDOSCOPY AND CLINICAL TRIALS J.H. Solhaug |
47 |
| HELICOBACTER PYLORI DIAGNOSTIC AND THERAPEUTIC MEASURES : ETHICAL ASPECTS B.H. Novis |
60 |
| BIOETHICS COMMITTEES C. Francesconi - C. Stanciu |
66 |
ETHICS AND RELIGION
N. ANTAKI
Ethics and Morals have etymologically the same meaning,
Ethics stemming from the Greek ethos and morals from the Latin adjective moralis (1). But,
in reality, these two words convey two different concepts. For a long time, morals,
defining the good and the bad, were used as a reference, as a rule of conduct for science
which had to abstain from everything that was morally bad. It can be of religious or
philosophical inspiration. Religious morals, taking its roots in faith, doctrine, sacred
texts and tradition, can differ according to the different religions; this is why there
are several religious morals as opposed to just one. For the catholic religion, for
example, moral conscience urges to love, to call upon the good and avoid the bad (2). It
prescribes to man the ways and rules of conduct leading to the promised beatitude (3).
Morals takes its roots in the faith that man was created as the image of God, and that God
made the total gift of himself in Jesus his son; this faith is the basis of catholic moral
precepts which respect life and human dignity.
Morals concerns what "should be" as opposed to "what is". It is
defined by four essential lines (4-5): inwardness: which calls upon one's own conviction,
one's own implication. It is not a simple exterior conformity.
Idealism: Morals is demanding, it suggests an ideal, it leads to a better self. It even
demands heroism in certain cases.
Universality: its precepts and authority extend to all men.
Immutability: it is permanent whatever the changes in history. But with the passing of centuries, societies no longer had in common à unanimous religious tradition nor a belief in the universality of moral faith inscribed in the heart of human nature, which replaced it since the age of enlightenment. we cannot assume that we all have the same concept of what is good.
Medical ethics were born because, on the one hand, the
world and societies became pluralists and one cannot impose à specific moral to all. We
have been lead to tolerate, for moral reasons, what we sometimes ourselves condemn for
moral reasons (6); and on the other hand because religious morals have sometimes been
unable to face new situations in the biomedical field.
It was attempted to set up the rules of common morals, named ethics, applicable to all,
ranging from the texts of the Human Rights to the rules established in Nuremberg and in
Helsinki. Then the legislator intervened by voting the bioethic laws.
These ethics are the putting into practice of principles of different origins and place
themselves downstream from morals. Instead of being à moral of conviction (religious) it
has become a moral of compromise (7). For some, it represents the smallest common
denominator acceptable by all. For others, this compromise is meant to bring the different
elements of society together on demanding issues (8)
Civil ethics have replaced, in the biomedical field,
religious morals. If morals is defined by inwardness, idealism, universality and
immutability, bioethics is on the contrary (9): pluralist = aiming to protect diversities.
minimalist = it is realistic. A law which is inapplicable is a bad law
exteriorized - it demands exterior obedience and does not care about personal feelings.
circumstantial = it addresses particular communities at a given time.
Bioethics presents itself as an alternative, although
complementary, to indifference or the incapability of morals to establish a dialogue with
the sciences of life (10). But it is admitted as evidence that ethical decisions are
precarious and in a large measure arbitrary because they are the result of negotiations
which can be challenged as new generations of speakers take part in the debate (11).
Religion and ethics meet on many issues. They can nevertheless diverge on important
matters such as voluntary interruption of pregnancy, contraception, in vitro fertilization
... In gastroenterology and in digestive endoscopy, ethics and religions have identical
positions on many issues.
Ethics and religion in gastroenterology
Many issues in the practice of gastroenterology and digestive endoscopy raise ethical
problems such as organ transplants, blood transfusion, medical responsibility, clinical
research and experimentation on humans, euthanasia and informed consent. 0n many of these
issues, the different religions have a similar approach and a similar attitude. The
religious approach considers that issues relating to the respect of the human being, its
integrity and life cannot be resolved by simple reference to conscience, be it common or
universal, but by reference to Faith, doctrine and sacred texts.
As far as the position of the different religions on gastroenterology ethics is concerned,
it varies according to the problems. The different religions are unanimous in allowing clinical
research and experimentation on man as long as they do not represent a threat
to the life or health of the volunteer, that he has given his free and informed consent
and that their aims are therapeutic.
They are unanimous in prohibiting active euthanasia
as nobody has the right to take away life even if the person concerned is in a vegetative
state of life, because as stipulated in the Jewish Theology, a fraction of infinity stays
infinity (12). If there are controversies on passive euthanasia, all religions
nevertheless agree not to confuse the maintenance of life and therapeutic relentlessness.
Informed consent and medical responsibility also make unanimity and medical ethics meet
the morals of the different religions on these issues. Blood transfusion is
acceptable and even desirable for all religions except, for Jehovah’s witnesses
(13-16). Even in 1927, well before the perfecting of transfusion techniques,
Jehovah’s witnesses explained that according to the Alliance concluded between
Jehovah and Humanity, no blood should be consumed in order to respect the sacred character
of life. Based on this doctrine they quoted the formal command given by God to Noah:
"Everything that moves and has life will be your nourishment. But you will not eat
flesh with its soul, that is to say blood. You will be answerable to me for your blood
" (GN 9:3 . 5). According to them, this ban was permanent and involved all those
wanting to remain faithful to the Alliance. It is for Jehovah’s witnesses a
fundamental belief, à conviction with profound implications as it touches their eternal
salvation.
During the decades following the declaration of these principles by their religious leaders, the witnesses have remained attached to the belief that one cannot accept blood even in life-threatening situations. They have rejected most of the new techniques refusing not only total blood but also red cells concentrates, plasma, white blood cells and platelets.
However there are a few methods on which their position is not as clear. It is the case of albumin, immunoglobulins, and preparation for hemophiliacs. Laws and jurisprudence are currently clear enough to allow Jehovah’s witnesses to refuse transfusions and to clear hospitals and doctors of their responsibility. The position is clear and without ambiguity: the patient’s will must be respected on condition that it is freely expressed. The discovery of the hepatic virus .B, C and G and the ravages of Aids have given more arguments to those who reprove transfusion against somebody's will, transfusion not being as safe as doctors once thought. Refusal of transfusion can go against the personal morals of the doctor, telling him to do everything to preserve the life and health of his patient, but bioethics bases itself on the immutable principle of respecting the wish of the person who has the right to refuse a treatment even at the cost of his life.
Let us now talk about organ transplants. Religious morals
and medical ethics admit that transplants should be a gift, clear, free and anonymous. In
addition, most religions have in common (17):
- The respect of the wishes of the deceased.
- The certainty of the irreversible character of death.
- The respect of the appearance of the corpse.
Unanimously a preliminary consent is requested from the donor (free consent and revocable
at any time), that the gift is free, based on the principle of the non patrimoniality of
the human-body (free, anonymous and non- patentability of the body and its parts) (18). In
addition, they proclaim that transplants should only be carried out with the therapeutic
aim to save a human life and not to experiment.
On all these points, the Catholic, 0rthodox, Protestant, Muslim, Buddhist and part of
Judaism religions agree. 0n the other hand, Hinduism and Shintoism are against
transplants, this is why there are virtually no hepatic transplants in Japan except from
partial transplants from live donors (19-23). The problem lies with the criteria of the
definition of death. For the above mentioned religions and for ethics, the death criteria
is cerebral death, which allows the taking of viable organs. 0n the other hand, for Islam,
the death criteria is not the cerebral death, but the definitive stopping of the heart
(24), therefore making it impracticable to transplant from dead donors. But a progressive
tendency (rejected by the strict Islam) accepts, since the Amman Conference of 1986,
cerebral death as an alternative to the definitive stopping of theheart in the definition
of death.
For strict Judaism, death is defined as the simultaneous abolition, total and
irreversible, of the respiratory, cardiac and neurologic functions, making transplants
impossible. But the favorable tendency towards transplants has increased thanks to two
ideas (25):
- The kidney taken and transplanted is alive again due to the transplant and therefore outside the laws on the respect of the body.
- The transplant aims at saving the life of the receiver and it prevails on all the interdictions of the Torah.
Remains the problem of the consent. If the informed, clear and revocable consent is an essential condition for all religions, two divergent points emerge:
- For Islam, even if a donor has given his consent while
still alive, it is the right of his heirs to dispose of his body after his death. They can
annul the consent given and refuse the organ donation expressed by the deceased (26). On
the other hand, to increase the number of organs to be transplanted, some laws no longer
request a clear or active consent and accept a presumed consent, i.e. the non-refusal of
transplant by the donor while still alive.
As far as organ transplants from a live donor are concerned (partial liver), religions and
ethics accept this as long as there are no other alternatives and if there is no negative
impact on the life or health of the donor and if the consent is given freely (quid
psychological pressure on a parent donor to his child?).
Finally we are heading for the concept of the death of the Brainstem as opposed to
cerebral death.
REFERENCES:
- GOLD F,, Ethique, éthique medical, bioéthique. Repères et situation
éthiques en médecine. Ellipses, 1996. 10-18.- GAUDIUM et SPES, Ch, 16, Concile Vatican II
- CATECHISME DE L'EGLISE CATHOLIQUE, Mame/Pl on, 1992;405
- CATECHISME DE L'EGLISE CATHOLIQUE, Mame/Plon, 1992;406-407
- DURANT G La bioéthique, méthodes et fondement, Les cahiers scientifiques,
Montréal, ACFAS, 1989; p.87-96- FAGOT.LARGEAULT A., La réflexion philosophique en bioéthique. Les fondements de la bioéthique, De Boeck, Université, 1992, p, 11-26
- GOLD F., Ethique, éthique médicale, bioéthique. Repères et situations
éthiques en médecine. Ellipses, 1996,p,10-18- GOLD F., Idem
- DURANT G Ethique, droit et régulation alternative. Les fondements de la
bioéthique, De Boech Université, 1992, p.63-75- DOUCET H., la contribution du théologien en bioéthique. Les fondements de la
bioéthique. De Boech Université, 1992, p.49-62- FAGOT.LARGEAULT A., La réflexion philosophique en bioéthique, Les cahiers
scientifiques, Montréal, ACFAS, 1989, p. 3-16- GUEDJ P; La recherche médicale dans le Judaïsme, la lettre de RAMBAM, Medica Judaica 23:11
- DEVINE R., Save the Body-Lose the Soul; Health Progress, June 1989
- THOMAS J.M. Meeting the surgical and ethical challenge presented by Jehovah's
Witnesses, Canadian medical association journal, vol 128 1153-1154, 1983- GARAY A., GONI P., La valeur juridique de l'attestation de refus de
transfusion sanguine. Les petites Affiches, N 97, p.14-18, 1993- JAMA, vol. 246,2471-2472, 1981
- JACOB I., prélèvements d'organes, Revivre, N° 54, 1992
- Loi N 94-654 du 29 Juillet 1994, le dictionnaire permanent Bioéthique e
Biotechnologies, Editions législatives.- KREIS H., Ethique et transplantation, Administration numéro spécial,
p;37-49, 1997- VERSPIEREN P. Transplantation et catholicisme, Administration numéro spécial p.51-53, 1997
- BOUBAKEUR D., l'Islam et la transplantation, Administration numéro spécial,
p.57-60, 1997- BOTBOL E., Ethique Juive et transplantation d'organes, Administration numéro
spécial, p.61-64, 1997- ABEL 0., l'éthique protestante, Administration numéro spécial p.65-66, 1997
- .ALBOUTI S.R., kadaya fikhiye mouassira, edition Farabi-Damas p.128-131,1994
- NAJMAN A., Greffes d'organes, une éthique de la décision, la lettre de RAMBAM, Médica Judaica N° 20, p.11-13
- ALBOUTI S.R., kadaya fikhiye mouassira, edition Farabi.Damas p.132, 1994
- THOUVENIN D., Les règles juridiques organisant l'activité de transplantation
- d'organes, Administration p.29-36, 1997
DUTIES OF THE ENDOSCOPIST
H. BEN KHELIFA, A. KILANI
INTRODUCTION
PRIMUM NON NOCERE
Gastro intestinal endoscopy (G.I) is neither infallible nor absolutely safe, and thus
becomes a subject of medical ethics which rely on 2 principles (1) :
1/Autonomy of the endoscopist,
2/Beneficence, nonmaleficence and justice for the patient.
The endoscopist must always consider the patient’s best interest and keep in mind
that diagnostic and therapeutic safety are foremost, and that endoscopy is not solely
guiding the endoscope. So, the duties of the endoscopist play in 3 ways :
COMPETENCE OF THE ENDOSCOPIST
Competence in endoscopy assumes a combination of technical and cognitive skills, and
requires correct interpretation of abnormal findings. In most countries the proper
background is considered to be a formal postgraduate training in gastroenterology.
a)Training :The trainee must learn when
endoscopy is indicated
(2 , 3 ) , how to reduce the possible danger of a false diagnosis, and of an iatrogenic
lesion, and how to use endoscopically derived informations in clinical practice ( 4
). An ethical problem arises in teaching endoscopy (8). The welfare of the patient must
always be ensured , so that he is never endangered or exposed to excessive discomfort by
the teaching process.
b) Maintaining competency in endoscopic skills is mandatory ,and so, the
learning process does not stop at the end of the training period, but should be an ongoing
educational process (6-7-8). It is imperative that the endoscopist documents his
continuing education effort in the rapidly developing field of GI endoscopy. Self training
must occur on a background of basic endoscopic skills , and each endoscopist must
assess when additional formal training is necessary before undertaking a new kind of
endoscopic procedure (6).
THE ENDOSCOPY UNIT
The endoscopy unit should be properly designed and establish guidelines to render the
examination efficient and safe (1O) with :
PREPROCEDURAL ASSESSMENT
a) Endoscopic competence of the endoscopist and his staff and appropriate endoscopy suite. These problems were discussed above.
b) Infection control,
c) Sedation and monitoring ,
d) Personal and expanded duty ,
e) Endoscopic complications, claims and risk management ,
f) Quality assurance.
The endoscopic devices must be considered semi-critical
material and should therefore be sterilized or at least receive high level disinfection.
Liquid chemical agents are used almost exclusively for disinfection. Several alternative
preparations are recommended : Of these glutaraldehyde at 2 % concentration is
the disinfectant most used and recommended as a first choice in various International
guidelines (2O). The disinfection of accessories must be of a high level. The re-use of
accessories labelled " for single use only " as a potential means to
reduce costs has not been carefully evaluated, but should be allowed only if disinfection
is effective (22).
A recent study was reported about the use of acidic electrolytic water potency for
endoscope disinfection, safety for the tissues of the subject, and low cost (19 ).
As regards the time of contact between the disinfectant and the endoscope, not less than
1O minutes are recommended. Mechanical cleaning is the first and most important step,
followed by high-level disinfection .The protection of the personnel is also important.
Standards to prevent contact with infectious blood or body fluids must be maintained.
Recent document on disinfection has been published on behalf of the ESGE (19).
Prophylactic antibiotics are recommended by ASGE (21) in patients with prothetic valves
and surgically constructed systemic pulmonary shunts. For the British Society of
Gastroenterology (16), it is also recommended when the patient is at a high risk of
endocarditis, or of symptomatic bacteraemia as a consequence of immunosuppression or
neutropenia. In most circumstances, parenteral Amoxicillline and Gentamycin are
recommended. The addition of Metronidazole is needed in patients with neutropenia.
Antibiotics prophlaxis is also recommended for all patients undergoing ERCP with evidence
of biliary stasis or pancreatic pseudo-cyst ( 22 ).
a) Sedation : consists in reducing the level of
consciousness induced by medications used to facilitate acceptance of endoscopic
procedures and to increase the comfort and safety of the examination (2). Benzodiazepines
are the most commonly used agents in endoscopy and the most frequently prescribed drugs
are Diazepam and Midozolam. Analgesia is almost associated, induced by the use of
medications primarily opiates. Intravenous sedation is certainly worth recommending,
especially for therapeutic endoscopic procedures ; however, it has been clearly shown
that it carries significant risks ( 26, 33).
b) Monitoring : ( 27,29) is mandatory and prudent, and consists in the continuous
assessment of the patient’s status, before, during, and after the administration of
sedatives. It improves the outcome, by decreasing the risks of sedation and of the
procedure, and should detect early signs of patient distress, before compromise to vital
functions occurs. Most endoscopists are currently employing electronic monitoring
equipment , but the best monitors of a patient’s safety are the physicians and
skilled assistants working as a team. Nothing replaces clinical assessment, and it is
important to underline that the ultimate responsibility for protecting patients lies with
the endoscopist and cannot be assigned to an assistant or an electronic monitoring device.
However, both may greatly improve the ability to detect patient distress in time ,
when intervention will prevent an otherwise adverse outcome.
Emergency assistance, as well as transport to local intensive care units should be readily
available. Whenever possible and appropriate the cooperation of an anesthesiologist will
avoid a lot of problems and reduce the responsibilities of the endoscopist .
c) Standard clinical monitoring should include heart rate, blood pressure and respiratory
rate, before sedation, during the procedure and immediately after , as well as before
discharge from the recovery area. Oxymetry is useful for detecting decrease in oxygen
saturation which usually carries little clinical risk. Continuous electrocardiographic
rhythm is also used. Devices are now available to monitor all these parameters.
d) Out patient and sedation :
The standard practice as documented by multiple surveys ( 25, 27) is to carry out
digestive endoscopy as a routine on an outpatient basis. It is also important to note that
one half of the world regards upper G.I endoscopy without sedation as being the
norm , and some authors suggest that endoscopy without sedation should be encouraged
for routine examinations ( 32). The safety aspects point strongly to increased use of
topical pharyngeal anesthesia and the reduction in the use of sedation ( 24). The use of
throat spray for diagnostic endoscopy is quite acceptable to patients in routine
diagnostic uppergastrointestinal endoscopy as it improves tolerance and facilitates
examination (28, 29).
In fact, the vast majority of endoscopic procedures can be performed without sedation (
32).
a) Define instances that place the endoscopist at risk
b) Determine the frequency and significance of these instances,
c) Apply risk treatment to individual cases,
d) Develop remedial and preventive measures.
There are several simple and easy risk techniques which can be incorporated into practice routine (47).
The occurrence of complications is not malpractice per se, whereas the failure to make a timely diagnosis of the complication, may be. Documentation is the shield against malpractice claims.
There is no simple definition of quality (1, 51). The purpose of standards and guidelines is to institute a more appropriate use of gastrointestinal endoscopy resulting in improved patient care which is a natural consequence of standards. Quality improvement in endoscopy directs attention to the procedure and the endoscopic unit. Endoscopic practice should be reviewed regularly by a committee of endoscopists. Individual physicians could also be reviewed on the management of cases falling outside a predetermined " threshold ". Again a comprehensive and standardized documentation would provide information for in-depth evaluation of specific aspects of patient care related to endoscopy.
CONCLUSION
Diagnostic and therapeutic safety in endoscopy is foremost. This implies formal training
and maintenance of competence of the endoscopist . The endoscopic unit should have
guidelines, and be well organized. The procedure implies good standards of care, including
a preprocedural consultation to document all information about patient and disease, to
discuss the aim of the procedure, the benefits and the risks, and to obtain an informed
consent which is the best risk management tool.
The risk of infection is real, and depends on cleaning and disinfection. Therefore, a high
level of disinfection of the endoscopes is needed. The most critical part of cleaning is
mechanical. Sedation with monitoring is an important part of the examination . The
physicians and skilled assistants are the best monitors of the patient’s safety. The
occurrence of complications is not malpractice per-se, whereas the failure to make a
timely diagnosis of the complication, may be. Documentation is the shield against
malpractice claims.
Evaluation of the examination performance is necessary to maintain, or even improve the
quality of care. Testing the appropriateness of indications, and of the use of a specific
examination or treatment is an integral part of the quality of medical care.
Unfortunately, in the developing countries these problems must be considered in other
terms, as related to the great number of examinations, the low number of endoscopes,
manpower shortage and also to the absence of specific areas reserved for endoscopy.
BIBLIOGRAPHY
DOCTRINE OF INFORMED CONSENT
M.A. LATORZEFF - J. ESCOURROU
INTRODUCTION
Advanced medicine; biomedical research, scientific development and strategies, have caused
a proliferation of choices in medical therapies.
More efficient, medicine has also become more harmful; more daring techniques, more active
therapies are associated with increased and perhaps unknowable risks.
If surgical or medical therapeutic imprudences are sanctionnable, taking risks is also a
factor of progress that allows us to give patients additional chances, on condition that:
- risks are identified
- assessed by the physician,
- proportional to the seriousness of the illness
- honestly explained to the patient , in order that he could take share the decision.
DEFINITION
Informed consent is the name for the general principle of law which states that a
physician in a non-emergency situation has an obligation to inform a patient of
"those risks, benefits and alternatives" which a reasonably prudent patient
would have considered material to his decision whether or not to undergo a proposed
treatment.(3)
The physician has to give the person he is going to care for information :
- loyal, clear and comprehensible
- appropriate to his condition
- adapted to his personality.(1)
Informed consent is a two outcome process:
- on the one hand, information of the person on the nature, objectives, constraints, and
known risks of the proposed treatment, - on the other hand, the free decision of this
person to undergo a surgical or medical treatment or to accept to take part in a research
procedure.
Thus defined this information enables the patient to give his consent to the decision that
his condition seems to impose.
JUDICIAL ASPECT
The concept of informed consent and the choice of the patient has gained strength in both
the legal and ethical arenas.
The person must know the risks, he or she must assume these risks voluntarily, but it
must not be against public policy to assume them.
Various laws regulate the physician /patient relationship such as:
- Nuremberg Code (1947)
- Recommendations guiding physicians in biomedical research involving human subjects adopted by :
- 18th World Medical Assembly, Helsinki (Finland), June 1954 and amended by the 29th World Medical Assembly Tokyo(Japan), October 1975,
- 35th World Medical Assembly, Venice(Italy), October1983,
- 41st World Medical Assembly, Hong Kong, September 1989...
"In any research on human beings, each potential subject must be adequately informed of the aims ,methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent preferably in writing." (2)
- Laws related to:
- donation and utilization elements and products of the human body.
- medical assistance to procreation and to prenatal diagnosis that requires an informed authorization and express consent.(1)- French rule (Huriet-Séruclat) , 20th December 1988, on persons' protection, insists particularly on getting free and informed consent of persons who involve themselves in biomedical researches.(1)
- The law related to the nominal data processing for research in the area of health to demands informed and express consent of concerned persons, 1st July 1994.(1)
- W.H.O declaration about patients' rights has anticipated this situation ( article 3.9, regional European office) - " patient's informed consent is necessary for all participation in medical teaching". (1)
ETHICAL CONSIDERATIONS
(International Ethic Code)
The concept of patient choice is primarily based on the respect of the ethical principle
of autonomy.(4)
Autonomy does not, however, grant patients a right of access to medical treatment simply
because they desire, or choose such treatment.(4)
The most difficult informed consent problems are those that arise from competently
performed but medically unnecessary procedures; the extreme cases are those that involve
vanity procedures, such as face-lifts, liposucion, and breast enhancements. They set an
informed consent dilemma.(7)
From this perspective, a physician should be allowed to require a patient to assume all
the risks.
But a more moralistic perspective is that it is improper for physicians to use their
skills and position of respect to perform purely commercial treatment. So Jurists tend
toward the moralistic view and tend to rule against the physician even if the consent has
not any ambiguities.
Besides, obligations, as a physician, can't only be limited to respect legal or judicial
dispositions;
A physician has to exercise his mission in the respect for human life, persons and their
dignity.(1)
In the process of discussing the risks, benefits and potential alternative to a given
treatment by a continuing dialogue the physician and the patient have an opportunity to
ensure that there are no misunderstandings about the patient's complaint and the
physician's proposals.
The patient/physician dialogue has necessarily to lead to an adequation between "what
the physician wants to disclose and what the patient can understand" .
Particular cases
ALTERNATIVE THERAPY
If an alternative therapy exists, the patient may have a personal preference, or may let
the physician decide. He may as well accept to be included in a protocol of research
intended to compare the terms of alternatives.
Voluntariness becomes a legal issue, if the physician coerces the patient into accepting a
treatment for which there are acceptable alternatives.(7)
Alternatives require qualified judgements, critical analysis , a clear basic choice,
colleagues' advice, all the more that a margin of dubiousness always remains, as regards
disease complications and treatment results.
THE PATIENT'S REFUSAL
Every person's body is considered inviolable, and consequently every competent adult, for
personal reasons, has the right to be free from unwanted medical or surgical treatment
nevertheless logical or obvious.
The patient might not reasonably reject all treatments but may justifiably argue he might
have chosen a different treatment.
The fact that serious risks or consequences may result from refusal of treatment does not
make faulty or defective the right of self determination.(5)
In this case, the physician has to try to convince the patient to change his mind, without
exerting on him or on his family excessive pressure.
If a patient persists in his resolution, the physician has to respect his refusal after
having told him of all the consequences .
Operating against patient's consent constitutes a professional misconduct that exposes the
physician to a disciplinary punishment and commits his civil liability.(1)
THE PATIENT UNABLE TO EXPRESS HIS WISH
If the patient is prevented from expressing his wish, under age children, patients in a
coma, serious mental illness ..., the physician cannot operate or give treatment without
his close relations' agreement except in emergency and impossibility cases.(1)
WRITTEN INFORMATION AND CONSENT
It's often recommended to get written consent concerning an important decision.
But except when required by law, this written consent has no absolute judicial value.(1)
Nevertheless this written information can testify that the patient has been actually
informed; it has the merit of leaving a trace.(1)
It represents a source which the concerned patient and his family can refer to.
Listing the advantages and the risks of a treatment, by specialities, pointing out
necessary but non alarming information, allows the patient to take time to think about it
, to get further information, before he adheres to the decision.
Written information, and consent are particularly essential in a hospital environment.
The patient comes into contact with a medical team, and healthcare providers have to see
that the patient receives necessary explanations about treatment and investigations that
are proposed and non imposed .
Hospitalization is often decided for serious , complicated or/and urgent cases. The
patient finds himself obliged to give his consent because he cannot see any other
alternative.
But a detailed consent form, listing all the risks of the treatment is unnecessary if a
patient can prove that a treatment is unnecessary, inappropriate or contra-indicated, then
consent to the risks of the treatment becomes ineffective.(7)
CONCLUSION
Informed consent undermines the theory that the patient has accepted that the
undifferentiated risks of therapy outweigh the risks of this condition.
Although the physician must tell the patient of the known risk of treatment, this is not a
guarantee that other problems cannot occur. Medicine is not a perfect science.
The patient may assume these unknown risks if three conditions are met:
- the risk is unknown or of such a low probability, that it is not known to be related to
the procedure.
- the patient is informed that the disclosed risks are not the only possible risks.
- the medical arguments for the treatment are sound.
The historical focus on physician and patient ought not to neglect the influence of other
parties on patients' rights. Society, other medical institutions, and increasingly,
healthcare insurers and organisations have interposed substantial barriers to the right of
the patient to be informed and to consent to the way they receive medical care.
Patients' autonomy can be eroded in many different ways, by many elements of the
system.(6)
REFERENCES:
Moore v. The Regents of the University of California: Balancing the need for biotechnology innovation against the right of informed consent, Maureen S. Dorney.
ETHICS AND MEDIA
JAIME CAMPOS
"You have to dream of the whole world, but never lose sight of the tiny villages". Rubén Darío.
Introduction
As we approach the millennium, our world has come to be typified by an extraordinary
mobility of information, but at the same time there is a spectacular compulsion for
wanting everything immediately, and this means that constraints are put on the time
available for research and reflection, those essential requirements for making an ethical
decision.
The invasion of privacy and the favouring of the individual, with the consequent
devaluation of the collective fabric and social experience, are resulting in our system of
life becoming standardised, and at the same time autochthonous values are being relegated
and their consequences are not being evaluated.
The information society that gave rise to so many hopes has not proved capable of
generating either growth or employment. Let us not forget that equal opportunities,
respect for humanistic values, the dignity that work and social protection bring, and a
deep-rooted attachment to one's country are essential and fundamental elements that give
life a sense and meaning.
The risks involved in entering the new time-space relationship will have to be reduced,
with technological innovation being brought into line with the above-mentioned needs.
Western man is thus losing track of the ideals of liberty and equality when he tries to
ignore the contradiction that exists between market interests and the interests of
objective, serene and reflective information, when he replaces ethics by a dangerous
alliance between profit and knowledge, thereby accentuating what Jean Bernard has called
"the discordance between progress in science and progress in learning".
The culture of the post-modern era, in the name of a false respect for differences, is
really, in the words of María Cristina Reigadas, "neutralising and nullifying them,
since everything is equal and nothing really matters".
Decision-making centres have moved from the national level to planetary level, and from
the public sphere to a number of private financial institutions whose sole aim is to earn
a quick profit for their coffers. In a competitive environment where fighting to death is
the name of the game, it is the weak who necessarily lose out in the end.
Information
Information to a large extent consolidates the production of news, with journalistic
technique being converted into advertising skill, where the logic of power and strength
makes all information equal instead of establishing that longed-for diversification. By
investing in the domain of genetic transformation, advertising monopolies have given rise
to a "Biolobby", where there is a danger of speculation appearing in
biotechnology. Those who hold the power to produce information and communications have won
immense political power for themselves, with the consequent explosion in
telecommunications. A communications monopoly in the hands of experts has converted what
is a right held by everyone into the profession of just a few.
Communication
This relates to the possibility of going back, of exchanges between human beings, between
poles with the same communicability coefficient. According to Althusser, the
communications media are one of the ideological instruments that uphold a state of affairs
aimed at supporting the interests of those who dominate society. For the financial world,
the computer is a fantastic instrument for concentrating power and management of the
immaterial. Telecommunications have transferred the financial marketplace to financial
space, and the immaterial has inverted the logic of former systems, although leaders have
not assumed that to govern is to foresee, to plan.
Anyway, we have to accept not only that the media are here to stay but also that they will
inexorably increase and expand their presence in coming years, and although they are
already an important part of our lives, we cannot and should not stand by and stop
criticising. Accumulated experience has shown us other ways of looking at the media and
getting involved; fortunately, receivers are becoming critical receivers, capable of
rejecting material or discovering meanings in it that were never envisaged by the
broadcaster; it can therefore be accepted that the media are offering more than they are
denying, as the possibility exists of a critical receiver communicating, and this makes us
reflect more when we read about social events.
It is also recommended that the communications media should look on themselves as
instruments that belong to the population, for transmitting its sentiments, feelings,
thoughts and position with relation to power, thus preserving its integrity and
independence. It is essential that bridges are built between the private and social
spheres, as these will encourage true integration and thereby permit a thoughtful
rationalisation of everything that goes to make up public opinion.
Reflections on Communication
A proposal should be put forward on communication whereby it is essentially looked on as a
revaluation of pluralism, a rescuing of the value of public opinion in bringing words and
dialogue together for development. Societies should not lose the ability to express doubt,
and hence dissidence, as this will prevent the irrational exuberance of the markets
becoming the only destiny we are allowed. Alvin Toffer recommends activating all
communication systems, to support the enrichment of education and information, and favours
public debate through networks between groups and nations.
T.V.
If nothing in the human being is simple, even less so is his relationship with TV, where
advertising and publicity, which have erroneously taken on a connotation of value, confuse
and mislead opinion without hindrance. The fact that people use TV to isolate themselves
from others should lead to the conclusion that something worth investigating is going on
in the environment.
With TV, the audio-visual predominates over the written and over logical reasoning;
sentiment and passion are linked to the trivial, which prevails first and foremost. During
this century we have passed from the confessional to psycho-analysis, and from this latter
to superfluous entertainment and leisure programmes, and the result has been behaviour
like that of a docile flock of sheep, as imposed consumerism has become linked to
showbusiness and not to active involvement for social transformation.
Despite this, however, we should not underrate the value of sensory-emotional material, as
against what is rational and intellectual, in merging serious rationality with ludic
pleasure and sensitivity. Paul Ricoeur suggests we acknowledge what each human being has
in the field of culture-communication relationships.
REFLECTIONS
We have to acknowledge that the media have made marvellous contributions. We intellectuals
and teachers have a commitment to see the other side of the coin and at the same time
understand other ways of looking at things. The increased range on offer means that
sources can be compared and other versions and perceptions looked at, although we should
always take cultural space into consideration in relationships with the media, as proposed
by Jesús Martín Barbero.
We should now pass from a technological viewpoint to a pedagogical one, in order to try
and incorporate the media into an attempt at dialogue. Introducing TV as a learning tool
means understanding the rules of the game and thus attempting to make the most of
narrative resources so that programmes can be used as a triggering device for reflections
and group work that is useful to the community. In other words, the aim should be to
encourage a dynamic way of dealing with information that will not only enable but also
induce the audience to handle various interpretations and readings of situations and the
main characters involved in these. The myth that it is the vertical and absolute word-law
which underlies and nurtures the visual language that is the educational axis of the
viewer can also be broken.
This means that all communication resources that education can benefit from should be
taken over, so as to promote the development of dialogue methodologies where teacher and
student work hand in hand to build not only the knowledge but also the coexistence that
will transform the word-law culture that for so many years has led us to look approvingly
on silence as the exemplary axis around which the educational environment revolves,
without any objections or questions.
Ethics
Occasionally, a doctor does not know how to use technology without physically or
psychologically hurting the human being; so-called "mirror-ethics" have
therefore been promoted, channelled by the scientific world either consciously or
unconsciously to ensure that the process does not get slowed down; also, scientific
declarations are frequently handled in an exaggerated or incomplete way for countless
numbers of sick people, as largely-incomprehensible medical terminology can only with very
great difficulty be transferred to everyday language when it comes to informing society on
health matters. Thus it is that the hopes both the healthy and the sick population have of
understanding and dealing with medical information that is of vital importance to
decisions that have to be made on the individual and collective quality of life generally
meet with frustration.
Our obligation is therefore to work in search of a new and more humane order, a morality
of doubt, even if only provisional, since in ethics as in other values the absolute does
not exist, and as Rousseau stated, "What do we learn in Phedra and Oedipus if not
that man is not free, and that heaven punishes him for the crimes it makes him
commit?"
McLuhan claims that a society is defined and typified by the communication technologies it
has available to it, and this communication society seems to be orientated towards
fantasizing on the world. Reality gets transformed at a speed that is greater than the
intellectual capacity to explain it. Multi-dimensional thought is necessary if this is to
be faced up to, where the complexity of human realities is respected. Science needs a
non-scientific substratum: cultural decisions, a love of knowledge, and metaphysical
obsessions. A subject has to be recognised as having ambiguities if an open,
interdisciplinary rationality is to be found that nurtures the dialectic between a
humanist culture and a scientific culture, between science and philosophy, human sciences
and natural sciences, knowledge and ethics, theory and policy. Only then will we be able
to enter an era where we can think of complexity and live in harmony with our myths.
Let us seek the ethics of an organised society that includes political ethics. Ethics that
do not aspire to regulate private life, that touch on the public sphere of harmony in the
search for a society that needs no fear or force if it is to achieve its goals, and which
makes alternatives possible for a pattern of communication norms that is richer and more
complex at international-exchange level.
Communication ethics require communicators to go beyond
their role of intermediary and take on that of a mediator, and therefore make
communication a strategic space in the struggle to abolish frontiers and exclusions and
make it possible for the right to live and think differently to be recognised. Edgar Morin
suggests on this point that "there is a dialectic between order, disorder and
organisation, and through this the universe is built, develops, gets destroyed, and
evolves".
The international community should finance social, educational and cultural research into
telecommunications and promote exchanges between groups that create communication
processes in the fields of science, education and culture. In this way, flexible
strategies can be drawn up that are in line with the interests and needs of each
community.
How can we reconcile the demands of this new philosophy
with the preservation of geographical, ethnic and cultural roots?
Victor Hugo provides us with part of the answer in Les Miserables, when he writes "Do
not take the flame where there is enough light!", and suggests that prudence and
common sense should be our prime guides. A more humane order needs to be sought, even if
this is only provisional, a morality of doubt, where the weight of the word is used, as
proposed by Etchegoyen, the coherence between thought and action and the generosity that
is implied by pardon, courage and tolerance.
Neither science nor technology are innocent or ingenuous products, as they too are
influenced by market logic and the logic of personal interest; communication should
therefore make us more careful and respectful of difference, that essential feature for
achieving true pluralism. Tolerance should be exercised at all times if we are to achieve
a connection between identity and innovation, between what we are and what we would like
to be.
BIBLIOGRAPHY
ETHICS, ENDOSCOPY AND COMPUTERS
F. VILLARDELL
INTRODUCTION
The irreversible trend towards the dependence on computers for the gathering, storage and
further treatment of clinical information, represents a most important progress in the
management of health care. However, the use of advanced information technology has made
many people aware of the associated pitfalls that threaten to undermine its benefits. The
most serious threat is that to the patient's right to privacy (1). There is widespread
concern about what kind of data are registered, their accuracy, the use that will be made
and the kind of control necessary to prevent undesirable access to them. Another issue is
the extent to which patients may have the opportunity to verify their personal records. A
particular problem relates to the storage and retrieval of "objective"
information, such as endoscopic images and reports (2). There is an increasing flow of
information between hospitals and public or private management systems that will become
more so with the widespread use of Internet. Concerns about potential misuse of computer
data were voiced as early as 1968 (3).
ENDOSCOPY AND THE COMPUTER
Endoscopy is the most important diagnostic tool available to the gastroenterologist and
endoscopic reports are essential components of the patients' history, and probably the
first documents that a specialist may consult in search of an objective diagnosis. The
continuous growth of endoscopic examinations and the easy possibility of storing and
transmitting images and reports to interested third parties raises anxiety about their
possible misuse. Computerized records may be used for purposes unrelated to the clinical
management of the patients, such as research, retrospective studies of data, and
increasingly, for auditing, cost-benefit analysis, efficiency studies and for
administrative purposes.
BENEFICENCE, MALEFICENCE AND THE COMPUTER
Computer ethics has been defined as being "the study of the way in which computers
present new versions of standard moral problems and dilemmas, causing existing standard
moral norms to be used in new and novel ways in attempt to resolve these issues" (4).
I would like to review the different ethical problems posed by computers as an aid to
endoscopists. It may be useful for this discussion to use the traditional ethical analysis
based in such standard concepts as beneficence, maleficence, autonomy and justice (5).
Beneficence: There are many ways in which the patient's management may benefit from the
computer. Various software programmes may be used to obtain a comprehensive history of the
patient, including accurate life-style parameters (6). Several diagnostic programmes have
been used in gastroenterology although the rates of success have been inconstant (7,8).
This is mostly due to the fact that although significant progress has been made in
modelling and simulating diagnoses (9), there are inherent difficulties in quantifying
qualitative data, such as those provided by endoscopic images. It is conceivable that
electronic devices may be used in the future for the analysis of endoscopic images that
may be transmitted to other centers for consultation and diagnostic decision making.
However, computer diagnosis will not result in widespread acceptability unless it exceeds
the average physician diagnostic ability, it is cost effective and transferable to other
institutions and possesses adequate privacy safeguards (10). This is not yet the case.
Computerized programmes (COMET) have also been used as an aid for obtaining a meaningful
patient's consent for given procedures (11).
The Internet facilities have been used to solve difficult diagnostic problems by way of
multiple consultations (12). Endoscopy information on-line is available from several
organizations, such as ASGE and ESGE and guidelines for endoscopic practice and teaching
modules are being provided by both organizations. Information on teaching and training is
also available. The Bowman-Gray school of Medicine offers an excellent site "Virtual
endoscopy center" and the Université Libre de Bruxelles also has a web site (13).
Maleficence: Organizations are increasingly computerizing the processing of personal
information. Advances in computer technology have led to the growth of databases holding
personal and other sensitive information in multiple formats, including text, pictures and
sound. This may occur without the knowledge of the individuals affected. Obviously, the
use of the computer should not bring harm to patients. The computer has no concept of
error and cannot quantify harm done by its mistakes (7). Inaccurate information may be
difficult to correct once it has been propagated in different files.
A negative duty, such as "do not harm"
(maleficence) is more binding than the duty of beneficence, (14). Harm may be produced by
such diverse things as assaulting privacy of patients by including their names in teaching
slides or in Internet documents or even by the harmful consequences associated with
excessive reliance on computer diagnosis which may result in an impaired ability of the
physician to make clinical judgements (10).
However the most significant cause of maleficence is the erosion of the individual's
privacy and confidentiality (1). Confidential information may be leaked by insiders or may
become public by way of careless bureaucratic propagation (15).
Lack of legislation allows for a proliferation of private sector computer data-bases and
data exchanges without regulation. There is so far no statutory guidance for persons
wronged by abuse of data. Cases have been reported of bankers calling loans to patients
with cancer, of companies that admit using medical records in hiring decisions under the
excuse of managing the costs of health care (4). A Harris poll of the general public in
1993 disclosed that a quarter of all respondents had experienced improper disclosure of
their medical information. (16).
MALICE
Maleficence in the use of computers should be distinguished from plain malice. Continuous
inspection of computer systems is necessary to avoid the numerous examples of malicious
actions by computer hackers that have been reported, such as blocking the Internet access,
altering inputs or appropriating them, using pirated or stolen software, gaining access to
data and disclosing and selling unauthorized data to third parties, or even introducing
viruses in order to destroy information. There are quite a few examples of data being sold
to unscrupulous vendors or to malpractice attorneys (17).
AUTONOMY
Of the four basic ethical principles as they may be applied to information and computer
ethics, the most important one is that of autonomy which includes the essential issues of
confidentiality and privacy.
Confidentiality : Confidentiality has been defined as " a rule or duty requiring one
entrusted with private or secret matters to refrain from divulging them, unless it is in
conflict with equal or stronger duties". The harm may be physical but more often
moral. The most common justification for breaking confidentiality is preventing harm to
society. (18). Essentially, medical confidentiality is the respecting of other people's
secrets in the sense of information they do not wish to have further disclosed without
their permission (19). It is the necessary ground of the doctor/patient relationship (6).
"The patient has the right of confidentiality. The physician should not reveal
confidential communications or information without the consent of the patient, unless
provided for by law or by the need to protect the well fare of the individual or the
public interest" (20).
Privacy : The concept of privacy is more difficult to define: it is based on the principle
of respect for persons and includes several elements such as solitude, intimacy and
anonymity (21). The most important aspects of privacy are the right to be free from
observation, the wish to avoid identification in a public setting or revealing intimate
aspects of his self to others. The right of autonomy includes the right to privacy ; it
was already present in the Hippocratic Oath.
Ingham (22) argues that privacy fulfils four important psychological needs: 1. Personal autonomy 2. emotional release 3. self-evaluation (after any personal crisis) 4. to allow limited and protected communication. The patient has the right to have the privacy of this information respected by the confidentiality afforded to it (23).
INFRINGING CONFIDENTIALITY
The increasing involvement of several other health related professions in medical care as
well as the changing patterns in inter-professional relationships offer many opportunities
to breach confidentiality. It has been calculated that as many as 25 professionals may
look at a patient's record in the hospital! (20).
Conflicts arising from individual interests may come into collision with those of groups
or institutions whether public or private.Medical audits trespassing autonomy are not
uncommon, especially as security measures in hospitals are usually insufficient.
Disclosures may occur to private or public insurers, for health evaluation, planning and
research, for medical audits, even for purposes totally unrelated to medical care (20).
Since the Hippocratic Oath, all codes of medical ethics affirm the importance of
confidentiality, although usually exceptions are made if the law requires to do so.
Confidentiality is eroded today by legal actions and by changes in the climate of public
opinion concerning the patient's rights to information (20). This increasingly diluted
confidentiality is fostered by the current systematic quest for effective diagnostic and
therapeutic procedures and more rational decisions (24) such as cost-efficiency and
cost-benefit analyses (25,26).
Physicians’ opinions on confidentiality are divided: for some of them confidentiality is a prima facie duty (27), while for others, confidentiality is a "decrepit" concept" (28).
EXCEPTIONS TO CONFIDENTIALITY
Legitimate exceptions to confidentiality according to the U.K. General Medical Council
(29) are:
a) when the patient gives consent
b) when other doctors participate in care. c) when a doctor believes that a close relative
should know and it is medically undesirable to ask the patients' consent. d) exceptionally
when the doctor believes that disclosing to a third party will be in the best interests of
the patient. e) if there are statutory or legal requirements to disclose. h) medical
research approved by a Committee. There is reasonable agreement in Western countries that
individuals have intellectual property rights regarding software, but this is not so in
the Far East where the predominant philosophy tends to treat intellectual property as
communal property.(30). In some instances, "whistleblowing", such as during the
conduct of clinical trials, is certainly permissible particularly if the threat of harm is
imminent and serious (31).
RIGHT TO PRIVACY
Privacy is a problem with a dilemma: on the one hand, there is a responsibility to share
information in an effort to advance knowledge and because legal and social obligations
that may require disclosure of data, but on the other, there is an individual right to
confidentiality, to be left alone, to be autonomous.
Velu (32) has identified five major aspects of the right to privacy under the European
Convention:
1) protection of an individual, physical and mental inviolability and his moral and
intellectual freedom
2) protection against attacks to individual honour and reputation
3) protection of an individual's name, identity and likeness against unauthorized use.
4) protection of individuals against being spied, watched or harassed
5) protection against disclosure of information covered by the duty of professional
secrecy
DATA PROTECTION
The likelihood that information will be improperly disclosed depends on two things: its
value and the number of individuals who have access to it (33).
Instances have been described of thefts of computers and subsequent blackmail attempts, of
abuses of prescription systems by drug companies etc. The main threats come more from
insiders than from outsiders and they are exacerbated by data aggregation which web
computer systems encourage.
Several national and international agencies have drafted resolutions concerning medical
confidentiality and data protection, among them the 27th World Medical Assembly (34),
which requested members of WMA "to reject all attempts having as a goal legislation
authorising any procedures to electronic data processing which could endanger or undermine
the right of a patient to secrecy", expressing "the strong opinion that medical
data banks should be available only to the medical profession and not linked to other
central data banks".
The BMA representative body already in 1978 urged the British Government "to
introduce adequate legislative safeguards before the implementation of any computer
system" (29). The BMA stressed that "in all medical records, information should
be regarded as held for the specific purpose of the continuing care of the patient and
should not be used without appropriate authorization by the responsible clinician".
The report went on, stressing that access to identifiable information should be restricted
to the person clinically responsible and that access to others should be allowed, when
practicable, with the consent of the patient. Furthermore an individual should not be
identifiable from data supplied for statistical or research purposes.
The Secretary of Health and Welfare of the United States (35) recently made the recommendation that " providers and payers and those receiving information under the provisions of the legislation without the patient's authorization be required to maintain "reasonable and appropriate" administrative, technical and physical safeguards". Although in his report, the Secretary recognized that no legislation could effectively specify how to do this, he stated that Federal legislation is needed because:
Very similar recommendations have been made by the Committee of Ministers of the Council of Europe to member states on the protection of medical data on 13 February 1997, requiring that the patient's authorization to disclose information should have to meet specific requirements (36).
PRINCIPLES OF DATA SECURITY
Threats to data privacy and confidentiality may range widely from the accidental release
of information to criminal violations of a health record bank system. It is obvious that
regardless of the level of safeguards, no system can provide 100% security.
Controlling input into the system and prevention to unauthorized
access to the data system, should be the primary safeguards. Risks increase with the
growth of the number of data and that of users. The greatest threats may emerge from
information technology which is not managed properly; many fear that this might happen
with the emergence of profit managed care.
Nine principles of data security have been drafted by Anderson on behalf of the British
Medical Association (37):
access control: list naming the people who may read the data and append more data to it.
record opening by clinician and the patient on the access control list.
control: one of the clinicians on the access control list must be marked as being
responsible.
consent and notification: The responsible clinician should notify the patient of the names
of his record access control list and subsequent additions or deletions.
persistence:. No one should have the ability to delete clinical information until the
appropriate time is expired
attribution: All accesses to the records should be marked with the name of the person
accessing the record, data and time.
information flow: Information derived from record A may be appended to record B if and
only B'saccess control list is contained in A's.
aggregation control: Patients should receive special notification if any person whom it is
proposed to add to their access control list already has access to personal health
information on a large number of people.
trusted computing base: computers that handle personal health information shall have a
subsystem that enforces the above principles in an effective way. Its effectiveness should
be evaluated by independent experts.
COMPUTERIZED DATA AND INFORMED CONSENT
Many publications comment on the difficulty in obtaining a meaningful patient's consent to
release information from computerized data. (38-43).
An important drawback is that many of investigations of data are retrospective in nature
such as epidemiological studies, cost-benefit analysis, auditing reports, etc. It has been
impossible to devise informed consent practices that satisfy, in full, the competing moral
imperatives of respect for autonomy on the one hand, and the concern for the value of
health information for the common good of society. The same conflict applies to Internet.
Informed consent cannot be entirely achieved at the beginning of any study even if it is
the intent of the researcher to do so, because the circumstances of the research are
constantly shifting and often the investigator and his associates are not sure about what
is being consented to (43).
In these instances, we should probably discuss atypical forms of consent, such as
"implied consent" or "alienated consent" (the patient lets the doctor
decide), as described by Jonsen (44).
PROTECTING PRIVACY WITH "SMART CARDS"
Plastic cards may store plenty of information (45,46). These are the so-called "smart
cards" (in opposition to "dumb" cards, i.e. credit cards that can carry
only 200 characters). Cards may be equipped with a tiny integrated circuit memory chip
that holds about 8 kilobytes (about four pages of double space typewritten text). They can
carry about 8000 characters secured against being read unless the person has an enabling
code (typically a PIN held by the card owner and an authorised reader system). In fact, a
miniature computer. Data can be added and updated after the card is issued. The card
software is installed at the time of manufacture and cannot be altered thereafter.
Smart cards have two important properties: they can carry a substantial quantity of data
in a computer readable form and can do it securely.
Ideally patients should be able to get access to their data, and an electronic signature
of the patient may be stored to guarantee his approval of the release of his data. The
memory of a smart card may be divided into several zones each with a different level of
security and requirement for gaining access. A secret zone that no one can read can be set
aside for the storage of passwords and cryptographic keys. Different users, such as a
first aid team, an administrator, a surgeon, or an endoscopist, may have access to
different data.
The data use WORM (write/once/read/many) which cannot be rewritten or erased. More recent
cards use softstrip technology, allowing the storage of 32 kylobytes of data (16 pages of
double
spaced type-written text). They are immune from destruction by magnetic fields and more
resistant to scratches and dirt. Models of this type have been tried, such as Exeter Care
Card pilot, or Panacea or the Quebec health card. Another system of this kind is being
used widely in France (45).
If we are planning to move health data around Internet and that seems inevitable, it is
clear that we must consider issues of security given the essentially open nature of
Internet, as the doctor may receive clinical details, x-rays, endoscopic images etc.)
(47-49). Smart cards may be of help because they may allow the removal of personal
identifiers when necessary.
Obviously privacy will not be absolute, as a data base must be stored in case of loss of
card or other accidents (47).
JUSTICE
Justice is here discussed in the judicial context, not as an ethical concern for equity.
The problems of liability are not easily solved. Although some agencies recommend that
infractors of the above recommendations be punished, one has doubts that this will be
implemented at the international level. In spite of some discussions at the Council of
Europe, "International ethics" seems to be a very distant goal (50).
CONCLUSIONS
The increasing tendency to use computer systems for the storage, treatment and
communication of medical data will very probably have a great impact in the next few years
on the management of endoscopic activities. It is conceivable that large amounts of
information, including endoscopic reports and images, will be openly and widely
transmitted through Internet and other devices. The advantages of computerized systems in
the clinical settings, including diagnostic programs, simulation for teaching purposes and
research, cannot be overemphasized. However, there is general concern for the protection
of privacy in computer stored data and in Internet. Although many directives and
recommendations by several national and international bodies are trying to implement valid
safeguards including the use of personal cards, ( 35-37, 47,51-54), we are still far from
providing adequate protection to the patient's privacy. Adequate legislation is needed at
national as well as international levels.
REFERENCES
Rogerson S. Computer and information ethics. Encyclopedia of Applied Ethics, vol.1, San Diego, Academic Press, 1998:563-570.
ETHICS AND MONEY
A view of ethics, money and collective resources
M.C. MILANO
When Jean Escourrou suggested that I write this chapter on
Ethics and Money I felt that I had to do it from my own Land and from Argentina’s own
history, intertwined with the reality of a Latin America, torn and impoverished.
This social reality is intimately bound to a model that is both economic and political.
How, then, are we to deal with the subject of money from within a society crushed by neo
liberalism, still ailing from a post war and that must, as every society, defend the stars
of social welfare ?
These stars ~ Food, Health Care, Education, Housing and Old Age Retirement ~ are placed in
the heart of a Public Health system that should be equitable, distributive and ethical.
(1)
Perhaps History was not the same in Europe as in Latin America. What happened here, in the
South, then, in the era of neo liberalism ?
In a poor Latin America several countries increased exports, thus allowing some nations to
experience an annual growth rate of 5% between 1950 and 1975. Figures showed that each
Latin American increased his/her income by 3.2% (a rise that would anyway prove
insufficient correlated with demographic growth), though this increase was not distributed
evenly and was in fact absorbed by the higher layers of society.
‘’Airs of welfare’’ spread, both from the UK with a promising National
Health Service, from the US proclaiming equity principles and from within Latin America
itself through a State generator of development. This Latin America failed to see that
such privileges would be temporary, as wealth was not being re applied as a resource.
Later did we realize that hard times would come only too soon. (1)
These patterns of a ‘’happy dream’’ conformed a society based on
consumption and oblivious of the means to support it, in a frame of political
authoritarianism and a ‘’practically liberal’’ market that was
beneficial to very few, made many suffer and planned little for the future. So that Fair
Play was neither play nor fair.
The state budget absorbed, and squandered, most of the public spending, actually leaving
social spending far behind. Concern was laid on the struggle against ‘’communist
contamination’’, while ‘’other’’ contamination disseminated
~ that of poverty and socioeconomic and infectious diseases such as cholera in Peru in the
late 80’s, and from there southwards. Money was spent on new aeroplanes, though we
lacked tap water in extensive areas of our countries. And the custody of the system was
heightened and good business rolled on, paying no heed to ‘’the unprotected of
Latin America’’. Eventually the storm reached the South.
The oil crisis along with progressive development of technology lowered prices in the
North making the South a low price provider. This allowed creditors to ‘’tighten
the rope’’ to a point that made true that statement of the United Nations
Program for the Development the more they pay, the more they owe.
In Argentina, in particular, to the
‘’change’’ operated in the early 70’s added the military coup of
76. The economic crisis eroded the meager hopes of a promised day once hoped for, the
country ‘s open veins bled secretly echoed by the chants of the world football cup of
‘78, and painful suppression and economic stagnation followed. The external debt grew
larger and eternal.
The 90’s found a country fighting with recession, as the rest of Latin America, with
a democracy hounded by increasing debt and adjustment, and paying , in turn, with a lack
of education, poverty, misery and hopelessness.
A deeper, more painful debt had been contracted. And it was that with the country’s
own citizens. (2)
In the years l982~l989 Latin America transferred to its creditors the sum of U$S 203.000
millions. In 1992 the debt had increased to U$S 101.000 millions.(3)
This is the beginning of the North ~ South conflict. A fact that is not merely economic
and political. It sets also a cultural difference, principally in terms of health
attention.
‘’The Third World’’, a conception that
was used to identify the poor countries, especially from the 70’s, actually means
‘’the poverty world’’ and was already present in the northern
countries. This notion has now changed and might be more accurately described as the world
of ‘’the two thirds’’ as defined by Xavier Gorostiaga. (4)
The 20% richer segment of the world’s population has an income that is 150 times
higher than the poorer 20%. (2)
In this frame of neo liberal markets the concept of ‘’democracy’’ is a
difficult one to keep, as it is the largest part of the population who will inevitably
receive the impact of adjustment.
The ordinary citizen became gradually aware that health and education were no longer
equitable and free of charge, that they had to pay for medical attention, in part or
totally, that the Public Hospital was a patient in the Intensive Care Unit and the money
was gone and still there were sick people to cure and children to educate.
And now who shall we turn to ? Shall we see whether our popular saying that
‘’God is Argentine’’ actually turns true ?
When the hour comes to figure out, to define distribution of resources, to answer the
demands of the World Bank, to choose between a net of ordinary tap water and computed
tomography, then either God’s telephone line happens to be busy, or He is expecting
someone else’s call. Now Society cannot wait any longer.
And so we walk on stage at the present Latin America, as
health care workers.
This introduction is simply meant as a general background of the hard social reality we
are confronted with in our daily lives and work and with which we have to interact in our
effort to integrate the results of international multicentric trials with the lack of
means, the ambition to publish and be included in foreign research with the absence of a
National Health Budget. And so...we come round to Ethics and Money, a current dilemma of
how to deal with such essential needs as primary attention, which, without due care, have
only given way to diseases that we wrongly thought eradicated ~ as is the case of Cholera,
Tuberculosis, Leper and Malnutrition.
Now if we come back to ‘’The Stars of Social Welfare’’ and take Food,
for instance, who can say that ‘’Food’’ shines brighter than,
let’s say, Old Age Retirement or Housing? However bright these stars may shine on
their own, all are needed ablaze to light a country’s way.
As defined by J.C. Escudero, ‘Food Security’ means the possibility for all human
beings to get the food they need to meet the demands of their genetic message or physical
activity, whereas ‘Food Insecurity’ happens when food intake stays below the
needed requirements, sometimes for natural causes but more often for social reasons or the
social processing of natural facts, eventually leading to impaired or retarded growth,
sickness or death.(5)
In 1991 ‘’The Hunger Report’’ stated
that 20% of the world’s total population (approximately 1.000 million people) do not
receive adequate nutritional energy to meet the minimal requirements, 24 million children
(16% ) present low weight at birth and 204 million children have low weight gain during
their first five years of life. According to the same report around 10.000 people, mostly
children under the age of six, die of malnutrition yearly. (The highest rates belong to
Asian, African and Latin American countries).
Which is then, our reality, within Latin America, within that "two thirds" of
the world, confronted with a distribution of resources that is insufficient, inequitable
and immensely selfish ?
Which is the role of a full time physician working in a public hospital as a health care
provider of a citizen that lacks health coverage, left to the "State’s
mercy" ?
Which decision making policy should then prove ethically sound when we have to decide
whether or not to accept high cost procedures ~ as is the case of Bone Marrow Transplant
(BMT) ~ that will be paid entirely by an impoverished State ?
The last issue of Clinical Oncology (6) lists detailed indications for BMT; these are
rather extended in our milieu. Is this ethical ?
In terms of cost alone, BMT rounds up to U$S 70.000; not
including transplant failure and subsequent expenses derived from chronic diseases in the
recipient, secondary endocrinology disorders, new tumors and, especially in children,
impaired growth and neurological disorders with the accompanying psycho social sequels.
If we think in terms of "Food Security", for a while, we have in our country
13.000.000 children and adolescents (30% of the country’s total population), one
third of which live in poverty (UNICEF available data), are consequently malnourished and
will never develop their full intellectual potential.(7).
The Argentine State provides schools and day care centers with a "glass of milk"
(milk plus basic foods) at a cost of 0.80 cents (1 peso = 1 dollar/day). Now, with a given
stipend of U$S 70.000 the State could offer 87.000 rations to 239 poor children during one
year, a basic nourishment they will not get otherwise.
Is it ethically sound for an impoverished state to dream of expensive treatments,
moderately cost ~ effective, in between socioeconomic crisis and an agonizing public
health ?
According to the latest World Bank Report, the cost of
health in Argentina goes up to almost U$S 20.000 millions yearly. A sum equivalent to 7%
of the country’s annual gross national product (GNP) or to U$S 600 per year per
inhabitant. This percentage is high compared with the rest of Latin America, but low
compared with 9.9% (Canada) and 14% (USA). It is financed by the State and the users. The
State supplies public hospitals with U$S 4.000 millions yearly.(8)
But then again, if we put to one side for a moment the crisis in the sector and the
distribution of resources, there is still the ethical question of "how to say
NO"(9) to patients, physicians and pharmaceutical industries; a concern involving not
only the southern countries, but now also present in the North. In The Lancet, in 1997,
(10) (11) evidence is given of how the industry exerted pressure on independent
researchers, terminated trials and manipulated patients advocacy via the media.
The Social Welfare Reform Law passed in the U.S. as
recently as August 1996 stated that the federal budget will be reduced in U$S 55.000
millions. This will bring about poverty for more than 2.6 million people. Will the North,
then, be able to go on spending ?
What about equity then ? What about first class and second class citizens ?
And if we turn to central Europe now, recent demonstrations in Amsterdam (June 1997)
claimed for the Unemployed (18 millions) and the Poor (50 millions). After the change of
the French Government, the German Economics Minister stated that Germany "will not
invest any more money in European Social Projects" (12). What has changed, then,
since that declaration of European Unity signed on the ruins of the post war, (Shuman
Declaration, May 9, 1950) where Germany proposed joint efforts under a common
administration? Are we witnessing the fall of out and out neo liberalism?
BMT, an example of "high tech" procedure, is now discussed amongst Americans as a negative factor on the health budget for primary attention and prevention. Far from the skepticism of the British, some Americans themselves have criticized their own "laissez faire" in faced with the "tragic choices"; and they question themselves on topics such as the high cost attention for the Elderly. In terms of cost alone, the largest health care expenses are those of old age. To avoid "over treating" and the use of expensive high tech at the end of their lives the elderly patients may be offered to sign "advance directives", thus resigning beforehand "heroic" manoeuvers (13). Is this not an example of a covert rationing to hold down state health costs? Are these patients actually being offered a safeguard ? Or subtly pushed to give way to feelings of anxiety and guilt and the fear to become a burden to their families ?
On the one hand, the ethics of palliative care and the
right to a dignified death "humanizes" a life’s end allowing patients to
meet again their loved ones, hampers Euthanasia (active, passive, direct, indirect,
voluntary, involuntary ) and also protects the patient from being "overpowered by
overzealous physicians or institutions" (13 ). But on the other hand, we must have
the courage to admit that we might also be pleasing a market that claims for shorter
hospital admissions, cost reduction of public expenses, and less money for the attention
of the terminal or the elderly.
We are then dealing with a hierarchy of values. Coming round to the "Stars of Social
Welfare" we might need to make it a priority, for instance, to build a tap water
network before buying a computed tomographer and to start with "assisted birth"
to reach, eventually, "assisted death".
In the past century philosophers and scholars were busy thinking of "birth control", while the turn of this century finds us worried about "death control". When thinking of the expenses at the end of a person’s life, we might as well look at those of the beginning of life. In the world of the "two thirds", more than 60 % of births do not have medical assistance.(14). In Bolivia, for instance, maternal mortality rate during labour is 400/100.00 (100 times higher than in Japan). We might as well turn our attention to "the Stars" of Food Security, Housing and Education; all of them essential for a person’s dignified life. A country that cannot afford to have medical attention at birth, that comes from malnourished mothers, that lacks proper housing and schooling is bound to underdevelopment and will obviously have no retirement benefits in old age.
In this frame of unattended needs the question is less to
deny a medical indication than rather to set a priority and be able to tell the "very
urgent" form the "important". G.Berlinger’s view of "Bio ethics
of Justification" may throw light on this matter when he speaks of the
"dubois" tendency to think that what is technically possible can actually be
done, it is fair that it be done and be considered legally right, for which it is
illegitimate to prevent it. (15)
BMT is an example of the pressure exerted on physicians to indicate expensive therapeutic
measures. There are reasons at the same time economic, social and ethical. First we have
to admit that it is a profitable practice, mainly for the so called "tertiary"
hospitals with the necessary infrastructure, trained staff and specialised laboratories.
Then ( which, in part, can set their minds to rest) the cost could be reimbursed by third
parties, as is the case with developed countries. Social reasons are more subtle; the urge
to meet "cutting edge research" (not to mention the hard sell machinery of the
pharmaceutical industry ) may push physicians and hospitals to overpower the patient,
added to the prevailing attitude in our culture to build on the fast and new. Then again
nothing should interfere with the ethical imperative of doing all for the
"patient". But... Is there always a reason, on ethical grounds, for expensive
indications ? Why do we more often indicate BMT in a child with acute leukaemia than a
liver transplant in a cirrhotic adult ? (16)
We might argue that both have equal rights to have access
to a transplant, but, is it really so ? Do we all have identical rights ? Are these rights
respected ? Are all patients equal before the State ? And before the physician ? Are they
all equally treated ? Is a hospital patient equal to a private one ? Are the rich and the
poor the same ? The ordinary and the interesting ? The easy and the difficult ? The
contagious and the terminal ? The old and the young ?
An article in the Journal of Clinical Oncology (17) mentions discriminative factors for
accessibility, such as race (patients were divided in white, black and
"others"), age and, notably, social coverage (private, uninsured and
underinsured).
Italian Democracy has established the so called "Tribunal for the patient’s
rights". In some cities, Toscana for instance, people collected signatures and a
letter was written demanding that a sick person be treated with dignity and understanding
by all health care workers, and his or her right to a global assistance be respected,
physically and psychosocially.(18)
There have been similar reactions in Latin America. In
Brazil, with the "Encontros Nacionais de Medicina Comunitaria", since 1978. And
from catholic progressive groups that understood health as a God’s law directed to us
all (so we all deserve it ). There is a reversal of the feeling of guilt for being sick;
disease results from a lacking situation, does not emanate from the person. There were
similar movements organized by workers in Sao Paulo, Brazil, after this initiative.
It is widely accepted that a person’s rights and obligations are closely correlated.
(19). As far as Health is concerned, the State has the obligation to provide all citizens
alike with the "Stars of Social Welfare" and all citizens alike are endowed the
right to get them, live with dignity, achieve fulfilment and be happy~ for the Greeks,
one’s ultimate end as a person.
Either from a religious perspective (as in Brazil’s example) or from the popular
belief, Ethics must defend the people’s basic needs ~ the powerful shining of the
"Stars of Social Welfare", all that dignifies Man, and hence, a Country.
From the very first of these lines I wondered at the question made by Jean Escourrou:
Ethics and Money; or actually Ethics or Money ?
REFERENCES:
Neri, A., Sur, Penuria y Después, Emece Editores, Bs.As., 1995, p14-p22-34.
Rebellato, José Luis. La Encrucijada de la Ética. Neoliberalismo. Conflicto Norte~Sur. Liberación Editorial. Nordan~Comunidad. Montevideo, Junio 1995. p. 55-65.
Borón, Atilio. Estado, Capitalismo y Democracia en América Latina. Imago Mundi 1992, Bs. As. p. 2l6-9
Gorostiaga, Xavier. La Mediación de las ciencias sociales y los cambios internacionales, Neoliberalismo y Pobres. El debate continental por la justicia. Corre~Gonzalez~Mora (eds.) Santa Fé de Bogota Cinep,1993, p. 563-587.
Escudero, J.C.,Notas sobre Seguridad Alimentaria, Salud, Problema y Debate, N 11, Invierno 1994, Bs. As.,p 5-16.
De Vita JC,Hellman VS,Rosemberg S.Cancer Principles and Practice of Oncology.5th edition,vol 2. 1997,Lippincot Raven (publishers).Philadelphia New York, p2206-2207.
Héctor Pavon, "Clarín" Newspaper, Bs As, August 3, 1997.
Bermúdez Ismael, "Clarín" Newspaper, Bs..As, February 2, 1997.
Daniels N., Why saying "no" to patients in United States is so hard. NEJM, vol. 314, n. 21, 1986, p. 1380 ~ 1383.
The Lancet. Good manners for the pharmaceutical industry, vol. 349, n. 9066, June 1997, p 1635.
The Lancet.A curious stopping rule from Hoescht Marion Roussel, vol. 350, n 9072, p155,June 1997.
Viceconte Araceli, "Clarin" Newspaper, Bs.As, June 15, 1997.
Callahan D.Controlling the Cost of Health. Care for the Elderly -Fair Means and Foul, NEngJ.Med,Sept 5,1996, p. 744.
Dr. José Portillo, personal communication, Latin American Congress of Social Medicine, Bs. As, March 1997.
Berlinger, G. Bioética: reglas y culturas. Salud ,Problema y Debate, primavera 96.,p 18.
Durbin Meg MD., BMT Transplantation; Economic, Ethical and Social Issues, Pediatrics, Vol. 82, n 5, November 1988.,p 774-782.
Mitchell, J. M, Meehan, K.R., et al. Access to Bone Marrow Transplantation for Leukaemia and Lymphoma: the role of socio- demographic factors. J Clin Onc 15: 1997, 2644-265
Berlinger, G., La Enfermedad, Lugar Editorial, Marzo 1994,p 124-125.
Jacques Maritain, Preliminary Notions of Moral Philosophy, Artes Graficas, Bs. As., 1966, p177.
ENDOSCOPY AND CLINICAL TRIALS
J.H. SOLHAUG
"In research on man the interest of science and
society should never take presedence over considerations related to the well-being of the
subject" (Declaration of Helsinki,1964)
Endoscopy has been one of the most expanding fields within clinical medicine during the
last 20-30 years. An Ovid Medline search of the literature with the text words,- endoscopy
and clinical trial, revealed an enormous increase in reported trials from 1966 to 1998,
1966-74 87 publications 1975-79 150 " 1980-84 237 " 1985-89 615 " 1990-94 1340 " 1995-97 1432 "
The rapid development and general adoption into common
practice of these new and expensive techniques creates several dilemmas,- How to learn?
How to teach? How to interpret the images? Which equipment? Which procedure? Need for
randomized studies? Cost and efficacy assessment, etc........ Any new procedure must be
compared with existing procedures or against untreated patients. Potential benefits and
risks of the new procedure must be carefully evaluated. Failure to do this is unethical.
Introduction of a new technical procedure is a form of research and should be assessed in
clinical trials like any new diagnostic or therapeutic procedure. It is covered by the
Declaration of Helsinki and should be approved by an Ethics Committee. The evolution of
new techniques implies research in patients. Developments in clinical practice often
contain elements of clinical research. The distinction between clinical practice and
clinical research may be unclear. Sometimes this lack on clarity may be used to avoid the
ethical review process which always should precede the introduction of new technologies.
Research on patients should always be submitted to the scrutiny of an ethics committee.
The continuing growth in use of endoscopy for diagnosis and treatment of patients urged
the need for reliable and solid data with respect to the application of endoscopic methods
to clinical problems. Any new discovery or any technical improvement runs the risk of its
overuse or being used in non-appropriate applications. This certainly applies also to
diagnostic and therapeutic endoscopical procedures. Before these new methods can be
compared with existing modalities they must first be tested in a small number of well
monitored patients to see if they have any diagnostic or therapeutic advantages. The
techniques of modern clinical medicine are the results of an accumulated corpus of
observation, recording, reflection, discussion and publishing (1).
When comparing the outcome of different endoscopy procedures the main problem is to avoid subjectivity. The results presented by different endoscopists must have the patient population and their lesion clearly defined. Detailed and understandable outcome measures are required. A major problem is that most results are reported by the people who have performed the procedure with an inherent risk of bias in collection and interpretation of the data. Conclusions are often drawn in order to show the superiority and to promote the technique possessed by the author(s) whose main supportive recommendations are prestige and passion of the experts. Diagnostic endoscopies and endoscopic applied therapy have been pioneered by enthusiasts and often adopted by consensus without scientific proof by conventional clinical trials. In some cases, the extended use of endoscopy has even continued in spite of negative trial results (2). However, there has been significant improvement in the quality of endoscopy reporting and documentation.
The question of the "best" therapy is most
appropriately answered by randomized trials comparing the different endoscopic modalities.
Since all these therapies seem to be highly effective, studies comparing them have to be
large in order to reach enough power to detect any differences. Many studies can therefore
be done only on a multicenter basis.
Thus, a common problem with research projects involving new technology is the fact that
researchers have insufficient time to study samples large enough to produce results that
are statistically reliable. The demand from patients, media and the industry may force the
researcher to publish and draw conclusions before an adequate evaluation is performed.
Otherwise, the method may be adopted by others and the new technique become established
routine - at which point proper evaluation becomes impossible. Thus, the resolution of
clinical problems must often be based on analyses of events and observations that occur in
non-experimental circumstances. By using adequate methods for collecting and analyzing
data, such observational data may, however, become of great clinical importance.
Any investigation or study in man designed to develop or
contribute to increased medical knowledge raises ethical issues and should be subject to
ethical reviews. Patient’s participation should be based on a full and understandable
explanation of the procedure including both benefits and hazards. Voluntary consent of the
patient is absolutely essential. It is the doctor’s duty to inform the patient
sufficiently to enable him to make up his own mind. The first sentence of the Nurenberg
code strongly underlines the consent requirement in research using human subjects. The
purpose of a procedure may be diagnostic, therapeutic or for research including the
development and assessment of new techniques. The patient should be fully informed of
which of these is applicable in his case. It is the obvious right of the patient to refuse
participation.
Introduction of new gastroenterological techniques are expensive and economic concerns
must influence the decision whether it is right for a community to bear the costs of the
new technology. If it is introduced at the expense of limited funds in a limited economy,
more essential medical care can be jeopardised. Then, fundamental ethical questions will
be raised.
We must also recognize the problems that introduction of
new, sophisticated and expensive technology brings to the developing countries. Medical
priorities and financial resources of a society must be taken into account and will govern
the size and the scope of the endoscopical facilities. Thus, what might be ethical to
introduce into one society might not be ethical in another, due to different cultural and
socio-economic differences.
Not all new technologies and clinical procedures can or should undergo a formal randomized
comparative assessment (3). Randomized trials are unfeasible for studying minor changes in
therapy or modifications due to rapid technological improvements in available diagnostic
or therapeutic procedures. Thus, despite the scientific superiority of the controlled
randomized clinical trial, observations occurring in the every-day care of patients
require also major attention. Long-term randomized trials will be frustrating in
circumstances where the available technique or treatment frequently changes and new
powerful regimens occur (4).
A major problem in assessing technical procedures is that the results often depend more on
the endoscopist than on the technical facilities. Thus, the problem of varying expertise
may play a major role in evaluating technical procedures. On the other hand, careful
registration and documentation of patients and patient outcome is necessary if any
judgement should be possible without randomized trials. End points of the study, relevant
protocol and unbiased assessment of the outcome must be clarified before the study starts.
Healthy volunteers present an obvious ethical challenge.
Clearly the kind of procedures they are asked to undergo is restricted. Diagnostic
procedures with minimal risks may be used while invasive procedures including biopsies are
questionable and endoscopic therapeutic procedures impermissible.
In clinical, technological research there is a close partnership between the industry and
the medical profession. In this cooperation the clinician must, of course, have the
freedom to conduct the study according to sound scientific principles, freedom to publish
the results and be aware of the ethical issues that may occur.
Looking back on the history of medicine the risk that a new technique will be introduced
and accepted without adequate evaluation is obvious. It soon becomes
"established". At this point prospective, controlled studies or proper
evaluation becomes impossible. It is difficult, also ethically, to do a trial once the
treatment has been generally accepted.
Evaluation of diagnostic technology.
The diagnostic yield in upper and lower endoscopies has been documented in numerous
reports and are well established clinical methods. There are, also, several prominent
issues that have been studied in randomized trials in evaluating endoscopic technology.
Sedation, cleaning regimens and endoscopic haemostasis are issues studied in well-designed
prospective trials (5,6,7,8). In endoscopic comparative pharmacological trials, blinded,
double-dummy study design is suitable (9).
Bile and pancreatic ducts. A large number of laboratory tests, radiological methods and endoscopic techniques are available for the evaluation of the jaundiced patient. The challenge is to select, on an individual basis the most efficient and cost-effective method as well as the therapeutic option with the lowest mortality and morbidity rates and the best short- and long-term results. Endoscopic retrograde cholangiopancreatography (ERCP) is a combined endoscopic and radiological technique requiring good cooperation between endoscopists and radiologists to achieve optimal results. It is well established in the diagnosis of biliary and pancreatic diseases, duct stones, inflammation and malignancies.
Morphological changes indicating biliary or pancreatic tumors should be proven by tissue diagnosis. Retrograde brush cytology through the duodenoscope is an effective method with a reasonable sensitivity and high specificity (10). Spinchter of Oddi manometry is still controversial and under investigation needing further documentation before introduction into general clinical work (11,12).
Enteroscopy. Several reports have been published dealing with intubation technique and clinical results in small-bowel endoscopy. This, often cumbersome and difficult method seems most useful in the investigation of occult gastro-intestinal bleeding (13,14) and in patients with uncertain diagnosis after pathological laboratory or radiological findings (15). Peroperative small-bowel enteroscopy in patients with occult intestinal bleeding undergoing diagnostic laparotomy seems effective in revealing the cause of bleeding (16).
Population screening. Extensive surveillance and
screening programs in polyp and cancer detection have been advocated to reduce cancer
mortality by removing precancerous mucosal changes and detecting malignancies at an early
and curable stage. Clinical studies have provided evidence that screening programs have an
impact on disease detection and mortality, specially in high-risk groups (17,18,19).
Universal screening programs are clearly not possible and a better definition of
sub-groups with patients at risk is necessary to optimalize the use of the available
resources. Surveillance colonoscopy studies has demonstrated a yield in revealing later
neoplasis (20,21,22). In the last years, the benefit and role of endoscopic surveillance
in patients with inflammatory bowel disease and following colo-rectal surgery has been
questioned (23,24). Further cost- benefit studies are awaited. The ethical dilemma of
randomizing people to a control arm in surveillance or screening studies is obvious. One
main difficulty of assessing the different screening and surveillance programs is the lack
of controlled studies.
The total cost of repeated colonoscopic investigations will increase due to the fact that
people become older and the number of patients needing follow-up will increase.It is
impossible, within the budgetary situation in most countries today to afford general
population screening and, therefore, it is important that surveillance and mass follow-up
programs are really scientifically based and correctly carried out in the right
population.
Future methods. A large number of papers have
confirmed the accuracy of endoscopic ultrasonography (EUS) in preoperative locoregional
staging of malignant tumors and in locating endocrine pancreatic tumors (25,26). It is
superior to CT or MRI in oesophageal (27) and pancreatic tumor staging (28). In a recent
study magnetic resonance imaging (MRI) compared favourably with EUS in the staging of
rectal cancer (29). The practical use of MRI in staging and detecting recurrences must be
further studied and evaluated in comparable studies. Thus, while some indications are
established on the basis of accumulated data, further prospective outcome studies using
EUS are desirable. EUS has not yet, reached general use and is still concentrated to a
limited number of hospitals. It is important to realize that unwillingness and an extended
"wait and see" attitude in introducing new and effective technology may also
give rise to serious ethical considerations.
The development of genetic and biological markers may replace future endoscopies, allowing
more optimal allocation of endoscopic resources for treatment and surveillance (30).
The advent of virtual endoscopy is gaining growing interest but must be tested against
available methods before being introduced into general practice. It may in the future
replace some of the diagnostic, endoscopic techniques but it is time-consuming and carries
the risk of additional radiation burden to the patient.
The advent of magnetic resonance cholangiopancreaticography (MRCP) is non-invasive and
will probably replace diagnostic ERCP’s leaving mainly the therapeutic role to ERCP.
Comparable studies are planned and awaited.
Evaluation of endoscopic treatment
Since its advent about two decades ago, therapeutic endoscopy has steadily grown and
proved to have an important impact in several clinical situations. Continuing improvements
in the endoscopes and accessories together with increased clinical competence are still
widening the use of endoscopic treatment modalities.
Esophagogastric varices. The traditional method
of sclerotherapy has been studied in randomized studies with respect to injection
technique and sclerosants. It has been challenged by new endoscopic modalitites, such as
cyanoacrylate injection (31) and variceal rubber band ligation (32). Prophylactic
sclerotherapy is still a controversial issue. While prophylactic sclerotherapy had a good
effect on the bleeding incidence, the impact on survival was more uncertain in two
prospective trials (33,34). In a multicenter, randomized study from Vienna, sclerotherapy
did not show any significant effect on either bleeding or survival (35). However, meta-
analysis of fourteen randomized studies has shown a significant benefit in Child B and C
patients (36).
Endoscopic variceal ligation has been compared to sclerotherapy in several studies
(37,38). Ligation is effective in stopping the bleeding with less risk of rebleeding and
complications. A meta-analysis of randomized trials confirmed the reduced risk of
rebleeding, the efficacy in eradicating the varices and reducing local complications (39).
Multi- band ligator devices permitting up to six ligations with a single scope insertion
without the need of an overtube have recently been introduced and are gaining increasing
popularity.
Upper gastro-intestinal non-variceal bleeding. A
peptic ulcer is still the most frequent cause of upper intestinal bleeding. Endoscopic
injection therapy is well established as a first hand treatment. Adding a sclerosant to
epinephrine injection does not seem to improve the results but increases the complication
rate (40). Histoacryl showed no benefit over epinephrine injection (41). In prospective
studies the outcome of epinephrine injection or sclerotherapy compared to laser treatment
was similar (42). The costs, however, are highly different!!!
In a prospective study from Taiwan a distilled water injection was as effective as
epinephrine injection in controlling ulcer bleeding (43). Fibrin sealants (a combination
of thrombin and fibrinogen) as an injection therapy are expensive and difficult to use and
do not offer any clinical advantages. Coagulation therapy using a heater or bipolar
electrocoagulation probe has no advantages compared to injection therapy (44).
Percutaenous endoscopic gastrostomy (PEG). The main interest has been focused on nutrition (45) and decompression in malignant intestinal obstruction (46). With the refinement of the technique and equipment the complication rate is reduced.
Therapeutic Biliary endoscopy. The management
of biliary stones was revolutionized with the introduction of endoscopic sphincterotomy
(ES). It has, since then, replaced surgery in the treatment of bileduct stones in elderly,
high risk patients. The benefits are less obvious in younger patients with less operative
risks. ES and removal of the duct stones before open cholecystectomy showed no advantages
compared with surgery alone in a randomized study (47). The treatment of obstructive
common bile duct stones complicated with acute cholangitis or pancreatitis in desperately
ill patients is an emergency situation calling for decompression. Endocopists have long
been convinced that urgent ERCP and ES with stone extraction or alternatively stenting
would be the method of choice (48,49). In randomized studies the advantage of endoscopic
decompression compared to surgical decompression has been demonstrated (50).
Endoscopic ballon dilatation of the biliary sphincter is an alternative for the removal of
bile duct stones. The main advantage of the balloon method is avoiding cutting the
sphincter with a decreased risk of perforation and bleeding complications. An Increased
risk of pancreatitis or difficulties in the removal of the stones have been the
theoretical disadvantages. In a randomized study Bergman et al. (51) compared the two
methods. The success and complication rates were similar while the risk of acute
cholecystitis in the follow-up period was reduced in the balloon dilated group indicating
that preservation of the sphincter function may prevent long-term complications. This
excellent study clearly demonstrates that it is possible to perform scientifically high
standard studies even within the field of endoscopical treatment.
A variety of lithotripsy techniques and dissolution therapies have been used in managing
big and difficult stones (52). Methods of stone extraction have been evaluated in
prospective studies (53).In follow-up studies after successful sphincterotomy and stone
extraction an expectant attitude with respect to surgical removal of the gallbladder is
appropriate(54,55).
In prospective, randomized studies different types of stents have been compared in
patients with malignant biliary obstruction (56,57).
Therapeutic pancreatic endoscopy. Endoscopic
therapy has been increasingly used in pancreatic disorders. Lack of prospective studies
and long-term results contribute to the uncertainty and controversies. In gallstone
pancreatitis, however, ES has been shown to reduce late pancreatic complications or
recurrences even in patients with the gallbladder "in situ" (58,59). These
findings indicate that sphincterotomy alone without surgery of the gallbladder is safe and
further surgery could be avoided in high risk patients. Randomized studies are lacking.
Early papillotomy has been advocated in patients with gallstone pancreatitis (60). In the
first randomized study reporting urgent ERCP with ES compared with conservative treatment
in patients with acute pancreatitis,- mortality and morbidity rates were reduced in the ES
group (61). Recently the significance of emergency ERCP has been questioned and elective
ERCP seems adequate even when remaining bile duct stones are assumed (62).
Pancreatic duct stenting seems to be beneficial in patients with pancreas divisum or
idiopathic recurrent pancreatitis (63). There is growing evidence in the literature that
endoscopic therapy is beneficial in the management of pancreatic duct stones and
pseudocysts (64,65,66).
Colonic tumors. Colon cancer screening and the removal of neoplastic tumors are considered to be the major factors in the improvement of survival rates in patients with colo-rectal neoplasies. Malignant polyps can be endoscopically removed. If the polyp is completely excised with no evidence of lymphovascular invasion further surgery seems unnecessary (67).
Malignant obstructions. The effect of endoscopic treatment of malignant obstructive diseases has been assessed, prospectively in several studies. Endoscopic therapy of tumorous obstruction has been dominated by laser treatment or expandable stents (68). These techniques are safe and technically feasible and indicated in selective patients for palliation.
Future methods. Photodynamic therapy has been
tested in the treatment of papillary tumors (69), in colosigmoid villous adenomas and
polyps of the colon (70), in oesophagogastric tumors (71) and in potentially malignant
mucosal changes (72).
The advent of laparoscopic biliary surgery has increased the demand for ERCP and
endoscopic therapeutic procedures being the methods of choice to confirm and treat the
majority of patients with bile duct injuries and residual stones following laparoscopic
cholecystectomy.
Concluding remarks. The need for cost
reduction is the driving force in most health systems at the moment. In the shrinking
health care budgets, a proper evaluation of new technologies and clinical strategies is
mandatory to secure optimal patient care and optimize cost-benefit outcome. The overall
cost and quality of life assessment in endoscopic research has been limited and must be
improved. Introduction of poorly assessed and poorly evaluated technology may be harmful
both to the individual and to the society.
The patient should be protected from unnecessary endoscopy and from an endoscopist without
adequate experience or competence. Without peer review the rate of unjustified or
inappropriate endoscopies reach 20-25%, representing hundreds of million of dollars spent
unnecessarily every year (73,74). New studies that better evaluate the value and cost-
effectiveness of endoscopic therapy or palliation and define subgroups that benefit the
most, are currently being conducted. These studies will have an important impact in future
evaluation and treatment of these patients. Further comparable studies concerning
diagnostic and therapeutic yield are desirable. Whether this will be constrained by
economic and other factors in the future, remains an open question.
In a survey of the literature it is obvious and encouraging to observe that the scientific
basis of new endoscopic technology before introduction into general use has improved. The
quality of documentation and endoscopic studies has markedly improved and ethical review
is now accepted as an integral part of serious endoscopic research.
REFERENCES:
HELICOBACTER PYLORI DIAGNOSTIC AND THERAPEUTIC MEASURES:
ETHICAL ASPECTS
A. H. NOVIS
Although great scientific strides have been made over the past decade in the Helicobacter
pylori saga, less attention has been given to the ethical questions involved in diagnosing
and treating the condition. One of the weightiest ethical conundrums is whether the H.
pylori infection should be treated under all circumstances.
This paper will not try to resolve such controversies, but rather try and indicate the
ethical positions gastroenterologists and other medical practitioners should consider when
dealing with their patients. The hope is to avoid the misuse of various breath tests and
serology in otherwise healthy population groups, thus avoiding much anxiety, while at the
same time, helping patients benefit from the tremendous depth of knowledge that has
emerged in the last decade and a half since Helicobacter pylori was rediscovered by Warren
and Marshall.
H. pylori infection is a very common condition. Epidemiological studies have shown that
perhaps half of the world’s population is infected with H. pylori and that most
infections begin in childhood.
In terms of the harm it does, infection with H. pylori has been identified as a definite
etiological factor in patients with peptic ulcer disease, low grade gastric MALT lymphoma
and gastritis. In addition, it has been identified as a risk factor for gastric
adeno-carcinoma of the antrum and corpus.
Pathogenic mechanisms by which H. pylori induces gastric injury are now fairly well
explained, but though there is an inverse relationship between socio-economic status and
the prevalence of infection, the exact mode of transmission remains a mystery.
Nevertheless, controversies surround the methods of diagnosing and treating dyspeptic
patients without ulcers and even those with suspected but unproven peptic ulcers. In
addition, controversy exists as to whether all H. pylori are intrinsically "bad"
and potentially dangerous, and thus should be eradicated, or whether some H. pylori are
"good" and therefore should be left alone.
In answering such ethical questions, the first factor to consider is the nature of the
patient-physician relationship. Not only is this of paramount importance, but attitudes to
this relationship have been undergoing profound change in recent times.
Once, a paternalistic attitude was the norm, based on the belief that "scientific
objectivity" was the dominant value in diagnosing and treating a patient, and in the
interests of scientific objectivity, the physician was best qualified to make decisions
without much reference to the patient. A non-paternalistic approach, on the other hand,
assumes that the patient has the right to full information about techniques and research
progress involved in his condition and its treatment.
Medical theorist Robert Veatch suggests in "The Patient-Physician Relation" (1)
a partnership model in which the principles of autonomy and justice take precedence over
beneficence, with the physician being obliged to create an atmosphere inducive to
questioning by the patient about, for example, H Pylori and the need or not for testing
and treatment.
The controversy about an active versus a passive patient involvement model is complicated
by the fact that so much is still not known about the condition.
Gastroenterologists have been and still are divided among those who believe that "the
only good Helicobacter is a dead one" and those who believe that possible
"good" Helicobacter should be protected.
This controversy is exemplified by two recent articles. On one hand, a recent editorial in
the British Medical Journal by Anthony Axon and David Forman (2), "Helicobacter
gastroduodenitis: a serious infectious disease" concluded that it is timely to
consider H pylori gastroduodenitis as a disease in its own right, with peptic ulcer and
gastric cancer as important complications. About 85% of infected individuals, they note,
"will not develop complications but until a reliable means can be found to identify
the 15% who will become seriously ill, all those with the disease must be considered at a
high risk of a potential fatal outcome."
On the other hand, an article by Martin Blaser (3) in the Lancet, "Not all
Helicobacter pylori strains are created equal; should all be eliminated?" suggested a
conceivable benefit to some infected people, and noted that at present, we are too
ignorant of the diversity of H. pylori strains and their interactions with human beings to
advocate their total elimination. It is very possible that in addition to the
"bad" or the "very bad" H pylori strains, there are also the
"good" or "neutral" strains.
In considering the ethical implications, primary consideration must be given to the
protection of the patient, since to practice medicine ethically, the physician must apply
his knowledge and power only for the benefit of the patient in particular and mankind in
general. This consideration also applies to the use of new diagnostic tests which have
allowed us in recent times to diagnose conditions in ways that were not possible in the
past. Helicobacter induced gastritis is but one example.
Perhaps we as physicians should adapt the words of the prophet Malachi, "What is good
and what is required of you but to do justice to your patients, show them love and
kindness and always walk humbly..."
The question, of course, is how to apply such exhortations to the ethics of new diagnostic
tests. Should we, or should we not, test in the case of H. Pylori? Most people agree that
once a positive test is found, then treatment is usually indicated. If positive, it is
probably not ethical to leave the patient untreated. Even if serious outcomes are
uncommon, it is appropriate at least to explain to the patient the potential effects of
treating or not treating.
Who then should we test and treat? If the answer is "everyone", then we have the
problem of expense, particularly in the developing countries, though perhaps less in the
West. The potential of inducing antibiotics resistance as well as the potential side
effects of therapy must also be taken into account. Should treatment be reserved for only
the "bad" strains, ie. Cag A positive and Vac A positive (Vacuolating cytotoxin
genotype.) (4) which have been associated with peptic ulcer and gastric cancer. Concerning
the host’s response to the H pylori, the host immune response, genetic factors and
life style habits are all factors of which the importance is not yet clear.
We should be asking ourselves a number of question: Is broad screening for H. Pylori
infection indicated? Which method of screening is the most specific and sensitive? Is
recognition of the most virulent strains of H. Pylori of importance? Is complete
eradication of H. Pylori appropriate? Should we screen and treat all patients with H.
Pylori gastritis?
In favor of this, 50% of the world’s populations are infected with H. Pylori, of whom
10% will develop complications and 2% die. These figures could all be reduced and primary
cancer prevention may thus be possible. In addition, the pool of infection would be much
reduced
Against screening and treating everyone with H. pylori gastritis are : the dubious ethics
of treating asymptomatic persons; the unrestrained use of antibiotics that could result in
resistant strains; the astronomical costs of such a project to any health fund or
government body. How can an undeveloped country afford such a proposal? There is evidence
that there has been a natural decline of the prevalence of infection as socio-economic
conditions have improved in countries so much that in certain countries, such as New
Zealand (5), it has dropped to under 10% of the population. Finally, there is the feeling
among the ecologically-minded that we should not "mess with the environment". H.
Pylori has probably been around since creation.
W De Boer at the recent International Workshop on Helicobacter pylori held in Lisbon (6)
summarized the salient points regarding gastric carcinoma and H pylori as follows. There
is evidence that H. Pylori infection increases the risk of gastric cancer two to three
fold (7) and that gastric cancer is the second most common cancer in the world and fourth
in the developed countries. However, rates are decreasing sharply in the West and the
risk/benefit ratio for primary prevention is unknown.
The question is whether preventive efforts should be focused on high risk groups only,
such as patients with a family history of gastric cancer or young patients who need long
term treatment with a proton pump inhibitor or on the whole population.
David Forman (8) at a recent meeting in Copenhagen reported data from a meta analysis of
eight prospective studies involving more than 700 patients with non-cardia gastric cancer
and showed the risk to be between 1-12 fold (combined average 2.8) for H. pylori
positivity and non-cardia gastric cancer. However, as regards gastric cardia cancer, H.
pylori may even have a protective effect, with a risk of between 0.8 - 1.3 (combined
average 0.9).
Other studies by Blaser in 1995 (3) and Parsonnet in 1997 (9) have shown a definitive
association between gastric cancer and CagA positive serology among H.pylori infected
subjects.
John Atherton (4) summarized the association between peptic ulceration and CagA positive
serology among H pylori infected subjects. Five studies have shown a significant increase
in the percentage of CagA positively in patients with an ulcer (8.2-100%) compared to
those with no ulcer (37-64%).
The ethics and advisability of testing and treating patients with non ulcer dyspepsia
(NUD) for H. pylori also requires looking at. Peter Malfertheiner in Lisbon (10) stated
that the relationship of non ulcer dyspepsia and H. pylori has yet to be confirmed. In
fact the prevalence of H. pylori has not been found to be any greater in NUD than in
asymptomatic population groups. There is also a lack of convincing evidence from well
designed studies that H. Pylori eradication alleviates symptoms in patients with NUD. It
may be that there is a subgroup of patients with NUD in whom eradication of H. Pylori will
be helpful. There is evidence that treatment of NUD patients simply converts a H. Pylori
positive to H. Pylori negative dyspeptic patient.
Therefore the question arises: is it ethical to test for and then eradicate H. Pylori to
cure a condition that may not be improved by eradication therapy? The decision to treat a
non ulcer dyspepsia should thus be made on a case for case basis and not on a consensus
statement.
Concerning the question of the value of some of the tests available to diagnose H. pylori
infections, such as the Urea breath tests and serology, the physician should be convinced
they are safe, accurate, sufficiently specific and useful as a diagnostic technique and
should use them under the correct circumstances only.
The Urea breath tests have been used for a number of years in patients with peptic ulcer
disease to diagnose the presence of H. pylori or to assess eradication. They are based on
the generation of CO2 in the stomach by the action of urease produced by the H. pylori on
ingested labelled urea. Labelled CO2 is absorbed in the blood and eliminated via the lungs
in the breath and the proportion of CO2 in the breath before and after the ingestion of
labelled urea is an indirect measure of the presence of H. pylori. Once we have decided to
do a UBT, the question becomes, is it ethical to do the 14-CUBT or should only the 13-CUBT
(11) be used. The non-radioactive 13-C test requires expensive equipment but it can be
used in young children (12). The test is easy to perform, does not require special
transport conditions but may be fairly expensive. The 14-C test is cheap but radioactive.
The radiation exposure is less than one day’s exposure to the sun and one-tenth of
that of a chest X-ray. However, there is the problem of environmental contamination with
an isotope that has a half-life of 5700 years (13). Both tests are very sensitive (95%)
and about 90-95% specific (14). False negative results can occur if done in proximity to
PPI(proton pomp inhibitor), bismuth or antibiotic therapy. Tests done less than one month
after therapy may give a false indication of eradication.
Laboratory serological tests for H pylori are based on the detection of IgG (occasionally
IgA) antibodies specific to H. pylori. Several commercial ELISA kits are available (15)
and eight of these have been compared in a multicenter study with satisfactory accuracy.
Their main use has been epidemiological studies (16). False negative results may occur in
children, the elderly and the immunocompromised. All commercial kits need validation on
the population to be studied by testing against a well-defined panel of sera to establish
a valid cut-off point. Serological tests are relatively specific, 70-90%, and sensitive ,
75-95%, and are inexpensive. Their role in confirming eradication is limited, however. The
instant result finger prick tests are less specific and less sensitive than the laboratory
based tests. Values range from 63-97% sensitivities and 68-92% specificities (17) (18).
On-site serological testing has also been promoted as a "test and treat"
strategy in a primary care setting.
Is testing after eradication therapy ethically necessary when we consider the cost
involved? Should patients who have had therapy be restested for confirmation of successful
eradication? This is also questionable.
Only 33 % of treated patients report symptom resolution after eradication of infection.
Triple therapy has an eradication rate of about 90% (19). However when questioned, 90% of
the patients who had become asymptomatic, desired confirmatory evidence of H.PYLORI
eradication (19).
Getting back to ethics, Pellagrino and Thomasma in their book "A Philosophic Basis of
Medical Practice" (20) stress that "treating patients in a technological fashion
is not being a true physician. Clinical concerns should go beyond the technical details of
biological tests." The choice of what is to be done cannot be the privilege
exclusively of the physician or the patient. The decision on what to do must arise somehow
from cooperation between the one who is in need, the patient, and the one who attempts to
alleviate that need, the physician.
There is often a fine line between advising based on knowledge of a particular case, and
telling a patient what to do in a paternalistic way. As gastroenterologists, we are
required to provide facts relating to H. pylori as well as an evaluative judgement of our
opinion. Such a judgement is formed after consideration of the body of medical evidence,
medical values and intuition based on past medical experience. An evaluative medical
judgement better equips the patient to decide what is best for his or herself (21).
The principles of the new Italian code of medical practice state that the conduct of the
physician should find inspiration in the equilibrium and interplay between science and
conscience, a middle ground conducive to responsible medical performance and to the
fulfilment of the patient’s interest
SUMMARY
The aim of this paper is not to come to a conclusion on whether we should regard H pylori
as sometimes or always a serious infection or perhaps even potentially beneficial, but to
discuss some facts which may help us come to an ethical decision on the recommendation of
Urea breath tests and/or serology tests to various population groups and on the subsequent
need for eradication therapy. At a time when guidelines are constantly changing as a
result of new scientific studies and discoveries, it is neither wise nor ethical to be
dogmatic on the subject. Rather, we should judge on a case by case basis, in order to
avoid the misuse of breath tests and serology tests to diagnose H. pylori infections in
otherwise healthy population groups and thus avoid much anxiety about the H. pylori
plague. In situations where indications for testing and treatment are not conclusively
recommended by consensus statements, patients should be given the facts and the physician
and patient should together come to a satisfactory decision about treatment and testing.
REFERENCES:
BIOETHICS COMMITTEES
C. FRANCESCONI - C. STANCIU
A. Definitions
Hospital Bioethics Committees (EC) are multidisciplinary organized bodies of people from
different backgrounds who should be able to identify, analyze and help resolve moral
problems that arise in the care of individual patients.
Research Ethics Committees (RECs) are multidisciplinary organized bodies of people from
different backgrounds who should be able to identify, analyze and help resolve moral
problems that arise in both clinical research and non-clinical biomedical research. A REC
can develop its action either at an institutional or at a national or regional level.
B. Origin and Composition
In 1803 Sir Thomas Percival in his book Medical Ethics was the first person to recognize
the need of an organized body of persons to exchange ideas concerning the development of
new medical procedures. In historical perspective this is probably the first time REC is
mentioned.
After the Second World War, as a consequence of the atrocities that were inflicted by the
Nazis under the excuse of "medical research", the first international research
code was developed: the Nuremberg Code which was subsequently improved at different
moments (Helsinki 1964, Tokyo 1975, Venice 1983, Hong Kong 1989 and CIOMS 1982 and 1993).
All these codes have in common the prescription of measures aimed to protect research
subjects against possible abuses. Different countries have national medical research codes
according to international rules but in accordance to moral and social values of a given
society.
The development of the renal dialyses units in the 1960s, raised a very difficult ethical
question to the nephrologists, with a number of patients far exceeding the number of
centers where the skills and machinery were available to the patients. At that time, in a
medical center a board of lay people selected patients to under go treatment; those
patients had a chance of surviving. This committee became known as the "God
Committee" for they had the power of life and death. "Social worth" and
"productivity" were values that were often taken into consideration to make this
choice.
In 1976 Karen Quinlan’s case posed a complex question to a judge who had to decide if
the patient’s family had the right to ask to the doctors responsible for her care to
interrupt the measures that kept her alive. At this moment she was in a persistent
vegetative state with no perspective of clinical improvement. The judge asked the Nursing
Home Ethics Committee, where she was maintained alive for help indeciding whether the
claim was morally acceptable or not. Than it was realized that the hospitals in the United
States did not have this kind of committee and that the people involved in the case, were
not aware of the pioneer paper written by Karen Teel, who, the previous year proposed the
constitution of multidisciplinary committees. So one was created at Karen’s nursing
home to answer the judge’s question. In the following years this kind of committee
was organized in a great number of American hospitals and also in countries all over the
world (1).
Committees that deal with ethical issues are usually composed of people from different backgrounds. Because EC and REC are organs responsible for the protection of patients and/or research subjects, they have the social obligation to protect the members of the community under its jurisdiction from any ethical infringement from the health professions. For this reason, society must be represented on these committees by people of both genders, different races, representative of the city or country, and sometimes, in special questions, by minorities when issues that are pertinent to them are brought up. It is also essential that different medical specialities be represented in these committees as well as members of other professions such as nurses, social workers, lawyers, church representatives, administrators, ethicists and lay people representing the community (1).
C. Responsibilities
REC and EC have different responsibilities. The former has to deal with the protection of
the rights and welfare of all human subjects exposed to scientific experimentation and the
latter with the protection of patients in medical institutions. The hospitals and the
different health care institutions like hospices, outpatient clinics, homes for orphans,
homes for elderly people and mental hospitals very often have moral questions and dilemmas
that are raised at the moment that physicians and staff of these institutions mentioned
above.
REC members have to review research protocols and in some circumstances to follow them to
be sure that, in delicate or risky research situations for the subjects, they are
protected by the research team (2). In some countries institutional REC has to report to
the national REC for the approval of research of new drugs, vaccines and new technologies.
Multicentric studies are evaluated in different ways in different countries; the ethics
evaluation can be independently performed by institutional, regional, national or
international EC. One important issue raised in the last CIOM’s International
Guidelines for Biomedical Research Involving Human Subjects (3) it needs to be mentioned.
Externally sponsored investigation of new drugs or any new technology, that has direct
implication in third world countries received special attention, as follows:
"Externally sponsored research entails two ethical obligations:
An external sponsoring agency should submit the research
protocol to ethical and scientific review according to the standards of the country at the
sponsoring agency, and the ethical standards applied should be no less exacting than they
would be in the case of research carried out in that country.
After scientific and ethical approval in the country of the sponsoring agency, the
appropriate authorities of the host country, including a national or local ethical review
committee or its equivalent, should satisfy themselves that the proposed research meets
their own ethical requirements."
In our personal experience, informed consent has been the most frequent cause of
interaction between REC and researchers. Problems related with its formal presentation are
the main reasons to return protocol to researchers asking for improvement. We ask for a
clear presentation of the topics so they can be perfectly understood by the research
subjects as recommended by international guidelines of research (CIOMS and the ICH
Harmonized Tripartite Guideline for Good Clinical Practice) (3,4). We think those joint
meetings between REC and Scientific Committees are very productive for two reasons: the
first is that a scientifically sound protocol is the basic ethical foundation of medical
research and second the fact that it decreases the evaluation time of the protocol.
EC have different responsibilities. First of all it is a consultation committee
rather than an executive one like REC. In most medical institutions EC works for:
a) education: its interaction with members of the health and administrative staff, through
the discussion of ethical matters related to their work with patients. This is an
important way of increasing the sensitivity of these professionals to the ethical aspects
of patient care. It has also the role of educating the members of the committee themselves
that will represent, at the end, a multiplier effect for the dissemination of ethical
issues;
b) policy formulation: EC can work at the request of the institutional administration or
its own initiative, when any measure that may improve or protect patients is contemplated.
As a consultant body, EC submits drafts for evaluation of the administrative authorities;
c) case consultation, which is done at the option of any person of the health team or even
of the patients. Moral issues in the care of terminal patients, allocation of scarce
resources, patient’s autonomy, conflicts between beneficence and autonomy,
fertilization and the interruption of pregnancy and moral problems in the care of AIDS
patients, usually related to confidentiality and privacy are usually submitted to the EC
(7).
EC members are expected to have some special skills in order to do their work in a more
effective way and, at the same time, to gain the trust of people that ask for their
advice. La Puma and Schneidermayer (8) suggest the following skills and roles for ethics
consultation members:
It is interesting to observe that these skills and roles
as well as the kind of cases that are brought to consultation described by American
authors have been observed by one of the authors (CF) to apply in the operation of an EC
in a developing country with a Latin culture.
However, there are some difficulties for ethics consultants and the teamwork of an EC. It
is difficult to pass enthusiasm and ethical knowledge to each member of the committee in
order to make the decision process more coherent and scientific and less based on
"gut feelings". It is expected from its member a kind of moral sensitivity and
not necessarily solid bioethical foundations. So the selection process of the EC
constituents is critical: it should be done neither on political nor on friendship
criteria. The feeling that only ethical consultants are experts in ethics, so that the
remaining members of the hospital staff and faculty should mention their moral commitment
regarding the care of their patients. Moral neutrality must be avoided at any cost.
In order to be efficient and reliable, ethical consultants
must promptly attend consultations. As EC members they are usually involved in their basic
activities, the availability of time is critical to meet the expectations of the community
institution. For this reason it is essential that at least 3 to 5 of its members have
similar skills to be able to attend urgent consultations.
Factors involving group dynamics can add some difficulty in the running of an EC. In
selection process it is essential to avoid persons with dogmatic, rude, narcissistic or
individualistic characteristic personality features or any other characteristic that can
harm teamwork in the discussion of delicate moral questions. It is also essential the
members be bound to confidentiality and privacy principles. The environment of the
meeting, when one brings his or her case to the group must be as friendly as possible to
avoid any threatening or intimidating feeling. The EC must also be alert and avoid
discussing non-moral issues like personal, deontological/legal and administrative
problems.
D. Ethics Committees of National and International
Organizations
Almost all national and international societies or organizations related to
gastroenterology, hepatology and gastrointestinal endoscopy place an Ethical Committee on
their bylaws. It usually has two roles:
a)one, and the most traditional, concerned with deontological questions, like professional
incorrect attitudes of their members, financial questions of reimbursement of professional
work and so on;
b) the OMGE EC has also been engaged in bioethical education and research in the last
years. It has been a very productive activity; for instance, the discussion in several
countries of issues of truth telling, using an international research sponsored by the
committee (9) as a base for the debate of moral principles like autonomy, beneficence,
veracity, fidelity and justice. The cross cultural differences observed in the
Pan-American, Brazilian, Rumanian, South-African meetings have been a very rich experience
both to the members of the committee who have participated in the events and also to the
audience who have praised greatly the open discussion of this matters. It is a very
promising fact the effort of OMGE and OMED to join some of their committees, the Ethics
Committee being the first one to share members of both organizations.
REFERENCES :
Tealdi JC, Mainetti JÁ: Hospital Ethics Committees in Bioethics Issues and Perspectives;
Editors: Connor SS Fuenzalida HL Pan American Health Organization 1990, 24-29.
Capron AM: Human Experimentation in Veatch RM Medical Ethics; Jones and Bartlett
Publishers 1989 , 125-172
International Ethical Guidelines for Biomedical Research Involving Human Subjects prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with World Heath Organization (WHO), 1993
ICH Harmonized Tripartite Guideline for Good Clinical Practice; supplement; Good Clinical Practice Journal;3:4,Sept/Oct 1996
Silverstein F., Larson EB, Rohrmann Jr. C.A.: Diagnostic and Therapeutic Modalities in Gastroenterology; General Considerations, in Textbook of Gastroenterology, Yamada T., Alpers D., Owang C., Powell D., Silverstein F., 2538-2544, JB Lipincott Company, Second Edition, Philadelphia EUA, 1995
Bouchard S., Barkun A.N., Barkun, J.S., Joseph L.: Technology Assesment in Laparoscopie General Surgery and Gastrointestinal Endoscopy: Science or Convenience?; Gastroenterology 110: 915-925, 1996
Junkerman CL: Manual for Ethics Committee Members Froedtert Memorial Lutheran Hospital& John L Doyne Hospital Joint Ethical Committee Milwaukee, Wisconsin 1994
La Puma J, Schneidermayer DL: Ethics Consultations and Skills, Annals Int. Med. 114, 155-160, 1991
Thomsen O.,Wulff HR, Martin A, Singer P: What do gastroentero- logists in Europe tell cancer patients? Lancet, 341, 473; 1993.
"This publication is supported
by an unrestricted educational grant from
Takeda Italia"
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