1. National Evidence-based Healthcare Collaborating Agency (NECA) provides scientific evidences to the policy
makers and the general public, by analyzing economical efficiency of pharmaceuticals, medical devices and
health technology ultimately contributing to the enhancement of public health. Evidence and Value is a
journal of NECA to develop the necessary evidences in healthcare sector for rational decision making and
efficient resource utilization.

2. ISSN 2092-7932
2 0 1 0 / F E B R U A R Y / V O L . 0 4
EVIDENCE
VALUE

3. Contents N E C A 2 0 1 0 F E B R U A R Y
CEO Column 03 What Common Principles Should Be Pursued in Order to Obtain the Ideal Medical
System?
Root 05 The Need for a Nationwide Healthcare Database Linkage Center
08 Ethical Issues Regarding the Use of Collective Health Record for Research Purposes
10 Legal Regulation of the Health Information Provision for Research by Public
Organizations
13 Foreign Case of the Use of Health Information for Research Purposes
17 The Necessity to Establish a Healthcare Database Linkage Center in Korea
Research Topic Survey 19 NECA Research Topic Suggestion Survey
Court of the Eastern Palace 20 Glucosamine and Chondroitin Products: Are They Being Used Appropriately?
Research Activity 22 An Outcomes Research of the Therapeutic Modalities for Postpartum Hemorrhage
Lecture 26 Methods to Measure the Results of Studies of Therapies: Proper Understanding, Proper
Application
NECA News 30 NECA news
February 2010 / Vol.04
Publishing Company National Evidence-based Healthcare Collaborating Agency [Changgyeong Building 6th and 8th and 9th and 11th floors, 28-7
Wonnam-dong, Jongno-gu, Seoul / 82-2-2174-2700) Publisher & Editor-in-Chief Dae-Seog Heo Publication Date February 22, 2010 (Vol. 4) Edit
Planning National Evidence-based Healthcare Collaborating Agency Executive Editor Byung Joo Park, Sang Il Lee, Soo Young Kim, Sang Moo Lee,
Hyun Joo Lee Staff Mi Hee Nam, Ha Young Choi, Jin Hee Kim, Che Lim Cheong, Ji Ae Park Design ChoonChu Communication (82-2-6332-6007)
Printing Company Nogin 2dcom All contents including texts and pictures that are in this book are copyrighted.
3 NECA

4. CEO COLUMN
What Common Principles Should
Be Pursued in Order to Obtain the
Ideal Medical System?
In the book Mongminsimseo, Chong Yag-yong recounted an ancient Chinese story. In an
excerpt from the book, Yagyong stated, Singongui, a local government official for the Chinese Sui
Dynasty, noticed that the majority of people in a contagious disease infected area greatly feared
the disease. It was not uncommon for afflicted patients to be abandoned, even by their own family
members. Thus, many people who were infected with this disease were left to die alone. Singongui
ordered the transfer of every patient to a government building. Since it was summertime, the
building corridor was filled with patients. Singongui brought a chair into the corridor and provided
24 hr care, using medicine that he purchased with his own salary. After the patients were cured,
Singongui summoned their relatives and admonished them. He said, Your life and death depends
on your fate. If this disease was contagious, I would have already died. All of the family members
felt ashamed, and thanked him for his generosity."
Approximately 200 years ago, in the absence of epidemic-associated medicine, Chong Yagyong
wrote, "Infectious disease patients are often avoided by other residents. However, we must
console and treat these patients to prevent further fear of this disease." Even at that time, Yagyong
was cognizant of the need to provide afflicted patients with food and care in order to prevent
unnecessary deaths.
The actions of Florence Nightingale toward wounded soldiers on the battlefield of Crimea in
1854 did not differ very much from Singongui's treatment of infectious disease patients. By simply
improving the hygiene of the facilities that accommodated the wounded soldiers, and also
providing clean water, food, as well as basic nursing skills, Nightingale effectively decreased the
death rate from 42% to 2%.
As these two real-life stories clearly demonstrate, the care and treatment of patients are as
important as proper medical techniques in order to help save the lives of many individuals.

5. However, medical treatment has traditionally been differentiated from other areas of scientific
technology due to the importance of patient care. Upon the development of science, modern
medicine has equipped itself with advanced medical devices, new techniques, and new drugs, and
conquered many diseases that could not be cured in the past. However, concerns have arisen
regarding whether the essence of medical treatment is being overlooked in the competition
among large hospitals to attract patients with expensive medical equipment and cutting-edge
medical techniques.
The issue of medical care is becoming increasingly important as the number of single-member
families continues to expand in today's society. The participation of nurses, social workers,
psychological counselors, caregivers, as well as doctors is essential in order to provide proper
patient care. Furthermore, other medical systems, such as health insurance, also play a very
important role in this process. Therefore, in order to offer the ideal medical services which people
desire, professionals of various occupations, as well as members of certain medical organizations
must work closely with one another. If these individuals and organizations are unable to cooperate
with one another, then they have lost sight of the intrinsic reason for their existence.
"What are the common principles that we must pursue in order to obtain the ideal medical
system?"
Currently, we are fortunate to possess medical techniques and drugs that could not have been
dreamed of 200 hundred years ago. However, the spirit and morale of Singongui and Nightingale
are needed more now than ever before, in order to truly advance our capabilities of patient care.
Feb. 2010
Dae-Seog Heo
04 NECA

6. ROOT Root : Solicitation of opinion and expertise of opinion leaders to facilitate decision-making
This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.
The Use of Linked Health Information for Research Purposes : The development of evidence-based healthcare policy
and the improvement of quality of healthcare service are dependent on the use of linked health information. Based on
evidence-based expert contributions, we will examine the need for a nationwide healthcare database linkage center,
analyze ethical and legal issues, and determine usage of such information in foreign cases to facilitate the use of linked
health information for research purposes.
List of articles in order of publication:
- The Need for a Nationwide Healthcare Database Linkage Center
- Ethical Issues Regarding the Use of Collective Health Record for Research Purposes
- Legal Regulation of the Health Information Provision for Research by Public Organizations
- Foreign Case of the Use of Health Information for Research Purposes
- The Necessity to Establish a Healthcare Database Linkage Center in Korea
The Need for a Nationwide
Healthcare Database Linkage Center
Byung-Joo Park Professor, Department of Preventive Medicine, Seoul National University College of Medicine
According to a study conducted by the United States Institute of Medicine, and published in the
Journal of the American Medical Association (JAMA), in 1994 the number of annual U.S. deaths from
adverse drug reactions (ADRs) reached 106,000, being estimated between the 4th or 5th major cause of
death in the U.S. However, drugs are indispensable in modern medicine as more than 60 percent of
patient care is currently dependent upon their effectiveness. Nonetheless, all drugs have positive effects
in curing diseases, but can also result in undesired adverse reactions. Thus, pharmaceutical companies
are striving to develop new drugs that are more effective but also safer for patients. In order to protect
the public from ADRs, government drug regulators thoroughly examine the therapeutic effects and
safety of new drugs before permitting their placement in the market. Government regulators also use a
drug surveillance system to continuously monitor the safety of these drugs. As a result of these efforts, a
number of previously evaluated drugs have been banned from the market due to serious ADRs that were
identified after use in patient care, despite earlier documentation regarding their effectiveness and
safety.
The spontaneous reporting system (SDS) is the first drug surveillance system that has been
introduced in several countries. It is a very economic and effective method that is capable of
discovering rare but clinically serious ADRs at an early stage, following the
introduction of drugs into the public market. However, SDS is also a passive
surveillance system in which the government waits for citizens,
including healthcare professionals, to report
February 2010 05

7. suspected ADRs. databases to evaluate the cause of ADRs. Several
The reports are then analyzed in order to determine decades ago, large U.S. healthcare corporations such
whether an ADR does in fact exist. Nevertheless, such as Group Health Cooperative, Kaiser-Permanente, and
passive surveillance systems are not as useful in United Health Group established their own health
countries where the percentage of ADR reporting is research centers to evaluate drug usage patterns
low. and investigate clinical progress following drug
The number of ADR reports in Korea has recently administration.
increased, but is still not compatible with SDS monitoring. These research centers scientifically assess the
In order to overcome this limitation, our exceptional benefits and injuries of specific drugs while generating
information technology (IT) skills should be used in the objective evidences, as shown in Table 1.
development of a new drug surveillance system. The
creation of IT infrastructure has lead to computerized As an example of government-controlled ADR monitoring,
medical records and health insurance system for all the Canadian province, Saskatchewan, maintains a
citizens. Information regarding people's use of computer database of all personal health information
healthcare services is stored in the database of the between birth and death for over one million residents.
Health Insurance Review and Assessment Service This database contains demographic information
(HIRA). Furthermore, Statistics Korea manages data such as gender, marital status, birth and death dates,
regarding deceased individuals, while the National prescriptions, admission and discharge dates,
Cancer Center (NCC) maintains cancer statistics. Thus, treatment techniques, diagnosis, and other relevant
the information amassed by these two organizations medical information. The cancer registration data of
can be used to build a new low cost drug surveillance Saskatchewan is also linked to this database. This
system that effectively monitors drug usage data. In information can readily be used in research studies for
some countries, studies are currently being conducted public interests. Previous studies have already
to examine ADR severity following drug administration. analyzed certain drug/ADR correlations such as
These studies also use health insurance claims between statins (hyperlipidemia drug) and cancer
Tab.1 Health research centers and insurance claims databases in the U.S.
Insurance Company Group Health Cooperative Kaiser Permanente United Health Group
Established in 1947 1933 1974
Subscribers Washington State, around 560,000 Nationwide, 8.2 million Nationwide, 50 million
Registration, prescriptions, inpatient/outpatient,
Registration, inpatient/outpatient, Registration, medical claims,
Details of data clinical examinations, radiological examinations,
discharge, diagnosis, etc. prescription claims, medical staff
cause of death, immunotherapy, etc
Research Center Center for Health Study Center for Health Research Center for Health Care Policy and Evaluation
Research Center established in 1983 1964 1989
Drug use assessments, provision of Epidemiological studies, economic Adverse events related to drugs, quality
Areas of study sampling framework for medical studies, analysis of healthcare programs, utilization management of healthcare systems, cost-
post marketing surveillance on safety, etc. of medical services effectiveness analysis
Use of alendronate for osteoporosis and
Use of antidepressant by pregnant women Drug use and cancer development, Vaccine
Examples of study incidence of the adverse esophageal and
and congenital anomalies use and the development of diseases
gastric events
06 NECA

8. development as well as between non-steroidal anti- information of Korean citizens and also provide the
inflammatory drugs and the development of acute renal required data for research purpose that are in the
failure. best interest of the public. Establishment of such a
center would greatly contribute to the improvement
The integration of currently existing electronic of overall public health.
databases in Korea would allow for early ADR
detection of specific drugs. The cooperation would Meanwhile, in order to assure the safe and effective
also help to rapidly and economically generate the use of health information, legal regulations must
basic databases required in the establishment of guarantee privacy protection, and appropriate laws
various health policies. Therefore, implementation of must be enacted and applied to all individuals. In
a nationwide healthcare database linkage center order to protect personal information, it is important
would provide the necessary data for research to increase the ethical awareness of hospitals that
purpose that could potentially benefit the general produce and manage health information, the
public. Such a center is integral in linking health nationwide healthcare database linkage center
insurance data maintained by HIRA, death data which integrates the data and researchers who
managed by Statistics Korea, cancer registration conduct the research studies. Moreover, in addition
data managed by NCC, national health and nutrition to continual improvements of security systems,
survey data maintained by the Korea Institute for concrete and practical privacy protection systems
Health and Social Affairs, and the electronic medical must also be implemented in order to prevent
records (EMR) of all hospitals. Furthermore, Korean internal and external intrusions of the information
citizens are given resident registration numbers that databases. These efforts together will allow for the
are unique personal identifiers. Combining currently most beneficial use off the collected health
stored computer data with resident registration information and ultimately lead to improvements in
numbers can help determine the percentage of public health.
ADRs, cancer development and mortality, as well as
their correlations with specific drugs. Similar to a
bank's management of their customer's money, a
data linkage center would manage the health
References
1. Byung-Joo Park, Development of an active monitoring system for adverse drug reactions, The Journal of Korean Society of
Clinical Pharmacology and Therapeutics, 1994;2:105-11. [Korean]
2. Park BJ, Clouse J, Wysowski D, Shatin D, Stergachis A. Incidence of adverse esophageal and gastric events in alendronate users.
Pharmacoepidemiol Drug Saf 2000;9:371-6.
3. Platt R, Davis R, Finkelstein J, Go AS, Gurwitz JH, Roblin D, Soumerai S, Ross-Degnan D, Andrade S, Goodman MJ, Martinson B,
Raebel MA, Smith D, Ulcickas-Yood M, Chan KA. Multicenter epidemiologic and health services research on therapeutics in the
HMO Research Network Center for Education and Research on Therapeutics. Pharmacoepidemiol Drug Saf 2001;10:373-7.
4. Rodriguez EM, StaffaJA, Graham DJ. The role of database in drug postmarketing surveillance. Pharmacoepidemol Drug Saf
2001;10:407-10.
5. Strom BL. Pharmacoepidemiology. 4th ed., John Wiley & Sons Ltd., 2005.
February 2010 07

9. ROOT
Ethical Issues Regarding the Use of
Collective Health Record for
Research Purposes
Ock-joo Kim Professor, Department of History of Medicine and Medical Humanities,
Seoul National University College of Medicine
Advancements in computer technology and research rather than for medical treatment.
the development of electronic health records have However, it is often impossible to receive personal
allowed for the use of large-scale health record consent from each patient for use in public studies
information in healthcare studies. However, usage of that require large scale health record information.
this information has raised concerns regarding ethical For example, studies that acquired data from the
issues of privacy and confidentiality. Therefore, many National Health Insurance Corporation were
countries have, or are currently considering the conducted under the discretion of the Institutional
application of strict laws concerning the confidentiality Review Board (IRB), but did not receive consent from
of health information. In this case, the term, privacy, the subjects. Studies such as this, which use a large-
refers to the self-controllability of personal scale database, cannot receive consent from each of
information. The term, confidentiality, indicates legal the millions of people involved, because it simply is not
and ethical obligations to refrain from revealing an feasible. Although there may be no physical harm to
individual's private information without consent. the patient if their collective health record is released
to third parties, other problems such as discrimination
Identity of subjects must remain private in employment, residence, and health insurance may
Patient health records contain very sensitive occur. Therefore, a subject's identity and private
information which requires strict confidentiality. Thus, information must remain confidential.
obtaining explicit permission from each individual Consequently, it is important for database management
before using their health record or information for to minimize identifiablity, and maximize anonymity, in
research purposes is absolutely essential to the order to reduce the risk of potential harm for each
principles of ethics. For example, the U.S. has enacted patient. From the perspective of biomedical ethics, the
a law that requires patient authorization before principles of non-maleficence and beneficence must
allowing personal health information to be utilized for be given priority over the principle of respect for
08 NECA

10. This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.
autonomy. Since perfect anonymity cannot be guaranteed,
The core ethical problem in the use of large-scale even in the case of unspecified data sets, anonymous
collective health information is achieving a balance collective health record cannot ensure the safety of
between the promotion of research for public good, the study, nor provide justification. Confidentiality can
and the protection of patient privacy. Thus, it is be improved if a part of the collective health information
necessary to maximize the utility of the information for that is used for research purposes, is permanently
research or public policy, while minimizing the deleted. Such a deletion may decrease the utility of the
possibility of privacy infringement. In order to initiate information used in research studies.
studies in the right direction, the role of 'honest
broker' is essential. This individual is responsible for Both the honest broker and IRB need to review the
the data, but cannot be directly related to the study. research plan to examine the content for essential
The 'honest broker' is accountable for providing information, the presence of personal identification,
anonymity and coding the data, managing the data and details of record linkage. Other important factors
with minimal social and ethical problems, and also to be evaluated include identifying personnel who will
providing the data to researchers. have access to the information, specific confidentiality
If patient consent is not received, and collective devices, and confirming that researchers will faithfully
health information is leaked during the course of a fulfill their obligations towards protecting patient
study, considerable regression in research ethics will confidentiality and privacy. The honest broker must
undoubtedly arise, as has been noted in past provide the necessary information that is required for
transgressions. The organizations that manage large- research studies with minimal identifiably following
scale collective health information must maintain a IRB approval and review of the research plan. Finally,
high level of data security, both technically and the researchers and honest broker must both sign a
physically, and also arrange for technical devices to contract that delineates how the data will be managed
ensure privacy. These safeguards will serve to gain and destroyed, prohibits sharing the data with third
society’s trust, ensuring the conduction of future parties, and how their compliance will be supervised.
research studies. Furthermore, because data leakage
often occurs by password exposure, the relevant Pursuit of public good using a confidential health
employees must be thoroughly educated in the record system
application of security systems, and also closely The ethical problems regarding the use of collective
supervised. health record for research purposes is directly related
to determining whether all of the associated parties
Continual database supervision by an honest broker can be trusted with regard to patient privacy protection
Recently, as the connection between large-scale and confidentiality. This ethical issue also includes
databases with other databases has become easier, public monitoring and supervision of the organization
the re-identification of patients is emerging as an that accumulates the collective health record.
important ethical issue. Information that once was Moreover, the general public should be consulted in
anonymous may be readily identified by simply linking the order to obtain their opinions concerning how the
available elements of the data together. Thus, various appropriate methods may be applied in order to use
methods to cope with this problem have been proposed. the collective health record for public good.
February 2010 09

11. ROOT
Legal Regulation of the Health
Information Provision for Research by
Public Organizations
Hyoung-Wook Park (Attorney at Law, M.D.) Professor, Department of Medical Law and Ethics,
Yonsei University College of Medicine
Concerns about privacy infringement have continued to increase upon advancements in
computer and communication technologies, as well as the arrival of the information society. The
medical field has not been immune to these apprehensions. The accelerated development of health
record systems and progressive discussions of the national infrastructure for healthcare
information has resulted in active discourse regarding legislation for the protection of health
information.
However, health record information is not a sanctuary that must be absolutely protected without any
exceptions. The release and use of private information are permitted under certain conditions, such as for
criminal investigations, prosecution of a court case, or during the conduction of court trials. In the United
States, despite the high social awareness of privacy protection, public organizations are permitted to
provide health records for research studies without obtaining patient consent.
For example, the Center for Medicare and Medicaid Service (CMS) is a public organization in the
UnitedStates. Within specified limits, this organization routinely provides health information of its
participants for research purposes. The Freedom of Information Act (FOIA), the Health Insurance
Portability and Accountability ACT (HIPAA), and Privacy Regulations all provide the legal grounds for the
disclosure of health information by CMS. The FOIA and Privacy Regulations impose the obligation for
information disclosure, while the specific limits of information disclosure are defined by the HIPAA and
Privacy Regulations.
HIPAA and Privacy Regulations differentiate 'non-identifiable' health record information from
'individually identifiable' information, thereby clarifying that not all health information can be
10 NECA

12. This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.
identified for each individual. Furthermore, HIPAA and Privacy Regulations clearly state that
protected health information (PHI) consist of data that can be associated with a particular
individual; however anonymous PHI is not protected by the law. Presently, privacy rules permit the
provision of health information for research studies without patient consent under the conditions
described below.
Health information provision under privacy rules in the United States
Firstly, anonymous PHI can be used or disclosed without consent from patients because, as
mentioned above, the scope of protection by HIPAA and Privacy Regulations is limited to
individually identifiable health information. However, if anonymous health information becomes
individually identifiable by any means, it is again included in the scope of protection by HIPAA and
Privacy Regulations.
Secondly, the limited dataset (LDS) of applicable organizations can be provided for research
purposes under a data use agreement with researchers. The main contents of the data use
agreement are as follows:
LDS can be used or disclosed only for the specified purpose.
Measures to ensure data protection must be provided.
Unauthorized use or disclosure of LDS must be reported to the applicable organization.
Subcontractors must agree to the same standards.
Individually identifiable information must not be converted, and the contact of
individual patients is not permitted.
Thirdly, PHI can be used for research when the Institutional Review Board (IRB) or the Privacy
Board provides written exemption of the conditions for authorization. This document must include
the following:
name of the IRB or the Privacy Board
exempted dat
a statement by IRB or the Privacy Board ensuring that all of the requirements for exemption
have been fulfilled
a short explanation by the IRB, or the Privacy Board, stating that the use of, or access to
PHI, is essential for specified research
a statement certifying that the exemption has been examined and approved under
normal procedures, and
signature of the chairman of the board.
February 2010 11

13. Fourth, PHI can be used for preliminary studies. If the applicable organization permits the use of
PHI for a preliminary study, the researchers must confirm the following:
PHI will be used only for the preparation of study protocol or similar purposes and
the PHI will not be removed and only used for the intended study.
Fifth, the health information of deceased individuals can be used for research. In the use of health
information of the deceased, the researcher must provide written proof confirming that the PHI is
essential for the study and that the requested data belong to the deceased.
Balance of public good and private information disclosure
In general, information disclosure and privacy protection are mutually antagonistic components.
The largest volume of information must be disclosed, however privacy must also be protected. There
are two potential solutions to overcome the conflict between the demands for information disclosure
and privacy protection. First, deletion of the appropriate data that contains identifiable information
will prevent privacy right infringement. Second, comparing the benefits between the attainments of
public good versus privacy right infringement, upon information disclosure, will also serve to
determine whether the demand for information disclosure conflicts with the demand for privacy
protection. In the UnitedStates,the laws and policies associated with the use of health information for
research purposes continue to fine-tune the balance between public good and private interests.
In Korea, the laws that regulate privacy in the public sector are The Personal Information
Protection of Public Organizations Act and The Information Disclosure of Public Organization Act.
Article 1, No. 2 of The Personal Information Protection of Public Organizations Act defines 'personal
information' as the information of living persons that may identify individuals by their name, resident
registration number, and image. Article 9, Clause 1, No. 6 of The Information Disclosure of Public
Organization Act defines 'protected information' as personal information that includes an
individual's name and resident registration number that, when disclosed, may infringe the privacy or
freedom of their private life.
In conclusion, current laws permit the use of individually unidentifiable health information for the
purpose of research studies. Nevertheless, public organizations such as the Health Insurance
Review & Assessment Service and the National Health Insurance Corporation have excessively
restricted the provision of this information to researchers. Recently, these organizations have
undergone a fortunate, although somewhat late, change in their attitude regarding this issue. In
future legislation, the interested parties must demonstrate their efforts to reach a reasonable
balance between the public interest of research and the private interest of personal health
information protection.
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14. ROOT This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.
Foreign Case of the Use of Health
Information for Research Purposes
Sang-Ho Yoo Professor, Department of Family Medicine, Hallym University College of Medicine
Recently, medical research using large-scale health information is rapidly increasing
within and outside the country. Useful results have been reported and the creation of new
databases facilitated by linking information between large-scale health records and other related
health records. However, ethical problems may arise when creating these highly valuable large-
scale databases, particularly due to the interlinking of data. The most serious problems are
infringement of privacy and violation of confidentiality. Ownership and control of data may also be
controversial.
It has been known that the identifiability of individuals increases when data containing private
information are interlinked. Therefore, in addition to the general confidentiality devices and
methods used for the collection, storage, and handling of health information, good procedures and
methods for data linkage must be provided in order to protect privacy and confidentiality. Most
valuable health information is stored by public organizations that have considerable legal
responsibility for using or releasing the data. The Personal Information Protection of Public
Organizations Act restricts arbitrary provision of private information to third parties by the data
processing staff of public organizations, and defines punishment for violations of this provision as
well.
The general principle for ensuring that ethical standards are adhered to in data linkage, is to
separate the linking process from the linked data. In principle, either the organization storing the
data or relevant experts, should perform the data linkage and provide researchers with only the
linked data from which individual identifiers have been removed. It is generally prohibited for
researchers to directly perform data linkage using individual identifiers, in order to prevent
confidentiality violation.
February 2010 13

15. However, most researchers want to directly perform data linkage for various reasons, and create
numerous new databases. It is desirable to immediately remove individual identifiers from the raw
data and connect the data with artificial identifiers. Furthermore, except in special cases, original
identifiers must be used only when the data are first linked.
The model case to be introduced in this report is the Western Australia Diabetes Linkage Project
conducted in the state of Western Australia. In this case, researchers were allowed to directly
perform data linkage while following the principles and procedures for ensuring ethical behavior
as mentioned above. This procedure is believed to be applicable to our situation.
This procedure consists of 2 phases, which are briefly described below.
The first phase comprises
signing of the memorandum of understanding (MOU) with related organizations
review of the ethical considerations in data linkage, and
creation of the linkage file.
The second phase comprises
signing of the memorandum of understanding (MOU) with related organizations
preparation of the project identification (ID) file
extraction and provision of the dataset by the data storage organization, and
final dataset linking and completion of data linkage by the researchers.
The most distinctive feature of this procedure is the exclusion of individual identification data by
the creation of a linkage file that plays the role of an individual identifier without the inclusion of any
individual identification data.
14 NECA

16. Procedu al details of the Western Australia Diabetes Linkage Project conducted in
the State of Western Australia
Western Australia Diabetes Linkage Project
Signing of the MOU by related organizations The public organizations storing the data,
the supervising organizations, and the research institutes sign a MOU for close cooperation
for the research project.
Review of ethical considerations in data linkage The Institutional Review Board (IRB/IEC) of
the data storage organization and the organization to which the researcher belongs, review the
ethical considerations in the data linkage.
Creation of a linkage file A linkage specialist who does not belong to either the data storage
organization or the research institute is selected, and original datasets are requested from the data
storage organizations that signed the MOU. This specialist creates a linkage key file which
connects the local ID of the dataset with a link ID, using a separate safe computer. After creating
the key file, all the individual identification information is immediately destroyed. The key file must
not contain any individual identifier or personal health information. The specialists who
participated in the linkage file creation may not participate in any future research or data analysis,
nor exchange information with the researchers.
Review of ethical considerations in individual research protocols by the relevant organization
The IRB/IEC of the organization to which the researcher belongs reviews the ethical
considerations in the research protocol.
Preparation of the project ID file To extract individual project datasets on the
researcher's request, the linkage specialist links a local ID with the project ID instead of
the link ID of the linkage key file, and hands it over to the person in charge of the data
storage organization, who then directly delivers the extracted data to the researcher.
Extraction and provision of the dataset by the data storage organization A representative
of the data storage organization extracts the dataset using individual identifiers as
requested by the researchers, and removes the individual identifiers before delivering the
dataset to the researchers with only a project ID.
Final dataset linking and completion of data linkage by researchers The researchers
directly link the dataset received from the data storage organization using the project ID.
Only the research team keeps the completed linkage database which is encrypted and
stored in an independent computer. Only the researchers who participate in the analysis
are allowed to access the password for the linkage data, and the data is destroyed
immediately upon completion of the analyses.
February 2010 15

17. The advantages of the procedure used by the Western Australia Diabetes Linkage Project are as
follows: first, confidentiality can be strictly secured. Although the link specialist is exposed to
individual identifiers when creating the linkage file, he/she is not exposed to the actual health
information. Thus, it is impossible to ascertain who the sensitive information belongs to.
Furthermore, the researchers are not exposed to individual identification data, and it is nearly
impossible to ascertain who the sensitive information belongs to even during the research.
Second, because the researchers can directly perform data linkage, while adhering to ethical
standards, they can collect data that corresponds to the purpose of their research. Third, it is
possible to conduct studies of public value by signing an MOU only once.
According to a report on the studies conducted using this procedure between 1990 and 2003 in
,
Western Australia, the researchers demand for data with individual identifiers decreased after
the introduction of the comprehensive population-based Data Linkage System. Thus, the Data
Linkage System improved confidentiality because the use of data with individual identifiers
decreased (Figure 1).
Fig. 1 Proportion of ethics-approved research projects using name-identified and data-linked
administrative health information in western australia between 1990-2003
References
1. Kelman CW, Bass AJ, Holman CD. Research use of linked health data-a best practice protocol. Aust N Z J
Public Health 2002;26:251-5.
2. Trutwein B, Holman CDJ, Rosman DL. Health data linkage conserves privacy in a research-rich
environment AEP 2006;16:279-80.
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18. ROOT This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.
The Necessity to Establish a
Healthcare Database Linkage
Center in Korea
‘Nothing is complete unless you put it in shape.’
Ki-Soo Park Professor, Department of Preventive Medicine, Gyeongsang National University School of
Medicine NECA Affiliated Researcher
‘Data’ are unprocessed, literally scattered facts. If these scattered data are interpreted
and stories hidden within them are carefully heard, they become “information”. Of the
information, the pieces that have already been verified and the know-how of using information are
collectively called “knowledge”. Therefore, the role of the government and researchers is to
transform data into information and enable people to use this information as knowledge.
From this view, if foreign clinical researchers envy our country, it should be due to the national
health insurance system. One of advantages of this system is that the health data of all people are
gathered in one database and, thus, studies based on this large population are possible. If studies
are conducted on these data, probably the largest number of research outcomes may be produced
in our country.
However, the reality is that many researchers who conducted studies using parts of the
database feel ill rather than feeling at ease. In the case of the national health insurance system,
the medical claims database of patients contains electronic health records of all people in our
country, which is very useful for evidence-based outcomes research and political healthcare
decision-making. In addition, statistical data (e.g. the cancer registry project) obtained through
surveys conducted with large, national budgets are also valuable for evidence-based healthcare
policies.
Necessity of collective management of databases
Healthcare related databases (e.g. the national human genome database, patient survey database
and insurance claims database) created by the Ministry of Health, Welfare and Family Affairs or
affiliated organizations (e.g. the Health Insurance Review and Assessment Service and the National
Health Insurance Corporation) are operated for the unique purposes of the individual organizations
February 2010 17

19. and, thus, the database has no compatibility with databases of other organizations or systems for
connected analyses. There are also many difficulties in applying government survey data to
purposes other than the original, intended purpose of the survey. Yet, data required in clinical
medical studies can be obtained only through the fusion of data retained by many organizations,
which show this situation is problematic.
In this case, individual organizations make independent judgments to decide to provide the data
established with government budgets, rather than consider national demand. Eventually,
personal information may not be protected properly and information necessary to policy decision
makers may not be provided on time. In order to develop timely evidence for healthcare policies,
databases of individual organizations should be integrated for management.
Examples of the United States: Utilization of the Medicare database
Recently in the United States, in response to the necessity to enlarge studies using patient
information, efforts have been made to develop systems to conduct studies more effectively and
efficiently while protecting patients‘ personal information, pursuant to the Health Insurance
Portability and Accountability Act (HIPPA).
As a preceding condition of these study systems, data building systems are being operated to
consider personal information protection and the use of personal information for public purposes.
That is, in the United States, the Centers for Medicare and Medicaid Service (CMS), which are federal
organizations, and the Research Data Assistance Center (ResDAC), a non-profit organization, are
operated for the rational utilization of the Medicare database.
In addition, as part of the comparative effectiveness research implemented by the Obama
government national healthcare reform plan, the Distributed Ambulatory Research in Therapeutics
Network (DARTNet) was established to integrate information on 400,000 patients from eight
organizations. This is an electronic health record database network made by the federal government
in 2008 (supported by the Agency for Healthcare Research and Quality (AHRQ)), set up as a private-
public network. DARTNet includes electronic health records (EHR), a pharmacy utilization database
and billing systems that went through standardization processes and personal information deletion
processes. This information was designed to be used during a patient encounter. In addition,
DARTNet can be used both for observational and experimental research, as well as observational
comparative effectiveness research (OCER).
In addition to the United States, England, France and Canada, other countries are showing
movements to use people s health information in the development of evidence-based health
policies and improvement of clinical practice quality. In our country, too, national interest should be
enhanced to advance from accumulating data to fusing data so that they can be utilized much more
efficiently and effectively.
18 NECA

20. Research Topic Survey
NECA
Research Topic
Suggestion Survey
After the success of the first topic suggestion survey in 2009, NECA opens the second topic
suggestion survey to the general public, universities, learned societies, medical institutions,
and health organizations. The purpose of this survey is to adopt social agendas in the
healthcare field through diverse paths and perform public research on the issue.
The expert committees and the Research Planning & Management Committee will review
proposed topics and consider their coincidence with the missions and vision of NECA, as
well as their need and urgency. The selected topics will undergo the final selection process
based on their practicality and appropriateness of performance, before being adopted as
official research projects of NECA.
(In English) Send your research proposal via email (juje neca.re.kr),
How to Suggest a fax (82-2-725-4917), or mail.
Research Topic (In Korean) Visit the NECA website (http://www.neca.re.kr) for
information on writing a proposal for your research topic.
Period Mar. 15 (Mon.) ~ Apr. 14 (Wed.), 2010
Eligible applicants: interested citizens, universities, learned societies,
Eligible applicants
medical institutions, healthcare research organizations, etc.
Contact: Research Planning Team, NECA
Contact
(Tel: 82-2-2174-2789, E-mail: topic2011 neca.re.kr)
February 2010 19

21. Court of Eastern Palace
Donggwoldo (Painting of Eastern Palace) : This astonishing 16-piece long bird-eye-view painting of
Changdeok-gung (palace) and Changgyeong-gung-(palace) painted by the members of Dohwaseo in the
late Joseon dynasty era. Coincidentally, this is the exact view from the National Evidence-based Healthcare
Collaborating Agency (NECA), situated in Wonnam-dong. National treasure No. 249. Collection of Korea University Museum.
THIS Page is aimed to draw out agreement of the experts in various groups on pending social issue
Glucosamine and Chondroitin Products:
Are They Being Used Appropriately?
Investigation of utilization and assessment of scientific evidence
Sang-Cheol Bae Principal investigator, Director, Hospital for Rheumatic Disease, Hanyang University
Principal investigator Sang-Cheol Bae (Director, Hospital for Rheumatic Disease, Hanyang University)
Yoon-Kyoung Sung (Hospital for Rheumatic Disease, Hanyang University), Soo-YoungKim
Presenters
(Department of Family Medicine, Hallym University Hospital)
Kyung-Ae Kim (Health Network), Hee-Chun Kim (CHA University, Department of Orthopedics),
Panelists Byung-Sung Kim (Department of Family Medicine, Kyung Hee University Hospital), Sun-Gun
Chung (Department of Rehabilitation Medicine, Seoul National University Hospital)
On January 27, NECA held a forum on the estimated by annual expenses spent by current
effects of glucosamine and chondroitin products. users of glucosamine, was approximately 280
At this forum, NECA shared findings from a study billion Korean Won. This is a heavy national burden
on the current use and effects of glucosamine and (for general adults aged 40 or older).
chondroitin products with the medical community, About 77.0% of the respondents who were
consumer representatives, and relevant experts; currently taking glucosamine preparations (991 out of
and it collected their opinions. 8,135 respondents) had not received any diagnosis of
osteoarthritis from a doctor. Furthermore, 42.8% were
Use of glucosamine or chondroitin products in taking glucosamine without joint pain (Figure 2). This
general population shows that many users of glucosamine are taking it to
NECA surveyed Korean adults for 12 days during improve general health or prevent osteoarthritis.
last September to determine the percentage of
people taking glucosamine products. In this survey, Assessment of effects according to glucosamine
about 12.2% of respondents answered "I am now components and use of glucosamine in
taking glucosamine," and those who have ever used musculoskeletal patients
glucosamine were around 30.0 % (Figure 1). In systematic reviews to investigate the effects of
The total expenditure by Korean adults for glucosamine therapy according to two components
purchasing glucosamine products which was (hydrochloride/sulfate), there is no evidence that
20 NECA

22. glucosamine hydrochloride is more effective than conclude that glucosamine has therapeutic effects.
placebo in osteoarthritis. Meanwhile, in investigating An analysis of two types of studies was undertaken:
the ingredients of domestic and imported glucosamine (1) studies to ensure that researchers are unaware
products registered in KFDA, 77.0% of 387 identifiable which group patients are being allocated to at the time
products were glucosamine hydrochloride. they enter the study and (2) studies that were not
In a survey of those who visited the department of funded by manufacturers. Results showed that
rheumatology in two university hospitals in Seoul, glucosamine was not effective in pain reduction and
15.8% of respondents answered "I am now taking functional improvement.
glucosamine," and the percentage including the It was also insufficient to conclude that chondroitin
respondents who answered "I have taken was effective in pain reduction, functional improvement,
glucosamine before" was approximately 38%. and prevention of joint space narrowing, compared to
It was found that the percentage of people taking placebo in osteoarthritis. Furthermore, glucosamine
glucosamine was high, even among patients with and chondroitin combination products also failed to
rheumatism that was not related to osteoarthritis. show significant differences in pain reduction, functional
Clinicians and healthcare providers need to educate improvement, and prevention of joint space narrowing,
patients for appropriate use of glucosamine. Further compared to placebo, and the quality of evidence was low.
research is needed to analyze the cause of misuse.
In literature searching, there was lack of data to
Findings from systematic review on clinical effectiveness reach conclusions that glucosamine is effective for
A systematic review on the clinical effectiveness of treatment and prevention of osteoarthritis.
glucosamine found that it had some significant effects
on pain reduction, functional improvement, and
Yoon-Kyoung Sung, Chan-Bum Choi (Hanyang University
prevention of joint space narrowing compared to
Hospital), Eun Bong Lee (Seoul National University Hospital), Soo
placebos, but the results were inconsistent. In meta- Young Kim (Hallym University Hospital), Hyun-Ju Seo, Chelim
analysis stratified by manufacturers, glucosamine Cheong, Jiae Park (NECA)
The final conculsion of this study will be published later
components (hydrochloride and sulphate), and source after further discussions with related policy makers, experts,
of funding, there was also insufficient evidence to and civic groups.
38.85
no diagnosis by Dr.
80 74.87 40 38.14
70 62.25 35
chondroitin
60 30
50 25
40 20 18.37
OA diagnosis by Dr.
30 23.57 15
glucosamine
20 17.75 10
12.18
10 7.82 5 4.64
0.13 1.43
0(%) 0(%)
current users former users non-users I don't know joint pain no joint pain
Fig. 1 Current use of glucosamine and chondroitin products Fig. 2 Joint pain and diagnosis of osteoarthritis (OA) from
a doctor among the current users of glucosamine
February 2010 21

23. Research Activity
Research Activity: Executive summary on the research activities of the National Evidence -
based Healthcane Collaborating Agency
An outcomes Research of the
Therapeutic Modalities for
Postpartum Hemorrhage
Jong-Myon Bae Principal investigator, NECA Chief Researcher
01. Background
Korea is facing a serious issue in maintaining its population due to the recent fall in birth rate
and a quickly-aging population. As postpartum hemorrhage (PPH) is one of the leading causes
of maternal mortality, we analyzed the current status and treatment of PPH in Korea. PPH is
mostly treated with uterus-contracting agents. However, a small proportion of PPH patients do
not respond to drugs and require a more definitive treatment such as hysterectomy or uterine
artery embolization (UAE). UAE has the advantages of preserving fertility while maintaining
acceptable safety and efficacy profiles.
02. Methodology
We analyzed the efficacy and safety of UAE by using claims data from the Health Insurance
Review and Assessment Service (HIRA), cohort data from one tertiary hospital in Gyeonggi-do,
systematic review and meta-analysis of the literature using data from Korea, and extensive
review of providers working at each level of care.
03. Results
Current status and treatment of PPH in Korea
Analysis of the 2008 HIRA data revealed that the incidence of PPH was about 4%, with more than
22 NECA

24. 18,142 cases. The incidence of PPH was higher in clinics than in tertiary hospitals and increased
with maternal age (Figure 1).
By the level of hospital By age groups
4.8%
(10,064) 4.4%
4.1% 3.9% 4.1% (276)
3.7% (7,964) (7,523) (2,339)
2.9% (6,164)
(1,543)
1.5%
(374)
Tertiary General 30 30 34 35 39 40
hospital hospital Hospital Clinic
Fig.1 The incidence rate of postpartum hemorrhage in 2008
Tertiary hospitals are specialist-training hospitals that have at least 20 departments of medical care and have been designated
by the Minister for Health, Welfare and Family Affairs. General hospitals are medical institutions that have at least 100 sickbeds
and a certain number of departments of medical care. Small hospitals are medical institutions with at least 30 sickbeds.
Approximately 97.1% of patients with PPH received general treatment such as uterus-
contracting agents and blood transfusion. Among them, only 10.9% received blood transfusion,
with the rate being lower in clinics than in tertiary hospitals. This may be due to the inadequate
facilities for blood transfusion in clinics and hospitals. Additionally, the cases of blood transfusion
were 1.39 and 1.9 times higher in the age groups of 35-39 and 40 and older, respectively, than in
women under 30. The number of patients who underwent UAE was 293 (1.6%), which was
higher than the 195 patients (1.1%) who underwent hysterectomy. In particular, in cases of
PPH occurring after a cesarean delivery, UAE was performed twice as many times as
hysterectomy. A greater percentage of patients aged 34 or younger underwent UAE than
hysterectomy (72.7% vs. 60.6%).
There was a great variation in the treatment received after PPH occurred and the
proportion between UAE and hysterectomy according to the region where PPH occurred. The
number of patients who received UAE was 15 times higher than those who underwent
hysterectomy in Gangwon-do, followed by 4.0 times in Gyeonggi-do, 2.8 times in Chungnam,
2.5 times in Daejeon, and 2.4 times in Seoul (Figure 2).
Approximately 95% of the patients with PPH received treatment in the same hospital, and
about 3.1% were transferred from a clinic to a tertiary hospital after the onset of PPH. Around
30% of the patients who were transferred to a tertiary or general hospital underwent UAE.
Seven of 9 patients from Incheon were transferred to either Seoul or Gyeonggi-do to receive
February 2010 23

25. UAE. This example indicates that most patients with PPH are transferred to large cities, where
they undergo UAE.
Retrospective cohort analysis
Between December 2003 and October 2009, UAE was performed on 183 patients with PPH in 1
hospital in Gyeonggi-do. Their average patient age was 32.8 (22-45) years, the success rate of
UAE was 98.4%, and the percentage of patients with short-term complications was 1.6%.
Among the 160 patients with a preserved uterus who could be followed up, 3 patients were
amenorrhea, 11 gave birth, 5 were pregnant, and 2 had an abortion.
Meta-analysis
We selected 9 articles of 125, through a domestic database search. We performed a meta-
analysis of these articles and the retrospective cohort studies to evaluate UAE as a treatment
for PPH. The success rate was found to be about 93% (95% CI: 89-96%), the percentage of
patients with short-term complications was about 8% (95% CI: 4-14%), the percentage of
patients with numbness in the lower limbs was about 10% (95% CI: 7-16%), and the percentage
of patients who started menstruating after UAE was about 98% (95% CI: 96-99%). Furthermore,
Fig.2 The proportion between uterine artery embolization and hysterectomy according to the region
24 NECA

26. among the 53 patients who wanted to become pregnant, 45 got pregnant, of which 26 gave
birth, 11 were pregnant, and 8 had an abortion.
Extensive review of providers working at each level of care
Interviews were performed with obstetricians and radiologists. Although they acknowledged
the superiority of UAE, their decisions to opt for UAE varied widely depending on their
environment and experience. Hospitals with a high percentage of transfer patients requiring the
UAE procedure commonly had close relationships with nearby tertiary hospitals that could also
perform UAE. Thus, the formation of a network between clinics that have a certain number of
births and their neighboring hospitals that have the facilities to conduct UAE was suggested.
Consultations with other experts also confirmed that the greatest factor negatively influencing
the choice to perform UAE was the weak network between clinics and tertiary hospitals that can
perform UAE.
04. Conclusions
The cohort study as well as the meta-analysis confirmed previous reports of the safety and
efficacy of UAE. Interviews with first-line providers and physicians working at hospitals capable
of performing UAE suggested that the formation of a strong network between clinics/small
hospitals and tertiary hospitals capable of performing UAE, was critical in facilitating the use of
UAE in PPH patients stable enough to receive the treatment.
Ho-Geol Ryu, Eun-Jin Jang, Mi-Hee Nam, Jeong-Hyun Cho, Na-Rae Lee (NECA), Joon-Seok Hong, Kyuseok
Kim, Chang-Jin Yoon (Seoul National University Bundang Hospital)
February 2010 25

27. Lecture
Methods to Measure the Results
of Studies of Therapies:
Proper Understanding, Proper
Application
Sang-Moo Lee NECA Chief Researcher
Research findings obtained through scientific evaluation include information on the
effectiveness, efficacy, efficiency (benefit), adverse effect, cost and/or burden (risk) of the relevant
intervention. Based on the findings, decisions will be made to determine whether or not to use the
relevant intervention. In this course, both researchers and decision makers should recognize how to
measure the effectiveness of therapeutic interventions and the characteristics of each intervention,
and understand how to select the result to be presented obtained through different measuring
methods. In this lecture, we will review the characteristics and limitations of methods to measure
treatment effects with dichotomous data values.
First, measures with relative characteristics include the relative risk (RR), the relative risk
reduction Y/X each group is the ratio between cases where the event of interest occurred and cases
where the event of interest did not occur. RR can be expressed as “The risk is ~ times higher
compared to the control group” and RRR can be expressed as “The risk has been decreased by ~%
compared to the control group.” Therefore, RR is a concept familiar to both patients and healthcare
professionals and is recommended for meta analyses. Also, RR is more consistent compared with
measures having absolute characteristics (Figure 1). Effectiveness measures with absolute characteristics
include absolute risk reduction (ARR) and numbers needed to be treated (NNT).
26 NECA

28. Fig. 1
Question: To patients who had adenomas removed: What particular drugs can be recommended
in order to prevent sporadic colorectal neoplasia? To answer to this question, let's consider the
celecoxib study to prevent colorectal adenoma(Bertagnolli, 2006). The findings of this study are
summarized as follows.
Indexes with relative characteristics (3yrs)
Adenoma No Adenoma
Celecoxib (n=679) 66 291
Placebo (n=685) 83 203
RR=0.64(0.48-0.85)
RRR=0.363 (0.154-0.52)
ARR=0.105(0.039-0.172)
NNT=9.493(6-26)
OR=0.55 (0.38-0.80)
The risk of event occurrence of the control group: X
The risk of event occurrence of the treatment group: Y
The relative risk (RR)of event occurrence in the therapy: Y/X
The relative risk reduction (RRR) of the therapy: (1-Y)/X
Compared to placebo, celecoxib reduced the occurrence of adenoma by 36 percent
(RRR=0.363, CI:0.154-0.52).
The odds ratio (OR) of celecoxib for the occurrence of adenoma is 0.55 (CI: 0.38-0.80).
The ARR of a therapy becomes X-Y and NNT becomes 1/(X-Y) as a reciprocal of ARR. ARR can
be stated a”The risk rate is different by ~ percent from the control group” and NNT can be stated as
“The number of patients who need to be treated for a patient to show the effectiveness of the
therapy,” that is, “It is effective in one patient when ~ patients are treated” (Figure 2).
Outcome measures with absolute characteristics may supplement measures with relative
characteristics. In measuring the benefits of a certain therapy in diverse conditions, there are
limitations of measures like RRR. Let s take two virtual therapies as examples for comparison
(Table 1).
Let s assume that, in the case of therapy A, among 1,000 patients treated, 100 patients showed
the adverse effect, whereas, in the control group, 200 patients out of 1,000 showed the adverse effect.
In the case of therapy B, among 10,000 patients treated, 100 patients showed the adverse effect,
whereas, in the control group, 200 patients out of 10,000 showed the adverse effect. Then, in both
cases, the value of RRR is 0.5 and, thus, both therapy A and B reduced risks by 50 percent. However,
when ARRs are reviewed, therapy A showed a 10 percent lower risk of harm compared with the
control group, whereas therapy B showed a risk of harm only 1 percent lower compared with the
control group. In case of NNT, when 10 patients were treated by therapy A, one patient could avoid
harm, whereas when 100 patients were treated by therapy B, one patient could show the benefit of
February 2010 27

29. Fig. 2
Measures with absolute characteristics
The risk of event occurrence in the control group: X
The risk of event occurrence of the treatment group: Y
The absolute risk reduction (ARR) of the therapy: X-Y 1 10 100
The number of patients needed to be treated (NNT)= 1/(X-Y)
Compared to placebo, the occurrence of adenoma among
8 adenoma
the celecoxib group was 10 percent lower
(ARR= 0.105, CI: 0.039-0.172). If nine patients are given
1 adenoma
celecoxib for 3 years, one patient will result to prevent the
prevented
occurrence of adenoma (NNT=9.493, CI:6-26).
To consider harm in addition to it, when 333 295
patients are treated, adenoma will be prevented in
37 patients and 1 patient will develop myocardial 37 adenoma
prevented
infarction due to celecoxib (NNT=9.493, CI: 6-26 and NNH
=333 (Kearney 2006), CI: 200-1,000). 1 myocardial
infarction
the therapy. Although the effects of the two therapies can be considered to be the same when judged
by RRR, the effects of the two therapies will be shown to be remarkably different when absolute
concept measures are used.
Using NNT values, rather than RRRs, may help to judge the benefits and harm considering the
costs of therapies as well as the extents and frequencies of adverse events. That is, although the
values of the two therapies cannot be considered the same, the effects look the same when analyzed
using RRR values. Examining NNT values has the advantage that by considering the number of
patients opportunities to make more rational decisions can be obtained, which do not factor in the
effect of treatments, treatment costs and the sizes of adverse events resulting from the treatments.
In addition, the methods to report the results of treatments affect the perception of the degree of
treatment effects. Healthcare professionals, political decision makers and the public commonly
showed that RRR, with its relative characteristics, could be used to make clearer judgments on
certain therapies compared with using ARR or NNT values with absolute characteristics.
Covey reported results of a systematic review on those studies that: (1) randomly assigned
participants to one measure format, or offered participants with different measure formats; (2)
measured participants evaluation of the efficacy of the treatment quantitatively, their willingness to
undertake the treatment themselves, or recommend it to others; and (3) compared relative
measures with absolute measures or NNT values.
28 NECA

30. Tab. 1 Outcome measures of supposed two therapies with various ways
Division Events No event RRR ARR NNT
occured occured (95% CI) (95% CI) (95% CI)
A group 100 900 50% 10% 10
Therapy A
Control group 200 800 (37.5-60) (6.9-13.1) (7.6-14.5)
B group 100 9,900 50% 1% 100
Therapy B
Control group 200 9,800 (36.5-60.6) (0.7-1.3) (74.8-150.7)
In this study, 31 unique experiments were included and analyzed. Although a significant amount of
heterogeneity was found, the treatments in studies that used the RRR format were consistently
evaluated more favorably compared with treatments with ARR or NNT formats.
Based on the results of the above studies, RRR, which has relative characteristics, tends to
overestimate the effectiveness of therapy compared with ARR or NNT, and thus, presenting only
RRR values could be risky. Therefore, ARR and NNT values should be presented along with RRR.
NNT can be used to compare many treatments on the same disease. However, are affected by the
degree of baseline risks, types of control groups and time spent to measure outcome. Thus,
comparisons can be made only after these conditions have been controlled.
References
1. Bertagnolli MM, et al. Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 2006;355:873-84.
2. Covey J. A meta-analysis of the effects of presenting treatment benefits in different formats. Med Decis Making
2007;27:638-54.
3. Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and
traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of
randomised trials. BMJ 2006;332:1302-8.
4. Kumana CR, Cheung BM, Lauder IJ. Gauging the impact of statins using number needed to treat. JAMA
1999;282:1899-901.
5. Moxey A, O’'Connell D, Mc Gettigan P, Henry D. Describing treatment effects to patients. J Gen Intern Med
2003;18:948-59.
Curriculum Vitae of Dr. Sang-Moo Lee
1989 Achieved specialty in internal medicine
1998 Ph.D. College of medicine, Soonchunhyang University
1999- 2000 Clinical research fellow, the clinical research center of the chronic obstructive
pulmonary disease and rehabilitation, Harbor-UCLA Medical Center, Torrance, CA, U.S.A.
Full-time lecturer and doctor, Department of internal medicine, Soonchunhyang University
Assistant professor, School of Medicine, Eulji University
Member of review and assessment committee and first head of new health technology
assessment division, Health Insurance Review and Assessment Service
2010 - Executive director of HTA research division, NECA
February 2010 29

31. NECA news
NEWS
Presentation of the results of the study on the effectiveness
of glucosamine and chondroitin therapy
On the 27th of January, a presentation of the results of the study
on the effectiveness of glucosamine and chondroitin therapy in
treating patients with osteoarthritis was held in Lee Kun-Hee
Auditorium, Samsung Cancer Research Building, Seoul National
University. Experts from the policy authority, medical professions
and civic groups participated in a forum held on the same
occasion. The results presented on this day provided an
opportunity to facilitate proper understanding of glucosamine therapy among 30 press and media representatives.
2010 NECA institution workshop
During a workshop from the 29th-31st of January, NECA
allocated time for all personnel to share the direction of projects
in 2010 and to discuss the direction of development. In this
workshop, measures to improve NECA research projects, mid-
long term strategies and plans to operate entrusted projects
were announced. In the divided task discussion sessions that
followed the announcement, groups discussed the direction of
development of NECA. CEO & President Dae-Seog Heo
extended his thanks to the personnel while looking back on the previous year in which the agency had run at a
breathless pace. He encouraged the personnel to further develop the NECA in 2010.
Ground oriented decision-making methodology symposium
On the theme, “Benefits and Harm. Its trade-off”, the agency held
a decision-making methodology symposium in Lee Kun-Hee
Auditorium in Samsung Cancer Research Building in Seoul
National University, at 2 PM on February 8.
In this symposium Dr. Reed Johnson from the Research Triangle
Institute (RTI) in the United States lectured on studies of the
risks-benefits of drugs reflecting patients’ preferences, and
presented objective methods to identify the benefits and harm of
therapies. The lecture provided a good opportunity to learn about the newest trend of studies in the U. S. and in Europe
where efforts are being made gradually to reflect the intentions of patients on drug regulations.
30 NECA

32. Renewed opening of NECA home page
The upgraded home page that delivers NECA news was
opened with renewed content on February 5, one year after its
launch in February 2009.
Menus in the wallpaper of the renewed home page were
configured to be simple to easily communicate the status of
the activities of NECA and to highlight the calendar function in
order to increase external experts’ participation in events
held by NECA.
In addition, the Knowledge Transfer and Implementation
Center (KTIC) website intends to provide grounds for evidence-based decision making in the healthcare service
area. Customized information is expected to serve the role of rearranging confusion in healthcare information.
The CEO & President of NECA, Dae-Seog Heo, was
selected as a Joongang Ilbo 2009 ”Saetdugi”
The Joongang Ilbo selected Dr. Dae-Seog Heo, the CEO &
President of NECA, as the 2009 science area “Saetdugi” The
“Saetdugi” refers to a person who tears down existing
barriers to open new stages. In a legal battle at the Supreme
Court in April last year, regarding “whether to legally permit
deaths with dignity,” President Heo supported the standpoint
of the family of an old woman, The woman Even though most
doctors know the necessity of the withdrawal to end sustaining meaningless life, such withdrawal is illegal under
the current law and most doctors cover up the issue. With the belief that the responsibility for withdrawing life
should be taken by hospitals rather than passed onto doctors, President Heo introduced “criteria for the
withdrawal of meaningless life sustaining treatment” to the medical ethics committee of Seoul National
University Hospital. These criteria were passed in July last year.
President Heo suggested discarding the term “death with dignity” and calling it instead “the suspension of
meaningless life sustaining treatment” (in the case of the Cardinal Stephen Kim Sou-hwan) or “the withdrawal
of meaningless life sustaining treatment” (in the case of Ms. Kim).
Additionally, the NECA made efforts to derive social consensus on this matter and raise great awareness in
religious organizations, civic groups and in overall society as well as in the medical world.
February 2010 31