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 0 1 0 / F E B R U A R Y / V O L . 0 4

ISSN 2092-7932

EVIDENCE VALUE

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3 NECA

CEO Column

Root

Research Topic Survey

Court of the Eastern Palace

Research Activity

Lecture

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Publishing Company National Evidence-based Healthcare Collaborating Agency [Changgyeong Building 6th and 8th and 9th and 11th floors, 28-7Wonnam-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.

Contents

February 2010 / Vol.04

N E C A 2 0 1 0 F E B R U A R Y

What Common Principles Should Be Pursued in Order to Obtain the Ideal Medical

System?

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

NECA Research Topic Suggestion Survey

Glucosamine and Chondroitin Products: Are They Being Used Appropriately?

An Outcomes Research of the Therapeutic Modalities for Postpartum Hemorrhage

Methods to Measure the Results of Studies of Therapies: Proper Understanding, Proper

Application

NECA news

11CEO COLUMN

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.

What Common Principles ShouldBe Pursued in Order to Obtain theIdeal Medical System?

04 NECA

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

05February 2010

⊙ 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

Root : Solicitation of opinion and expertise of opinion leaders to facilitate decision-makingThis 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 policyand the improvement of quality of healthcare service are dependent on the use of linked health information. Based onevidence-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 linkedhealth 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

ROOT

The Need for a Nationwide Healthcare Database Linkage CenterByung-Joo Park Professor, Department of Preventive Medicine, Seoul National University College of Medicine

06 NECA

suspected ADRs.

The reports are then analyzed in order to determine

whether an ADR does in fact exist. Nevertheless, such

passive surveillance systems are not as useful in

countries where the percentage of ADR reporting is

low.

The number of ADR reports in Korea has recently

increased, but is still not compatible with SDS monitoring.

In order to overcome this limitation, our exceptional

information technology (IT) skills should be used in the

development of a new drug surveillance system. The

creation of IT infrastructure has lead to computerized

medical records and health insurance system for all

citizens. Information regarding people's use of

healthcare services is stored in the database of the

Health Insurance Review and Assessment Service

(HIRA). Furthermore, Statistics Korea manages data

regarding deceased individuals, while the National

Cancer Center (NCC) maintains cancer statistics. Thus,

the information amassed by these two organizations

can be used to build a new low cost drug surveillance

system that effectively monitors drug usage data. In

some countries, studies are currently being conducted

to examine ADR severity following drug administration.

These studies also use health insurance claims

databases to evaluate the cause of ADRs. Several

decades ago, large U.S. healthcare corporations such

as Group Health Cooperative, Kaiser-Permanente, and

United Health Group established their own health

research centers to evaluate drug usage patterns

and investigate clinical progress following drug

administration.

These research centers scientifically assess the

benefits and injuries of specific drugs while generating

objective evidences, as shown in Table 1.

As an example of government-controlled ADR monitoring,

the Canadian province, Saskatchewan, maintains a

computer database of all personal health information

between birth and death for over one million residents.

This database contains demographic information

such as gender, marital status, birth and death dates,

prescriptions, admission and discharge dates,

treatment techniques, diagnosis, and other relevant

medical information. The cancer registration data of

Saskatchewan is also linked to this database. This

information can readily be used in research studies for

public interests. Previous studies have already

analyzed certain drug/ADR correlations such as

between statins (hyperlipidemia drug) and cancer

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

▼Tab.1 Health research centers and insurance claims databases in the U.S.

Use of antidepressant by pregnant womenand congenital anomalies

Drug use and cancer development, Vaccineuse and the development of diseases

Drug use assessments, provision ofsampling framework for medical studies,post marketing surveillance on safety, etc.

Epidemiological studies, economicanalysis of healthcare programs, utilizationof medical services

Adverse events related to drugs, qualitymanagement of healthcare systems, cost-effectiveness analysis

Registration, prescriptions, inpatient/outpatient,clinical examinations, radiological examinations,cause of death, immunotherapy, etc

Registration, inpatient/outpatient,discharge, diagnosis, etc.

Registration, medical claims, prescription claims, medical staff

Details of data

Research Center

Research Center established in

Areas of study

Examples of study

Center for Health Study Center for Health Research Center for Health Care Policy and Evaluation

1983 1964 1989

Use of alendronate for osteoporosis andincidence of the adverse esophageal andgastric events

development as well as between non-steroidal anti-

inflammatory drugs and the development of acute renal

failure.

The integration of currently existing electronic

databases in Korea would allow for early ADR

detection of specific drugs. The cooperation would

also help to rapidly and economically generate the

basic databases required in the establishment of

various health policies. Therefore, implementation of

a nationwide healthcare database linkage center

would provide the necessary data for research

purpose that could potentially benefit the general

public. Such a center is integral in linking health

insurance data maintained by HIRA, death data

managed by Statistics Korea, cancer registration

data managed by NCC, national health and nutrition

survey data maintained by the Korea Institute for

Health and Social Affairs, and the electronic medical

records (EMR) of all hospitals. Furthermore, Korean

citizens are given resident registration numbers that

are unique personal identifiers. Combining currently

stored computer data with resident registration

numbers can help determine the percentage of

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

information of Korean citizens and also provide the

required data for research purpose that are in the

best interest of the public. Establishment of such a

center would greatly contribute to the improvement

of overall public health.

Meanwhile, in order to assure the safe and effective

use of health information, legal regulations must

guarantee privacy protection, and appropriate laws

must be enacted and applied to all individuals. In

order to protect personal information, it is important

to increase the ethical awareness of hospitals that

produce and manage health information, the

nationwide healthcare database linkage center

which integrates the data and researchers who

conduct the research studies. Moreover, in addition

to continual improvements of security systems,

concrete and practical privacy protection systems

must also be implemented in order to prevent

internal and external intrusions of the information

databases. These efforts together will allow for the

most beneficial use off the collected health

information and ultimately lead to improvements in

public 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.

07February 2010

08 NECA

⊙ Advancements in computer technology and

the development of electronic health records have

allowed for the use of large-scale health record

information in healthcare studies. However, usage of

this information has raised concerns regarding ethical

issues of privacy and confidentiality. Therefore, many

countries have, or are currently considering the

application of strict laws concerning the confidentiality

of health information. In this case, the term, privacy,

refers to the self-controllability of personal

information. The term, confidentiality, indicates legal

and ethical obligations to refrain from revealing an

individual's private information without consent.

∷ Identity of subjects must remain private

Patient health records contain very sensitive

information which requires strict confidentiality. Thus,

obtaining explicit permission from each individual

before using their health record or information for

research purposes is absolutely essential to the

principles of ethics. For example, the U.S. has enacted

a law that requires patient authorization before

allowing personal health information to be utilized for

research rather than for medical treatment.

However, it is often impossible to receive personal

consent from each patient for use in public studies

that require large scale health record information.

For example, studies that acquired data from the

National Health Insurance Corporation were

conducted under the discretion of the Institutional

Review Board (IRB), but did not receive consent from

the subjects. Studies such as this, which use a large-

scale database, cannot receive consent from each of

the millions of people involved, because it simply is not

feasible. Although there may be no physical harm to

the patient if their collective health record is released

to third parties, other problems such as discrimination

in employment, residence, and health insurance may

occur. Therefore, a subject's identity and private

information must remain confidential.

Consequently, it is important for database management

to minimize identifiablity, and maximize anonymity, in

order to reduce the risk of potential harm for each

patient. From the perspective of biomedical ethics, the

principles of non-maleficence and beneficence must

be given priority over the principle of respect for

ROOT

Ethical Issues Regarding the Use ofCollective Health Record for Research PurposesOck-joo Kim Professor, Department of History of Medicine and Medical Humanities,

Seoul National University College of Medicine

09February 2010

autonomy.

The core ethical problem in the use of large-scale

collective health information is achieving a balance

between the promotion of research for public good,

and the protection of patient privacy. Thus, it is

necessary to maximize the utility of the information for

research or public policy, while minimizing the

possibility of privacy infringement. In order to initiate

studies in the right direction, the role of 'honest

broker' is essential. This individual is responsible for

the data, but cannot be directly related to the study.

The 'honest broker' is accountable for providing

anonymity and coding the data, managing the data

with minimal social and ethical problems, and also

providing the data to researchers.

If patient consent is not received, and collective

health information is leaked during the course of a

study, considerable regression in research ethics will

undoubtedly arise, as has been noted in past

transgressions. The organizations that manage large-

scale collective health information must maintain a

high level of data security, both technically and

physically, and also arrange for technical devices to

ensure privacy. These safeguards will serve to gain

society’s trust, ensuring the conduction of future

research studies. Furthermore, because data leakage

often occurs by password exposure, the relevant

employees must be thoroughly educated in the

application of security systems, and also closely

supervised.

∷ Continual database supervision by an honest broker

Recently, as the connection between large-scale

databases with other databases has become easier,

the re-identification of patients is emerging as an

important ethical issue. Information that once was

anonymous may be readily identified by simply linking the

available elements of the data together. Thus, various

methods to cope with this problem have been proposed.

Since perfect anonymity cannot be guaranteed,

even in the case of unspecified data sets, anonymous

collective health record cannot ensure the safety of

the study, nor provide justification. Confidentiality can

be improved if a part of the collective health information

that is used for research purposes, is permanently

deleted. Such a deletion may decrease the utility of the

information used in research studies.

Both the honest broker and IRB need to review the

research plan to examine the content for essential

information, the presence of personal identification,

and details of record linkage. Other important factors

to be evaluated include identifying personnel who will

have access to the information, specific confidentiality

devices, and confirming that researchers will faithfully

fulfill their obligations towards protecting patient

confidentiality and privacy. The honest broker must

provide the necessary information that is required for

research studies with minimal identifiably following

IRB approval and review of the research plan. Finally,

the researchers and honest broker must both sign a

contract that delineates how the data will be managed

and destroyed, prohibits sharing the data with third

parties, and how their compliance will be supervised.

∷ Pursuit of public good using a confidential health

record system

The ethical problems regarding the use of collective

health record for research purposes is directly related

to determining whether all of the associated parties

can be trusted with regard to patient privacy protection

and confidentiality. This ethical issue also includes

public monitoring and supervision of the organization

that accumulates the collective health record.

Moreover, the general public should be consulted in

order to obtain their opinions concerning how the

appropriate methods may be applied in order to use

the collective health record for public good.

This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.

10 NECA

⊙ 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

ROOT

Legal Regulation of the Health Information Provision for Research byPublic OrganizationsHyoung-Wook Park (Attorney at Law, M.D.) Professor, Department of Medical Law and Ethics,

Yonsei University College of Medicine

11February 2010

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.

This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.

12 NECA

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.

13February 2010

⊙ 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.

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 HealthInformation for Research PurposesSang-Ho Yoo Professor, Department of Family Medicine, Hallym University College of Medicine

14 NECA

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.

15February 2010

Procedural details of the Western Australia Diabetes Linkage Project conducted inthe 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.

16 NECA

References

1. Kelman CW, Bass AJ, Holman CD. Research use of linked health data-a best practice protocol. Aust N Z JPublic Health 2002;26:251-5.

2. Trutwein B, Holman CDJ, Rosman DL. Health data linkage conserves privacy in a research-richenvironment AEP 2006;16:279-80.

Fig. 1 Proportion of ethics-approved research projects using name-identified and data-linked

administrative health information in western australia between 1990-2003

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).

17February 2010

⊙ ‘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

ROOT This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.

The Necessity to Establish aHealthcare Database LinkageCenter 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

18 NECA

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.

NECAResearch Topic Suggestion Survey

11Research Topic Survey

How to Suggest a

Research Topic

Eligible applicants

Period

(In English) Send your research proposal via email (juje@neca.re.kr),

fax (82-2-725-4917), or mail.

(In Korean) Visit the NECA website (http://www.neca.re.kr) for

information on writing a proposal for your research topic.

Mar. 15 (Mon.) ~ Apr. 14 (Wed.), 2010

Eligible applicants: interested citizens, universities, learned societies,

medical institutions, healthcare research organizations, etc.

Contact: Research Planning Team, NECA

(Tel: 82-2-2174-2789, E-mail: topic2011@neca.re.kr)

19February 2010

Contact

●

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.

●

⊙ On January 27, NECA held a forum on the

effects of glucosamine and chondroitin products.

At this forum, NECA shared findings from a study

on the current use and effects of glucosamine and

chondroitin products with the medical community,

consumer representatives, and relevant experts;

and it collected their opinions.

Use of glucosamine or chondroitin products in

general population

NECA surveyed Korean adults for 12 days during

last September to determine the percentage of

people taking glucosamine products. In this survey,

about 12.2% of respondents answered "I am now

taking glucosamine," and those who have ever used

glucosamine were around 30.0 % (Figure 1).

The total expenditure by Korean adults for

purchasing glucosamine products which was

estimated by annual expenses spent by current

users of glucosamine, was approximately 280

billion Korean Won. This is a heavy national burden

(for general adults aged 40 or older).

About 77.0% of the respondents who were

currently taking glucosamine preparations (991 out of

8,135 respondents) had not received any diagnosis of

osteoarthritis from a doctor. Furthermore, 42.8% were

taking glucosamine without joint pain (Figure 2). This

shows that many users of glucosamine are taking it to

improve general health or prevent osteoarthritis.

Assessment of effects according to glucosamine

components and use of glucosamine in

musculoskeletal patients

In systematic reviews to investigate the effects of

glucosamine therapy according to two components

(hydrochloride/sulfate), there is no evidence that

Glucosamine and Chondroitin Products:Are They Being Used Appropriately?

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

Sang-Cheol Bae (Director, Hospital for Rheumatic Disease, Hanyang University)

Yoon-Kyoung Sung (Hospital for Rheumatic Disease, Hanyang University), Soo-YoungKim(Department of Family Medicine, Hallym University Hospital)

Kyung-Ae Kim (Health Network), Hee-Chun Kim (CHA University, Department of Orthopedics),Byung-Sung Kim (Department of Family Medicine, Kyung Hee University Hospital), Sun-GunChung (Department of Rehabilitation Medicine, Seoul National University Hospital)

Principal investigator

Presenters

Panelists

11Court of Eastern Palace

20 NECA

Investigation of utilization and assessment of scientific evidence

Sang-Cheol Bae Principal investigator, Director, Hospital for Rheumatic Disease, Hanyang University

glucosamine hydrochloride is more effective than

placebo in osteoarthritis. Meanwhile, in investigating

the ingredients of domestic and imported glucosamine

products registered in KFDA, 77.0% of 387 identifiable

products were glucosamine hydrochloride.

In a survey of those who visited the department of

rheumatology in two university hospitals in Seoul,

15.8% of respondents answered "I am now taking

glucosamine," and the percentage including the

respondents who answered "I have taken

glucosamine before" was approximately 38%.

It was found that the percentage of people taking

glucosamine was high, even among patients with

rheumatism that was not related to osteoarthritis.

Clinicians and healthcare providers need to educate

patients for appropriate use of glucosamine. Further

research is needed to analyze the cause of misuse.

Findings from systematic review on clinical effectiveness

A systematic review on the clinical effectiveness of

glucosamine found that it had some significant effects

on pain reduction, functional improvement, and

prevention of joint space narrowing compared to

placebos, but the results were inconsistent. In meta-

analysis stratified by manufacturers, glucosamine

components (hydrochloride and sulphate), and source

of funding, there was also insufficient evidence to

conclude that glucosamine has therapeutic effects.

An analysis of two types of studies was undertaken:

(1) studies to ensure that researchers are unaware

which group patients are being allocated to at the time

they enter the study and (2) studies that were not

funded by manufacturers. Results showed that

glucosamine was not effective in pain reduction and

functional improvement.

It was also insufficient to conclude that chondroitin

was effective in pain reduction, functional improvement,

and prevention of joint space narrowing, compared to

placebo in osteoarthritis. Furthermore, glucosamine

and chondroitin combination products also failed to

show significant differences in pain reduction, functional

improvement, and prevention of joint space narrowing,

compared to placebo, and the quality of evidence was low.

In literature searching, there was lack of data to

reach conclusions that glucosamine is effective for

treatment and prevention of osteoarthritis.

OA

dia

gnos

is b

y D

r.

n

o di

agno

sis

by D

r.

Fig. 1 Current use of glucosamine and chondroitin products

gluc

osam

ine

cho

ndro

itin

23.57

12.18

0.13

17.75

80

70

60

50

40

30

20

10

0(%)

joint pain no joint pain

18.37

4.64

Fig. 2 Joint pain and diagnosis of osteoarthritis (OA) from

a doctor among the current users of glucosamine

38.1438.85

non-userscurrent users former users I don't know

74.87

1.43

62.25

7.82

40

35

30

25

20

15

10

5

0(%)

●

Yoon-Kyoung Sung, Chan-Bum Choi (Hanyang UniversityHospital), Eun Bong Lee (Seoul National University Hospital), SooYoung Kim (Hallym University Hospital), Hyun-Ju Seo, ChelimCheong, Jiae Park (NECA)※ The final conculsion of this study will be published laterafter further discussions with related policy makers, experts, and civic groups.

21February 2010

22 NECA

11Research Act iv i ty

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

An outcomes Research of the Therapeutic Modalities for Postpartum HemorrhageJong-Myon Bae Principal investigator, NECA Chief Researcher

Research Activity: Executive summary on the research activities of the National Evidence -

based Healthcane Collaborating Agency

23February 2010

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.

Fig.1 The incidence rate of postpartum hemorrhage in 2008

By age groupsBy the level of hospital

1.5%(374)

2.9%(1,543)

3.7%(6,164)

4.8%(10,064)

Tertiaryhospital

Generalhospital Hospital Clinic

4.1%(7,964)

4.1%(2,339)

3.9%(7,523)

4.4%(276)

30 30∼34 35∼39 40≤

18,142 cases. The incidence of PPH was higher in clinics than in tertiary hospitals and increased

with maternal age (Figure 1).

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

24 NECA

Fig.2 The proportion between uterine artery embolization and hysterectomy according to the region

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,

25February 2010

●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)

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.

11Lecture

26 NECA

⊙ 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).

Methods to Measure the Results of Studies of Therapies: Proper Understanding, ProperApplication Sang-Moo Lee NECA Chief Researcher

27February 2010

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

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).

Fig. 1

28 NECA

Fig. 2

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.

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

The number of patients needed to be treated (NNT)= 1/(X-Y)

Compared to placebo, the occurrence of adenoma among

the celecoxib group was 10 percent lower

(ARR= 0.105, CI: 0.039-0.172). If nine patients are given

celecoxib for 3 years, one patient will result to prevent the

occurrence of adenoma (NNT=9.493, CI:6-26).

To consider harm in addition to it, when 333

patients are treated, adenoma will be prevented in

37 patients and 1 patient will develop myocardial

infarction due to celecoxib (NNT=9.493, CI: 6-26 and NNH

=333 (Kearney 2006), CI: 200-1,000).

1

8 adenoma

1 adenoma

prevented

37 adenoma

prevented

295

1 myocardial

infarction

10 100

29February 2010

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.

Tab. 1 Outcome measures of supposed two therapies with various ways

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 Making2007;27:638-54.

3. Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors andtraditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis ofrandomised trials. BMJ 2006;332:1302-8.

4. Kumana CR, Cheung BM, Lauder IJ. Gauging the impact of statins using number needed to treat. JAMA1999;282:1899-901.

5. Moxey A, O’'Connell D, Mc Gettigan P, Henry D. Describing treatment effects to patients. J Gen Intern Med2003;18:948-59.

Curriculum Vitae of Dr. Sang-Moo Lee

1989 Achieved specialty in internal medicine1998 Ph.D. College of medicine, Soonchunhyang University1999- 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 UniversityAssistant professor, School of Medicine, Eulji UniversityMember of review and assessment committee and first head of new health technology assessment division, Health Insurance Review and Assessment Service2010 - Executive director of HTA research division, NECA

Events occured

100

200

100

200

A group

Control group

B group

Control group

Therapy A

Therapy B

No eventoccured

900

800

9,900

9,800

RRR(95% CI)

50%(37.5-60)

50%(36.5-60.6)

ARR(95% CI)

10%(6.9-13.1)

1%(0.7-1.3)

NNT(95% CI)

10(7.6-14.5)

100(74.8-150.7)

Division

30 NECA

11NECA 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.

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.

31February 2010