National Evidence-based Healthcare Collaborating Agency (NECA) provides scientific evidences to the policy
makers and the ...
ISSN 2092-7932




   2 0 1 0 / F E B R U A R Y / V O L . 0 4




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




CEO Column         ...
CEO COLUMN




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


      In t...
However, medical treatment has traditionally been differentiated from other areas of scientific
      technology due to th...
ROOT                                                                         Root : Solicitation of opinion and expertise ...
suspected ADRs.                                                                            databases to evaluate the cause...
development as well as between non-steroidal anti-                 information of Korean citizens and also provide the
inf...
ROOT


Ethical Issues Regarding the Use of
Collective Health Record for
Research Purposes
Ock-joo Kim Professor, Departmen...
This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.




autonomy....
ROOT



      Legal Regulation of the Health
      Information Provision for Research by
      Public Organizations
      ...
This article is entirely based on the author's personal opinion, which is unrelated to the position of NECA.




identifie...
Fourth, PHI can be used for preliminary studies. If the applicable organization permits the use of
            PHI for a p...
ROOT                                          This article is entirely based on the author's personal opinion, which is un...
However, most researchers want to directly perform data linkage for various reasons, and create
      numerous new databas...
Procedu al details of the Western Australia Diabetes Linkage Project conducted in
the State of Western Australia

Western ...
The advantages of the procedure used by the Western Australia Diabetes Linkage Project are as
      follows: first, confid...
ROOT                                         This article is entirely based on the author's personal opinion, which is unr...
and, thus, the database has no compatibility with databases of other organizations or systems for
      connected analyses...
Research Topic Survey




     NECA
     Research Topic
     Suggestion Survey

     After the success of the first topic ...
Court of Eastern Palace


                           Donggwoldo (Painting of Eastern Palace) : This astonishing 16-piece l...
glucosamine hydrochloride is more effective than                                       conclude that glucosamine has thera...
Research Activity
 Research Activity: Executive summary on the research activities of the National Evidence -
 based Healt...
18,142 cases. The incidence of PPH was higher in clinics than in tertiary hospitals and increased
with maternal age (Figur...
UAE. This example indicates that most patients with PPH are transferred to large cities, where
      they undergo UAE.


 ...
among the 53 patients who wanted to become pregnant, 45 got pregnant, of which 26 gave
birth, 11 were pregnant, and 8 had ...
Lecture



      Methods to Measure the Results
      of Studies of Therapies:
      Proper Understanding, Proper
      Ap...
Fig. 1

   Question: To patients who had adenomas removed: What particular drugs can be recommended
   in order to prevent...
Fig. 2

            Measures with absolute characteristics


            The risk of event occurrence in the control group...
Tab. 1 Outcome measures of supposed two therapies with various ways


           Division                   Events        ...
NECA news




                                            NEWS


                                                        P...
Renewed opening of NECA home page
                                                     The upgraded home page that deliver...
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2010.february.vol04

  1. 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. 2. ISSN 2092-7932 2 0 1 0 / F E B R U A R Y / V O L . 0 4 EVIDENCE VALUE
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 12 NECA
  14. 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. 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. 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. 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. 16 NECA
  18. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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