(Real World Data를 활용한 임상연구) What is Real-World Evindenc..?

김헌성 한국성인간호학회 2018 성인간호학회 학술대회 Vol.2018 No.12

Future and Development Direction of Digital Healthcare

김헌성,권인호,차원철 대한의료정보학회 2021 Healthcare Informatics Research Vol.27 No.2

Objectives: Digital healthcare is expected to play a pivotal role in patient-centered healthcare. It empowers patients by informing,communicating, and motivating them. However, a pragmatic evaluation of the present status of digital healthcarehas not been presented; therefore, we aimed to examine the status of digital healthcare in Korea. Methods: This article discussesdigital healthcare, examples of assessment in Korea and other countries, the implications of past examples, and futuredirections for development. Results: Over the years, various clinical studies have used clinical evidence to assess the feasibilityof digital healthcare. If feasible, it is actually clinically effective. If it is effective, can it be commercialized at an acceptablecost? These questions have been investigated in various evidence-based studies. In addition, great efforts are being made tosecure ample evidence to assess various aspects of digital healthcare, such as safety, quality, end-user experience, and equity. Conclusions: Digital healthcare requires a deep understanding of both the technical and medical aspects. To strengthen thecompetence of the medical aspect, medical staff, patients, and the government must work together with continuous interestin this goal.

New Directions in Chronic Disease Management

김헌성,조재형,윤건호 대한내분비학회 2015 Endocrinology and metabolism Vol.30 No.2

A worldwide epidemic of chronic disease, and complications thereof, is underway, with no sign of abatement. Healthcare costs have increased tremendously, principally because of the need to treat chronic complications of non-communicable diseases including cardiovascular disease, blindness, end-stage renal disease, and amputation of extremities. Current healthcare systems fail to provide an appropriate quality of care to prevent the development of chronic complications without additional healthcare costs. A new paradigm for prevention and treatment of chronic disease and the complications thereof is urgently required. Several clinical studies have clearly shown that frequent communication between physicians and patients, based on electronic data transmission from medical devices, greatly assists in the management of chronic disease. However, for various reasons, these advantages have not translated effectively into real clinical practice. In the present review, we describe current relevant studies, and trends in the use of information technology for chronic disease management. We also discuss limitations and future directions.

Lessons from Use of Continuous Glucose Monitoring Systems in Digital Healthcare

김헌성,윤건호 대한내분비학회 2020 Endocrinology and metabolism Vol.35 No.3

We live in a digital world where a variety of wearable medical devices are available. These technologies enable us to measure ourhealth in our daily lives. It is increasingly possible to manage our own health directly through data gathered from these wearable devices. Likewise, healthcare professionals have also been able to indirectly monitor patients’ health. Healthcare professionals have accepted that digital technologies will play an increasingly important role in healthcare. Wearable technologies allow better collectionof personal medical data, which healthcare professionals can use to improve the quality of healthcare provided to the public. The useof continuous glucose monitoring systems (CGMS) is the most representative and desirable case in the adoption of digital technology in healthcare. Using the case of CGMS and examining its use from the perspective of healthcare professionals, this paper discusses the necessary adjustments required in clinical practices. There is a need for various stakeholders, such as medical staff, patients,industry partners, and policy-makers, to utilize and harness the potential of digital technology.

Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)

김헌성,이수현,Tong Min Kim,Ju Han Kim 대한고혈압학회 2019 Clinical Hypertension Vol.25 No.1

Background: Randomized controlled trials can be expensive and time-consuming, leading to medical researchers utilizing real-world evidence (RWE) based on already-collected data. We aimed to conduct various RWE studies on angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blocker (ARB), commonly used as firstline therapy for blood pressure, and to develop a multi-center clinical data mart (CDM) of ACEI/ARB for various clinical purposes. Methods: Data from electronic medical records of St. Mary’s Hospital and the Seoul National University Hospital were collected. We obtained blood and urine test results of patients within the 30 days prior to their first prescription of ACEI or ARB, as well as the first date of diagnosis and presence of various chronic and cardiovascular diseases using the International Classification of Diseases-10 classification. One researcher managed data quality and collation for each hospital in order to facilitate patient anonymity. When results were unclear, the responsible investigator for each hospital attempted to resolve ambiguities by direct chart review. Results: A total of 102,333 patients who were prescribed ACEI or ARB for the first time were included (21,481 ACEI, 80,551 ARB, and 301 both). Our ACEI/ARB-CDM included short-term studies (within 12 months) to observe changes in various blood or urinary laboratory test values after the initial prescription of ACEI or ARB and long-term studies to confirm the incidence of various diseases. Conclusion: We established a CDM of RWE for ACEI/ARB prescription, which included various clinical studies. As we accumulate experience in this process, we expect that the use of RWE research will grow and develop.

Proceed with Caution When Using Real World Data and Real World Evidence

김헌성,김주한 대한의학회 2019 Journal of Korean medical science Vol.34 No.4

Clinical studies can be conducted to gather real world evidence (RWE) not available from randomized controlled trials, providing new information and knowledge. Although the concept of RWE emerged relatively recently, numerous clinical studies are utilizing it. However, many researchers are engaging in trial and error that may not overcome the various biases that occur in electronic medical record (EMR)-based RWE studies. While RWE can reflect the real world, there are still limitations to its acceptance. There are many hurdles in using RWE and solutions must be explored. Results based on RWE may be overestimated and it can be difficult to derive good quality results. This paper discusses data quality management, direct chart review, sample size, study design, and the interpretation of EMR- based RWE. More specifically, this paper shares the experience of the various hurdles that occur when conducting RWE studies and discusses the easy-to-false errors. RWE is still in the developmental stage and numerous aspects of RWE use remain unclear. Nonetheless, despite its many limitations, increasing use of RWE is still anticipated. This will require continued experience and effort in using RWE, as well as upgrading RWE research through the accumulation of information on such experiences and efforts.

Dementia Research Using Healthcare Big Data

김헌성,김대진 대한치매학회 2019 Dementia and Neurocognitive Disorders Vol.18 No.3

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Drug Repositioning: Exploring New Indications for Existing Drug-Disease Relationships

김헌성 대한내분비학회 2022 Endocrinology and metabolism Vol.37 No.1

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Development of Clinical Data Mart of HMG-CoA Reductase Inhibitor for Varied Clinical Research

김헌성,김현아,정유진,김동민,양소정,백선정,이승환,조재형,최인영,윤건호 대한내분비학회 2017 Endocrinology and metabolism Vol.32 No.1

Background: The increasing use of electronic medical record (EMR) systems for documenting clinical medical data has led to EMRdata being increasingly accessed for clinical trials. In this study, a database of patients who were prescribed statins for the first timewas developed using EMR data. A clinical data mart (CDM) was developed for cohort study researchers. Methods: Seoul St. Mary’s Hospital implemented a clinical data warehouse (CDW) of data for ~2.8 million patients, 47 million prescriptionevents, and laboratory results for 150 million cases. We developed a research database from a subset of the data on the basisof a study protocol. Data for patients who were prescribed a statin for the first time (between the period from January 1, 2009 to December31, 2015), including personal data, laboratory data, diagnoses, and medications, were extracted. Results: We extracted initial clinical data of statin from a CDW that was established to support clinical studies; the data was refinedthrough a data quality management process. Data for 21,368 patients who were prescribed statins for the first time were extracted. We extracted data every 3 months for a period of 1 year. A total of 17 different statins were extracted. It was found that statins werefirst prescribed by the endocrinology department in most cases (69%, 14,865/21,368). Conclusion: Study researchers can use our CDM for statins. Our EMR data for statins is useful for investigating the effectiveness oftreatments and exploring new information on statins. Using EMR is advantageous for compiling an adequate study cohort in a shortperiod.

Apprehensions about Excessive Belief in Digital Therapeutics: Points of Concern Excluding Merits

김헌성 대한의학회 2020 Journal of Korean medical science Vol.35 No.45

Digital therapeutics (DTx), like drugs or medical devices, 1) must prove their effectiveness and safety through clinical trials; 2) are provided to patients through prescriptions from doctors; and 3) may require the approval of regulatory agencies, though this might not be mandatory. Although DTx will play an important role in the medical field in the near future, some merits of DTx have been exaggerated at this crucial juncture. In the medical field, where safety and effectiveness are important, merely reducing the development time and costs of DTx is not advantageous. The adverse effects of DTx are not yet well-known, and will be identified eventually, with the passage of time. DTx is beneficial for the collection and analysis of real-world data (RWD); however, they require new and distinct work to collect and analyze high-quality RWD. Naturally, whether this is possible must be independently ascertained through scientific methods. Depending on the type of disease, it is not recommended that DTx be prescribed, even if the patient rejects conventional treatment. Prescription of conventional pharmacotherapy is often necessary, and if the prescription of DTx is inadequate, the critical time for initial treatment may be missed. There is no basis for continuing DTx use by patients. Rather, the rate of continuity of DTx use is extremely low. While many conventional pharmacotherapies have undergone numerous verification and safety tests over a long time, barriers to the application of DTx in the medical field are lower than those for conventional pharmacotherapies. Considering these reasons, except for certain special cases, an approach to DTx is needed that complements the prescription of conventional pharmacotherapy by the medical staff. When DTx are prescribed by doctors who clearly know their advantages and disadvantages, the doctors' expertise may undergo further refinement, and the quality of medical care is expected to improve.