1.Should We Consider Value Frameworks for Cancer Drugs as Oncology's Landscape Evolves?; from an Oncologist Perspective in Korea
Do Yeun KIM ; Hyerim HA ; SeungJin BAE ; Jin-Hyoung KANG
Journal of Korean Medical Science 2021;36(29):e191-
Background:
As the role of immunotherapies and personalized medicine grow, cancer patients have faced many choices in treatments and have suffered financial toxicity. These challenges brought the need for the value framework (VF) to guide treatment decision making.
Methods:
A survey was taken to 102 oncologists about perception for VF. They were asked about priorities among several considerations when they prescribe cancer drugs. Their views on the need for development and potential implications of VF in Korea were assessed, also.
Results:
The survey shows that 90% of the respondents choose clinical efficacy as the most important value in cancer drugs selection, and the cost of drug was more weighted value in immune checkpoint inhibitors (13.7%). Approximately half (53.9%) answered that they were aware of the existing VFs. Over 90% of respondents agreed with the need for development of a VF for cancer drugs based on Korean healthcare system and further usefulness for decisions about reimbursement issues. Seventy-one percent answered that two representative VFs (American Society Clinical Oncology-VF and European Society for Medical OncologyMagnitude of Clinical Benefit Scale) should be reflected in value measurement of cancer drugs in Korea.
Conclusion
The Korean oncologists recognized the necessity for the clinical application of VF. Further discussion between the stakeholders should be followed to alleviate the financial burden through the value-based decision making of cancer drugs.
2.Should We Consider Value Frameworks for Cancer Drugs as Oncology's Landscape Evolves?; from an Oncologist Perspective in Korea
Do Yeun KIM ; Hyerim HA ; SeungJin BAE ; Jin-Hyoung KANG
Journal of Korean Medical Science 2021;36(29):e191-
Background:
As the role of immunotherapies and personalized medicine grow, cancer patients have faced many choices in treatments and have suffered financial toxicity. These challenges brought the need for the value framework (VF) to guide treatment decision making.
Methods:
A survey was taken to 102 oncologists about perception for VF. They were asked about priorities among several considerations when they prescribe cancer drugs. Their views on the need for development and potential implications of VF in Korea were assessed, also.
Results:
The survey shows that 90% of the respondents choose clinical efficacy as the most important value in cancer drugs selection, and the cost of drug was more weighted value in immune checkpoint inhibitors (13.7%). Approximately half (53.9%) answered that they were aware of the existing VFs. Over 90% of respondents agreed with the need for development of a VF for cancer drugs based on Korean healthcare system and further usefulness for decisions about reimbursement issues. Seventy-one percent answered that two representative VFs (American Society Clinical Oncology-VF and European Society for Medical OncologyMagnitude of Clinical Benefit Scale) should be reflected in value measurement of cancer drugs in Korea.
Conclusion
The Korean oncologists recognized the necessity for the clinical application of VF. Further discussion between the stakeholders should be followed to alleviate the financial burden through the value-based decision making of cancer drugs.
3.Juvenile Idiopathic Scoliosis.
Min Seok KANG ; Seung Woo SUH ; Seungjin CHOI ; Jin Ho HWANG
The Journal of the Korean Orthopaedic Association 2016;51(2):117-124
Juvenile idiopathic scoliosis includes scoliosis diagnosed from three to ten years old according to the chronological age. Spine growth in juveniles does not occur at a rapid rate spinal deformity does not show rapid progress. However, because of the intimate relationship between chest wall growth and the spine, decrease of chest wall capacity due to scoliosis could lead to development of cardiovascular and pulmonary complication, especially in early age. In scoliosis in early age, other causes of the deformity including neurological problems should be evaluated. If the scoliosis angle is more than 25 degrees, it could progress very easily, thus aggressive treatment is needed. A new growing-sparing surgical technique (growing rod and growth modulation) is introduced for improvement of spine and chest growth, and for prevention of crankshaft phenomenon.
Congenital Abnormalities
;
Scoliosis*
;
Spine
;
Thoracic Wall
;
Thorax
4.Potentials of Smart dynamometer use for clinical and self-management of rehabilitation in breast cancer survivors: a feasibility study
Seungjin KANG ; Sooyoung YOO ; Hyunyoung BAEK ; Junheon LEE ; Younggeun CHOI ; Hyangjung KIM ; Hyoseok YI ; Eun Joo YANG
Biomedical Engineering Letters 2019;9(2):211-219
The aim of this study was to examine the feasibility of the Smart dynamometer as a rehabilitation exercise device in a daily care by comparing with the existing medical devices. We used and analyzed clinical and measurement data of breast cancer survivors who have used Smart dynamometer during their rehabilitation after breast cancer surgery. The Smart dynamometer was compared with the two existing devices of Takei dynamometer and surface electromyography (sEMG) that were used in routine care, respectively. Three key components of the rehabilitation exercise devices were analyzed to validate the feasibility of the Smart dynamometer: grip strength, reaction time, and grip endurance time. Pearson's correlation analysis was performed to compare the statistical significance between the devices. The data of 12 and 15 female breast cancer patients were analyzed for comparing the Smart dynamometer with Takei dynamometer and sEMG, respectively. There was a very weak correlation between the maximum values from the Takei and the Smart dynamometers in the affected and non-affected arms of breast cancer patients (r = 0.5321, 0.4733). Comparisons of 3 features between the Smart dynamometer and sEMG showed that there were strong positive correlations for both reaction time and endurance time in the affected and non-affected arms (r > 0.9). The feasibility of the Smart dynamometer for the possible use in a daily rehabilitation exercise was partially verified. Moreover, since the Smart dynamometer was highly correlated with time-related variables, it was important and significant to measure both grip strength and time-related information.
Arm
;
Breast Neoplasms
;
Breast
;
Electromyography
;
Feasibility Studies
;
Female
;
Hand Strength
;
Humans
;
Reaction Time
;
Rehabilitation
;
Self Care
;
Survivors
5.Laboratory Environment Monitoring: Implementation Experience and Field Study in a Tertiary General Hospital.
Seungjin KANG ; Hyunyoung BAEK ; Sunhee JUN ; Soonhee CHOI ; Hee HWANG ; Sooyoung YOO
Healthcare Informatics Research 2018;24(4):371-375
OBJECTIVES: To successfully introduce an Internet of Things (IoT) system in the hospital environment, this study aimed to identify issues that should be considered while implementing an IoT based on a user demand survey and practical experiences in implementing IoT environment monitoring systems. METHODS: In a field test, two types of IoT monitoring systems (on-premises and cloud) were used in Department of Laboratory Medicine and tested for approximately 10 months from June 16, 2016 to April 30, 2017. Information was collected regarding the issues that arose during the implementation process. RESULTS: A total of five issues were identified: sensing and measuring, transmission method, power supply, sensor module shape, and accessibility. CONCLUSIONS: It is expected that, with sufficient consideration of the various issues derived from this study, IoT monitoring systems can be applied to other areas, such as device interconnection, remote patient monitoring, and equipment/environmental monitoring.
Electric Power Supplies
;
Environmental Monitoring
;
Hospitals, General*
;
Internet
;
Methods
;
Monitoring, Physiologic
6.Cervical Lymphadenitis Caused by Group D Non-typhoidal Salmonella Associated with Concomitant Lymphoma.
Seungjin LIM ; Sun Young CHO ; Jungok KIM ; Doo Ryeon CHUNG ; Kyong Ran PECK ; Jae Hoon SONG ; Kyung Sun PARK ; Nam Yong LEE ; Seok Jin KIM ; Cheol In KANG
Infection and Chemotherapy 2013;45(2):234-238
Non-typhoidal Salmonella species are important foodborne pathogens that can cause gastroenteritis, bacteremia, and subsequent focal infections. Non-typhoidal salmonellosis is problematic, particularly in immunocompromised hosts. Any anatomical site can be affected by this pathogen via hematogenous seeding and may develop local infections. However, cervical lymphadenitis caused by non-typhoidal Salmonella species is rarely reported. Herein, we have reported a case of cervical lymphadenitis caused by group D non-typhoidal Salmonella associated with lymphoma.
Bacteremia
;
Focal Infection
;
Gastroenteritis
;
Immunocompromised Host
;
Lymphadenitis
;
Lymphoma
;
Salmonella
;
Salmonella Infections
;
Seeds
7.Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design
Hyerim HA ; Hee Yeon LEE ; Jee Hyun KIM ; Do Yeun KIM ; Ho Jung AN ; SeungJin BAE ; Hye-sung PARK ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(4):991-1013
Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.
8.Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design
Hyerim HA ; Hee Yeon LEE ; Jee Hyun KIM ; Do Yeun KIM ; Ho Jung AN ; SeungJin BAE ; Hye-sung PARK ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(4):991-1013
Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.
9.Identification of Viral Particles in Infant Cutaneous Tissue in Cases of Covid Toes
Kyungmin KIM ; Seungjin SON ; Tae-Jong KANG ; Dongkyun HONG ; Kyung Eun JUNG ; Jin-Man KIM ; Jung-Min SHIN ; Jin PARK ; Young LEE
Korean Journal of Dermatology 2024;62(7):412-417
Coronavirus disease 2019 (COVID-19), a multi-organ disease impacting the respiratory system and various organs, has recently been linked to diverse cutaneous manifestations. COVID toes, a cutaneous sign of COVID-19 infection, is relatively common in children and young adults, although its clear association with COVID-19 has not been widely reported. This report presents the case of a 1-year-old infant with COVID toes. The patient exhibited violaceous discoloration in the distal toes. Further, the patient exhibited no symptoms of COVID-19 infection and the enzyme-linked immunosorbent assay was negative for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2); therefore, the patient was initially diagnosed with frostbite. However, the infant’s condition deteriorated despite treatment with nonsteroidal anti-inflammatory drugs and a warm-water bath. After a skin biopsy and serum SARS-CoV-2 test, the patient was diagnosed with COVID toes and treated with systemic steroids, photobiomodulation therapy, and dressing. This case underscores the importance of recognizing chilblain-like lesions in pediatric patients during the COVID-19 pandemic, emphasizing the need for awareness of COVID toes among healthcare professionals.
10.Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design
Hyerim HA ; Hee Yeon LEE ; Jee Hyun KIM ; Do Yeun KIM ; Ho Jung AN ; SeungJin BAE ; Hye-sung PARK ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(4):991-1013
Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.