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Safe Utilization and Sharing of Genomic Data: Amendment to the Health and Medical Data Utilization Guidelines of South Korea
Get PDFPURPOSE: In 2024, medical researchers in the Republic of Korea were invited to amend the health and medical data utilization guidelines (Government Publications Registration Number: 11-1352000-0052828-14). This study aimed to show the overall impact of the guideline revision, with a focus on clinical genomic data. MATERIALS AND METHODS: This study amended the pseudonymization of genomic data defined in the previous version through a joint study led by the Ministry of Health and Welfare, the Korea Health Information Service, and the Korea Genome Organization. To develop the previous version, we held three conferences with four main medical research institutes and seven academic societies. We conducted two surveys targeting special genome experts in academia, industry, and institutes. RESULTS: We found that cases of pseudonymization in the application of genome data were rare and that there was ambiguity in the terminology used in the previous version of the guidelines. Most experts (>~90%) agreed that the 'reserved' condition should be eliminated to make genomic data available after pseudonymization. In this study, the scope of genomic data was defined as clinical next-generation sequencing data, including FASTQ, BAM/SAM, VCF, and medical records. Pseudonymization targets genomic sequences and metadata, embedding specific elements, such as germline mutations, short tandem repeats, single-nucleotide polymorphisms, and identifiable data (for example, ID or environmental values). Expression data generated from multi-omics can be used without pseudonymization. CONCLUSION: This amendment will not only enhance the safe use of healthcare data but also promote advancements in disease prevention, diagnosis, and treatment
A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma: In-Depth Analysis of Nintedanib Arm from the KCSG HN 15-16 TRIUMPH Trial
Get PDFPURPOSE: Precision oncology approach for recurrent and metastatic head and neck squamous cell carcinoma (HNSCC) is necessary due to its dismal prognosis. We performed a genomic profile-based umbrella trial of patients with platinum-refractory HNSCC (KCSG-TRIUMPH). Here, we present an in-depth report of the the nintedanib arm (arm 3) of the current trial. MATERIALS AND METHODS: The TRIUMPH study was a multicenter, open-label, single-arm phase 2 trial, in which patients were assigned to treatment arms based on next-generation sequencing (NGS)-based, matching genomic profiles. Patients whose tumors harbor fibroblast growth factor receptor (FGFR) alteration were enrolled in the nintedanib arm (arm 3) as part of the TRIUMPH study. The primary endpoint was the overall response rate (ORR), and secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and biomarker analysis. RESULTS: Between October 2017 and August 2020, 207 were enrolled in the TRIUMPH study, and eight were enrolled in the nintedanib arm. ORR and disease control rate were 42.9% and 57.1%, respectively. The median PFS was 5.6 months and the median duration of response was 9.1 months. Median OS was 11.1 months. One patient maintained the partial response for 36 months. Overall, the toxicity profiles were manageable. CONCLUSION: Single-agent nintedanib has demonstrated significant efficacy in FGFR-mutated, recurrent or metastatic HNSCC patients, with tolerable toxicity profiles. The results from the study have provided the basis for routine NGS screening and FGFR-targeted therapy. Because of the small number of patients due to slow accrual in this study, further studies with a larger cohort are warranted for statistical power
Clinical characteristics and prognostic factors of non-tuberculous mycobacterial disease in patients with rheumatoid arthritis
Get PDFBackground/Aims: This study aimed to identify the clinical characteristics of patients with concurrent rheumatoid arthritis (RA) and suspected non-tuberculous mycobacterial (NTM) infections as well as determine their prognostic factors. Methods: We retrospectively reviewed the medical records of 91 patients with RA whose computed tomography (CT) findings suggested NTM infection. Subsequently, we compared the clinical characteristics between patients with and without clinical or radiological exacerbation of NTM-pulmonary disease (PD) and investigated the risk factors for the exacerbation and associated mortality. Results: The mean age of patients with RA and suspected NTM-PD was 65.0 ± 10.2 years. The nodular/bronchiectatic (NB) form of NTM-PD was the predominant radiographic feature (78.0%). During follow-up, 36 patients (41.9%) experienced a radiological or clinical exacerbation of NTM-PD, whereas 12 patients (13.2%) died. Combined interstitial lung disease (ILD), microbiologically confirmed NTM-PD, and NB with the fibrocavitary (FC) form on chest CT were identified as risk factors for the clinical or radiological exacerbation of NTM-PD. Hydroxychloroquine use was identified as a good prognostic factor. Conversely, history of tuberculosis, ILD, smoking, microbiologically confirmed NTM-PD, and NB with the FC form on chest CT were identified as poor prognostic factors for mortality in suspected NTM-PD. Conclusions: ILD and NB with the FC form on chest CT were associated with NTM-PD exacerbation and mortality. Hydroxychloroquine use may lower the risk of NTM-PD exacerbation. Therefore, radiographic features and presence of ILD should be considered when predicting the prognosis of patients with RA and suspected NTM-PD
Physiology- or Imaging-Guided Strategies for Intermediate Coronary Stenosis
Get PDFImportance: Treatment strategies for intermediate coronary lesions guided by fractional flow reserve (FFR) and intravascular ultrasonography (IVUS) have shown comparable outcomes. Identifying low-risk deferred vessels to ensure the safe deferral of percutaneous coronary intervention (PCI) and high-risk revascularized vessels that necessitate thorough follow-up can help determine optimal treatment strategies. Objectives: To investigate outcomes according to treatment types and FFR and IVUS parameters after FFR- or IVUS-guided treatment. Design, Setting, and Participants: This cohort study included patients with intermediate coronary stenosis from the Fractional Flow Reserve and Intravascular Ultrasound-Guided Intervention Strategy for Clinical Outcomes in Patients With Intermediate Stenosis (FLAVOUR) trial, an investigator-initiated, prospective, open-label, multicenter randomized clinical trial that assigned patients into an IVUS-guided strategy (which recommended PCI for minimum lumen area [MLA] ≤3 mm2or 3 mm2 to 4 mm2with plaque burden [PB] ≥70%) or an FFR-guided strategy (which recommended PCI for FFR ≤0.80). Data were analyzed from November to December 2022. Exposures: FFR or IVUS parameters within the deferred and revascularized vessels. Main Outcomes and Measures: The primary outcome was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, and revascularization at 2 years. Results: A total of 1619 patients (mean [SD] age, 65.1 [9.6] years; 1137 [70.2%] male) with 1753 vessels were included in analysis. In 950 vessels for which revascularization was deferred, incidence of TVF was comparable between IVUS and FFR groups (3.8% vs 4.1%; P =.72). Vessels with FFR greater than 0.92 in the FFR group and MLA greater than 4.5 mm2or PB of 58% or less in the IVUS group were identified as low-risk deferred vessels, with a decreased risk of TVF (hazard ratio [HR], 0.25 [95% CI, 0.09-0.71]; P =.009). In 803 revascularized vessels, the incidence of TVF was comparable between IVUS and FFR groups (3.6% vs 3.7%; P =.95), which was similar in the revascularized vessels undergoing PCI optimization (4.2% vs 2.5%; P =.31). Vessels with post-PCI FFR of 0.80 or less in the FFR group or minimum stent area of 6.0 mm2or less or with PB at stent edge greater than 58% in the IVUS group had an increased risk for TVF (HR, 7.20 [95% CI, 3.20-16.21]; P <.001). Conclusions and Relevance: In this cohort study of patients with intermediate coronary stenosis, FFR- and IVUS-guided strategies showed comparable outcomes in both deferred and revascularized vessels. Binary FFR and IVUS parameters could further define low-risk deferred vessels and high-risk revascularized vessels
Risk factors for ground-level fall injuries during active activity in older patients
Get PDFIn older patients, ground-level falls are the most common cause of injury. Many intrinsic and extrinsic factors influence ground fall injuries. However, the characteristics and severity of ground fall injuries have not been compared according to the activity levels. We compared the characteristics of ground fall injuries by the activity level to establish a preventive strategy for ground fall injuries in older patients. We retrospectively reviewed the records of older patients who were admitted to six university hospitals for ground-level fall injuries from 2011 to 2020. The patients were classified into active and inactive groups. Active activities were defined as paid work, exercise and leisure activities. General and clinical characteristics of both groups for ground-level fall injury were analyzed. Propensity score matching analysis (1:1) was performed for baseline characteristics (sex, age and alcohol consumption). A total of 33,924 patients were enrolled, of which 4887 (14.4%) were classified in the active group. Injury severity was not different between the active and inactive groups. The main factors significantly associated with ground fall injuries during activities in elderly patients were male sex, age from 65 to 74 years and 75 to 84 years compared to greater than 85 years, an injury time other than 00:00–05:59, alcohol consumption, sloping floor and floor type other than concrete. After propensity score matching analysis, the factors associated with ground-level fall injuries in older patients when they were active were a time of injury from 06:00–17:59 compared to 00:00–05:59, slippery floor, slope, the absence of obstacles and type of floor other than concrete. We should establish preventive strategies for reducing ground-level fall injuries in older patients during activity, which could include wearing compatible footwear, caution on sloping areas, and maintenance of unpaved roads
Suprapatellar intramedullary nail combined with screw fixation has comparable surgical outcomes to minimally invasive locking plate fixation in ipsilateral tibial plateau and shaft fractures
No full textPurpose: To compare union rate, union time, alignment, and complication rate in ipsilateral tibia plateau and shaft fractures treated via suprapatellar intramedullary nailing with screw fixation and minimally invasive locking plate fixation. Materials and methods: A retrospective study was conducted on 48 patients who underwent minimally invasive plate fixation (n = 35) or suprapatellar intramedullary nailing with screw fixation (n = 13), for the treatment of ipsilateral tibial plateau and shaft fractures with at least 1-year follow-up. Union rate, union time, radiologic alignment, and complication rate such as malalignment, nonunion, and fracture-related infection (FRI) were investigated. Results: Demographic data were not different between the two groups. Coronal plane alignment was 0.17 ± 4.23 in the plate group and −0.48 ± 4.17 in the intramedullary nail group (p = 0.637). Sagittal plane alignment was −0.13 ± 5.20 in the plate group and −1.50 ± 4.01 in the suprapatellar intramedullary nail group (p = 0.313). Coronal and sagittal malalignment recorded equal results: (p > 0.99), FRI (p = 0.602), nonunion and union times recorded (p = 0.656) and (p = 0.683, 0.829), respectively, and showed no significant difference between the two groups. Conclusion: Suprapatellar intramedullary nailing with screw fixation had similar surgical outcomes with minimally invasive locking plate fixation in ipsilateral tibial plateau and shaft fractures in terms of union rate, union time, alignment, and complication rate. Thus, frequent use of intramedullary nailing combined with screw fixation is anticipated in patients with ipsilateral tibial plateau and shaft fractures when the soft tissue condition is not desirable. Level of evidence: Level II
Long-term effects of maxillary skeletal expander treatment on functional breathing
Get PDFObjective: To investigate the long-term effects of maxillary skeletal expander (MSE) treatment on functional breathing. Methods: Objective measures of breathing, the peak nasal inspiratory flow (PNIF), and peak oral inspiratory flow (POIF), and subjective measures of breathing, the visual analog scale (VAS) and nasal obstruction symptom evaluation (NOSE) survey, were used to investigate the long-term effects of MSE in functional breathing. Seventeen patients, mean age 19.4 ± 3.9 years treated at the UCLA Orthodontics Clinic were assessed on their functional breathing at 3 timepoints: pre-expansion (T0), post-expansion (T1), and post-orthodontic treatment (T2). Results: Immediately after expansion (T1), all the objective functional breathing values were significantly increased in comparison to T0 (P < 0.05). The VAS total, VAS right and VAS left were significantly lower at T1 in comparison to T0 (P < 0.05). At 26.8 ± 3.9 months after MSE expansion (T2), PNIF total, PNIF right, PNIF left, and POIF were significantly higher when compared to T0 (P < 0.05). Also, VAS total, VAS right and VAS left were significantly lower at T2 when compared to T0 (P < 0.05). Additionally, there was a positive correlation between PNIF and the magnitude of expansion at anterior nasal spine and zygomaticomaxillary point (ZMA). There was a positive correlation between total VAS and the magnitude of expansion at the ZMA. There were no significant changes for the NOSE subjective breathing measurement at all time comparisons. Conclusions: Overall, MSE treatment produces an increased objective and subjective airway improvement that continues to remain stable in the long-term post expansion
Ultrasonographic assessment of abnormal fetal growth related to uteroplacental-fetal biometrics and Doppler (U-AID) indices: Protocol for multicenter retrospective cohort study trial
Get PDFFetal growth restriction (FGR) is one of the leading causes of perinatal morbidity and mortality. Many studies have reported an association between FGR and fetal Doppler indices focusing on umbilical artery (UA), middle cerebral artery (MCA), and ductus venosus (DV). The uteroplacental-fetal circulation which affects the fetal growth consists of not only UA, MCA, and DV, but also umbilical vein (UV), placenta and uterus itself. Nevertheless, there is a paucity of large-scale cohort studies that have assessed the association between UV, uterine wall, and placental thickness with perinatal outcomes in FGR, in conjunction with all components of the uteroplacental-fetal circulation. Therefore, this multicenter study will evaluate the association among UV absolute flow, placental thickness, and uterine wall thickness and adverse perinatal outcome in FGR fetuses. This multicenter retrospective cohort study will include singleton pregnant women who undergo at least one routine fetal ultrasound scan during routine antepartum care. Pregnant women with fetuses having structural or chromosomal abnormalities will be excluded. The U-AID indices (UtA, UA, MCA, and UV flow, placental and uterine wall thickness, and estimated fetal body weight) will be measured during each trimester of pregnancy. The study population will be divided into two groups: (1) FGR group (pregnant women with FGR fetuses) and (2) control group (those with normal growth fetus). We will assess the association between U-AID indices and adverse perinatal outcomes in the FGR group and the difference in U-AID indices between the two groups
Psychological Safety in Simulation and Psychological Intrinsic Factors Among Korean Undergraduate Nursing Students: A Cross-Sectional Study
No full textBackground: There is a gap in the literature exploring individual students' psychological intrinsic factors and how these factors influence psychological safety in simulation among nursing students with diverse cultural backgrounds. The aim of this study was to explore the associations between psychological safety in simulation and students’ individual psychological intrinsic factors, including self-compassion, anxiety sensitivity, and resilience. Methods: This study was the first part of a multicultural comparison study on satisfaction and psychological safety in simulation, and a comparison of intrinsic characteristics between nursing students in South Korea and the United States, using a descriptive, exploratory, and correlational design. An online survey was used to measure the study variables for 186 Korean students. Data were analyzed using descriptive statistics, Pearson's correlation, and linear mixed models to examine factors associated with psychological safety. Results: All the psychological intrinsic factors (self-compassion, anxiety sensitivity, and resilience) were significantly associated with psychological safety, after controlling the demographic characteristics. Higher psychological safety was associated with higher self-compassion (p = .014), lower anxiety sensitivity (p < .001), and higher resilience (p = .018). Conclusion: Psychological safety in simulation is influenced by students’ psychological intrinsic factors. Efforts to recognize anxiety sensitivity, students’ self-compassion and resilience would be essential to provide a psychologically safe educational environment for nursing
