• Title/Summary/Keyword: informed consent

Search Result 435, Processing Time 0.022 seconds

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
    • /
    • v.22 no.2
    • /
    • pp.179-188
    • /
    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

Developing Measurement Items for the Service Quality of Clinical Trials based on the Brady & Cronin Model (Brady & Cronin의 모델에 기반한 임상시험 서비스 질 측정 문항 개발)

  • Go-Eun Lee;Sanghee Kim;Sue Kim;Sang Hui Chu;Jeong-Ho Seok;So Yoon Kim
    • The Journal of KAIRB
    • /
    • v.6 no.1
    • /
    • pp.17-31
    • /
    • 2024
  • Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.

  • PDF

Deriving Criteria Weights for Acute Care Hospital Accreditation in South Korea: Using Analytic Hierarchy Process (급성기병원 인증기준의 가중치 도출: 계층적 분석법을 활용하여)

  • Hwa Yeong Oh;Hyeon-Jeong Lee;Minsu Ock;In Ho Kim;Ho Yeol Jang;Ji-Eun Choi
    • Quality Improvement in Health Care
    • /
    • v.30 no.1
    • /
    • pp.33-43
    • /
    • 2024
  • Purpose:The acute hospital accreditation program launched in South Korea has shown positive effects on safety culture and quality of care. However, relative weights have not yet been investigated for accreditation criteria with a hierarchical structure. This study aimed to derive the relative weights of acute-care hospital accreditation criteria. Methods: We conducted an online survey using the analytic hierarchy process (AHP) technique to assess the validity, importance, and urgency of acute hospital accreditation criteria. The AHP online survey link was distributed in November 2022 after obtaining informed consent from 10 experts in hospital accreditation. Results: 'Basic value system' ranked highest, while 'patient care system' ranked second in terms of validity, importance, and urgency. 'Performance management system' had the lowest validity and urgency, while 'organizational management system' carried the lowest importance. Within the 'patient care system' domain, 'surgery and anesthesia sedation management' scored highest in validity and importance, and 'patient care' scored highest in urgency. 'Care delivery system and evaluation' received the lowest scores for all three aspects. In the 'organizational management system' domain, infection control ranked highest in terms of validity, importance, and urgency. The lowest validity was observed for 'management and organizational operation' and the lowest importance and urgency were noted for 'human resource management'. Conclusion: The weights for validity, importance, and urgency, as shown in each domain and chapter, and the number of measurable elements included, are largely inconsistent. This study will contribute to the development of the structure and scientific improvement of accreditation standards.

Distribution of maternal risk factors for orofacial cleft in infants in Indonesia: a multicenter prospective study

  • Andi Tajrin;M. Ruslin;Muh. Irfan Rasul;Nurwahida;Hadira;Husni Mubarak;Katharina Oginawati;Nurul Fahimah;Ikeu Tanziha;Annisa Dwi Damayanti;Utriweni Mukhaiyar;Asri Arumsari;Ida Ayu Astuti;Farah Asnely Putri;Shinta Silvia
    • Archives of Craniofacial Surgery
    • /
    • v.25 no.1
    • /
    • pp.11-16
    • /
    • 2024
  • Background: The pathogenesis of orofacial cleft (OFC) is multifactorial, involving both genetic and non-genetic factors, the latter of which play a key role in the development of these anomalies. This paper addresses the incidence of OFC in Indonesia, with a focus on identifying and examining the distribution of contributory factors, including parental medical history, pregnancy history, and environmental influences. Methods: The study was conducted through the collection of primary data. An interdisciplinary research team from Indonesia administered a standardized questionnaire to parents who had children with OFC and who had provided informed consent. The case group comprised 133 children born with cleft lip and/or palate, and the control was 133 noncleft children born full-term. The risk factors associated with OFC anomalies were analyzed using the chi-square test and logistic regression. All statistical analyses were performed using SPSS version 25. A p-value of 0.05 or less was considered to indicate statistical significance. Results: The study comprised 138 children, of whom 82 were boys (59.4%) and 56 were girls (40.6%). Among them, 45 patients (32.6%) presented with both cleft lip and cleft palate, 25 individuals (18.1%) had a cleft palate only, and 28 patients (20.3%) had a cleft lip only. OFC was found to be significantly associated with a maternal family history of congenital birth defects (p<0.05), complications during the first trimester (p<0.05), consumption of local fish (p<0.05), caffeine intake (p<0.05), prolonged medication use (p<0.05), immunization history (p<0.05), passive smoking (p<0.05), and X-ray exposure during pregnancy (p<0.05). Conclusion: The findings indicate close relationships between the incidence of OFC and maternal medical history, prenatal factors, and environmental influences.

Association between High Diffusion-Weighted Imaging-Derived Functional Tumor Burden of Peritoneal Carcinomatosis and Overall Survival in Patients with Advanced Ovarian Carcinoma

  • He An;Jose AU Perucho;Keith WH Chiu;Edward S Hui;Mandy MY Chu;Siew Fei Ngu;Hextan YS Ngan;Elaine YP Lee
    • Korean Journal of Radiology
    • /
    • v.23 no.5
    • /
    • pp.539-547
    • /
    • 2022
  • Objective: To investigate the association between functional tumor burden of peritoneal carcinomatosis (PC) derived from diffusion-weighted imaging (DWI) and overall survival in patients with advanced ovarian carcinoma (OC). Materials and Methods: This prospective study was approved by the local research ethics committee, and informed consent was obtained. Fifty patients (mean age ± standard deviation, 57 ± 12 years) with stage III-IV OC scheduled for primary or interval debulking surgery (IDS) were recruited between June 2016 and December 2021. DWI (b values: 0, 400, and 800 s/mm2) was acquired with a 16-channel phased-array torso coil. The functional PC burden on DWI was derived based on K-means clustering to discard fat, air, and normal tissue. A score similar to the surgical peritoneal cancer index was assigned to each abdominopelvic region, with additional scores assigned to the involvement of critical sites, denoted as the functional peritoneal cancer index (fPCI). The apparent diffusion coefficient (ADC) of the largest lesion was calculated. Patients were dichotomized by immediate surgical outcome into high- and low-risk groups (with and without residual disease, respectively) with subsequent survival analysis using the Kaplan-Meier curve and log-rank test. Multivariable Cox proportional hazards regression was used to evaluate the association between DWI-derived results and overall survival. Results: Fifteen (30.0%) patients underwent primary debulking surgery, and 35 (70.0%) patients received neoadjuvant chemotherapy followed by IDS. Complete tumor debulking was achieved in 32 patients. Patients with residual disease after debulking surgery had reduced overall survival (p = 0.043). The fPCI/ADC was negatively associated with overall survival when accounted for clinicopathological information with a hazard ratio of 1.254 for high fPCI/ADC (95% confidence interval, 1.007-1.560; p = 0.043). Conclusion: A high DWI-derived functional tumor burden was associated with decreased overall survival in patients with advanced OC.

MRI Evaluation of Suspected Pathologic Fracture at the Extremities from Metastasis: Diagnostic Value of Added Diffusion-Weighted Imaging

  • Sun-Young Park;Min Hee Lee;Ji Young Jeon;Hye Won Chung;Sang Hoon Lee;Myung Jin Shin
    • Korean Journal of Radiology
    • /
    • v.20 no.5
    • /
    • pp.812-822
    • /
    • 2019
  • Objective: To assess the diagnostic value of combining diffusion-weighted imaging (DWI) with conventional magnetic resonance imaging (MRI) for differentiating between pathologic and traumatic fractures at extremities from metastasis. Materials and Methods: Institutional Review Board approved this retrospective study and informed consent was waived. This study included 49 patients each with pathologic and traumatic fractures at extremities. The patients underwent conventional MRI combined with DWI. For qualitative analysis, two radiologists (R1 and R2) independently reviewed three imaging sets with a crossover design using a 5-point scale and a 3-scale confidence level: DWI plus non-enhanced MRI (NEMR; DW set), NEMR plus contrast-enhanced fat-saturated T1-weighted imaging (CEFST1; CE set), and DWI plus NEMR plus CEFST1 (combined set). McNemar's test was used to compare the diagnostic performances among three sets and perform subgroup analyses (single vs. multiple bone abnormality, absence/presence of extra-osseous mass, and bone enhancement at fracture margin). Results: Compared to the CE set, the combined set showed improved diagnostic accuracy (R1, 84.7 vs. 95.9%; R2, 91.8 vs. 95.9%, p < 0.05) and specificity (R1, 71.4% vs. 93.9%, p < 0.005; R2, 85.7% vs. 98%, p = 0.07), with no difference in sensitivities (p > 0.05). In cases of absent extra-osseous soft tissue mass and present fracture site enhancement, the combined set showed improved accuracy (R1, 82.9-84.4% vs. 95.6-96.3%, p < 0.05; R2, 90.2-91.1% vs. 95.1-95.6%, p < 0.05) and specificity (R1, 68.3-72.9% vs. 92.7-95.8%, p < 0.005; R2, 83.0-85.4% vs. 97.6-98.0%, p = 0.07). Conclusion: Combining DWI with conventional MRI improved the diagnostic accuracy and specificity while retaining sensitivity for differentiating between pathologic and traumatic fractures from metastasis at extremities.

A Legal Analysis on the Absence of Provisions Regarding Non-relative Patients in the Act of Decisions-Making in Life-Sustaining Medicine (연명의료결정법에서 무연고자 규정미비 등에 관한 법적 고찰)

  • Moon, Sang Hyuk
    • The Korean Society of Law and Medicine
    • /
    • v.24 no.4
    • /
    • pp.103-128
    • /
    • 2023
  • According to the current act of Decision-Marking in Life-Sustaining Medicine, the decision to withhold or discontinue life-sustaining treatment is primarily based on the wishes of a patient in the dying process. Decision-making regarding life-sustaining treatment for these patients is made by the patient, if he or she is conscious, directly expressing his/her intention for life-sustaining treatment in writing or verbally or by writing an advance medical directive and physician orders for life-sustaining treatment. It can be exercised. On the other hand, if the patient has not written an advance medical directive or physician orders for life-sustaining treatment, the patient's intention can be confirmed with a statement from the patient's family, or a decision to discontinue life-sustaining treatment can be made with the consent of all members of the patient's family. However, in the case of an unrelated patient who has no family or whose family is unknown, if an advance medical directive or physician orders for life-sustaining treatment are not written before hospitalization and a medical condition prevents the patient from expressing his or her opinion, the patient's will cannot be known and the patient cannot be informed. A situation arises where a decision must be made as to whether to continue or discontinue life-sustaining treatment. This study reviewed discussions and measures for unbefriended patients under the current law in order to suggest policy measures for deciding on life-sustaining treatment in the case of unbefriended patients. First, we looked at the application of the adult guardian system, but although an adult guardian can replace consent for medical treatment that infringes on the body, permission from the family court is required in cases where death may occur as a direct result of medical treatment. It cannot be said to be an appropriate solution for patients in the process of dying. Second, in accordance with Article 14 of the Life-Sustaining Treatment Decision Act, we looked at the deliberation of medical institution ethics committees on decisions to discontinue life-sustaining treatment for patients without family ties.Under the current law, the medical institution ethics committee cannot make decisions on discontinuation of life-sustaining treatment for unbefriended patients, so through revision, matters regarding decisions on discontinuation of life-sustaining treatment for unbefriended patients are reflected in Article 14 of the same Act or separate provisions for unbefriended patients are made. It is necessary to establish and amend new provisions. In addition, the medical institution ethics committee must make a decision on unbefriended patients, but if the medical institution cannot make such a decision, there is a need to revise the law so that the public ethics committee can make decisions, such as discontinuing life-sustaining treatment for unbefriended patients.

In Vitro imaging of MRI and Ultrasound for Colorectal Carcinoma (직결장암 조직의 자기공명영상과 초음파 소견에 대한 비교 연구)

  • Lee, Hwang Kyu;Jee, Keum Nahn;Hong, Sujin;Koh, Jae Hyang
    • Investigative Magnetic Resonance Imaging
    • /
    • v.17 no.2
    • /
    • pp.133-143
    • /
    • 2013
  • Purpose : To evaluate and compare the accuracy of magnetic resonance imaging (MRI) and ultrasound (US) for detection and estimation of invasion depth of colorectal carcinoma (CRC) by correlation with histopathologic findings in vitro, and to find out the best MR pulse sequence for accurate delineation of tumor from surrounding normal tissue. Materials and Methods: Resected specimens of CRC from 45 patients were examined about tumor detectability and invasion depth of US using high frequency (5-17 MHz) linear transducer in a tube filled with normal saline and MRI in a 8-channel quadrate head coil. The institutional review board approved this study and informed consent was waived. MRI with seven pulse sequences of in- and out-of-phases gradient echo T1 weighted images, fast spin echo T2 weighted image and its fat suppression image, fast imaging employing steady-state acquisition (FIESTA) and its fat suppression image, and diffusion weighted image (DWI) were performed. In each case, both imaging findings of MRI and US were evaluated independently for detection and estimation of invasion depth of tumor by consensus of two radiologists and were compared about diagnostic accuracy according to the histopathologic findings as reference standard. Seven MR pulse sequences were evaluated on the point of accurate delineation of tumor from surrounding normal tissue in each specimen. Results: In specimens of CRC, both imaging modalities of MRI (91.1%) and US (86.7%) showed relatively high diagnostic accuracy to detect tumor and evaluate invasion depth of tumor. In early CRC, diagnostic accuracy of US was 87.5% and that of MRI was 75.0%. There was no statistically significant difference between two imaging modalities (p > 0.05). The best pulse sequence among seven MR sequences for accurate delineation of tumor from surrounding normal tissue in each specimen of CRC was fast spin echo T2 weighted image. Conclusion: MRI and US show relatively high diagnostic accuracy to detect tumor and evaluate invasion depth of resected specimen of CRC. The most excellent pulse sequence of MRI for accurate delineation of tumor from surrounding normal tissue in CRC is fast spin echo T2 weighted image.

NORMOBARIC OXYGEN($O_2$) ADMINISTRATION EFFECT ON ATTENTION AND MEMORY FUNCTION IN TEENAGE ADOLESCENTS (10대 청소년의 주의력과 기억능력에 미치는 정상기압 산소흡입 효과)

  • Kim, Byung-Hyo;Kim, Young-Mi;Cho, Soo-Churl;Kim, Boong-Nyun
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
    • /
    • v.13 no.1
    • /
    • pp.76-84
    • /
    • 2002
  • Objectives:This study was conducted to investigate the effect of oxygen on attention and memory functions in healthy adolescents. Methods:The participant subjects were recruited from local advertisement. All subjects are students attending ordinary middle and high school. Their degree of achievement was average or below average. Before the study, its nature and purpose were fully explained to the patients and their parents, and a written informed consent was obtained from each child's parent and a written assent from each child for entire the procedure. The Ethics Committee and Clinical Research Committee of Gyeongsang National University Hospital approved the protocol. For baseline assessment, all subjects received tests for attention and memory. All tests were conducted by a certified psychologist. Stroop test, continuous performance test and trail making test A and B were used for evaluation of attention. As memory tests, we used memory assessment scale(MAS), standardized memory assessment tools. Ten to fourteen days after initial assessments, same tests was applied to the same subjects after prior 5 minute oxygen inhalation. Results:1) Attention test:Improved performances in trail making part B, and stroop test were found in normobaric oxygen inhalation group compared to air inhalation group. Improved reaction time in those tests seemed to reflect the enhanced executive prefrontal activity. 2) Memory test:More words and digits memorization were found in short-term memory subscale score in MAS in oxygen inhalation group compared to air inhalation group. This finding suggested the improved working memory function after oxygen inhalation. Conclusion:Though interpreted cautiously, these results suggested that normobaric oxygen inhalation could enhance executive function and working memory of prefrontal lobe. Further study, however, should be performed to investigate the mechanism of effects of oxygen on cognitive enhancement.

  • PDF

A Study on the Relationship between Adiponectin, BDNF and Leptin with Abdominal Fat Thickness in Male Workers (남성 근로자의 복부지방두께와 adiponectin, BDNF 및 leptin의 관련성)

  • Ko, Kyung-Sun;Choi, Yoon-Jung
    • Journal of radiological science and technology
    • /
    • v.36 no.3
    • /
    • pp.209-217
    • /
    • 2013
  • Adiponectin (AdipoN), brain-derived nerotrophic factor (BDNF) and leptin (LeP) are mainly secreted from adipose tissue and are known to be involved in regulation of the development of obese. However, there are not many studies on the association between abdominal fat and neuropeptides such as AdipoN, BDNF and LeP. The aim of this study was undertaken to investigate the association between abdominal fat thickness, neuropeptides and cardiovascular disease (CVD) risk factors. The participants in the study were 138 male employees without CVD. This study was approved by the Institutional Review Board of Occupational Safety and Health Research Institute. Written informed consent for the participants in this study was obtained from all individuals. We obtained subcutaneous fat thickness (SFT) and visceral fat thickness (VFT) by using ultrasonography and neuropeptides levels were measured with ELISA kit according to the method suggested by kit manufacturer. The mean SFT and VFT were $1.58{\pm}0.51$ and $4.52{\pm}1.44$ cm. The mean concentrations of AdipoN, BDNF and LeP were $3.14{\pm}3.52$ ng/ml, $24.11{\pm}8.52$ pg/ml and $4.27{\pm}2.38$ ng/ml, respectively. VFT were positively correlated with total cholesterol (r=0.217, p<0.05), LDL-cholesterol (r=0.271, p<0.01), triglyceride (r=0.233, p<0.05) and insulin (r=0.338, p<0.01), but was inversely correlated with HDL-cholesterol (r=-420, p<0.01). AdipoN levels were positively correlated with HDL-cholesterol (r=0.220, p<0.05) and were inversely correlated with total cholesterol (r=-0.196, p<0.05), LDL-cholesterol (r=-0.190, p<0.05), triglyceride (r=-0.199, p<0.05), SFT (r=-0.195, p<0.05) and VFT (r=-0.412, p<0.01). However, LeP levels showed a reverse trend to AdipoN. AdipoN level was significantly higher in non-obese participants (BMI<25 kg/m), but LeP concentration was significantly higher in obese participants (BMI>25 kg/m) than in non-obese. On multiple logistic regression analysis, obese were significantly associated with AdipoN (odds ratio=0.784) and LeP (odds ratio=1.494). These results suggested that AdipoN and LeP concentrations are affected abdominal fat and that dysfunction and/or declination in the production and secretion of neuropeptides might induced ultimately obese and CVD.