Background: Active surveillance (AS) has emerged as a viable management strategy for low-risk papillary thyroid microcarcinoma (PTMC), following pioneering trials at Kuma Hospital and the Cancer Institute Hospital in Japan. Numerous prospective cohort studies have since validated AS as a management option for low-risk PTMC, leading to its inclusion in thyroid cancer guidelines across various countries. From 2016 to 2020, the Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro) enrolled 1,177 patients, providing comprehensive data on PTMC progression, sonographic predictors of progression, quality of life, surgical outcomes, and cost-effectiveness when comparing AS to immediate surgery. The second phase of MAeSTro (MAeSTro-EXP) expands AS to low-risk papillary thyroid carcinoma (PTC) tumors larger than 1 cm, driven by the hypothesis that overall risk assessment outweighs absolute tumor size in surgical decision-making. Methods: This protocol aims to address whether limiting AS to tumors smaller than 1 cm may result in unnecessary surgeries for low-risk PTCs detected during their rapid initial growth phase. By expanding the AS criteria to include tumors up to 1.5 cm, while simultaneously refining and standardizing the criteria for risk assessment and disease progression, we aim to minimize overtreatment and maintain rigorous monitoring to improve patient outcomes. Conclusion This study will contribute to optimizing AS guidelines and enhance our understanding of the natural course and appropriate management of low-risk PTCs. Additionally, MAeSTro-EXP involves a multinational collaboration between South Korea and Australia. This cross-country study aims to identify cultural and racial differences in the management of low-risk PTC, thereby enriching the global understanding of AS practices and their applicability across diverse populations.

Background: Active surveillance (AS) has emerged as a viable management strategy for low-risk papillary thyroid microcarcinoma (PTMC), following pioneering trials at Kuma Hospital and the Cancer Institute Hospital in Japan. Numerous prospective cohort studies have since validated AS as a management option for low-risk PTMC, leading to its inclusion in thyroid cancer guidelines across various countries. From 2016 to 2020, the Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro) enrolled 1,177 patients, providing comprehensive data on PTMC progression, sonographic predictors of progression, quality of life, surgical outcomes, and cost-effectiveness when comparing AS to immediate surgery. The second phase of MAeSTro (MAeSTro-EXP) expands AS to low-risk papillary thyroid carcinoma (PTC) tumors larger than 1 cm, driven by the hypothesis that overall risk assessment outweighs absolute tumor size in surgical decision-making. Methods: This protocol aims to address whether limiting AS to tumors smaller than 1 cm may result in unnecessary surgeries for low-risk PTCs detected during their rapid initial growth phase. By expanding the AS criteria to include tumors up to 1.5 cm, while simultaneously refining and standardizing the criteria for risk assessment and disease progression, we aim to minimize overtreatment and maintain rigorous monitoring to improve patient outcomes. Conclusion This study will contribute to optimizing AS guidelines and enhance our understanding of the natural course and appropriate management of low-risk PTCs. Additionally, MAeSTro-EXP involves a multinational collaboration between South Korea and Australia. This cross-country study aims to identify cultural and racial differences in the management of low-risk PTC, thereby enriching the global understanding of AS practices and their applicability across diverse populations.

Background: Active surveillance (AS) has emerged as a viable management strategy for low-risk papillary thyroid microcarcinoma (PTMC), following pioneering trials at Kuma Hospital and the Cancer Institute Hospital in Japan. Numerous prospective cohort studies have since validated AS as a management option for low-risk PTMC, leading to its inclusion in thyroid cancer guidelines across various countries. From 2016 to 2020, the Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro) enrolled 1,177 patients, providing comprehensive data on PTMC progression, sonographic predictors of progression, quality of life, surgical outcomes, and cost-effectiveness when comparing AS to immediate surgery. The second phase of MAeSTro (MAeSTro-EXP) expands AS to low-risk papillary thyroid carcinoma (PTC) tumors larger than 1 cm, driven by the hypothesis that overall risk assessment outweighs absolute tumor size in surgical decision-making. Methods: This protocol aims to address whether limiting AS to tumors smaller than 1 cm may result in unnecessary surgeries for low-risk PTCs detected during their rapid initial growth phase. By expanding the AS criteria to include tumors up to 1.5 cm, while simultaneously refining and standardizing the criteria for risk assessment and disease progression, we aim to minimize overtreatment and maintain rigorous monitoring to improve patient outcomes. Conclusion This study will contribute to optimizing AS guidelines and enhance our understanding of the natural course and appropriate management of low-risk PTCs. Additionally, MAeSTro-EXP involves a multinational collaboration between South Korea and Australia. This cross-country study aims to identify cultural and racial differences in the management of low-risk PTC, thereby enriching the global understanding of AS practices and their applicability across diverse populations.

Background: Active surveillance (AS) has emerged as a viable management strategy for low-risk papillary thyroid microcarcinoma (PTMC), following pioneering trials at Kuma Hospital and the Cancer Institute Hospital in Japan. Numerous prospective cohort studies have since validated AS as a management option for low-risk PTMC, leading to its inclusion in thyroid cancer guidelines across various countries. From 2016 to 2020, the Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro) enrolled 1,177 patients, providing comprehensive data on PTMC progression, sonographic predictors of progression, quality of life, surgical outcomes, and cost-effectiveness when comparing AS to immediate surgery. The second phase of MAeSTro (MAeSTro-EXP) expands AS to low-risk papillary thyroid carcinoma (PTC) tumors larger than 1 cm, driven by the hypothesis that overall risk assessment outweighs absolute tumor size in surgical decision-making. Methods: This protocol aims to address whether limiting AS to tumors smaller than 1 cm may result in unnecessary surgeries for low-risk PTCs detected during their rapid initial growth phase. By expanding the AS criteria to include tumors up to 1.5 cm, while simultaneously refining and standardizing the criteria for risk assessment and disease progression, we aim to minimize overtreatment and maintain rigorous monitoring to improve patient outcomes. Conclusion This study will contribute to optimizing AS guidelines and enhance our understanding of the natural course and appropriate management of low-risk PTCs. Additionally, MAeSTro-EXP involves a multinational collaboration between South Korea and Australia. This cross-country study aims to identify cultural and racial differences in the management of low-risk PTC, thereby enriching the global understanding of AS practices and their applicability across diverse populations.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

Background: A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. Methods: The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. Results: The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. Conclusion The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.

BACKGROUND: Adipose-derived stem cells (ADSCs) exert immunomodulatory effects in the treatment of transplant rejection. This study aimed to evaluate the effects of ADSCs on the skin graft survival in a human-to-rat xenograft transplantation model and to compare single and multiple injections of ADSCs. METHODS: Full-thickness human skin xenografts were transplanted into the backs of Sprague–Dawley rats. The rats were injected subcutaneously on postoperative days 0, 3, and 5. The injections were as follows: triple injections of phosphate-buffered saline (PBS group), a single injection of ADSCs and double injections of PBS (ADSC 9 1 group), and triple injections of ADSCs (ADSC 9 3 group). The immunomodulatory effects of ADSCs on human skin xenografts were assessed. RESULTS: Triple injections of ADSCs considerably delayed cell-mediated xenograft rejection compared with the PBS and ADSC 9 1 groups. The vascularization and collagen type 1–3 ratios in the ADSC 9 3 group were significantly higher than those in the other groups. In addition, intragraft infiltration of CD3-, CD4-, CD8-, and CD68-positive cells was reduced in the ADSC 9 3 group. Furthermore, in the ADSC 9 3 group, the expression levels of proinflammatory cytokine interferon-gamma (IFN-c) were decreased and immunosuppressive prostaglandin E synthase (PGES) was increased in the xenograft and lymph node samples. CONCLUSION This study presented that triple injections of ADSCs appeared to be superior to a single injection in suppressing cell-mediated xenograft rejection. The immunomodulatory effects of ADSCs are associated with the downregulation of IFN-c and upregulation of PGES in skin xenografts and lymph nodes.

Background: This study aimed to determine whether serum uric acid (SUA) levels are associated with various indices of liver damage in the adult Korean population. Methods: We used the Seventh (VII) Korean National Health and Nutritional Examination Surveys. Our study population comprised 6,007 men and 8,488 women. Levels of SUA were divided into four groups (≤ 5.3, 5.3–6.0, 6.0–7.0, and > 7.0 mg/dL for men and ≤ 4.0, 4.0–4.8, 4.8–6.0, and > 6.0 mg/dL for women). Elevated liver enzyme levels were defined as > 35 (men) and > 31 (women) IU/L for aspartate aminotransferase (AST), > 45 (men) and > 34 (women) IU/L for alanine aminotransferase (ALT). Hepatic steatosis index and fibrosis (FIB)-4 index was used to determine nonalcoholic fatty liver disease (NAFLD) and liver FIB, respectively. Adjusted odds ratios (aORs) were calculated by logistic regression analysis for liver enzymes, NAFLD, and liver FIB, according to the SUA level. Results: Among women, the 4.8–6.0 and > 6.0 mg/dL SUA groups showed higher ORs of elevated AST (aOR, 1.78 and 2.03; 95% confidence interval [CI], 1.37–2.32 and 1.40–2.96, respectively; P < 0.001) and the 4.0–4.8, 4.8–6.0, and > 6.0 mg/dL SUA groups showed a higher ORs of ALT elevation (aOR, 1.35, 2.26, and 2.37; 95% CI, 1.02–1.79, 1.72–2.97, and 1.60–3.50, respectively; P < 0.001) compared to the lowest level SUA group. Among women with normal ALT, > 6.0 mg/dL SUA group showed higher OR of NAFLD status (aOR, 1.52; 95% CI, 1.06–2.19). Among men and women with NAFLD, hyperuricemia showed higher ORs of liver FIB (aOR, 2.25 and 1.89; 95% CI, 1.21–4.19 and 1.09–3.27, respectively) than the lowest level SUA group. Conclusion High SUA levels may be associated with elevated liver enzymes and NAFLD, mainly in women. Even in women with normal ALT levels, SUA levels may predict the NAFLD status. Hyperuricemia may predict advanced liver FIB in both men and women with NAFLD. Further studies investigating the causal effects of SUA on liver damage are required.