• Title/Summary/Keyword: eligibility criteria

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Predicting Successful Conservative Surgery after Neoadjuvant Chemotherapy in Hormone Receptor-Positive, HER2-Negative Breast Cancer

  • Ko, Chang Seok;Kim, Kyu Min;Lee, Jong Won;Lee, Han Shin;Lee, Sae Byul;Sohn, Guiyun;Kim, Jisun;Kim, Hee Jeong;Chung, Il Yong;Ko, Beom Seok;Son, Byung Ho;Ahn, Seung Do;Kim, Sung-Bae;Kim, Hak Hee;Ahn, Sei Hyun
    • Journal of Breast Disease
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    • v.6 no.2
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    • pp.52-59
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    • 2018
  • Purpose: This study aimed to determine whether clinicopathological factors are potentially associated with successful breast-conserving surgery (BCS) after neoadjuvant chemotherapy (NAC) and develop a nomogram for predicting successful BCS candidates, focusing on those who are diagnosed with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative tumors during the pre-NAC period. Methods: The training cohort included 239 patients with an HR-positive, HER2-negative tumor (${\geq}3cm$), and all of these patients had received NAC. Patients were excluded if they met any of the following criteria: diffuse, suspicious, malignant microcalcification (extent >4 cm); multicentric or multifocal breast cancer; inflammatory breast cancer; distant metastases at the time of diagnosis; excisional biopsy prior to NAC; and bilateral breast cancer. Multivariate logistic regression analysis was conducted to evaluate the possible predictors of BCS eligibility after NAC, and the regression model was used to develop the predicting nomogram. This nomogram was built using the training cohort (n=239) and was later validated with an independent validation cohort (n=123). Results: Small tumor size (p<0.001) at initial diagnosis, long distance from the nipple (p=0.002), high body mass index (p=0.001), and weak positivity for progesterone receptor (p=0.037) were found to be four independent predictors of an increased probability of BCS after NAC; further, these variables were used as covariates in developing the nomogram. For the training and validation cohorts, the areas under the receiver operating characteristic curve were 0.833 and 0.786, respectively; these values demonstrate the potential predictive power of this nomogram. Conclusion: This study established a new nomogram to predict successful BCS in patients with HR-positive, HER2-negative breast cancer. Given that chemotherapy is an option with unreliable outcomes for this subtype, this nomogram may be used to select patients for NAC followed by successful BCS.

A Review on End-of-life Care System between South Korea and the United States (한국과 미국의 생애말기케어 시스템 비교 연구)

  • Choi, Ji-Won;Rhee, YongJoo
    • Journal of Digital Convergence
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    • v.17 no.9
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    • pp.301-310
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    • 2019
  • This study aims to examine eligibilities, services and delivery of services for the current end-of-life care and analyze the quality control of services for end-of-life care. We analyzed the literature and laws on end-of-life systems in Korean and the United States. Current end-of-life care, hospice and palliative care in Korea is being provided mainly in hospital setting. Quality control for the services focuses on setting the criteria for structures in hospitals (i.e. staffing, facilities and equipment). Whereas American end-of-life care system has much broader eligibility for service beneficiaries and provides care mostly at home. Also quality control for services includes process (delivering service) and outcomes, such as monitoring performance indicators and consumer's satisfaction. This is linked to annual payment. The comparative analysis findings contributed to give the next direction of current Korean end-of-life care system. It is nessary to establish the better and extensive end-of-life care system in Korea in considering other countries' end-of-life care systems based on more future research.

Effect of garlic (Allium sativum L.) as a functional food, on blood pressure: a meta-analysis of garlic powder, focused on trials for prehypertensive subjects (기능성식품으로서 마늘의 혈압 개선 기능성 평가: 마늘건조분말의 준건강인 대상 연구에 대한 메타분석)

  • Kwak, Jin Sook;Kim, Ji Yeon
    • Journal of Nutrition and Health
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    • v.54 no.5
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    • pp.459-473
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    • 2021
  • Purpose: Although numerous systematic reviews or meta-analysis have reported the hypotensive effects of garlic, the application of these results in the area of functional food is limited. This is because the trials used various garlic preparations and patients with differing hypertensive intensities. To validate the use of garlic powder as a blood pressure lowering functional food, we performed the current meta-analysis, focusing on the study of prehypertensive subjects. Methods: Literature search was carried out using various database up to July 2020, including PubMed, Cochrane, ScienceDirect and Korean studies Information Service System, and each study was screened by pre-stated inclusion/exclusion criteria. We identified nine trials that met the eligibility, of which two studies with moderate or high risk of bias were excluded. Results: Meta-analysis of the seven studies revealed that an intake of garlic powder significantly lowered the systolic blood pressure (SBP) and diastolic blood pressure (DBP) by -6.0 mmHg (95% confidence interval [CI], -11.2, -0.8; p = 0.025) and -2.7 mmHg (95% CI, -5.3, -0.1; p = 0.046), respectively. Shapes of the funnel plot for both SBP and DBP seemed symmetrical, and the Egger's regression revealed no publication bias. Moreover, duration of the intervention period was inversely associated with the pooled effects of garlic powder on SBP (p = 0.019) and DBP (p = 0.019), and this result was supported by the subgroup-analysis. The daily dose of garlic powder, baseline value of each biomarker, and subject number, did not moderate the effects on SBP and DBP. Conclusion: Results of the present meta-analysis indicate that garlic powder supplements are superior to placebo for improving the BP in prehypertensive individuals.

Efficacy of glycine powder air-polishing in supportive periodontal therapy: a systematic review and meta-analysis

  • Zhu, Mengyuan;Zhao, Meilin;Hu, Bo;Wang, Yunji;Li, Yao;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • v.51 no.3
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    • pp.147-162
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    • 2021
  • Purpose: This systematic review and meta-analysis was conducted to assess the effects of glycine powder air-polishing (GPAP) in patients during supportive periodontal therapy (SPT) compared to hand instrumentation and ultrasonic scaling. Methods: The authors searched for randomized clinical trials in 8 electronic databases for relevant studies through November 15, 2019. The eligibility criteria were as follows: population, patients with chronic periodontitis undergoing SPT; intervention and comparison, patients treated by GPAP with a standard/nozzle type jet or mechanical instrumentation; and outcomes, bleeding on probing (BOP), patient discomfort/pain (assessed by a visual analogue scale [VAS]), probing depth (PD), gingival recession (Rec), plaque index (PI), clinical attachment level (CAL), gingival epithelium score, and subgingival bacteria count. After extracting the data and assessing the risk of bias, the authors performed the meta-analysis. Results: In total, 17 studies were included in this study. The difference of means for BOP in patients who received GPAP was lower (difference of means: -8.02%; 95% confidence interval [CI], -12.10% to -3.95%; P<0.00001; I2=10%) than that in patients treated with hand instrumentation. The results of patient discomfort/pain measured by a VAS (difference of means: -1.48, 95% CI, -1.90 to -1.06; P<0.001; I2=83%) indicated that treatment with GPAP might be less painful than ultrasonic scaling. The results of PD, Rec, PI, and CAL showed that GPAP had no advantage over hand instrumentation or ultrasonic scaling. Conclusions: The findings of this study suggest that GPAP may alleviate gingival inflammation more effectively and be less painful than traditional methods, which makes it a promising alternative for dental clinical use. With regards to PD, Rec, PI, and CAL, there was insufficient evidence to support a difference among GPAP, hand instrumentation, and ultrasonic scaling. Higher-quality studies are still needed to assess the effects of GPAP.

The Effect of Converting Health Insurance Qualification on Medical Use (건강보험가입자의 의료급여 자격변동에 따른 의료이용행태 변화 연구)

  • Na, Young-Kyoon;Cha, Yerin;Kim, Nayoung;Lee, Youngjae;Lee, Yong-Gab;Lim, Seungji
    • Health Policy and Management
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    • v.30 no.4
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    • pp.460-466
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    • 2020
  • Background: The purpose of this study is to analyze whether there is a change in patterns of medical use among those likely to be converted their health insurance qualifications when the family support rule is alleviated. There is no empirical analysis that converting health insurance qualification will affect the increase in medical use. Methods: For analysis, data were extracted from the national health insurance eligibility and medical care database. To identify analysis targets similar to that of medical aids' characteristics among health insurance coverage, we compared income, property level, and medical use patterns through basic statistical analysis and used a difference-in-difference (DID) analysis to estimate the net effect of changes in medical use following the change of qualifications. Results: The main results are as follows. The results show that those who are under the 5% income group (1st income group) of health insurance coverage are the most similar to the medical aids group. DID analysis shows that changes in the medical use of people who maintain their national insurance qualification and who are not. As a results, the number of hospitalized days of converting group was reduced by 3.5 days while outpatient days were increased by 1.8 days. Conclusion: As a result, there was not much difference in the patterns of medical use for the under 5% income group who are likely to be eligible for expanded medical aids when the family support rule is alleviated. In addition, more than 30% of them are in arrears with their health insurance premiums, causing inconvenience in using medical services. These findings suggest the need of abolishing the criteria obligated to support family, and great efforts should be made to contribute to non-paid poor and remove their medical blind spot.

Evaluation of Clinical Outcomes by Therapeutic Dosing Interval of Denosumab (Prolia®) and Calcium-Vitamin D Prescriptions (Denosumab (Prolia®)의 투여 간격 및 칼슘·비타민 D 복합제제 처방 여부에 따른 임상적 결과 평가)

  • Kim, Youkyeong;Kim, Junghyun;Doh, Hyunjeong;Jeong, Young Mi;Lee, Jeonghwa;Lee, Ju-Yeun;Lee, Euni
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.3
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    • pp.185-190
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    • 2022
  • Background: Denosumab (Prolia®) is administered every 6 months for osteoporosis treatment. Co-administration of calcium and vitamin D is required to minimize hypocalcemia risk. We evaluated clinical outcomes based on the administration interval of denosumab and co-prescription with calcium-vitamin D combination products. Methods: A retrospective study was conducted using electronic medical records from 668 patients who started denosumab therapy between January 1 and December 31, 2018, at Seoul National University Bundang Hospital. Clinical outcomes, as measured by changes in T-score, were evaluated by the intervals and concurrent prescriptions with calcium-vitamin D combination products. Results: Of the 668 patients, 333 patients met the eligibility criteria. These patients were divided into two groups based on appropriateness of the administration interval: "Appropriate" (304 patients, 91.3%) and "Inappropriate" (29 patients, 8.3%). T-score changes were significantly higher in the "Appropriate" than in the "Inappropriate" group (0.30±0.44 vs. 0.13±0.37, p=0.048). At the beginning of the treatment, 221 patients (66.4%) were prescribed calcium-vitamin D combination products, but the changes in T-scores were not significantly different by the prescription status of the product (0.29±0.46 vs. 0.28±0.38, p=0.919). Conclusion: T-scores were significantly improved in patients with appropriate administration intervals. No significant changes in T-scores were observed by the prescription status with calcium-vitamin D combination products. For optimal treatment outcomes, prescribers should encourage adherence to the approved prescription information on dosage and administration, and pharmacists should provide medication counseling for patients.

The Effects of Nursing Educations on Anxiety, Uncertainty, Pain for Patients with Benign Tumor of Uterine: A Systematic Review and Meta-Analysis (자궁양성종양 환자의 수술 사전 교육이 불안, 불확실성, 통증에 미치는 효과: 체계적 문헌고찰 및 메타분석)

  • Park, Seo-A;Kim, Gaeun;Kim, Hye-Young
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.22 no.5
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    • pp.207-220
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    • 2021
  • This study aimed to evaluate the impact of education and counselling by nurses on anxiety, uncertainty, and pain in patients with benign uterine tumors. Electronic databases, including PubMed, OVID, CINAHL, Google Scholar, and Korean databases and were searched during January 2020. A total of 401 studies were identified of which 13 were suitable for meta-analysis. Cochrane's risk of bias tool and the R version 3.5.2 (Meta-analysis with R) program were used for analysis. The authors performed a meta-analysis of the 13 trials that met eligibility criteria. The findings in this study indicate that the effect size of nursing education for anxiety was Hedges' g=-0.89 (95% CI:-1.39 to -0.47), as indicated by a "large effect size" and the effect size of pain was Hedges' g=-0.49 (95% CI:-0.95 to -0.02) as indicated by a "moderate effect size". The effect size of uncertainty was Hedges' g=-1.38 (95% CI:-3.98 to 1.23), and it was not statistically significant. In the meta-subgroup analyses by approach intervention type, cognitive-behavioral programs, demonstration intervention, and relaxation therapy had a significant effect. The risk of publication bias was low. It may therefore be concluded that pre-operative education by nurses for patients with benign uterine tumors would affect their levels of anxiety, uncertainty, and pain.

Cognitive and Psychological Characteristics of Psychiatric Patients with Military Service Eligibility Issues (군 복무 적합성 판정을 위해 내원한 환자들의 인지적 및 심리적 특성)

  • Nam, Jisoo;Choi, Junho;Kim, Eunkyeong
    • Korean Journal of Psychosomatic Medicine
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    • v.27 no.2
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    • pp.119-129
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    • 2019
  • Objectives : The purpose of this study was to examine cognitive and psychological characteristics of patients who visited psychiatric outpatient clinic with military service suitability issues. Methods : Since January, 2017 to September, 2018, patients were recruited from the department of psychiatry of university hospital. Participants were diagnosed using DSM-5 criteria by board certified psychiatrists. And each of participants tested with K-WAIS-IV, K-SCL-95 by clinical psychologist. The data were analyzed using SPSS 18.0. Results : The results indicated 24.6% of the patients have significantly low level of intellectual functioning. and 10.8% of the patients have borderline level of intellectual functioning, and 26.3% of them were below average. The results of psychological characteristics showed patients have cautious and potentially dangerous level of depression, anxiety, agoraphobia, and suicidal idea. And PTSD subscale's mean score was above problematic level. Next, we divided patients into two groups based on question of whether the patient is eligible to serve in the military service or not arises from recruitment process or army training center. But two group didn't differ significantly. And for further analyses, we also divided patients into two groups based on if they got single psychiatric diagnosis or more than one psychiatric diagnosis. Conclusions : The results indicated that group which has coexisting psychiatric disorders were more depressed, had higher level of anger and aggression, and had more serious levels of suicidal ideas than single psychiatric diagnosis group. The implications and limitations were discussed along with some suggestions for the future studies.

Conservative Surgery and Primary Radiotherapy for Early Bresst Cancer: Yonsei Cancer Center Experience (조기 유방암에서 보존적 수술후 방사선치료: 연세암센터 경험)

  • Suh Chang Ok;Lee Hy De;Lee Kyung Sik;Jung Woo Hee;Oh Ki Keun;Kim Gwi Eon
    • Radiation Oncology Journal
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    • v.12 no.3
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    • pp.337-347
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    • 1994
  • Breast conserving surgery and irradiation is now accepted as preferable treatment method for the patients with stage I and II breast cancer. Our institution activated team approach for breast conservation in 1991 and treated one hundred and fourty patients during the next three years. Purpose : To present our early experience with eligibility criteria, treatment techniques, and the morbidities of primary radiotherapy. Materials and Methods: Sixty four patients with early stage breast cancer who received breast conserving treatment between January 1991 and December 1992 were evaluated. All patients received partial mastectomy(wide excision to quadrantectomy) and axillary node dissection followed by radiotherapy. Total dose of 4500-5040 cGy in 5-5 1/2 weeks was given to entire involved breast and boost dose of 1000-2000 cGy in 1-2 weeks was given to the primary tumor site. Linac 4 MV X-ray was used for breast irradiation and electron beam was used for boost. Thirty five Patients received chemotherapy before or after radiotherapy. Patients characteristics, treatment techniques, and treatment related morbidities were analyzed. Results : Age distribution was ranged from 23 to 59 year old with median age of 40. Twenty-seven patients had T1 lesions and 34 patients had T2 lesions. In three patients, pathologic diagnosis was ductal carcinoma in situ. Thirty-seven Patients were N0 and 27 patients were Nl. There were three recurrences, one in the breast and two distant metastases during follow-up period(6-30 months, median 14 months). Only one breast recurrence occured at undetected separate lesion with microcalcifications on initial mammogram. There was no serious side reaction which interrupted treatment courses or severe late complication. Only one symptomatic radiation pneumonitis and one asymptomatic radiation pneumonitis were noted. Conclusions: Conservative surgery and primary radiotherapy for early breast cancer is Proven to be safe and comfortable treatment method without any major complication. Long-term follow up is needed to evaluate our treatment results in terms of loco-regional control rate, survival rate, and cosmetic effect.

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A Prospective Randomized Comparative Clinical Trial Comparing the Efficacy between Ondansetron and Metoclopramide for Prevention of Nausea and Vomiting in Patients Undergoing Fractionated Radiotherapy to the Abdominal Region (복부 방사선치료를 받는 환자에서 발생하는 오심 및 구토에 대한 온단세트론과 메토클로프라미드의 효과 : 제 3상 전향적 무작위 비교임상시험)

  • Park Hee Chul;Suh Chang Ok;Seong Jinsil;Cho Jae Ho;Lim John Jihoon;Park Won;Song Jae Seok;Kim Gwi Eon
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.127-135
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    • 2001
  • Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

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