• Title/Summary/Keyword: Adverse outcomes

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Peripheral Blood Immune Cell-based Biomarkers in Anti-PD-1/PD-L1 Therapy

  • Kyung Hwan Kim;Chang Gon Kim;Eui-Cheol Shin
    • IMMUNE NETWORK
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    • v.20 no.1
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    • pp.8.1-8.15
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    • 2020
  • Immune checkpoint blockade targeting PD-1 and PD-L1 has resulted in unprecedented clinical benefit for cancer patients. Anti-PD-1/PD-L1 therapy has become the standard treatment for diverse cancer types as monotherapy or in combination with other anticancer therapies, and its indications are expanding. However, many patients do not benefit from anti-PD-1/PD-L1 therapy due to primary and/or acquired resistance, which is a major obstacle to broadening the clinical applicability of anti-PD-1/PD-L1 therapy. In addition, hyperprogressive disease, an acceleration of tumor growth following anti-PD-1/PD-L1 therapy, has been proposed as a new response pattern associated with deleterious prognosis. Anti-PD-1/PD-L1 therapy can also cause a unique pattern of adverse events termed immune-related adverse events, sometimes leading to treatment discontinuation and fatal outcomes. Investigations have been carried out to predict and monitor treatment outcomes using peripheral blood as an alternative to tissue biopsy. This review summarizes recent studies utilizing peripheral blood immune cells to predict various outcomes in cancer patients treated with anti-PD-1/PD-L1 therapy.

Frailty assessed by the electronic frailty index and its impact on health outcomes in older adults with chronic diseases: a systematic review (전자허약지수(electronic frailty index)를 활용한 만성질환 노인의 허약평가와 건강결과 간의 관계: 체계적 고찰)

  • Jung-Wook Shin;Min-Young Yu;Youn-Jung Son
    • Journal of Korean Biological Nursing Science
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    • v.25 no.4
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    • pp.229-242
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    • 2023
  • Purpose: The electronic frailty index (eFI), which is derived from electronic health records, has been recommended as screening tool for frailty due to its accessibility and ease of use. The objective of this systematic review was to identify the prevalence of frailty assessed by the eFI and its influence on health outcomes in older adults with chronic diseases. Methods: We searched PubMed, Embase, Web of Science, CINAHL, SCOPUS, Cochrane, Google search, and nursing journals in Korean from January 2016 to December 2022. Results: Twelve studies were analyzed. The eFI score, based on routine clinical data, was associated with adverse health outcomes. The most frequent outcome studied was mortality, and the eFI was associated with increased mortality in nine studies. Other outcomes studied included hospitalization, length of stay, readmission, and institutionalization in relation to hospital care usage, and cardiovascular events, stroke, GI bleeding, falls, and instrumental activities of daily life as health conditions. Conclusion: Early identification of frailty in older adults with chronic diseases can decrease the burden of disease and adverse health outcomes. The eFI has a good discriminative capacity to identify frail older adults with chronic diseases.

The Effects of Elderly Frailty on Adverse Outcomes (노인 허약이 부정적 결과요인에 미치는 영향)

  • Lee, Jeong Wook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.8
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    • pp.87-97
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    • 2020
  • The aim of this study was to examine empirically the causal relationship between significant adverse outcomes of elderly frailty. The 2017 National Survey on Old Adults was used to test this, but only nine variables necessary for the hypothesis test were abstracted from it. The results of the hypothesis test are summarized as follows. The sub-variables of adverse outcomes, such as disabilities in daily living activities, disabilities in instrumental daily living activities, and health care utilization, were analyzed empirically by inputting sub-variables of six frailty factors into hierarchical regression analysis. In the final model, the physical activities, emotional control, and social support were verified as significant variables influencing the disabilities in daily living activities. These included the following: physical activities, sensory functions, cognition, emotional control and social support as those influencing disabilities in the instrumental daily living activities; and nutrition, physical activities, sensory functions, emotional control, and social support as those influencing the health care utilization. Based on the results of the hypothesis test, it is necessary to develop and implement personalized health management programs that specifically identify elderly weakness factors that affect adverse outcomes, such as disabilities or health care utilization.

A Study on the Risk Factors for Maternal and Child Health Care Program with Emphasis on Developing the Risk Score System (모자건강관리를 위한 위험요인별 감별평점분류기준 개발에 관한 연구)

  • 이광옥
    • Journal of Korean Academy of Nursing
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    • v.13 no.1
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    • pp.7-21
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    • 1983
  • For the flexible and rational distribution of limited existing health resources based on measurements of individual risk, the socalled Risk Approach is being proposed by the World Health Organization as a managerial tool in maternal and child health care program. This approach, in principle, puts us under the necessity of developing a technique by which we will be able to measure the degree of risk or to discriminate the future outcomes of pregnancy on the basis of prior information obtainable at prenatal care delivery settings. Numerous recent studies have focussed on the identification of relevant risk factors as the Prior infer mation and on defining the adverse outcomes of pregnancy to be dicriminated, and also have tried on how to develope scoring system of risk factors for the quantitative assessment of the factors as the determinant of pregnancy outcomes. Once the scoring system is established the technique of classifying the patients into with normal and with adverse outcomes will be easily de veloped. The scoring system should be developed to meet the following four basic requirements. 1) Easy to construct 2) Easy to use 3) To be theoretically sound 4) To be valid In searching for a feasible methodology which will meet these requirements, the author has attempted to apply the“Likelihood Method”, one of the well known principles in statistical analysis, to develop such scoring system according to the process as follows. Step 1. Classify the patients into four groups: Group $A_1$: With adverse outcomes on fetal (neonatal) side only. Group $A_2$: With adverse outcomes on maternal side only. Group $A_3$: With adverse outcome on both maternal and fetal (neonatal) sides. Group B: With normal outcomes. Step 2. Construct the marginal tabulation on the distribution of risk factors for each group. Step 3. For the calculation of risk score, take logarithmic transformation of relative proport-ions of the distribution and round them off to integers. Step 4. Test the validity of the score chart. h total of 2, 282 maternity records registered during the period of January 1, 1982-December 31, 1982 at Ewha Womans University Hospital were used for this study and the“Questionnaire for Maternity Record for Prenatal and Intrapartum High Risk Screening”developed by the Korean Institute for Population and Health was used to rearrange the information on the records into an easy analytic form. The findings of the study are summarized as follows. 1) The risk score chart constructed on the basis of“Likelihood Method”ispresented in Table 4 in the main text. 2) From the analysis of the risk score chart it was observed that a total of 24 risk factors could be identified as having significant predicting power for the discrimination of pregnancy outcomes into four groups as defined above. They are: (1) age (2) marital status (3) age at first pregnancy (4) medical insurance (5) number of pregnancies (6) history of Cesarean sections (7). number of living child (8) history of premature infants (9) history of over weighted new born (10) history of congenital anomalies (11) history of multiple pregnancies (12) history of abnormal presentation (13) history of obstetric abnormalities (14) past illness (15) hemoglobin level (16) blood pressure (17) heart status (18) general appearance (19) edema status (20) result of abdominal examination (21) cervix status (22) pelvis status (23) chief complaints (24) Reasons for examination 3) The validity of the score chart turned out to be as follows: a) Sensitivity: Group $A_1$: 0.75 Group $A_2$: 0.78 Group $A_3$: 0.92 All combined : 0.85 b) Specificity : 0.68 4) The diagnosabilities of the“score chart”for a set of hypothetical prevalence of adverse outcomes were calculated as follows (the sensitivity“for all combined”was used). Hypothetidal Prevalence : 5% 10% 20% 30% 40% 50% 60% Diagnosability : 12% 23% 40% 53% 64% 75% 80%.

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Outpatient Day-Care Management of Unruptured Intracranial Aneurysm: A Retrospective Cohort Study

  • Dae Chul Suh;Yun Hyeok Choi;Sang Ik Park;Suyoung Yun;So Yeong Jeong;Soo Jeong;Boseong Kwon;Yunsun Song
    • Korean Journal of Radiology
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    • v.23 no.8
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    • pp.828-834
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    • 2022
  • Objective: This study aimed to assess the outcomes of outpatient day-care management of unruptured intracranial aneurysm (UIA), and to present the risks associated with different management strategies by comparing the outcomes and adverse events between outpatient day-care management and management with longer admission periods. Materials and Methods: This retrospective cohort study used prospectively registered data and was approved by a local institutional review board. We enrolled 956 UIAs from 811 consecutive patients (mean age ± standard deviation, 57 ± 10.7 years; male:female = 247:564) from 2017 to 2020. We compared the outcomes after embolization among the different admission-length groups (1, 2, and ≥ 3 days). The outcomes included pre- and post-modified Rankin Scale (mRS) scores and rates of adverse events, cure, recurrence, and reprocedure. Events were defined as any cerebrovascular problems, including minor and major stroke, death, or hemorrhage. Results: The mean admission period was 2 days, and 175 patients (191 aneurysms), 551 patients (664 aneurysms), and 85 patients (101 aneurysms) were discharged on the day of the procedure, day 2, and day 3 or later, respectively. During the mean 17-month follow-up period (range 6-53 months; 2757 patient years), no change in post-mRS was observed compared to pre-mRS in 99.6% of patients. Cure was achieved in 95.6% patients; minimal recurrence that did not require re-procedure occurred in 3.5% patients, and re-procedure was required in 2.3% (22 of 956) patients due to progressive enlargement of the recurrent sac during follow up (mean 17 months, range, 6-53 months). There were eight adverse events (0.8%), including five cerebrovascular (two major stroke, two minor strokes and one transient ischemic stroke), and three non-cerebrovascular events. Statistical comparison between groups with different admission lengths (1, 2, and ≥ 3 days) revealed no difference in the outcomes. Conclusion: This study revealed no difference in outcomes and adverse events according to the admission period, and suggested that UIA could be managed by outpatient day-care embolization.

Outcomes of 1st Remission Induction Chemotherapy in Acute Myeloid Leukemia Cytogenetic Risk Groups

  • Zehra, Samreen;Najam, Rahela;Farzana, Tasneem;Shamsi, Tahir Sultan
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.12
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    • pp.5251-5256
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    • 2016
  • Background: Diagnostic karyotyping analysis is routinely used in acute myeloid leukemia (AML) clinics. Categorization of patients into risk stratified groups (favorable, intermediate and adverse) according to cytogenetic findings can serve as a valuable independent prognostic factor. Method and Material: A retrospective descriptive study was conducted based on the patient records of newly diagnosed non-M3 AML young adult cases undergoing standard 3+7 i.e, Daunorubicin and Ara-C (DA) as remission induction chemotherapy. Diagnostic cytogenetic analysis reports were analyzed to classify the patients into risk stratified groups according to South West Oncology Group criteria and prognostic significance was measured with reference to achievement of haematological remission after 1st induction chemotherapy. Results:A normal karyotype was commonly expressed, found in 47.2% of patients, while 65% (n=39) appeared to have intermediate risk cytogenetics, and 13.3% (n=8) adverse or unclassified findings. Favourable cytogenetics was least frequent in the patient cohort, accounting for only 8.3 % (n=5).The impact of cytogenetic risk groups on achievement of haematological remission was evaluated by applying Pearson Chi-square, and was found to be non-significant (df=12, p=0.256) but when the outcomes of favourable risk groups with intermediate, adverse and unclassified findings compared, results were highly significant (df=6, p=0.000) for each comparison. In patients of the favourable cytogenetic risk group, HR?? was reported in 40% (n=2/5), as compared to 62.2% (n=23/37) in the intermediate cytogenetic risk group, 57.1% (n=4/7) in the adverse cytogenetic risk group and 28.6% (n=2/7) in hte unclassified cytogenetic risk group. Conclusion: Cytogenetic risk stratification for AML cases following criteria provided by international guidelines did not produce conclusive results in our Pakistani patients. However, we cannot preclude an importance as the literature clearly supports the use of pretreatment karyotyping analysis as a significant predictive marker for clinical outcomes. The apparent differences between Pakistani and Western studies indicate an urgent need to develop risk stratification guidelines according to the specific cytogenetic makeup of South Asian populations.

Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study

  • Cho, Soo-Kyung;Kim, Dam;Yoo, Dasomi;Jang, Eun Jin;Jun, Jae-Bum;Sung, Yoon-Kyoung
    • Journal of Ginseng Research
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    • v.42 no.2
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    • pp.144-148
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    • 2018
  • Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG) on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40) treatment or placebo (n = 40) groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). The secondary outcomes were development of adverse events (AEs) and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR $3.5{\pm}1.0$) at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16). Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients.

Direct-to-implant breast reconstruction following nipple-sparing mastectomy: predictive factors of adverse surgical outcomes in Asian patients

  • Su, Chun-Lin;Yang, Jia-Ruei;Kuo, Wen-Ling;Chen, Shin-Cheh;Cheong, David Chon-Fok;Huang, Jung-Ju
    • Archives of Plastic Surgery
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    • v.48 no.5
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    • pp.483-493
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    • 2021
  • Background Direct-to-implant (DTI) breast reconstruction after nipple-sparing mastectomy (NSM) with the use of acellular dermal matrix (ADM) provides reliable outcomes; however, the use of ADM is associated with a higher risk of complications. We analyzed our experiences of post-NSM DTI without ADM and identified the predictive factors of adverse surgical outcomes. Methods Patients who underwent NSM and immediate DTI or two-stage tissue expander (TE) breast reconstruction from 2009 to 2020 were enrolled. Predictors of adverse endpoints were analyzed. Results There were 100 DTI and 29 TE reconstructions. The TE group had a higher rate of postmastectomy radiotherapy (31% vs. 11%; P=0.009), larger specimens (317.37±176.42 g vs. 272.08±126.33 g; P=0.047), larger implants (360.84±85.19 g vs. 298.83±81.13 g; P=0.004) and a higher implant/TE exposure ratio (10.3% vs. 1%; P=0.035). In DTI reconstruction, age over 50 years (odds ratio [OR], 5.43; 95% confidence interval [CI], 1.50-19.74; P=0.010) and a larger mastectomy weight (OR, 1.65; 95% CI, 1.08-2.51; P=0.021) were associated with a higher risk of acute complications. Intraoperative radiotherapy for the nipple-areolar complex increased the risk of acute complications (OR, 4.05; 95% CI, 1.07-15.27; P=0.039) and the likelihood of revision surgery (OR, 5.57; 95% CI, 1.25-24.93; P=0.025). Conclusions Immediate DTI breast reconstruction following NSM is feasible in Asian patients with smaller breasts.

Comparative Analysis of the Seriousness of the Adverse Events and Risk of Targeted Therapy for Metastatic Renal Cell Carcinoma Among Medical Professionals (전이성신세포암 표적치료제의 부작용 심각도 및 위해에 대한 전문가그룹별 비교분석)

  • Park, Mi-Hae;Rhee, Jin-Nie;Lee, Eui-Kyung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.2
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    • pp.100-105
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    • 2011
  • The perception of the 20 adverse events of targeted therapy for metastatic renal cell carcinoma was compared among medical professionals. Thirty-seven oncologists, 167 nurses and 79 pharmacists participated in the survey, and the response rate was 61.9%, 98.2%, 84.9%, respectively. Results showed that the most serious adverse event was GI perforation (8.83 points, 10 being the most serious), whereas the least serious was anemia (5.32 points). There were significant differences among oncologists, nurses and pharmacists especially for the moderately-serious adverse event such as wound-healing complication and lymphopenia. Adverse Events Composite Score (AECS) for each targeted therapy was calculated by multiplying adverse event incidence rate and seriousness score. Sunitinib had the highest score at 6.86 point and bevacizumab had the lowest at 2.1. Among professional groups oncologists showed the lowest AECS, whereas nurses had the highest. The gap on the perception of the adverse events among medical professionals needs to be reduced to get better outcomes of medical therapies for cancer patients.

Evidence for adverse effect of perinatal glucocorticoid use on the developing brain

  • Chang, Young Pyo
    • Clinical and Experimental Pediatrics
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    • v.57 no.3
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    • pp.101-109
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    • 2014
  • The use of glucocorticoids (GCs) in the perinatal period is suspected of being associated with adverse effects on long-term neurodevelopmental outcomes for preterm infants. Repeated administration of antenatal GCs to mothers at risk of preterm birth may adversely affect fetal growth and head circumference. Fetal exposure to excess GCs during critical periods of brain development may profoundly modify the limbic system (primarily the hippocampus), resulting in long-term effects on cognition, behavior, memory, co-ordination of the autonomic nervous system, and regulation of the endocrine system later in adult life. Postnatal GC treatment for chronic lung disease in premature infants, particularly involving the use of dexamethasone, has been shown to induce neurodevelopmental impairment and increases the risk of cerebral palsy. In contrast to studies involving postnatal dexamethasone, long-term follow-up studies for hydrocortisone therapy have not revealed adverse effects on neurodevelopmental outcomes. In experimental studies on animals, GCs has been shown to impair neurogenesis, and induce neuronal apoptosis in the immature brains of newborn animals. A recent study has demonstrated that dexamethasone-induced hypomyelination may result from the apoptotic degeneration of oligodendrocyte progenitors in the immature brain. Thus, based on clinical and experimental studies, there is enough evidence to advice caution regarding the use of GCs in the perinatal period; and moreover, the potential long-term effects of GCs on brain development need to be determined.