• Title/Summary/Keyword: Non-clinical outcomes

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Clinical Analysis of Traumatic Pancreatic Injury (개복 수술로 확인된 외상성 췌장 손상 환자에 대한 임상적 고찰)

  • HwangBo, Seon-Mi;Kwon, Young-Bong;Yun, Kyung-Jin;Kwon, Hyung-Jun;Chun, Jae-Min;Kim, Sang-Geol;Park, Jin-Young;Hwang, Yun-Jin;Yun, Young-Gook
    • Journal of Trauma and Injury
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    • v.24 no.2
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    • pp.68-74
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    • 2011
  • Purpose: Although pancreas injury is rare in abdominal trauma, it poses a challenge to the surgeon because its clinical features are not prominent and the presence of main duct injury cannot be easily identified by imaging studies. Furthermore, severe pancreas injuries require a distal pancreatectomy or a pancreaticoduodnectomy which are associated considerable morbidity and mortality. We reviewed the clinical features of and outcomes for patients with pancreas injury. Methods: For 10 years from Jan. 2001 to Dec. 2010, thirty-four patients were diagnosed as having pancreas injury by using an explo-laparotomy. Patients successfully treated by non-operative management were excluded. Patients were divided into early (n=18) and delayed surgery groups (n=11) based on an interval of 24hours between injury and surgery. The clinical features of and the outcomes for the patients in both groups were compared. Results: Males were more commonly injured (82.4% vs.17.6%). The mean age was 37.2 years. The injury mechanisms included vehicle accidents (62.9%, 22/34), assaults (20%, 7/34), and falls (11.4%, 3/34). The head and neck of the pancreas was most commonly injured, followed by the body and the tail (16, 12, and 6 cases).Of the 34 patients, 26 (76.5%) patients had accompanying injuries. Grade 1 and 2 occurred in 14 (5 and 9) patients, and grade 3, 4, and 5 occurred in 20 (16, 3, and 1) patients. The early and delayed surgery groups showed no difference in surgical outcomes. Two patients with grade 3 in the early surgery group died after surgery,one due to massive hemorrhage and the other due to septic shock. Of the five patients initially managed non-operatively, three developed peripancreatic necrosis and two developed pseudocyst. All five patients were successfully cured by surgery. Conclusion: All cases of pancreas injury in this study involved blunt injury, and accompanying injury to major vessels or the bowel was the major cause of mortality. Surgery delayed for longer than 24 hours after was not associated with adverse outcomes.

An R package UnifiedDoseFinding for continuous and ordinal outcomes in Phase I dose-finding trials

  • Pan, Haitao;Mu, Rongji;Hsu, Chia-Wei;Zhou, Shouhao
    • Communications for Statistical Applications and Methods
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    • v.29 no.4
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    • pp.421-439
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    • 2022
  • Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan et al. (2007) and Pan et al. (2014), gBOIN design by Mu et al. (2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next that determines the dose for the next cohort of patients, select, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.

Clinical Characteristics, Risk Factors, and Outcomes of Acute Pulmonary Embolism in Thailand: 6-Year Retrospective Study

  • Pattarin Pirompanich;Ornnicha Sathitakorn;Teeraphan Suppakomonnun;Tunlanut Sapankaew
    • Tuberculosis and Respiratory Diseases
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    • v.87 no.3
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    • pp.349-356
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    • 2024
  • Background: Acute pulmonary embolism (APE) is a fatal disease with varying clinical characteristics and imaging. The aim of this study was to define the clinical characteristics, risk factors, and outcomes in patients with APE at a university hospital in Thailand. Methods: Patients diagnosed with APE and admitted to our institute between January 1, 2017 and December 31, 2022 were retrospectively enrolled. The clinical characteristics, investigations, and outcomes were recorded. Results: Over the 6-year study period, 369 patients were diagnosed with APE. The mean age was 65 years; 64.2% were female. The most common risk factor for APE was malignancy (46.1%). In-hospital mortality rate was 23.6%. The computed tomography pulmonary artery revealed the most proximal clots largely in segmental pulmonary artery (39.0%), followed by main pulmonary artery (36.3%). This distribution was consistent between survivors and non-survivors. Multivariate logistic regression analysis revealed that APE mortality was associated with active malignancy, higher serum creatinine, lower body mass index (BMI), and tachycardia with adjusted odds ratio (95% confidence interval [CI]) of 3.70 (1.59 to 8.58), 3.54 (1.35 to 9.25), 2.91 (1.26 to 6.75), and 2.54 (1.14 to 5.64), respectively. The prediction model was constructed with area under the curve of 0.77 (95% CI, 0.70 to 0.84). Conclusion: The overall mortality rate among APE patients was 23.6%, with APE-related death accounting for 5.1%. APE mortality was associated with active malignancy, higher serum creatinine, lower BMI, and tachycardia.

Hospital-Acquired Pressure Injury: Clinical Characteristics and Outcomes in Critical Care

  • Hyun, Sookyung;Moffatt-Bruce, Susan;Newton, Cheryl;Hixon, Brenda
    • International Journal of Advanced Culture Technology
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    • v.7 no.2
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    • pp.28-33
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    • 2019
  • Electronic health records (EHRs) enable us to use and re-use electronic data for various multiple purposes, such as public reporting, quality improvement, and patient outcomes research. Current hospital-acquired pressure injury (HAPI) risk assessment instruments have not been specifically developed for intensive care unit (ICU) patients and showed false positive rates in this specific populations. Previous research studies report a number of risk factors; however, it is still not clear what factors influence ICU HAPI in this population. As part of a larger research study, we performed an exploratory analysis by using a large electronic health record data. The aims of this study were to compare characteristics of patients who developed HAPIs during their ICU stay with those who did not, and to determine whether the two groups were different in the aspects of length of ICU stay, discharge disposition, and discharge destinations. We conducted chi-square test and t-test for group comparison. Association was examined by using bivariate analyses. Pearson correlation coefficients were used to examine correlation between LOS and number of medications. Our findings suggest a number of consistent and potentially modifiable risk factors, such as sedation, feeding tubes, and the number of medications administered. The mortality of the HAPI group was significantly higher than the non-HAPI group in our data. Discharge disposition was significantly different between the groups. 67% of the HAPI group transferred to intermediate or long-term care hospitals whereas 57.7% of the non-HAPI group went home after discharge. Awareness of these risk factors can lead to clinical interventions that can be preventative in the ICU setting.

Usefulness of Shock Index to Predict Outcomes of Trauma Patient: A Retrospective Cohort Study

  • Kim, Myoung Jun;Park, Jung Yun;Kim, Mi Kyoung;Lee, Jae Gil
    • Journal of Trauma and Injury
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    • v.32 no.1
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    • pp.17-25
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    • 2019
  • Purpose: We investigated how prehospital, emergency room (ER), and delta shock indices (SI) correlate with outcomes including mortality in patients with polytrauma. Methods: We retrospectively reviewed the medical records of 1,275 patients who visited the emergency department from January 2015 to April 2018. A total of 628 patients were enrolled in the study. Patients were divided into survivor and non-survivor groups, and logistic regression analysis was used to investigate independent risk factors for death. Pearson coefficient analysis and chi-square test were used to examine the significant relationship between SI and clinical progression markers. Results: Of 628 enrolled patients, 608 survived and 27 died. Multivariate logistic regression analysis reveals "age" (p<0.001; OR, 1.068), "pre-hospital SI >0.9" (p<0.001; OR, 11.629), and "delta SI ${\geq}0.3$" (p<0.001; OR, 12.869) as independent risk factors for mortality. Prehospital and ER SIs showed a significant correlation with hospital and intensive care unit length of stay and transfusion amount. Higher prehospital and ER SIs (>0.9) were associated with poor clinical progression. Conclusions: SI and delta SI are significant predictors of mortality in patients with polytrauma. Moreover, both prehospital and ER SIs can be used as predictive markers of clinical progression in these patients.

Uropathogenic Escherichia coli ST131 in urinary tract infections in children

  • Yun, Ki Wook;Lee, Mi-Kyung;Kim, Wonyong;Lim, In Seok
    • Clinical and Experimental Pediatrics
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    • v.60 no.7
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    • pp.221-226
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    • 2017
  • Purpose: Escherichia coli sequence type (ST) 131, a multidrug-resistant clone causing extraintestinal infections, has rapidly become prevalent worldwide. However, the epidemiological and clinical features of pediatric infections are poorly understood. We aimed to explore the characteristics of ST131 Escherichia coli isolated from Korean children with urinary tract infections. Methods: We examined 114 uropathogenic E. coli (UPEC) isolates from children hospitalized at Chung-Ang University Hospital between 2011 and 2014. Bacterial strains were classified into STs by partial sequencing of seven housekeeping genes (adk, fumC, gyrB, icd, mdh, purA, and recA). Clinical characteristics and antimicrobial susceptibility were compared between ST131 and non-ST131 UPEC isolates. Results: Sixteen UPEC isolates (14.0%) were extended-spectrum ${\beta}-lactamase$ (ESBL)-producers; 50.0% of ESBL-producers were ST131 isolates. Of all the isolates tested, 13.2% (15 of 114) were classified as ST131. There were no statistically significant associations between ST131 and age, sex, or clinical characteristics, including fever, white blood cell counts in urine and serum, C-reactive protein, radiologic abnormalities, and clinical outcome. However, ST131 isolates showed significantly lower rates of susceptibility to cefazolin (26.7%), cefotaxime (40.0%), cefepime (40.0%), and ciprofloxacin (53.3%) than non-ST131 isolates (65.7%, 91.9%, 92.9%, and 87.9%, respectively; P<0.001 for all). ESBL was more frequently produced in ST131 (53.3%) than in non-ST131 (8.1%) isolates (P<0.01). Conclusion: ST131 E. coli isolates were prevalent uropathogens in children at a single medical center in Korea between 2011 and 2014. Although ST131 isolates showed higher rates of antimicrobial resistance, clinical presentation and outcomes of patients were similar to those of patients infected with non-ST131 isolates.

Evauation of Injury Mechanism and Clinical Outcome Between Non-Traumatic and Traumatic Type II Slap Lesions (제 2형 SLAP 병변의 외상 유무에 따른 손상 기전 및 치료 결과의 분석)

  • Kim, Yong-Ju;Jeong, Hoon;Ha, Jong-Kyoung;Lee, Kwan-Hee;Choi, Sung-Hyun
    • Clinics in Shoulder and Elbow
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    • v.13 no.2
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    • pp.244-249
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    • 2010
  • Purpose: Our goal of this study was to compare the mechanism of injury and the clinical outcomes between the non-traumatic and traumatic type II SLAP lesions. Materials and Methods: From January 2007 to May 2009, the sunjects of this study were 27 patients who had undergone operations for isolated type II SLAP lesions. The lesions were classified according to Burkhart's method. The lesions that were located on the anterior-superior labrum were classified as type I, those lesions located on the posterior-superior labrum were classified as type II and those lesions located on the anterior-posterior labrum were classified as type III. The clinical outcomes were evaluated by the UCLA score and the KSS score preoperatively and postoperatively. Results: Of the 27 cases, 16 cases were traumatic and eleven cases were non-traumatic. In the traumatic group, there were 12, 2 and 2 cases of type I, type II and type III, respectively (p=0.013). In non-traumatic group, there were 2, 6 and 3 cases of type I, type II and type III (p=0.026). Anterior lesions were more frequent in the traumatic group and posterior lesions were more frequent in the non-traumatic group. For the clinical outcomes, the mean preoperative UCLA score and KSS score were 18 (range: 14~23) and 48 (range: 32~76), respectively, and the postoperative UCLA score and KSS score were 32 (range: 28~33) and 86 (range: 71~92), respectively, in the traumatic group, and the preoperative UCLA score and KSS score were 21 (18~25) and 58 (41~68), respectively, and the postoperative UCLA score and KSS score were 29 (26~31) and 81 (68~89), respectively in the non-traumatic group. There was no significant statistical difference of clinical outcomes between the two groups (p=0.317, 0.405). Conclusion: In this study, the anatomical feature of type II SLAP lesion was associated with a trauma mechanism. Therefore, a trauma mechanism must be considered when planning the surgical treatment for type II SLAP lesions.

Spin in Randomised Clinical Trial Reports of Interventions for Obesity (비만 중재 관련 무작위배정 비교임상연구 보고의 spin 연구)

  • Lee, Sle;Won, Jiyoon;Kim, Seoyeon;Park, Su Jeong;Lee, Hyangsook
    • Korean Journal of Acupuncture
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    • v.34 no.4
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    • pp.251-264
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    • 2017
  • Objectives : To identify the prevalence and types of spin in randomised controlled trials(RCTs) of obesity with statistically non-significant results for primary outcomes to provide adequate reporting directions. Methods : Spin is specific reporting strategy that could lead the readers to misinterpret the results of RCTs. RCTs on obesity with statistically non-significant primary outcomes published from July 2015 to June 2016 were retrieved from PubMed. All included RCTs were classified into 3 intervention categories. The identification and classification of spin in the included articles was performed by two independent researchers. Results : Among 46 RCTs with statistically non-significant primary outcomes, 32 studies were assessed as having at least one spin in title, abstract or main text. Of these, 9 articles were on complementary and alternative medicine, 7 on western medicine and 16 on dietary supplement and exercise. The frequency of spin among the types of interventions was similar. The most common type of spin was 'focusing on statistical significance within-group comparison' in results section of abstract and main text, and 'focusing only on treatment effectiveness with no consideration of statistical significance' in conclusion section of abstract and main text. Studies where random sequence generation was appropriately done was less likely to have spin. Conclusions : As a majority of obesity RCTs have spin, researchers should pay more attention to adequately interpreting and reporting statistically non-significant results.

Anorexigenic peptide (leptin, obestatin, nesfatin-1) levels and their impact on assisted reproductive technology treatment outcomes in patients with polycystic ovary syndrome

  • Varli, Bulut;Sukur, Yavuz Emre;Ozmen, Batuhan;Erguder, Berrin Imge;Sonmezer, Murat;Berker, Bulent;Atabekoglu, Cem;Aytac, Rusen
    • Clinical and Experimental Reproductive Medicine
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    • v.48 no.4
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    • pp.368-373
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    • 2021
  • Objective: In this study we aimed to assess anorexigenic peptide levels in patients with or without polycystic ovary syndrome (PCOS) and their effects on assisted reproductive treatment (ART) outcomes. Methods: A prospective case-control study was conducted in a tertiary care university-based ART clinic. Eighty-three patients were included in the study. The PCOS group included 41 patients, and the non-PCOS group included 42 controls. The 2003 Rotterdam criteria were used for PCOS patient selection. The ART indications in the non-PCOS group were tubal factor or unexplained infertility. Venous blood samples were taken on the third day of the menstrual cycle to determine the serum anorexigenic peptide levels. The enzyme-linked immunosorbent assay method was used for laboratory analyses. Results: In the PCOS group, serum obestatin levels were significantly lower than in the control group, but serum anorexigenic peptide levels were similar in PCOS patients with or without clinical pregnancy. Ovarian hyperstimulation syndrome (OHSS) was diagnosed only in PCOS patients, and the obestatin levels of OHSS patients were significantly lower than those of other PCOS patients. Conclusion: Baseline anorexigenic peptide levels did not affect the clinical pregnancy rate in ART cycles. Obestatin may play a role in the pathophysiology of OHSS. This possibility should be confirmed in further research.

Management of Chronic Kidney Disease-Mineral Bone Disorder with Sevelamer Hcl Phosphate Binder in Korean Patients with Dialysis (Sevelamer 인결합제와 투석환자의 Chronic Kidney Disease-Mineral Bone Disorder 관리)

  • Shin, Seung Woo;Sin, Hye Yeon
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.97-106
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    • 2016
  • Background: Sevelamer is associated with reduced complications of chronic kidney disease-mineral bone disorder (CKD-MBD) resulted from hyperphosphatemia, which may contribute mortality, in CKD patients with dialysis. So far clinical outcomes of sevelamer on mortality and risk of cardiovascular mortality related to CKD-MBD are debating. Purpose of this study was to evaluate the effectiveness of sevelamer HCl on mortality of secondary hyperparathyroidism (SHPT), risk of cardiovascular mortality and, frequency of osteopathy in end stage renal disease (ESRD) patients with dialysis. Methods: We retrospectively reviewed the electronic medical records of 536 patients with ESRD, who were admitted for moderate to severe SHPT, for 36 months. 75 patients who met inclusion criteria were evaluated for the efficacy of sevelamer (mean serum iPTH = 487.5 pg/mL). Results: Sevelamer intervention was not associated with increased three-year survival time compared with non-sevelamers group [average survival month: 30.4 months in sevelamer group, 26.8 months in non-sevelamer group, p = 0.463]. Sevelamer intervention was not associated with significant mortality benefit and cardiovascular mortality benefit as compared to non-sevelamer group [sevelamer group: non-sevelamer group, all-cause mortality (iPTH > 600 pg/mL): 14.3% (1/34): 20% (1/41) p = 0.962, OR = 0.935, 95% CI, 0.058-14.98, heart disease mortality: 6.67% (2/30): 0% (0/32) p = 0.138]. Sevelamer was not associated with significantly lower cumulative incidence of osteopathy compared to non-sevelamer group (sevelamer group: non-sevelamer group, 5.9% (2/34):9.8% (4/41); p = 0.538; OR = 0.578; 95% CI, 0.099-3.367). Conclusion: Sevelamer was not associated with decreased all-cause mortality and risk of cardiovascular mortality compared to non-sevelamer group in ESRD patients with SHPT.