• Title/Summary/Keyword: observational clinical study

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Rates and subsequent clinical course of fetal congenital anomalies detected by prenatal targeted ultrasonography of 137 cases over 5 years in a single institute: a retrospective observational study

  • Haewon Choi;Hyo-Shin Kim;Joon Sakong
    • Journal of Yeungnam Medical Science
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    • v.40 no.3
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    • pp.268-275
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    • 2023
  • Background: With the establishment of international guidelines and changes in insurance policies in Korea, the role of targeted ultrasonography has increased. This study aimed to identify the rates and clinical course of anomalies detected using prenatal targeted ultrasonography. Methods: This study was a retrospective analysis of all pregnancies with targeted ultrasonography performed in a single secondary medical center over 5 years. Results: Fetal anomalies were detected by targeted ultrasonography in 137 of the 8,147 cases (1.7%). The rates of anomalies were significantly higher in female fetuses (2.0% vs. 1.3%). In cases of female fetuses, the rate of anomalies was significantly higher in the advanced maternal age group (2.4% vs. 1.2%). In cases of male fetuses, the rate of anomalies was significantly higher in nulliparous (2.4% vs. 1.5%) and twin (5.7% vs. 1.9%) pregnancies. Pulmonary anomalies were significantly more common in the multiparity group (17.6% vs. 5.8%). Among the 137 cases, 17.5% terminated the pregnancy, 16.8% were diagnosed as normal after birth, and 42.3% were diagnosed with anomalies after birth or required follow-up. Conclusion: Through the first study on the rates and clinical course of anomalies detected by targeted ultrasonography at a single secondary center in Korea, we found that artificial abortions were performed at a high rate, even for relatively mild anomalies or anomalies with good prognosis. We suggest the necessity of a nationwide study to establish clinical guidelines based on actual incidences or prognoses.

An analysis of the causes of prehospital delays in patients with suspected acute stroke (급성 뇌졸중 의심 환자의 병원 전 지연 원인 분석)

  • Lee, Nam-Jin;Moon, Jun-Dong
    • The Korean Journal of Emergency Medical Services
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    • v.24 no.2
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    • pp.27-38
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    • 2020
  • Purpose: Stroke is a time-sensitive disease that could have reduced complications and mortality with timely diagnosis and treatment. This study aimed to analyze the causes of delay in detecting the clinical signs and symptoms of stroke. Methods: This retrospective observational study analyzed the emergency medical services reports of suspected stroke patients with positive predictive values on the Cincinnati Prehospital Stroke Scale. The study was conducted in Daejeon, Republic of Korea from January 1, 2016 through December 31, 2017. Results: Prolonged prehospital time was associated with high blood pressure, history of cerebrovascular disease, and incidences during daily activities, and sleep. High blood pressure and complications from a previous stroke strongly associated with the prolonged stroke-detection phase (p<.05). Total prehospital time was shortened when patients had evident stroke symptoms, such as decreased level of consciousness, dysarthria, and hemiplegia (p<.05). There was no significant difference in gender or age as a factor that delayed the total prehospital time of the suspected stroke patients. Conclusion: Many patients did not recognize the early clinical symptoms and signs of a stroke. Furthermore, risk factors, such as high blood pressure and history of stroke, prolonged the total prehospital time. Therefore, we need targeted interventions that educate about warning symptoms of stroke, along with emphasis on the importance of emergency calls to substantially reduce the prehospital delays.

Bone-level implants placed in the anterior maxilla: an open-label, single-arm observational study

  • Gao, EnFeng;Hei, Wei-Hong;Park, Jong-Chul;Pang, KangMi;Kim, Sun Kyung;Kim, Bongju;Kim, Soung-Min;Lee, Jong-Ho
    • Journal of Periodontal and Implant Science
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    • v.47 no.5
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    • pp.312-327
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    • 2017
  • Purpose: This study assessed marginal bone remodeling and soft tissue esthetics after the loading of single bone-level implants in the anterior maxilla. Methods: An open, single-arm observational clinical trial with 3 years of follow-up was performed, including 22 implants. The patients presented with a single tooth gap in the anterior maxilla (tooth positions 14-24), with natural or restored adjacent teeth. An implant was placed at least 8 weeks post-extraction and healed submerged for 6 weeks. After the second-stage operation, a fixed provisional prosthesis was provided. The final restoration was placed 6 months after the provisional restoration. The time of the provisional crown connection was considered to be the baseline in this study. Esthetic parameters and the marginal bone level were assessed at 6, 12, 24, and 36 months. Results: All implants were well integrated in the bone. A statistically significant increase was found in the mean implant stability quotient between the time of the provisional prosthesis and the time of the final prosthesis. Most implants (95.5%) revealed marginal bone resorption (<0.5 mm), and just 1 implant (4.5%) showed a change of 2.12 mm from baseline to 36 months (mean $0.07{\pm}0.48mm$), while the crestal bone level decreased significantly, from $2.34{\pm}0.93mm$ at baseline to $1.70{\pm}1.10mm$ at 36 months. The facial gingival margin and papilla were stable and the esthetic scores indicated high patient and dentist satisfaction. Conclusions: Platform-switching bone-level implants placed in maxillary single-tooth gaps resulted in successful osseointegration with minimal marginal bone resorption. The peri-implant soft tissue was also esthetically satisfying and stable.

Clinical Features of Acute Acetanilide Herbicide Poisoning (급성 아세트아닐라이드계 제초제 중독의 임상 분석)

  • Park, Cheol-Sang;Lee, Mi-Jin;Park, Seong-Soo;Jeong, Won-Joon;Kim, Hyun-Jin
    • Journal of The Korean Society of Clinical Toxicology
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    • v.9 no.2
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    • pp.49-55
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    • 2011
  • Purpose: Acetanilide has been in widespread use as an amide herbicide compound. However, available data regarding acute human poisoning is scarce. The aim of this study was to analyze the clinical characteristics of acetanilide poisoning in order to identify the risk factors associated with severity. Methods: We conducted a retrospective observational study encompassing the period January 2005 to December 2010, including adult ED patients suffering from acetanilide intoxication. Toxicological history, symptoms observed, clinical signs of toxicity, and laboratory test results were collected for each patient. The patients were classified into two groups for analysis, according their poisoning severity score (PSS). Resulting clinical data and prognostic variables were compared between mild-to-moderate poisoning (PSS 1/2 grades), and severe poisonings and fatalities (PSS 3/4 grades). Results: There were a total of 37 patients, including 26 alachlor, 6 s-metolachlor, 4 mefenacet, and 1 butachlor cases. The majority of patients (81.1%) were assigned PSS 1/2 grades. Changes in mental status and observation of adverse neurologic symptoms were more common in the PSS 3/4 group. The median ingested volume of amide herbicide compound was 250 ml (IQR 200-300 ml) in the PSS 3/4 group, and 80 ml (IQR 50-138 ml) in the PSS 1/2 group. Also, the median GCS observed in the PSS 3/4 group was 13 (IQR 10-14), which was markedly low as compared to a median GCS of 15 in the PSS 1/2 group. Overall mortality rate was 5.4%, and profound cardiogenic shock was observed prior to death in all fatalities. Conclusion: When compared to previous reports, acute acetanilide poisoning resulted in relatively moderate severity. The presence of neurologic manifestations, hypotension, lower GCS score, and larger ingested volumes was associated with more serious effects and mortalities.

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Review of the Large-Scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC (2000년부터 독일에서 수행된 대규모 침 임상연구들에 대한 고찰: ASH, ART, ARC, GERAC)

  • Yoon, Juyeon;Han, Kuk-In;Jeong, Jinsu;Lee, Seungho;Jang, Insoo
    • Korean Journal of Acupuncture
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    • v.30 no.1
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    • pp.21-26
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    • 2013
  • Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

Clinical spectrum and short-term outcomes of multisystem inflammatory syndrome in children in a south Indian hospital

  • Balagurunathan, Muruganantham;Natarajan, Thrilok;Karthikeyan, Jothilakshmi;Palanisamy, Venkateshwaran
    • Clinical and Experimental Pediatrics
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    • v.64 no.10
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    • pp.531-537
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    • 2021
  • Background: Multisystem inflammatory syndrome in children (MIS-C) is a new hyperinflammatory variant that evolved during the coronavirus disease 2019 pandemic. Although the precise pathophysiology of MIS-C is uncertain, it is thought to be due to immune dysregulation occurring after recovery from acute infection. Purpose: Our study aimed to analyze the clinical spectrum, laboratory parameters, imaging characteristics, treatment strategies, and short-term outcomes of children with a diagnosis of MIS-C. Methods: This retrospective and prospective observational study included children less than 16 years of age who were admitted to the pediatric unit of a tertiary care teaching hospital in south India between August 2020 to January 2021 with a diagnosis of MIS-C according to World Health Organization criteria. Results: Twenty-one children were included in the analysis; all had fever with variable combinations of other symptoms. The mean age was 6.9 years; 71.4% were male. Gastrointestinal (80.9%) and cardiovascular (80.9%) systems were the most commonly affected. The majority of children had elevated inflammatory markers, and 16 (76.2%) had echocardiographic abnormalities mimicking Kawasaki disease. Eleven children (52.4%) required intensive care admission, 3 (14.3%) required supplemental oxygen, and 4 (19%) required inotropes. Nine (42.9%) were treated with intravenous immunoglobulin alone, 6 (28.6%) with steroids alone, and 3 (14.3%) with steroids and immunoglobulin. The median hospital stay was 6 days; there were no fatalities. Overweight/obesity, elevated ferritin, and mucocutaneous involvement were significantly associated with a prolonged hospital stay (≥7 days). Sixteen children (76.2%) were followed up till now and all of them had no clinical concerns. Conclusion: MIS-C is an emerging disease with variable presentation. A high index of suspicion is necessary for its early identification and appropriate management. Further research is essential for developing optimal treatment strategies.

A Retrospective Observational Study on the Emotional Characteristics of Hwa-Byung Inpatients in a Korean Medicine Hospital Using the Core Seven-Emotions Inventory-Short Form (한방병원에 입원한 화병 환자의 정서적 특성에 대한 핵심칠정척도 단축형을 활용한 후향적 관찰연구)

  • Kim, Ju Yeon;Kang, Dong Hoon;Kang, Hyung-Won;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.1
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    • pp.1-19
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    • 2022
  • Objectives: The objective of this study was to confirm the Chiljeong (七情) characteristics of Hwa-byung patients using the core seven-emotions inventory-short form. Methods: We conducted a retrospective observational study based on the electronic medical records from a Korean medicine hospital. We included patients who were diagnosed with Hwa-byung and examined with Core Seven-Emotions Inventory-short Form (CSEI-S) during hospitalization periods. We presented the characteristics of Hwa-byung by demographic information, CSEI-S, Hwa-byung scale, and Korean Symptom Checklist 95. A correlation analysis was performed between CSEI-S and other clinical and psychological characteristics. Results: The Chiljeong characteristics of Hwa-byung were high in the order of Sorrow (悲), Thought (思), Fear (恐), Fright (驚), Depression (憂), Joy (喜), and Anger (怒). There was no significant difference between each emotion. After combined Korean medical treatment, Sorrow (悲) and Thought (思) significantly decreased. There were static correlations between sorrow (悲) and fright (驚), thought (思) and sorrow (悲), depression (憂) and sorrow (悲), depression (憂) and fright (驚), thought (思) and depression (憂), fear (恐) and fright (驚), anger (怒) and thought (思), thought (思) and fright (驚), sorrow (悲) and fear (恐). Sorrow (悲) and Hwa-byung characteristics scale showed static correlation. Joy (喜) showed a static correlation with disharmony between the heart and kidney scores of the Hwa-byung pattern identification. Between KSCL-95 and CSEI-S, static correlation appeared in depression (憂) with depression, anxiety, and sleep problem scale, sorrow (悲) with depression and anxiety, fright (驚) with depression and obsessive symptoms. Conclusions: Despite several limitations due to the study design and small sample size, this research successfully used CSEI-S to study the Chiljeong (七情) characteristics of Hwa-byung for the first time.

Review of Economic Evaluation Studies for Drug Reimbursement Decision (의약품 보험급여 결정을 위한 경제성평가 연구의 평가)

  • Choi Sang-Eun;Sullivan Sean D.
    • Health Policy and Management
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    • v.15 no.4
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    • pp.1-25
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    • 2005
  • Legislation on pharmaceutical reimbursement decision using economic evaluation results was made in Korea in fm, but has yet to be fully implemented. We evaluated the quality of Korean economic evaluation studies of pharmaceuticals to understand gaps between legislation and implementation. From this evaluation, we propose policy options that might strengthen the research Infrastructure In order to support such studies. We reviewed 23 published studies for drugs conducted between 1996 and 2004. Evaluation criteria included methodological characteristics, healthcare system characteristics, population characteristics, and applicability of results. Large variation in study quality was observed, particularly with study design, outcome data, treatment patterns and interpretation. Korean clinical data used was mostly from observational studies of 1-2 hospitals. Foreign data was extracted from clinical trials that did not Include Asian population and their selection criterion was not clarified. With respect to treatment patterns, medical records and hospital bills were used without adjustment regarding area, hospital type, and others. And next frequent situation relied on expert opinion from academic physicians in specialty practice. preference measures, when used, were not elicited from the Korean population. $78.3\%$ of studies did not clarify the funding source. If the Korean economic evaluation policy is to provide meaningful data for decision makers, the quality of cost-effectiveness studies will need to improve dramatically. This may involve access to or creation of better data, more diverse funding, unproved training of researchers and evaluators, and partnerships with technology manufacturers.

The Impact of Mechanical Ventilation Duration on the Readmission to Intensive Care Unit: A Population-Based Observational Study

  • Lee, Hyun Woo;Cho, Young-Jae
    • Tuberculosis and Respiratory Diseases
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    • v.83 no.4
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    • pp.303-311
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    • 2020
  • Background: If the duration of mechanical ventilation (MV) is related with the intensive care unit (ICU) readmission must be clarified. The purpose of this study was to elucidate if prolonged MV duration increases ICU readmission rate. Methods: The present observational cohort study analyzed national healthcare claims data from 2006 to 2015. Critically ill patients who received MV in the ICU were classified into five groups according to the MV duration: MV for <7 days, 7-13 days, 14-20 days, 21-27 days, and ≥28 days. The rate and risk of the ICU readmission were estimated according to the MV duration using the unadjusted and adjusted analyses. Results: We found that 12,929 patients had at least one episode of MV in the ICU. There was a significant linear relationship between the MV duration and the ICU readmission (R2=0.85, p=0.025). The total readmission rate was significantly higher as the MV duration is prolonged (MV for <7 days, 13.9%; for 7-13 days, 16.7%; for 14-20 days, 19.4%; for 21-27 days, 20.4%; for ≥28 days, 35.7%; p<0.001). The analyses adjusted by covariables and weighted with the multinomial propensity scores showed similar results. In the adjusted regression analysis with a Cox proportional hazards model, the MV duration was significantly related to the ICU readmission (hazard ratio, 1.058 [95% confidence interval, 1.047-1.069], p<0.001). Conclusion: The rate of readmission to the ICU was significantly higher in patients who received longer durations of the MV in the ICU. In the clinical setting, closer observation of patients discharged from the ICU after prolonged periods of MV is required.

Sevoflurane with opioid or dexmedetomidine infusions in dogs undergoing intracranial surgery: a retrospective observational study

  • Marquez-Grados, Felipe;Vettorato, Enzo;Corletto, Federico
    • Journal of Veterinary Science
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    • v.21 no.1
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    • pp.8.1-8.11
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    • 2020
  • This study reports the clinical use of two sevoflurane-based anesthetic techniques in dogs undergoing craniectomy. Twenty-one animals undergoing elective rostrotentorial or transfrontal craniectomy for brain tumor excision, anesthetized with sevoflurane, were enrolled in this retrospective, observational study. Anesthetic records were allocated to two groups: Sevo-Op (sevoflurane and short acting opioid infusion): 8 dogs and Sevo-Dex (sevoflurane and dexmedetomidine infusion): 13 dogs. Average mean arterial pressure (MAP), heart rate, end-tidal carbon dioxide, end-tidal sevoflurane and intraoperative infusion rates during surgery were calculated. Presence of intra-operative and post-operative bradycardia, tachycardia, hypotension, hypertension, hypothermia, hyperthermia was recorded. Time to endotracheal extubation, intraoperative occurrence of atrioventricular block, postoperative presence of agitation, seizures, use of labetalol and dexmedetomidine infusion were also recorded. Data from the two groups were compared with Fisher's exact test and unpaired t tests with Welch's correction. Odds ratio (OR) and 95% confidence interval (CI) were calculated for categorical variables. Intra-operatively, MAP was lower in Sevo-Op [85 (± 6.54) vs. 97.69 (± 7.8) mmHg, p = 0.0009]. Time to extubation was longer in Sevo-Dex [37.69 (10-70) vs. 19.63 (10-25), p = 0.0033]. No differences were found for the other intra-operative and post-operative variables investigated. Post-operative hypertension and agitation were the most common complications (11 and 12 out of 21 animals, respectively). These results suggest that the infusion of dexmedetomidine provides similar intra-operative conditions and post-operative course to a short acting opioid infusion during sevoflurane anesthesia in dogs undergoing elective rostrotentorial or transfrontal intracranial surgery.