• Title/Summary/Keyword: observational clinical study

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Pharmaceutical Drug Poisoning after Deregulation of Over the Counter Drug Sales: Emergency Department Based In-depth Injury Surveillance (편의점 안전상비의약품 판매 허용 이후 치료 약물 중독)

  • Kim, Sung Ho;Kim, Hyunjong;Lee, Ji Sook;Park, Junseok;Kim, Kyung Hwan;Shin, Dong Wun;Kim, Hoon;Park, Joon Min;Jeon, Woochan
    • Journal of The Korean Society of Clinical Toxicology
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    • v.16 no.2
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    • pp.141-148
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    • 2018
  • Purpose: The Korean government approved selected nonprescription drugs (Over-The-Counter drug; OTC drug) to be distributed in convenience stores from 15. Nov. 2012. This study examined the changes in the incidence and the clinical outcome of acute pharmaceutical drug poisoning after the deregulation of OTC drug sales. Methods: This study analyzed the data of Emergency Department based Injury In-depth Injury Surveillance (EDIIS), Korea Centers for Disease Control and Prevention, from 2011 to 2014. The following items were examined: age, gender, intention, alcohol association, pharmaceutical drugs resulting acute poisoning, the clinical outcomes in emergency department, and the admission rate of intensive care unit (ICU). This is a retrospective cross section observational study. Results: A total of 10,162 patients were subject to pharmaceutical drug poisoning. Acute poisoning by acetaminophen and other drugs were 1,015 (10.0%) and 9,147 (90.0%) patients, respectively. After the deregulation of OTC drug sales, acute poisoning by other drugs increased from 4,385 to 4,762 patients but acute poisoning by acetaminophen decreased from 538 to 477 patients (p<0.05). The rate of admission of acetaminophen poisoning increased from 36.1% (194/538) to 46.8% (223/477). The admission rate to the ICU by acetaminophen poisoning increased from 4.6% (25/538) to 11.3% (54/477) after the deregulation of OTC drug sales (p<0.05). Conclusion: Since the deregulation of OTC drugs sales, pharmaceutical drug poisoning has increased but acetaminophen poisoning has decreased. The rate of hospitalization and ICU admission by pharmaceutical drug poisoning with or without acetaminophen has also increased.

Medical Students Understanding of The Scope of Plastic Surgery

  • Mohammad K.H.B. Abdulaziz;Mohammad Al-Jamali;Sundus Al-Mazidi;Sarah Albuloushi;Ahmad B. Al-Ali
    • Archives of Plastic Surgery
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    • v.51 no.2
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    • pp.251-257
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    • 2024
  • Background Plastic surgery has developed to benefit in a variety of challenging areas formerly handled by other disciplines. Medical students do not have a clear picture of plastic surgery as a career due to lacking scope, clinical practice, and understanding of plastic surgery as a clinical area of expertise, including general practitioners, nursing staff, medical trainees, and the general public, and misconceptions about the extent of reconstructive and plastic surgery. Methods A cross-sectional observational study was conducted on Kuwait University Medical students (2nd-7th Years) over a period of 1 month. A questionnaire and a consent form were provided to eligible students. The inclusion criteria were Kuwait University Medical students from 2nd to 7th Years with signed consent form. The response was collected via email sent in coordination with the Vice Dean of Student Affairs in the Faculty of Medicine. Using statistical package for the social sciences, responses were statistically analyzed. Pearson's chi-square test was used to calculate p-values, where p < 0.05 was considered statistically significant. Results A total of 244 eligible medical students, 121 males and 123 females, were included in the study, with a mean age of 21 (±2) years. Similarly, 126 (51.6%) were preclinical students (2nd-4th-year students), while 118 (48.4%) were clinical students (5th-7th-year students). About 79.8% of medical students believed that plastic surgery plays an essential role in trauma management, whereas 9.2% did not consider plastic surgery significant for trauma management. This study found that only 15.5% of medical students were interested in enrolling in plastic surgery residency after graduation, while 47.1% of students did not consider plastic surgery residency after graduation. However, 37.4% were uncertain. The two most driving factors in deciding on plastic surgery residency were expected income (61.8%) and lifestyle (14.3%). Conclusion Improving medical students' education quality can enhance their perception and awareness of plastic surgery. Students should be taught the broader scope of plastic surgery. The inclusion of formal training during undergraduation is the essence of time and should be added to or improved during plastic surgery rotations with more emphasis on reconstructive and hand/peripheral nerve surgery. Student-led interest groups can be a useful tool for educating students about their specialty.

Risk indicators related to periimplant disease: an observational retrospective cohort study

  • Poli, Pier Paolo;Beretta, Mario;Grossi, Giovanni Battista;Maiorana, Carlo
    • Journal of Periodontal and Implant Science
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    • v.46 no.4
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    • pp.266-276
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    • 2016
  • Purpose: The aim of the present study was to retrospectively investigate the influence of potential risk indicators on the development of peri-implant disease. Methods: Overall, 103 patients referred for implant treatment from 2000 to 2012 were randomly enrolled. The study sample consisted of 421 conventional-length (>6 mm) non-turned titanium implants that were evaluated clinically and radiographically according to preestablished clinical and patient-related parameters by a single investigator. A non-parametric Mann-Whitney U test or Kruskal-Wallis rank test and a logistic regression model were used for the statistical analysis of the recorded data at the implant level. Results: The diagnosis of peri-implant mucositis and peri-implantitis was made for 173 (41.1%) and 19 (4.5%) implants, respectively. Age (${\geq}65$ years), patient adherence (professional hygiene recalls <2/year) and the presence of plaque were associated with higher peri-implant probing-depth values and bleeding-on-probing scores. The logistic regression analysis indicated that age (P=0.001), patient adherence (P=0.03), the absence of keratinized tissue (P=0.03), implants placed in pristine bone (P=0.04), and the presence of peri-implant soft-tissue recession (P=0.000) were strongly associated with the event of peri-implantitis. Conclusions: Within the limitations of this study, patients aged ${\geq}65$ years and non-adherent subjects were more prone to develop peri-implant disease. Therefore, early diagnosis and a systematic maintenance-care program are essential for maintaining peri-implant tissue health, especially in older patients.

Effect of Traditional Korean Medicine Treatment Including Acupotomy on the Level of Pain and Quality of Life of Patients with Cervical Herniated Intervertebral Disc: A Retrospective Observational Study

  • Kim, Beom Seok;Sung, Ki Jung;Lee, Ye Ji;Jeon, Ju Hyun;Kim, Young Il
    • Journal of Acupuncture Research
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    • v.38 no.3
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    • pp.227-232
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    • 2021
  • Background: The purpose of this study was to statistically analyze the treatment effect and patient satisfaction of traditional Korean medicine, including acupotomy treatment of cervical herniated intervertebral disc. Methods: This was a retrospective study of 22 patients who received traditional Korean medicine including acupotomy treatment amongst all patients diagnosed with cervical herniated intervertebral discs at the Korean Medicine hospital in Daejeon, Korean, from January 01, 2020 to April 30, 2021. The clinical data from patient medical records were statistically analyzed. Results: The Numeric Rating Scale, the European Quality of Life 5 Dimensions, and the European Quality of Life Visual Analogue Scale questionnaire scores were each compared before and after traditional Korean medicine treatment, including acupotomy, showed significantly improved scores after treatment (p < 0.001). Out of a total of 22 patients, 11 rated the treatment "very satisfactory" (50%), 5 "satisfactory" (22.7%), 5 "indifferent" (22.7%), 1 "unsatisfactory" (4.5%), and 0 "very unsatisfactory" (0%). Of the total 22 patients, 17 patients (77.3%) were willing to have further treatment, and 5 patients (22.7%) were not willing. Conclusion: Traditional Korean medicine treatment including acupotomy was an effective treatment for cervical herniated intervertebral discs. To determine the effect of an individual application (e.g., acupotomy) of traditional Korean medicine treatment for cervical herniated intervertebral disc, a prospective, controlled study is needed.

Implications of Emphysema and Lung Function for the Development of Pneumonia in Patients with Chronic Obstructive Pulmonary Disease

  • Hong, Yoonki;Lee, Jae Seung;Yoo, Kwang Ha;Lee, Ji-Hyun;Kim, Woo Jin;Lim, Seong Yong;Rhee, Chin Kook;Lee, Sang-Do;Oh, Yeon-Mok
    • Tuberculosis and Respiratory Diseases
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    • v.79 no.2
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    • pp.91-97
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    • 2016
  • Background: Chronic obstructive pulmonary disease (COPD) is sometimes complicated with pneumonia, but little is known about the risk factors that promote the development of pneumonia in COPD. These risk factors were evaluated in the present study. Methods: The data of 324 patients with COPD from a prospective multi-center observational cohort with obstructive lung disease were evaluated retrospectively. To identify risk factors for the development of pneumonia in COPD, the clinical and radiological data at enrollment and the time to the first episode of pneumonia were analyzed by Cox proportional hazard analysis. Results: The median follow-up time was 1,099 days and 28 patients (8.6%) developed pneumonia. The Cox analysis showed that post-bronchodilator forced expiratory volume in one second ($FEV_1$, % of predicted) and the computed tomography (CT) emphysema extent (inspiratory V950) were independent risk factors for the development of pneumonia (post-bronchodilator $FEV_1$: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-1.00; p=0.048 and inspiratory V950: HR, 1.04; 95% CI, 1.01-1.07; p=0.01). Conclusion: Emphysema severity measured by CT and post-bronchodilator $FEV_1$ are important risk factors for the development of pneumonia in COPD.

Observational Study on Patient's Satisfactions and Quality of Life (QoL) Among Cancer Patients Receiving Treatment with Palliative Care Intent in a Tertiary Hospital in Malaysia

  • Sharifa Ezat, Wan Puteh;Fuad, Ismail;Hayati, Yaakub;Zafar, Ahmed;Wanda Kiyah, George Albert
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.2
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    • pp.695-701
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    • 2014
  • The main objective of palliative treatment for cancer patients has been to maintain, if not improve, the quality of life (QoL). There is a lack of local data on satisfaction and QoL among cancer patients receiving palliative treatment in Malaysia. This study covers patients with incurable, progressive cancer disease receiving palliative treatment in a teaching hospital in Kuala Lumpur, comparing the different components of QoL and correlations with patient satisfaction. A cross-sectional survey using Malay validated SF36 QoL and PSQ-18 (Short Form) tools was carried out between July 2012 -January 2013 with 120 cancer patients receiving palliative treatment, recruited into the study after informed consent using convenient sampling. Results showed that highest satisfaction were observed in Communication Aspect ($50.6{\pm}9.07$) and the least in General Satisfaction ($26.4{\pm}5.90$). The Mental Component Summary ($44.9{\pm}6.84$) scored higher when compared with the Physical Component Summary ($42.2{\pm}7.91$). In this study, we found that patient satisfaction was strongly associated with good quality of life among cancer patients from a general satisfaction aspect (r=0.232). A poor significant negative correlation was found in Physical Component (technical quality, r=-0.312). The Mental Component showed there was a poor negative correlation between time spent with doctor (r=-0.192) and accessibility, (r=-0.279). We found that feeling at peace and having a sense of meaning in life were more important to patients than being active or achieving good physical comfort. More studyis needed to investigate patients who score poorly on physical and mental component aspects to understand their needs in order to achieve better cancer care.

The Natural History and Growth Rate of Meningiomas

  • Han, Jung-Ho;Seol, Ho-Jun;Kim, Dong-Gyu;Jung, Hee-Won
    • Journal of Korean Neurosurgical Society
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    • v.39 no.3
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    • pp.198-203
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    • 2006
  • Objective : To evaluate the natural histories and growth rates of meningiomas, the authors perform this retrospective observational study and attempt to identify those factors predicting tumor growth. Methods : Between 1993 and 2004, a total of 83 patients were diagnosed by computed tomography[CT] scans or magnetic resonance[MR] imaging as having an intracranial meningioma, and were treated by observation only using regular clinical and radiological examinations. Twenty-six of these 83 patients, with available data were included in this study. Follow up periods ranged from 9 to 137 months [mean, 55.6 mo.; median, 60 mo.]. The tumor volumes, absolute growth rates, and tumor doubling times were calculated. Results : Patient age and sex distributions were comparable to those of other studies, but exceptionally 16 meningiomas [62%] were located at the skull base in the present study. During follow-up monitoring, the majority of meningiomas grew, though 77% showed low absolute annual growth rates [$<1cm^3/yr$]. The tumor doubling times ranged from 2.87 to 201.72 years [mean, 42.91 yr]. Based on Imaging analysis, peritumoral edema and the absence of calcification were probable factors predicting tumor growth. Tumor-related symptoms seemed to be slightly related to tumor growth. Other factors, e.g., gender, age, tumor location, and T2-weighted signal Intensities on MR imaging, were not significantly related to tumor growth. Conclusion : This study shows that the majority of meningiomas are slow growing. However, variations in tumor growth are unexplained, thus individualized optimal treatment strategies should be provided in each meningioma.

Sensitivity, specificity, and predictive value of cardiac symptoms assessed by emergency medical services providers in the diagnosis of acute myocardial infarction: a multi-center observational study

  • Park, Jeong Ho;Moon, Sung Woo;Kim, Tae Yun;Ro, Young Sun;Cha, Won Chul;Kim, Yu Jin;Shin, Sang Do
    • Clinical and Experimental Emergency Medicine
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    • v.5 no.4
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    • pp.264-271
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    • 2018
  • Objective For patients with acute myocardial infarction (AMI), symptoms assessed by emergency medical services (EMS) providers have a critical role in prehospital treatment decisions. The purpose of this study was to evaluate the diagnostic accuracy of EMS provider-assessed cardiac symptoms of AMI. Methods Patients transported by EMS to 4 study hospitals from 2008 to 2012 were included. Using EMS and administrative emergency department databases, patients were stratified according to the presence of EMS-assessed cardiac symptoms and emergency department diagnosis of AMI. Cardiac symptoms were defined as chest pain, dyspnea, palpitations, and syncope. Disproportionate stratified sampling was used, and medical records of sampled patients were reviewed to identify an actual diagnosis of AMI. Using inverse probability weighting, verification bias-corrected diagnostic performance was estimated. Results Overall, 92,353 patients were enrolled in the study. Of these, 13,971 (15.1%) complained of cardiac symptoms to EMS providers. A total of 775 patients were sampled for hospital record review. The sensitivity, specificity, positive predictive value, and negative predictive value of EMS provider-assessed cardiac symptoms for the final diagnosis of AMI was 73.3% (95% confidence interval [CI], 70.8 to 75.7), 85.3% (95% CI, 85.3 to 85.4), 3.9% (95% CI, 3.6 to 4.2), and 99.7% (95% CI, 99.7 to 99.8), respectively. Conclusion We found that EMS provider-assessed cardiac symptoms had moderate sensitivity and high specificity for diagnosis of AMI. EMS policymakers can use these data to evaluate the pertinence of specific prehospital treatment of AMI.

Real-World Impact of Modern Reperfusion Therapy for Acute Ischemic Stroke : A Nationwide Population-Based Data Study in Korea

  • Yung Ki Park;Byul-Hee Yoon;Yu Deok Won;Jae Hoon Kim;Hee In Kang
    • Journal of Korean Neurosurgical Society
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    • v.67 no.2
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    • pp.186-193
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    • 2024
  • Objective : The treatment paradigm for acute ischemic stroke has undergone several major changes in the past decade, contributing to improved patient prognosis in clinical practice. However, the extent to which these changes have affected patient prognosis in the real-world is yet to be clarified. This study aimed to evaluate the real-world impact of modern reperfusion therapy for acute ischemic stroke using data from the National Health Insurance Service in Korea. Methods : This study included patients aged 18-80 years who were admitted via the emergency room with an I63 code between 2011 and 2020. The rates of intravenous thrombolysis use and endovascular treatment according to the year of admission were investigated. Furthermore, the rates of decompressive craniectomy and 3-month mortality were also analyzed. The 10-year observational period was divided into three periods based on the 2015 guideline change as follows : prior, 2011-2014; transitional, 2015-2016; and modern, 2017-2020. Results : A total of 307117 patients (mean age, 65.7±10.9 years) were included, and most patients were male (59.7%). The rate of endovascular treatment gradually increased during the study period from 0.71% in the prior period to 1.32% in the transitional period and finally to 1.85% in the modern period. Meanwhile, the 3-month mortality rate gradually decreased from 4.78% in the prior period to 4.03% in the transitional period and to 3.71% in the modern period. Conclusion : In Korea, the mortality rate decreased as the rate of modern reperfusion therapy increased in patients with acute ischemic stroke. Overall, technical and scientific advances in reperfusion therapy have improved the outcome of patients with acute ischemic stroke in Korea.

Safety and Effectiveness of Indacaterol in Chronic Obstructive Pulmonary Disease Patients in South Korea

  • Yum, Ho-Kee;Kim, Hak-Ryul;Chang, Yoon Soo;Shin, Kyeong-Cheol;Kim, Song;Oh, Yeon-Mok
    • Tuberculosis and Respiratory Diseases
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    • v.80 no.1
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    • pp.52-59
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    • 2017
  • Background: Inhaled indacaterol (Onbrez Breezhaler), a long-acting ${\beta}_2$-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. Methods: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or $300{\mu}g$), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. Results: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. Conclusion: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.