• 제목/요약/키워드: Prospective clinical evaluation

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국내 한의학 관련 학술지에 게재된 전향적 임상연구의 윤리적 측면 분석 (Analysis on The Status of Prospective Clinical Researches Related to Korean Oriental Medicine and their Ethical Aspects)

  • 김윤영;권지혜;이시우;유종향
    • 동의생리병리학회지
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    • 제26권6호
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    • pp.849-854
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    • 2012
  • In this research, the status of prospective clinical researches related to Korean Oriental Medicine was identified from the papers published in domestic Korean medicine journals for the past 10 years, and the ethical validity of them were evaluated. Selection of researches and assessment on the ethical validity were made from the evaluation of two independent persons and the adjustment of the third party, and the collected data was analyzed using SPSS 17.0 software. The yearly status of prospective clinical researches related to Korean oriental medicine showed that the average number of them, which was six before 2005, was decreased to only one in 2006, and it started to recover gradually after 2007. The result of ethical validity test of prospective clinical researches related to oriental medicine showed that 5 researches (12.2%) in "unbiased selection of subjects and recruitment", 15 researches (36.6%) in "informed consent", 10 researches (24.4%) in "ethical considerations for vulnerable subjects", and 8 researches (19.5%) in "pre-deliberation and ethical oversight of the IRB" were appropriate to the ethical standards. The interest for clinical researches has been increased, and the ethical aspect of the clinical researches has been emphasized in oriental medicine. The results reported here are expected to provide a help to perform an ethical oriental medicine related clinical researches.

Response Evaluation of Chemotherapy for Lung Cancer

  • Hwang, Ki-Eun;Kim, Hak-Ryul
    • Tuberculosis and Respiratory Diseases
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    • 제80권2호
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    • pp.136-142
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    • 2017
  • Assessing response to therapy allows for prospective end point evaluation in clinical trials and serves as a guide to clinicians for making decisions. Recent prospective and randomized trials suggest the development of imaging techniques and introduction of new anti-cancer drugs. However, the revision of methods, or proposal of new methods to evaluate chemotherapeutic response, is not enough. This paper discusses the characteristics of the Response Evaluation Criteria In Solid Tumor (RECIST) version 1.1 suggested in 2009 and used widely by experts. It also contains information about possible dilemmas arising from the application of response assessment by the latest version of the response evaluation method, or recently introduced chemotherapeutic agents. Further data reveals the problems and limitations caused by applying the existing RECIST criteria to anti-cancer immune therapy, and the application of a new technique, immune related response criteria, for the response assessment of immune therapy. Lastly, the paper includes a newly developing response evaluation method and suggests its developmental direction.

치매의 한약물 치료에 대한 체계적 임상논문 고찰 - 국내문헌을 중심으로 - (A Systematic Review of Clinical Studies for Herbal Medicine of Dementia - based on Korean Literature -)

  • 권용주;조혜영;황의완;조성훈
    • 동의신경정신과학회지
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    • 제21권4호
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    • pp.151-161
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    • 2010
  • Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

Serial venous lactate measurement following gastrointestinal surgery in horses

  • Smanik, Lauren E.;Moser, Darla K.;Rothers, Kris P.;Hackett, Eileen S.
    • Journal of Veterinary Science
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    • 제23권5호
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    • pp.66.1-66.8
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    • 2022
  • Background: Prospective clinical study of blood lactate concentration in horses undergoing colic surgery is needed to determine utility in outcome prediction. Objectives: To evaluate venous lactate measurements in horses following colic surgery, including immediately after anesthetic recovery and daily throughout hospitalization, as well as to determine if lactate concentrations were significantly higher in horses that developed postoperative complications or did not survive to hospital discharge. Methods: Horses > 1 year of age undergoing surgery for colic and recovered from general anesthesia were sampled. A portable lactate meter was used to measure venous samples collected immediately following anesthetic recovery and daily throughout hospitalization. Complications arising during hospitalization and survival to hospital discharge were recorded. Results: Fifty one horses were enrolled, ranging in age from 2 to 29 years. Lactate concentration immediately following anesthetic recovery was higher in horses that developed complications during hospitalization (p = 0.046). The odds of developing complications postoperatively were doubled for horses with a venous lactate concentration > 5 mmol/L. Lactate measurements in non-survivors were significantly higher compared to survivors by 96 h postoperatively (p < 0.006). Conclusions: Higher venous lactate concentrations in the postoperative colic period were associated with an increased risk of complications and death. Results suggest horses with higher venous lactate measurements in recovery are more likely to have postoperative complications, with the odds of developing complications doubled for horses with a venous lactate > 5 mmol/L. Evaluation of venous lactate could provide information on prognosis in the postoperative period for horses with surgical colic.

간호학 임상실습교육의 현황과 발전방안 (Current Status and Future Direction of Nursing Education for Clinical Practice)

  • 신수진;양은배;황은희;김건희;김윤주;정덕유
    • 의학교육논단
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    • 제19권2호
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    • pp.76-82
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    • 2017
  • The quantitative expansion of nursing schools has necessitated the qualitative improvement of nursing education, which requires the development of nursing education for clinical practice. To identify strategies for strengthening the educational capacity of clinical fields and nursing schools, this study first examined the current status of nursing education for clinical practice, and then proposed several prospective directions for education. Nursing clinical practice-related studies from several Korean and international electronic databases were reviewed. Insufficient training hospitals and lack of qualified clinical training instructors were the main problems found within nursing educational resources for clinical practice, while the simple practice contents based on observation and inadequate evaluations were the main problems found in nursing educational management for clinical practice. This study suggests better standards and educational accountability for training hospitals and programs to nurture human resources for clinical practice, as well as a variety of training methods to integrate practical training courses and the expansion of formation evaluation. Based on these results, it is necessary to establish governance for nursing education for clinical practice and clarify the role and standards of each practitioner, strengthen the educational role of the hospital, and improve the system. In addition, introducing various types of education methods and strengthening evaluation standards are needed in order to enhance nursing education for clinical practice.

STN DBS of Advanced Parkinson's Disease Experienced in a Specialized Monitoring Unit with a Prospective Protocol

  • Lee, Ji-Yeoun;Han, Jung-Ho;Kim, Han-Joon;Jeon, Beom-Seok;Kim, Dong-Gyu;Paek, Sun-Ha
    • Journal of Korean Neurosurgical Society
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    • 제44권1호
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    • pp.26-35
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    • 2008
  • Objective : In the evaluation of patients with Parkinson's disease (PD), most neurologists only see their patients during a limited period of their fluctuating 24-hour-a-day lives. This study aimed to assess the short-term outcome of STN stimulation for patients with advanced PD evaluated in a 24-hour monitoring unit for movement disorder (MUMD) using a prospective protocol. Methods : Forty-two patients with advanced PD consecutively treated with bilateral STN stimulation using multi-channel microelectrode recording were included in this study. All patients were evaluated using a 24-hour MUMD with a video recording/editing system and were evaluated with a prospective protocol of the Unified Parkinson's Disease Rating Scale, Hoehn and Yahr Staging, Schwab and England Activities of Daily Living, levodopa equivalent daily dose (LEDD), Short Form-36 Health Survey, and neuropsychological tests. Magnetic resonance (MR) images of the brain were performed prior to and six months after surgery. Results : All patients were evaluated at three and six months after surgery. There was a rapid and significant improvement of the motor symptoms, especially in tremor and rigidity, after STN stimulation with low morbidity. Dyskinesia was markedly decreased with much lowered LEDD values by 50% after STN stimulation. 1.5T MR images were safely taken according to the manufacturer's guidelines at six months after surgery without any adverse effects in 41 patients treated with STN stimulations. Conclusion : Evaluations in a 24-hour monitoring unit could reduce the dose of medication efficiently to an optimal level with patients' comfort and improve the clinical symptoms in harmony with STN stimulation.

파킨슨병 변증 유형 및 지표 분포에 대한 전향적 다기관 관찰연구 프로토콜 (An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson's Disease)

  • 조혜연;권오진;서복남;박성욱;유호룡;장정희
    • 대한한방내과학회지
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    • 제45권1호
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    • pp.1-10
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    • 2024
  • Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

Prospective Clinical Trial of Survival Rate for Two Different Implant Surfaces Using the Osstem(R) SS II Non-submerged Implant System in Partially Edentulous Patients

  • Kim, Su-Gwan;Lim, Chae-Su;Oh, Min-Seok;Park, Jin-Sung;Kim, Seo-Yoon;Seol, Ka-Young
    • Journal of Korean Dental Science
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    • 제2권2호
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    • pp.35-41
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    • 2009
  • Objective : This study sought to investigate the clinical survival rate of two implants with different surfaces: resorbable blasting media (RBM)-treated and calcium metaphosphate (CMP)-coated implant. Study design : SSII non-submerged implants (Osstem, Seoul, Korea) were placed in a total of 48 patients with mean age of 38.8. At least 31 patients in the experimental group had a CMP-coated implant, and 1 patient in the control group received a, RBM surface implant. The evaluation period was between April 2006 and December 2007. Radiographs, periotest, clinical periodontal examination, and prosthetic adjustment and occlusion were used. Results : The survival rate of the experimental and control groups after 1 year was 97.2% and 100%, respectively. The Wald confidence interval reported for the experimental group was not inferior to the control group. Conclusion : No significant differences were found between the RBM and CMP groups. The observed data suggest that CMP-coated methods can provide favorable clinical results for the functioning and healing of dental implants.

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A 2-year clinical evaluation of Sculpture crowns

  • Ku, Chul-Whoi;Yang, Hong-So
    • 대한치과보철학회지
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    • 제38권6호
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    • pp.806-813
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    • 2000
  • Statement of problems. There are only a few studies available that deal with the clinical behavior of ceromer systems as potential substitutes for metal-ceramic crowns. Purpose. This prospective study was initiated to evaluate the clinical performance of 35 Sculpture crowns after 2 years in service. Material and methods. Thirty five Sculpture crowns were placed for 20 patients (7 men and 13 women). All patients were treated by the same dentist, and all restorations were fabricated by the same dental laboratory. Crown placement involved both the anterior and posterior regions of the dental arches. Patients were evaluated by two examiner at baseline, 12, and 24 months using the CDA quality assessment system in addition to periodontal criteria. Results. Of 34 crowns remaining in the study after 2 years, only one crown had experienced a marginal fracture. The crown was replaced as a result of recurrent caries. All remaining crowns were ranked as either excellent or acceptable for surface and color, anatomic form, and marginal integrity. Conclusion. The 2-year clinical observations and ranking with the CDA quality assessment criteria supported the conclusion that Sculpture crowns may be used in substitutes for metal-ceramic crowns.

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Retrospective and Prospective Determination of the Cow's Milk-Related Symptom Score (CoMiSSTM) Values in Symptomatic Infants

  • Kozlowska-Jalowska, Anna;Horvath, Andrea;Vandenplas, Yvan;Szajewska, Hania
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제24권4호
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    • pp.384-391
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    • 2021
  • Purpose: The Cow's Milk-related Symptom Score (CoMiSSTM) was developed as an awareness tool for evaluating cow's milk-related symptoms in otherwise healthy children. Using a convenience sample of participants, this cross-sectional study aimed to determine CoMiSSTM values of symptomatic infants based on retrospectively or prospectively obtained information. Methods: CoMiSSTM values were determined in infants aged <12 months with symptoms suggestive of cow's milk protein allergy or functional gastrointestinal disorders. The exclusion criteria were previous diagnosis with acute or chronic disease, treatment with a therapeutic formula, and in case of breastfeeding, an elimination diet followed by the mother. Two CoMiSSTM values were assessed. A retrospective collection was defined as the collection of data after initial contact with the medical center but before the first medical consultation. A prospective collection was defined as the collection of data within 24 hours from the time of medical consultation but before starting any therapeutic intervention. The CoMiSSTM total and individual component scores obtained retrospectively or prospectively were compared between groups using the Wilcoxon signed-rank test. Results: This study was performed between August and November 2019. Data of 110 children (62 males and 48 females), with a mean±standard deviation age of 18.2±11.7 weeks, were obtained. The total CoMiSSTM value (p<0.001) and some individual component scores (crying, regurgitation, and stool) were significantly lower when collected prospectively than when collected retrospectively. Conclusion: CoMiSSTM values were retrospectively and prospectively determined. Lower CoMiSSTM values were obtained during prospective evaluation. Possible differences should be considered when using CoMiSSTM in clinical practice.