• 제목/요약/키워드: Clinical statistics

검색결과 1,481건 처리시간 0.036초

임상시험에서의 통계 활용 (Usage of Statistics in Clinical Trials)

  • 안홍엽
    • Journal of Hospice and Palliative Care
    • /
    • 제13권1호
    • /
    • pp.1-6
    • /
    • 2010
  • 임상시험은 인간을 대상으로 약물 또는 치료법의 효과를 검증하는 것을 목적으로 하고 있다. 성공적인 임상시험을 위해서는 단순한 자료분석에만 통계의 이용을 제한하지 않고 다양한 영역으로 활용의 폭을 넓히는 것이 필요하다. 연구계획단계에서부터 구체적이고 체계적으로 통계의 활용을 고려하기 위해 효과에 대한 정의, 적정한 표본크기 산정, 통계분석 방법 등 전반적인 통계의 응용을 고찰한다.

A Review of the Statistical Analysis used in Clinical Articles Published on Journal of Korean Neurosurgical Society

  • Kang, Wee-Chang
    • Journal of Korean Neurosurgical Society
    • /
    • 제40권4호
    • /
    • pp.304-308
    • /
    • 2006
  • Statistical analyses used in clinical articles published on the Journal of Korean Neurosurgical Society were identified and appropriateness of statistical aspects in reporting results was assessed. Forty seven clinical articles were selected in this study, which were published from February, 2005 to February, 2006 on the journal. The frequency of statistical analysis was as follows : descriptive statistics only 24 [51.1%]. one type of statistical method 10 [21.3%], two or more methods 13 [27.6%]. An assessment of statistical aspects was performed in 24 clinical articles reporting inferential statistics. Ten articles [41.7%] did not adequately describe or reference all statistical methods used. There were six articles [25.0%] not reporting the confidence level used as the critical criteria of the statistical significance. In thirteen articles [54.2%] it seems more appropriate to implement multivariate analyses in addition to univariate analyses. We recommend that the journal readers should concentrate on improving their knowledge of basic statistics and statistical review for manuscripts submitted should be sought from professionals in the fields of biostatistics and epidemiology.

백신임상시험에 대한 통계적 고찰 (Statistical Consideration of Vaccine Clinical Trials)

  • 남주선;강승호
    • 응용통계연구
    • /
    • 제24권4호
    • /
    • pp.633-646
    • /
    • 2011
  • 인류의 평균수명 연장과 삶의 질 향상을 위해서 암 예방을 위한 백신 뿐 아니라 치료를 위한 백신 등 백신에 대한 많은 연구가 진행되고 있다. 또한 2009년 전 세계를 공포로 몰았던 신종인플루엔자 등 신종바이러스 유행으로 백신에 대한 임상시험과 연구는 더욱더 활기를 띄게 되었다. 본 논문에서는 백신에 대한 임상시험에서 고려해야할 통계학적인 부분에 대해 기술하고, 현재 우리나라를 포함한 전 세계적인 백신의 개발 현황에 대해서도 언급하겠다.

Clinical statistics: five key statistical concepts for clinicians

  • Choi, Yong-Geun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
    • /
    • 제39권5호
    • /
    • pp.203-206
    • /
    • 2013
  • Statistics is the science of data. As the foundation of scientific knowledge, data refers to evidentiary facts from the nature of reality by human action, observation, or experiment. Clinicians should be aware of the conditions of good data to support the validity of clinical modalities in reading scientific articles, one of the resources to revise or update their clinical knowledge and skills. The cause-effect link between clinical modality and outcome is ascertained as pattern statistic. The uniformity of nature guarantees the recurrence of data as the basic scientific evidence. Variation statistics are examined for patterns of recurrence. This provides information on the probability of recurrence of the cause-effect phenomenon. Multiple causal factors of natural phenomenon need a counterproof of absence in terms of the control group. A pattern of relation between a causal factor and an effect becomes recognizable, and thus, should be estimated as relation statistic. The type and meaning of each relation statistic should be well-understood. A study regarding a sample from the population of wide variations require clinicians to be aware of error statistics due to random chance. Incomplete human sense, coarse measurement instrument, and preconceived idea as a hypothesis that tends to bias the research, which gives rise to the necessity of keen critical independent mind with regard to the reported data.

간호대학생의 자기주도학습, 핵심간호술 수행자신감, 임상실습 교육환경과 임상수행능력 간의 관계 (Correlations among Self-directed Learning, Confidence of Performance in Core Nursing Skills, Clinical Learning Environment and Clinical Competency in Nursing Students)

  • 구윤정
    • 문화기술의 융합
    • /
    • 제9권1호
    • /
    • pp.501-511
    • /
    • 2023
  • 본 연구는 G시에 소재하는 간호대학생 178명을 대상으로 자기주도학습, 핵심간호술 수행자신감, 임상실습 교육환경 및 임상수행능력 간의 상관관계를 살펴보기 위한 서술적 조사연구이다. 자료수집은 2019년 9월 24일부터 10월 19일까지 이루어졌으며, 자료분석은 IBM SPSS Statistics 21.0 프로그램을 사용하여 변수의 평균과 표준편차, 실수와 백분율로 분석하였고, 일반적 특성에 따른 변수의 차이는 independent t-test, ANOVA로 분석하였고, 변수 간의 상관관계는 Pearson's correlation coefficients로 분석하였다. 연구결과, 자기주도학습 3.36점, 핵심간호술 수행자신감 3.42점, 임상실습 교육환경 3.20점, 임상수행능력 3.66이었다. 자기주도학습, 핵심간호술 수행자신감, 임상실습 교육환경과 임상수행능력 간에는 유의한 정적 상관관계가 있었다. 이에 간호대학생의 임상수행능력을 향상사키기 위하여 핵심간호술 교육을 체계화하고, 유기적인 산학협력을 통하여 임상실습 교육환경을 지속적으로 개선시켜 나가야 할 것이다.

Two Bayesian methods for sample size determination in clinical trials

  • Kwak, Sang-Gyu;Kim, Dal-Ho;Shin, Im-Hee;Kim, Ho-Gak;Kim, Sang-Gyung
    • Journal of the Korean Data and Information Science Society
    • /
    • 제21권6호
    • /
    • pp.1343-1351
    • /
    • 2010
  • Sample size determination is very important part in clinical trials because it influences the time and the cost of the experimental studies. In this article, we consider the Bayesian methods for sample size determination based on hypothesis testing. Specifically we compare the usual Bayesian method using Bayes factor with the decision theoretic method using Bayesian reference criterion in mean difference problem for the normal case with known variances. We illustrate two procedures numerically as well as graphically.

Prediction Models for Solitary Pulmonary Nodules Based on Curvelet Textural Features and Clinical Parameters

  • Wang, Jing-Jing;Wu, Hai-Feng;Sun, Tao;Li, Xia;Wang, Wei;Tao, Li-Xin;Huo, Da;Lv, Ping-Xin;He, Wen;Guo, Xiu-Hua
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제14권10호
    • /
    • pp.6019-6023
    • /
    • 2013
  • Lung cancer, one of the leading causes of cancer-related deaths, usually appears as solitary pulmonary nodules (SPNs) which are hard to diagnose using the naked eye. In this paper, curvelet-based textural features and clinical parameters are used with three prediction models [a multilevel model, a least absolute shrinkage and selection operator (LASSO) regression method, and a support vector machine (SVM)] to improve the diagnosis of benign and malignant SPNs. Dimensionality reduction of the original curvelet-based textural features was achieved using principal component analysis. In addition, non-conditional logistical regression was used to find clinical predictors among demographic parameters and morphological features. The results showed that, combined with 11 clinical predictors, the accuracy rates using 12 principal components were higher than those using the original curvelet-based textural features. To evaluate the models, 10-fold cross validation and back substitution were applied. The results obtained, respectively, were 0.8549 and 0.9221 for the LASSO method, 0.9443 and 0.9831 for SVM, and 0.8722 and 0.9722 for the multilevel model. All in all, it was found that using curvelet-based textural features after dimensionality reduction and using clinical predictors, the highest accuracy rate was achieved with SVM. The method may be used as an auxiliary tool to differentiate between benign and malignant SPNs in CT images.

Clinical Risk Factor Analysis for Breast Cancer: 568,000 Subjects Undergoing Breast Cancer Screening in Beijing, 2009

  • Pan, Lei;Han, Li-Li;Tao, Li-Xin;Zhou, Tao;Li, Xia;Gao, Qi;Wu, Li-Juan;Luo, Yan-Xia;Ding, Hui;Guo, Xiu-Hua
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제14권9호
    • /
    • pp.5325-5329
    • /
    • 2013
  • Objectives: Although there are many reports about the risk of breast cancer, few have reported clinical factors including history of breast-related or other diseases that affect the prevalence of breast cancer. This study explores these risk factors for breast cancer cases reported in Beijing in 2009. Materials and Methods: Data were derived from a Beijing breast cancer screening performed in 2009, of 568,000 women, from 16 districts of Beijing, all aged between 40 and 60 years. In this study, multilevel statistical modeling was used to identify clinical factors that affect the prevalence of breast cancer and to provide more reliable evidence for clinical diagnostics by using screening data. Results and Conclusion: Those women who had organ transplants, compared with those with none, were associated with breast cancer with an odds ratio (OR)=65.352 [95% confidence interval (CI): 8.488-503.165] and those with solid breast mass compared with none had OR=1.384 (95% CI: 1.022-1.873). Malignant tendency was strongly associated with increased risk of breast cancer, OR=207.999(95% CI: 151.950-284.721). The risk of breast cancer increased with age, $OR_1$=2.759 (95% CI: 1.837-4.144, 56-60 vs. 40-45), $OR_2$=2.047 (95% CI: 1.394-3.077, 51-55 vs. 40-45), $OR_3$=1.668 (95% CI: 1.145-2.431). Normal results of B ultrasonic examination show a lower risk among participants, OR= 0.136 (95% CI: 0.085-0.218). Those women with ductal papilloma compared with none were associated with breast cancer, OR=6.524 (95% CI: 1.871-22.746). Therefore, this study suggests that clinical doctors should pay attention to these high-risk factors.

Statistical Considerations in the Design of Biosimilar Cancer Clinical Trials

  • Ahn, Chul;Lee, Seung-Chun
    • 응용통계연구
    • /
    • 제24권3호
    • /
    • pp.495-503
    • /
    • 2011
  • When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

동의신경정신과학회지에 발표된 임상연구논문들의 통계방법 기술 및 적용 현황 (Present Status of Description and Application of Statistics in Clinical study papers in the Journal of Oriental Neuropsychiatry.)

  • 조성훈;황의완;이태림
    • 동의신경정신과학회지
    • /
    • 제18권3호
    • /
    • pp.15-21
    • /
    • 2007
  • This study was done to review problems in terms of statistical description and statistical application and analysis. Methods; The authors reviewed 42 statistical clinical study papers excluding 12 Overview papers, 75 Descriptive papers, 48 Animal studies out of 177 papers in the Journal of Oriental Neuropsychiatry in the 5 years from 2002 to 2006. Results : 1) 3 papers(7.1%) had no description of statistical method, only P-values, 25 papaers(59.5%) had tables without description of statistical method, 1 paper (2.3%) had no description of statistical method in study method. 2) 10 papers(23.8%) contained problems in terms of statistical application and analysis. 6papers (6/23, 26.0%) for Student t-test, 2 papers(2/7 28.6%)for $X^2$- test, 1 paper(1/15 6.7%) for the analysis of variance, 1 paper(1/6 16.7%) for Pearson correlation contained statistical problems. Conclusion : It was suggested that consultation of investigators with statisticians and more extensive statistical refereeing, the form of the guidelines for description and application of statistics are needed.

  • PDF