No abstract available.
Research Design

No abstract available.
Research Design*

In a clinical controlled trial involving repeated measures of continuous outcomes such as quality of life, distress, pain, activity level at baseline and after treatment, the possibilities of analyzing these outcomes can be numerous with quite varied findings. This paper examined four methods of statistical analysis using data from an outcome study of a clinical controlled trial to contrast the statistical power on those with baseline adjustment. In this study, data from a CCT with women with breast cancer were utilized. The experiment (n=67) and control (n=74) were about equal ratio. Four method of analysis were utilized, two using ANOVA for repeated measures and two using ANCOVA. The multivariate between subjects of the combined dependents variables and the univariate between subjects test were examined to make a judgement of the statistical power of each method. The results showed that ANCOVA has the highest statistical power. ANOVA using raw data is the least power and is the worst method with no evidence of an intervention effect even when the treatment by time interaction is statistically significant. In conclusion, ANOVA using raw data is the worst method with the least power whilst ANCOVA using baseline as covariate has the highest statistical power to detect a treatment effect other than method. The second best method as shown in this study was in using change scores of the repeated measures.
Research Design

Research Design

No abstract available.
Research ; Research Design ; Writing

Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.
Biomedical Research ; Humans ; Research Design

A study on the shaking disease among coal miners in Quang Ninh was implemented by measurement of the shaking perception. The results found that the shaking perception of miners who have been working in coal mine for 5 years and over was significantly reduced compared with this of control. The test of shaking perception by diapason C128 is easy to use everywhere and has a specific significant for finding the shaking disease.
Perception ; Research Design

BACKGROUND: Since the Korean Journal of Family Medicine (KJFM) started publishing in 1980, randomized controlled trials (RCTs) and non-randomized controlled studies (NRSs) consistently have increased in quality and quantity. Although there have been several studies on the quality assessment of RCTs in Korea, there has been no study on quality assessment of NRSs. Thus, this study evaluated NRS in the KJFM to assess the quantity and quality. METHODS: Upon extracting NRSs for assessing the intervention effects from all the articles published in the KJFM from 1980 to 2006, assessments were made on methodological index for non-randomized studies (MINORS). Also, the analysis were made upon the proportion of NRSs within original articles according to two categories (comparative study, noncomparative study). The mean scores by research methods and years, and total scores and mean scores of yearly research methods were analyzed. RESULTS: A total of 34 trials on NRSs were selected. In 1980s, 0.65% of the total selected original articles, in 1990s, 1.54%, and in 2000s 5.11% were NRSs. According to the research designs, the mean scores of MINORS were before and after study 8.5, interrupted Time Series 9.7 (out of 16), controlled before and after 13.5, quasi randomized trial 12.6, and non randomized trial 13 (out of 24). Before and after design was the most frequently used (55.9%). CONCLUSION: Although NRSs consistently increased in quantity, the assessed mean scores were low and most articles used before and after design. Thus, there should be studied using appropriate research methods in the future.
Humans ; Korea ; Research Design

The quality control problems of 49 institutional level medical device clinical trials in hospital from 2016 to 2021 were summarized, and the causes of the problems were analyzed from the perspective of all parties involved in the clinical trial. The improvement measures were discussed, which including improving the management system, strengthening the training of researchers and optimizing the selection method, strengthening the responsibility and regulation consciousness of applicants, and formulating the selection basis of applicants and so on. All the above aims to ensure the quality of clinical trials and provide reference for clinical trial managers and implementers.
Quality Control ; Research Design

PURPOSE: The purpose of this study was to examine the factors influencing glass particle contamination in single dose glass ampules upon opening. METHOD: The study was single case experimental design. Different methods of opening ampule (hand, wooden stick), different sizes of ampules(1cc, 2cc) and different sizes of needles(17gauge, 23gauge, 5micrometer filter) were evaluated. Eighteen ampules were randomly assigned in each group. The number of glass ampule particles > or =10micrometer was counted by microscope. RESULTS: There was no significant difference in the number of particles aspirated by opening methods. But number of glass particles was much lower when using 1cc ampules rather than 2cc ampules and was also much lower when using smaller size needles and needles which include a 5micrometer filter rather than larger size of needles. CONCLUSION: We suggest that larger bore or unfiltered needles increase the risk of aspirating more glass particles than smaller bore or filter needles. In addition, these data show that a wooden stick can be used as a method opening glass ampules.
Glass* ; Needles ; Research Design