Pub Date : 2019-09-23DOI: 10.15406/bbij.2019.08.00285
Nazrul Islam Mondal, Md. Mostaured Ali Khan, R. Islam, S. Kaikobad, Golam Mustagir, N. Tasneem
The infection of human immunodeficiency virus (HIV) is responsible for an incurable infectious disease named “Acquired immune deficiency syndrome (AIDS)”, one of the biggest global health challenges in recent years. After identifying the first case of this chronic life-threatening ailment in the USA in 1981, the HIV/AIDS infection has permeated quickly to many countries.1 According to World Health Organization, 36.9 million people were living with HIV in 2017, especially, women are in greater risk constituting 51% of all adults living with HIV, increasing at a rate of 7000 young women become infected per week.2,3 Besides, South-East Asian countries contain 2nd highest amount of HIV infections, 3.5 million people, right after the Africa.3 The first case of HIV/AIDS was reported in Bangladesh in 1989. In 2011, the number of HIV-positive people was 2,533 but the amount has dramatically increased in last six years and stand at around 13000 infected people with around 1700 new cases in 2017.3,4 and 34% of which are females aged 15 and over.2 HIV/AIDS can transmit person to person through sexual contact with an infected person and through infected blood transmition.5
{"title":"Knowledge about HIV/AIDS among women in Bangladesh: an urban-rural comparison of trend, attitude and determinants","authors":"Nazrul Islam Mondal, Md. Mostaured Ali Khan, R. Islam, S. Kaikobad, Golam Mustagir, N. Tasneem","doi":"10.15406/bbij.2019.08.00285","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00285","url":null,"abstract":"The infection of human immunodeficiency virus (HIV) is responsible for an incurable infectious disease named “Acquired immune deficiency syndrome (AIDS)”, one of the biggest global health challenges in recent years. After identifying the first case of this chronic life-threatening ailment in the USA in 1981, the HIV/AIDS infection has permeated quickly to many countries.1 According to World Health Organization, 36.9 million people were living with HIV in 2017, especially, women are in greater risk constituting 51% of all adults living with HIV, increasing at a rate of 7000 young women become infected per week.2,3 Besides, South-East Asian countries contain 2nd highest amount of HIV infections, 3.5 million people, right after the Africa.3 The first case of HIV/AIDS was reported in Bangladesh in 1989. In 2011, the number of HIV-positive people was 2,533 but the amount has dramatically increased in last six years and stand at around 13000 infected people with around 1700 new cases in 2017.3,4 and 34% of which are females aged 15 and over.2 HIV/AIDS can transmit person to person through sexual contact with an infected person and through infected blood transmition.5","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74134583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-13DOI: 10.15406/bbij.2019.08.00284
A. Golikov, P. Frantsuzov, M. Nikitin, Eugenia Strebulaeva
{"title":"Statistics based algorithm for exact quantitation of [biotechnology] seed traits without reference material","authors":"A. Golikov, P. Frantsuzov, M. Nikitin, Eugenia Strebulaeva","doi":"10.15406/bbij.2019.08.00284","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00284","url":null,"abstract":"","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86496892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-12DOI: 10.15406/bbij.2019.08.00283
B. Khoundabi, A. Ansar, S. Hashemian
The Pain, Agitation, Delirium (PAD) guideline has been reviewed and compiled by the American Chest Physicians College and American Respiratory Medicine Association. This guideline provides a multidisciplinary and interdisciplinary approach to solving problems related patient PAD. The management of patients will facilitate by using this guideline through a chain of services in accordance with Treat, Assess and Prevent in relation to each Pain, Agitation and Delirium problem.1–3
{"title":"Impact of PAD guideline on masih daneshvari hospital ICU","authors":"B. Khoundabi, A. Ansar, S. Hashemian","doi":"10.15406/bbij.2019.08.00283","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00283","url":null,"abstract":"The Pain, Agitation, Delirium (PAD) guideline has been reviewed and compiled by the American Chest Physicians College and American Respiratory Medicine Association. This guideline provides a multidisciplinary and interdisciplinary approach to solving problems related patient PAD. The management of patients will facilitate by using this guideline through a chain of services in accordance with Treat, Assess and Prevent in relation to each Pain, Agitation and Delirium problem.1–3","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75996980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-08DOI: 10.15406/bbij.2019.08.00282
Lishamol Tomy, Jiju Gillariose
The Rayleigh distribution was introduced by Rayleigh2 and originally proposed in the fields of acoustics and optics. It has emerged as a special case of the Weibull distribution. The Rayleigh distribution has widely used in communication theory to describe hourly median and instantaneous peak power of received radio signals. Moreover, It has received a considerable attention from engineers and physicists for modeling wave propagation, radiation, synthetic aperture radar images, and other related phenomena. There have been many forms for the Rayleigh distribution to provide flexibility for modeling data. Vod3,4 proposed a powerful extension of the Rayleigh distribution and studied its properties. Its probability density function (pdf) is given by
{"title":"A generalized Rayleigh distribution and its application","authors":"Lishamol Tomy, Jiju Gillariose","doi":"10.15406/bbij.2019.08.00282","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00282","url":null,"abstract":"The Rayleigh distribution was introduced by Rayleigh2 and originally proposed in the fields of acoustics and optics. It has emerged as a special case of the Weibull distribution. The Rayleigh distribution has widely used in communication theory to describe hourly median and instantaneous peak power of received radio signals. Moreover, It has received a considerable attention from engineers and physicists for modeling wave propagation, radiation, synthetic aperture radar images, and other related phenomena. There have been many forms for the Rayleigh distribution to provide flexibility for modeling data. Vod3,4 proposed a powerful extension of the Rayleigh distribution and studied its properties. Its probability density function (pdf) is given by","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82169901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-08DOI: 10.15406/bbij.2019.08.00281
Okeh Uchechukwu Marius, Obiora-Ilouno Happiness
The receiver operating characteristic (ROC) curve is a standard tool used to evaluate the performance of a diagnostic test when measurement of test results are either continuous or ordinal.1 In 1950s the methodology of ROC was first developed by electrical and radar engineers during World War II for signal detection theory in battle fields.2 In an ROC curve, the true positive rate (TPR) is plotted against the false positive rate (FPR) across all possible cut-off values in other to make meaningful decision. The area under the ROC curve (AUC) is a summary index for measuring the diagnostic accuracy. AUC ranges from 0 to 1 inclusive and the greater the value of AUC close to 1, the better the discriminatory power of the diagnostic procedure. Often times, the aim of many diagnostic studies is to compare the accuracy of diagnostic tests to determine the superiority of one test over another test for a certain condition or disease when data measurement may be on any scale. Statistical inference may be based on parametric, nonparametric or semi-parametric statistics. If the statistical inference is nonparametric, the difference between correlated AUCs for paired data was first proposed by DeLong et al.,3 and it is based upon asymptotic theory for U-statistics.4 But the validity of this or any other method relays on large sample size and when the sample size is small, the validity of the test for the difference between two or more AUCs may not be achieved. Two permutation tests for paired receiver operating characteristic (ROC) studies currently exist: one proposed by Venkatraman & Begg5 and the more recent test of Bandos et al.,6 The test of Bandos et al.,6 directly tests for an equality of AUCs, while the test of Venkatraman & Begg5 is more general and tests for equality of the underlying ROC curves. As a result, the test of Venkatraman & Begg5 is less powerful for testing equality of AUCs. Both permutation tests are executed by permuting the labels of the two tests within each diseased and non-diseased subject. Such an approach implicitly assumes that both tests are exchangeable within subject and requires an appropriate transformation, such as ranks, for tests differing in scale. Bandos et al.,6 compared the performance of their test to that of DeLong et al.,3 using simulation and found that the permutation test had greater power than the nonparametric test developed by DeLong et al.,3 when there was moderate correlation between two tests, large AUCs, and small sample sizes.
受试者工作特征(ROC)曲线是一个标准的工具，用于评估诊断测试的性能，当测试结果的测量是连续的或顺序的在20世纪50年代，ROC方法首先由电气和雷达工程师在第二次世界大战期间开发，用于战场上的信号检测理论在ROC曲线中，在其他所有可能的截止值上绘制真阳性率(TPR)与假阳性率(FPR)，以做出有意义的决策。ROC曲线下面积(AUC)是衡量诊断准确性的总结性指标。AUC取值范围为0 ~ 1，且AUC值越接近1，诊断程序的鉴别能力越强。通常情况下，许多诊断研究的目的是比较诊断测试的准确性，以确定一种测试比另一种测试对某种情况或疾病的优越性，当数据测量可以在任何尺度上。统计推断可以基于参数统计、非参数统计或半参数统计。如果统计推断是非参数的，配对数据的相关auc之间的差异首先由DeLong等人提出3，它是基于u统计的渐近理论但是，这种方法或任何其他方法的有效性依赖于大样本量，当样本量较小时，可能无法实现对两个或多个auc之间差异的检验的有效性。配对受试者工作特征(ROC)研究目前存在两种排列检验:一种是由Venkatraman & beg5提出的，另一种是Bandos等人最近的检验，6 . Bandos等人的检验，6 .直接检验auc的相等性，而Venkatraman & beg5的检验更一般，检验潜在ROC曲线的相等性。因此，Venkatraman & beg5的检验在检验auc的相等性方面效力较弱。这两种排列测试都是通过在每个患病和非患病受试者中排列两种测试的标签来执行的。这种方法隐含地假设这两种测试在主题内是可交换的，并且需要对不同规模的测试进行适当的转换，例如等级。Bandos et al.，6使用模拟将他们的测试性能与DeLong et al.，3进行了比较，发现当两个测试之间存在中等相关性，auc较大，样本量较小时，排列测试比DeLong et al. 3开发的非参数测试具有更大的功效。
{"title":"An extended McNemar test for comparing correlated proportion of positive responses","authors":"Okeh Uchechukwu Marius, Obiora-Ilouno Happiness","doi":"10.15406/bbij.2019.08.00281","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00281","url":null,"abstract":"The receiver operating characteristic (ROC) curve is a standard tool used to evaluate the performance of a diagnostic test when measurement of test results are either continuous or ordinal.1 In 1950s the methodology of ROC was first developed by electrical and radar engineers during World War II for signal detection theory in battle fields.2 In an ROC curve, the true positive rate (TPR) is plotted against the false positive rate (FPR) across all possible cut-off values in other to make meaningful decision. The area under the ROC curve (AUC) is a summary index for measuring the diagnostic accuracy. AUC ranges from 0 to 1 inclusive and the greater the value of AUC close to 1, the better the discriminatory power of the diagnostic procedure. Often times, the aim of many diagnostic studies is to compare the accuracy of diagnostic tests to determine the superiority of one test over another test for a certain condition or disease when data measurement may be on any scale. Statistical inference may be based on parametric, nonparametric or semi-parametric statistics. If the statistical inference is nonparametric, the difference between correlated AUCs for paired data was first proposed by DeLong et al.,3 and it is based upon asymptotic theory for U-statistics.4 But the validity of this or any other method relays on large sample size and when the sample size is small, the validity of the test for the difference between two or more AUCs may not be achieved. Two permutation tests for paired receiver operating characteristic (ROC) studies currently exist: one proposed by Venkatraman & Begg5 and the more recent test of Bandos et al.,6 The test of Bandos et al.,6 directly tests for an equality of AUCs, while the test of Venkatraman & Begg5 is more general and tests for equality of the underlying ROC curves. As a result, the test of Venkatraman & Begg5 is less powerful for testing equality of AUCs. Both permutation tests are executed by permuting the labels of the two tests within each diseased and non-diseased subject. Such an approach implicitly assumes that both tests are exchangeable within subject and requires an appropriate transformation, such as ranks, for tests differing in scale. Bandos et al.,6 compared the performance of their test to that of DeLong et al.,3 using simulation and found that the permutation test had greater power than the nonparametric test developed by DeLong et al.,3 when there was moderate correlation between two tests, large AUCs, and small sample sizes.","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77354026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-01DOI: 10.15406/bbij.2019.08.00279
D. Chakrabarty
The history of the beginning of the development of the theory of statistics had been lost in the dust of antiquity.1–5 It has been found that statistics in ancient times was used by the governments in keeping records related to administrative matters like birth, death, population, etc. while it has been found that John Grant is the first man to make study on birth, death, expectation of life etc. from statistical point of view in the 17th century.6 Statistics now has been found to be a major player in playing the role of understanding various phenomena in almost every branch of science. At the current stage of human civilization, statistics has become an unavoidable and essential analytical tool for scientific research.7,8 The discipline of biostatistics9–15 has been developed for the interest of research in bioscience, life science, biology and some allied fields.
{"title":"Association of statistics with biostatistics Research","authors":"D. Chakrabarty","doi":"10.15406/bbij.2019.08.00279","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00279","url":null,"abstract":"The history of the beginning of the development of the theory of statistics had been lost in the dust of antiquity.1–5 It has been found that statistics in ancient times was used by the governments in keeping records related to administrative matters like birth, death, population, etc. while it has been found that John Grant is the first man to make study on birth, death, expectation of life etc. from statistical point of view in the 17th century.6 Statistics now has been found to be a major player in playing the role of understanding various phenomena in almost every branch of science. At the current stage of human civilization, statistics has become an unavoidable and essential analytical tool for scientific research.7,8 The discipline of biostatistics9–15 has been developed for the interest of research in bioscience, life science, biology and some allied fields.","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75548338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-01DOI: 10.15406/bbij.2019.08.00280
K. Shukla
In the new era, uses of different life time distributions have been becoming more important because of increasing varieties of products and their survivors. Especially in reliability analysis, one can know failure rate as well time to survive of products, which can be calculated using different models. One parameter distribution can be applied easily way for any dataset, and its characteristics and mathematical properties can be calculated. Its applications are crucial in biostatistics as well as actuarial sciences and related field. The event may be failure of a piece of equipment, death of a person, development (or remission) of symptoms of disease, health code violation (or compliance). The modeling and statistical analysis of lifetime data are crucial for statisticians, research workers and policy makers in almost all applied sciences including engineering, medical science/biological science, insurance and finance, amongst others. Many statisticians have been proposed many distributions of one parameter and two parameters, but in this study, specially focused on some selected one parameter, most of them have been proposed recently. In this paper, author is tried to compare statistics of one parameter lifetime distributions using different lifetime data-sets from Engineering, medical sciences and social sciences. Different distributions have been proposed by different statisticians. Names of distributions of one parameter and their introducers are given in Table 1.
{"title":"A comparative study of one parameter lifetime distributions","authors":"K. Shukla","doi":"10.15406/bbij.2019.08.00280","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00280","url":null,"abstract":"In the new era, uses of different life time distributions have been becoming more important because of increasing varieties of products and their survivors. Especially in reliability analysis, one can know failure rate as well time to survive of products, which can be calculated using different models. One parameter distribution can be applied easily way for any dataset, and its characteristics and mathematical properties can be calculated. Its applications are crucial in biostatistics as well as actuarial sciences and related field. The event may be failure of a piece of equipment, death of a person, development (or remission) of symptoms of disease, health code violation (or compliance). The modeling and statistical analysis of lifetime data are crucial for statisticians, research workers and policy makers in almost all applied sciences including engineering, medical science/biological science, insurance and finance, amongst others. Many statisticians have been proposed many distributions of one parameter and two parameters, but in this study, specially focused on some selected one parameter, most of them have been proposed recently. In this paper, author is tried to compare statistics of one parameter lifetime distributions using different lifetime data-sets from Engineering, medical sciences and social sciences. Different distributions have been proposed by different statisticians. Names of distributions of one parameter and their introducers are given in Table 1.","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83737406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-27DOI: 10.15406/bbij.2019.08.00278
Othmar W. Winkler
Everybody dealing with data will, at one time or another, employ regression analysis. This very unusual case happened during the exploratory phase of the data of a sex-discrimination lawsuit.1 The 32 librarians,16 male and 16 equally qualified female librarians of that government agency, appeared to be ideally suited to initiate discovery of the claimed discrimination in that professional workforce. Simple linear regressions of salary and length of employment, computed separately for the male and the female librarians, was a first approach to reveal the supposed existence and nature of sex-discrimination. Though expecting differences between these two regressions, the author was unprepared to make sense of the women’s regression and incredulous. The fundamental insight gained by resolving this statistical puzzle should be of general interest.
{"title":"A Statistical mystery resolved","authors":"Othmar W. Winkler","doi":"10.15406/bbij.2019.08.00278","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00278","url":null,"abstract":"Everybody dealing with data will, at one time or another, employ regression analysis. This very unusual case happened during the exploratory phase of the data of a sex-discrimination lawsuit.1 The 32 librarians,16 male and 16 equally qualified female librarians of that government agency, appeared to be ideally suited to initiate discovery of the claimed discrimination in that professional workforce. Simple linear regressions of salary and length of employment, computed separately for the male and the female librarians, was a first approach to reveal the supposed existence and nature of sex-discrimination. Though expecting differences between these two regressions, the author was unprepared to make sense of the women’s regression and incredulous. The fundamental insight gained by resolving this statistical puzzle should be of general interest.","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76505324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-16DOI: 10.15406/BBIJ.2019.08.00277
Heon-Jae Jeong, Wui-Chiang Lee, Son Deog Hyeon, Lee Jung Hwa, Ryu Su Sang, Shin Hye Yoo, E. Bae, Chul-Ho Kim, S. Han
The Safety Attitudes Questionnaire (SAQ) has been one of the most popular instruments for gauging safety culture among healthcare workers (HCWs) in hospitals around the world.1 South Korea is one such country that has benefited from SAQ for years.2 However, despite its positive impact on improving safety, the SAQ Korean version (SAQ-K) has a couple of weaknesses. First, considering HCWs’ large workload, the SAQ-K included too many items, leading respondents to not care or even drop out in the middle of completing the questionnaire. In addition, several items contained unclear expressions due to the English-to-Korean translation. In this study, we tried to develop a newer version of the SAQ with a string tag of ‘-K2’ by completely resolving these problems with the previous instrument. SAQ-K2 is kinder to respondents by providing a smaller number of items in a more explicit and more natural translation.
{"title":"An efficiency-oriented reform of safety attitudes questionnaire–Korean version (Development of SAQ-K2)","authors":"Heon-Jae Jeong, Wui-Chiang Lee, Son Deog Hyeon, Lee Jung Hwa, Ryu Su Sang, Shin Hye Yoo, E. Bae, Chul-Ho Kim, S. Han","doi":"10.15406/BBIJ.2019.08.00277","DOIUrl":"https://doi.org/10.15406/BBIJ.2019.08.00277","url":null,"abstract":"The Safety Attitudes Questionnaire (SAQ) has been one of the most popular instruments for gauging safety culture among healthcare workers (HCWs) in hospitals around the world.1 South Korea is one such country that has benefited from SAQ for years.2 However, despite its positive impact on improving safety, the SAQ Korean version (SAQ-K) has a couple of weaknesses. First, considering HCWs’ large workload, the SAQ-K included too many items, leading respondents to not care or even drop out in the middle of completing the questionnaire. In addition, several items contained unclear expressions due to the English-to-Korean translation. In this study, we tried to develop a newer version of the SAQ with a string tag of ‘-K2’ by completely resolving these problems with the previous instrument. SAQ-K2 is kinder to respondents by providing a smaller number of items in a more explicit and more natural translation.","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78743973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-16DOI: 10.15406/bbij.2019.08.00276
Zhengning Lin
Assessment of change in exercise capacity using the 6-minute walk distance (6MWD) tests has been the primary endpoint in many pulmonary arterial hypertension (PAH) and neuromuscular disorder clinical trials. However, large power losses were observed in the primary endpoint of 6MWD analysis in well-powered placebo-controlled studies. One study is a new drug application (NDA) of drisapersen in 2015. The drisapersen NDA included 3 placebo-controlled studies to demonstrate efficacy for Duchenne Muscular Dystrophy, a rare progressive neuromuscular disorder that is ultimately fatal for boys at a young age. Change in 6MWD is the primary endpoint. While the two smaller proof-of-concept pilot studies showed consistent treatment differences, the larger and only well-powered placebo-controlled study failed to detect a treatment difference. The statistical power of the pre-planned primary analysis was reduced from the planned 90% to only 53% as a result of the increased standard deviation from the planned 55 meters to the actual 87 meters, based on the parametric model of mixed model repeated measurement (MMRM) assuming normal data distribution.
{"title":"Assessing the impact of extreme values in clinical studies−a latent variable approach","authors":"Zhengning Lin","doi":"10.15406/bbij.2019.08.00276","DOIUrl":"https://doi.org/10.15406/bbij.2019.08.00276","url":null,"abstract":"Assessment of change in exercise capacity using the 6-minute walk distance (6MWD) tests has been the primary endpoint in many pulmonary arterial hypertension (PAH) and neuromuscular disorder clinical trials. However, large power losses were observed in the primary endpoint of 6MWD analysis in well-powered placebo-controlled studies. One study is a new drug application (NDA) of drisapersen in 2015. The drisapersen NDA included 3 placebo-controlled studies to demonstrate efficacy for Duchenne Muscular Dystrophy, a rare progressive neuromuscular disorder that is ultimately fatal for boys at a young age. Change in 6MWD is the primary endpoint. While the two smaller proof-of-concept pilot studies showed consistent treatment differences, the larger and only well-powered placebo-controlled study failed to detect a treatment difference. The statistical power of the pre-planned primary analysis was reduced from the planned 90% to only 53% as a result of the increased standard deviation from the planned 55 meters to the actual 87 meters, based on the parametric model of mixed model repeated measurement (MMRM) assuming normal data distribution.","PeriodicalId":90455,"journal":{"name":"Biometrics & biostatistics international journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83895947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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