International Journal of Clinical Biostatistics and Biometrics is an international, peer reviewed, open access journal on conceptual, constructive, experimental, computational, investigational, or theoretical work in all areas of biostatistics and biometrics. The Journal provides the authors with a great platform for publication of their work and for the exchange of their ideas. We aim to publish highest quality clinical content via open access platform providing the readers without charge, immediate and unlimited access.
International Journal of Clinical Biostatistics and Biometrics publishes articles on Data Modeling, Bayesian Probability, Bioinformatic Methods, Biological Experimental Data Modeling, Biostatistic Theory and Methods, Climate and Environmental Data Modeling, Clinical Study Design and Analysis, Clinical Trials and Assessment Methods, Computational Biology, Distribution and Modeling of Disease Dynamics, Epidemiological Data Modeling and Analysis, Evolution and Population Genetics, Genetics and Genetic Epidemiology, Health Services Research and Assessment, Mathematical Biology, Medical Imaging Data Modeling, Pain Management Anesthesia, Public Health and Healthcare Evaluation, Public Health Policy Research, Statistical Computation and Applications, etc. All articles published in the journal are subject to a rigorous peer review process.
Articles Search by Keyword | Journal title | Author name | DOI
Open Access DOI:10.23937/2469-5831/1510043
Haitao Pan, Chai-Wei Hsu, Rongji Mu and Shouhao Zhou
Article Type: Methodology | First Published: December 09, 2021
Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, to describe the event of a patient who experiences a dose-limiting toxicity. However, there is a growing interest in dose-finding studies involving non-binary outcomes, defined by either the weighted sum of rates of vari...
Open Access DOI:10.23937/2469-5831/1510042
Derviş Topuz and Kenan Kiliç
Article Type: Research Article | First Published: September 06, 2021
The aim of this study is to determine whether the potential toxic copper element values measured in soils (X1), vegetables (X2) and waters (X3) have an effect on the copper elements in the stomach and intestinal tissue (Yi) (ppm) of individuals in an area of approximately 2400 km2 covering the east of Erciyes strato volcano. We applied Diamond’s fuzzy least squares (FLS) method, which assumes that the deviation between the observed and the predicted values is due to the fuzziness of the coeffi...
Open Access DOI:10.23937/2469-5831/1510041
Adisa Jamiu SAKA
Article Type: Medical Statistics | First Published: August 16, 2021
Human heart is a strong muscle that pumps blood to the body. A normal, healthy adult heart is about the size of human clenched fist and it is like an engine that makes a car works, moves and functions properly as such, the heart keeps the body running. A healthy heart supplies the body with just the right amount of blood at the right rate for whatever the body is doing at that time. The flow of blood to the heart could be reduced by plaque build-up or blockage by a plaque suddenly ruptures, thes...
Open Access DOI:10.23937/2469-5831/1510040
Efficacy and Safety of Rilpivirine-Based Antiretroviral Therapy in Treatment-Naïve and Treatment-Experienced HIV-1- Positive Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
Lazzarin A, Rusconi S, Antinori A, Galeone C, Uglietti A, Termini R and Mancusi D
Article Type: Meta-Analysis | First Published: August 16, 2021
Rilpivirine (RPV) is a second-generation non-nucleoside reverse-transcriptase inhibitor used in combination antiretroviral therapy (cART) in naive and experienced HIV-positive adult subjects. To evaluate its efficacy and safety in these patient settings, we performed a metaanalysis of randomized controlled trials with available data at 48 and 96 weeks of follow-up. We considered 4 studies involving 2336 cART-naïve patients and 8 studies involving 3165 cART-experienced virologically controlled p...
Open Access DOI:10.23937/2469-5831/1510039
Emmanuel Azuaba, Bimba John Samson, Edwin Ehi Eseigbe, Tamber Jighjigh Abraham, Yusuf Musa, Akude Christian, Isah Omeiza Haroun and Oniore Jonathan Ojarikre
Article Type: Original Research | First Published: July 28, 2021
COVID-19 virus has spread everywhere in Africa and to the 36 states of Nigeria, including the Federal Capital Territory (FCT), Abuja. The outbreak of COVID-19 in Lagos, since February 27, 2020 has generated 158,506 confirmed cases, including 1,969 deaths, as of 8 March 2021. In most cases, community transmission is the prime factor in which the viruses are fast spreading. Fortunately, there has never been a reported incidence of COVID-19 infection on any of the Nigerian university campuses. We a...
Open Access DOI:10.23937/2469-5831/1510038
Article Type: Original Article | First Published: June 28, 2021
Phase III superiority clinical trials have negative results (new treatment is not statistically better than standard of care) due to a number of factors, including patient and disease heterogeneity. However, even a treatment regime that fails to show population-level clinical improvement will have a subgroup of patients that attain a measurable clinical benefit. The goal of this paper is to modify the Patient Rule-Induction Method to identify statistically significant subgroups, defined by clini...
Open Access DOI:10.23937/2469-5831/1510037
Derviş Topuz and Adnan Karaibrahimoğlu
Article Type: Research Article | First Published: June 28, 2021
In the fuzzy regression models that are fitted by using fuzzy logic, every regression coefficient should be estimated at a certain level of a fuzziness tolerance because of dividing the error value into the coefficient. This study aims to compute the coefficient and deviation values of classical least squares (OLS) and fuzzy interval regression models on a sample data set and interpret them comparatively. There were totally 514 patients with OSAS (Obstructive Sleep Apnea Syndrome) who admitted t...
Open Access DOI:10.23937/2469-5831/1510036
Merve Parmaksiz, Hayal Boyacioğlu, Pelin Güneri and Nezaket Ezgi Özer
Article Type: Research Article | First Published: June 28, 2021
In this study, the objective was to compare different estimation methods in diagnostic meta-analysis. In this scope, DerSimonian and Laird (DL), Restricted Maximum Likelihood (REML), Sidik and Jonkman (SJ), Hedges and Olkin (HO), Maximum Likelihood (ML), Paule and Mandel (PM) estimation methods were examined. In the implementation part, effectiveness of Clinical Oral Examination (COE) in predicting the diagnosis of histological dysplasia or Oral Squamous Cell Carcinoma (OSCC) was studied. Meta a...
Open Access DOI:10.23937/2469-5831/1510035
Jorge Alberto Achcar, Ricardo Puziol de Oliveira and Emerson Barili
Article Type: Original Article | First Published: April 21, 2021
Monthly tuberculosis (TB) counts from January 2001 to December 2018 showed an upward trend (data from SINAN - Information System for Notifiable Diseases). The increase in the incidence of TB in general is associated with an increase in the rate of extreme poverty, an increase in AIDS cases and other factors. Combining the polynomial linear regression and stochastic volatility models, the purpose of this study was to analyze monthly count data as well as the AIDS/TB, extreme poverty/TB and urban/...
Open Access DOI:10.23937/2469-5831/1510034
Theofilidis Antonis and Fountoulakis Konstantinos
Article Type: Original Article | First Published: April 09, 2021
Schizophrenia is a chronic and severe mental disorder affecting 20 million people worldwide. Characterized by distortions in thinking, perception, emotions, language, sense of self and behaviour. Differences in body mass index, weight and height, in patients with schizophrenia, mood disorders vs. normal controls. The study sample included 76 patients with unipolar depression, 16 patients with schizoaffective disorder, 122 patients with schizophrenia, and 78 patients with other mental disorders,...
Open Access DOI:10.23937/2469-5831/1510033
Article Type: Research Article | First Published: January 20, 2021
The number of fatalities caused by the COVID virus is not only extremely high but also increasing at an alarming rate. The many strategies that are being used throughout the world, to control the pandemic, are being overwhelmed mercilessly by the global pandemic. In this paper three different optimization strategies are used to determine the best strategy that can minimize the damage. It is also demonstrated that for one value of the number of infected subjects two values of recovered and perish...
Open Access DOI:10.23937/2469-5831/1510032
Eitan Flor, Florence George and BM Golam Kibria
Article Type: Original Article | First Published: November 14, 2020
With the rise of the COVID-19 pandemic, several changes occurred in the lifestyle and habits of human life. These include various voluntary and mandatory governmental restrictions, limiting social interaction by encompassing social distancing, travel limitations, social gatherings, personal mobility, as well as closures and reduced capacities in sectors such as retail, restaurants, and the entertainment industry. The purpose of the restrictions ideally intended to reduce the transmission rate of...
Open Access DOI:10.23937/2469-5831/1510031
Issam Dawoud and BM Golam Kibria
Article Type: Original Article | First Published: November 11, 2020
This paper proposes a new biased estimator for estimating the regression parameters for the multiple linear regression models when the regressors are correlated. Theoretical comparisons and simulations results show that, the proposed estimator performs better than other existing estimators under some conditions in the smaller mean squares error sense. A real-life dataset is analyzed to illustrate the findings of the paper. The ordinary least squares (OLS) estimator is the best linear unbiased es...
Open Access DOI:10.23937/2469-5831/1510030
Huiding Chen, Ao Yuan and Ming T Tan
Article Type: Research Article | First Published: October 14, 2020
Biomarker targeted two-stage adaptive design is used increasingly in early-stage clinical trials in a variety of therapeutic areas including oncology, where the sample size of the trial is re-estimated based on the first stage data. In such trials often the sample size is moderate, and so incorporating prior information and using robust methods are desirable. In this article, to improve upon existing methods using parametric normal models, we propose a nonparametric Bayesian approach for designi...
Open Access DOI:10.23937/2469-5831/1510029
Alberto Saraiva Tibúrcio, MD and Fabíola Curvello Leite Tibúrcio, MD
Article Type: Patient Care | First Published: August 26, 2020
Pulmonary thromboembolism is a clinical condition that is difficult to diagnose and highly lethal if not diagnosed and treated in time. The COVID-19 pandemic has greatly increased the incidence of PTE in patients affected by the SARS-CoV-2 virus. On July 16, 2020, at the time of making this manuscript, the COVID-19 pandemic, a disease caused by the new coronavirus SARS-CoV-2, has already reached more than 13.7 million confirmed cases on a global scale and about six thousand deaths daily, totalin...
Open Access DOI:10.23937/2469-5831/1510028
Robert Magari, PhD, Mohamad Hasan, PhD and Karen Lo
Article Type: Original Article | First Published: July 10, 2020
The need for multiregional clinical trials for in vitro diagnostic devices and extrapolating results in a new region is increasing in recent years. In this paper we are providing strategies for consideration of bridging studies for the two most common types of clinical trials for in vitro diagnostic, method comparison and diagnostic clinical performance trials. Bridging studies should be considered when the expected agreement in the new region is inferior to the agreement in the original trial. ...
Open Access DOI:10.23937/2469-5831/1510027
Matthew Ekum and Adeyinka Ogunsanya
Article Type: Research Article | First Published: June 27, 2020
COVID-19 is the disease caused by a novel coranavirus, which outbreak started in Wuhan community of China during December, 2019. World Health Organisation (WHO) started reporting cases of COVID-19 on 21st January. In this research, we aimed at forecasting new cases of COVID-19 per day, using data collected from 21st January to 10th June, 2020, spanning 142 days, by fitting polynomial models. Different model selection criteria were used to determine the most appropriate model among assumed models...
Open Access DOI:10.23937/2469-5831/1510026
Tadeusz R Ostrowski, MD and Tadeusz Ostrowski, PhD
Article Type: Original Article | First Published: June 05, 2020
The paper focuses on four basic statistics of dichotomous diagnostic tests, i.e. sensitivity, specificity, positive and negative predictive value, and some of their derivates, like Youden index and predictive summary index, and on further derivates of these derivates, i.e. Matthews correlation coefficient (or Yule phi), chi squared test and Cramer’s V coefficient. The paper contains also the necessary and sufficient conditions for a test to be invalid, to be uninformative and the necessary con...
Open Access DOI:10.23937/2469-5831/1510025
Adnan N Kiani, Babatunde Olaiya, Richard Berg and Ateeq Rehman
Article Type: Research Article | First Published: March 19, 2020
ACGME has put great emphasis on scholarly activity during residency, yet ACGME has not been able to identify gaps in achieving these goals. We possess longitudinal data for the last 10 years across our residency training programs. With this, we have identified missing gaps as well as propose interventions to address gaps. The research design employs utilizing a standardized research instrument (questionnaire), answered by every resident at the onset and completion of residency training. This que...
Open Access DOI:10.23937/2469-5831/1510024
Maxim S Kodryan, Anna V Kuznetsova, Luidmila L Klimenko, Aksana N Mazilina, Ivan V Baskakov and Oleg V Senko
Article Type: Research Article | First Published: March 04, 2020
It is known that vascular endothelial growth factor (VEGF) expression is a response to hypoxia. On the other hand hypoxia may be detected by oximetry parameters including venous CO-oximetry indices or corresponding partial pressures of O2 and CO2. However significant correlation ties between VEGF levels and oximetry parameters were not found in groups of patients with ischemic stroke and transient ischemic attack. At that some effect related to the relationship between VEGF and sO2 was observed ...
Open Access DOI:10.23937/2469-5831/1510023
Article Type: Original Article | First Published: December 14, 2019
Pharmacovigilance is the primary method used to identify hazards associated with medicinal products. Using generalized likelihood ratio tests, we examed the adverse reaction signals of the drug class Monoamine oxidase inhibitors (MAOIs) from World Health Organization’s Pharmacovigilance Database. The proposed test procedure has the ability of detecting adverse reactions of multiple drugs simultaneously. Our findings sugggest there are 23 common Adverse reaction signals detected within this dru...
Open Access DOI:10.23937/2469-5831/1510022
Ilker Etikan, Ogunjesa Babatope, Kabiru Bala and Savas Ilgi
Article Type: Research Article | First Published: September 30, 2019
According to the United Nations Sustainable Development Goals, countries all over the world are expected to create a healthy living environment for the populace most especially the vulnerable population of which children are examples. Despite the reducing trend in the under-five mortality rate in some developing nations, some nations still have a high record of under-five mortality. This study adopted the use of a One-way Analysis of Variance (ANOVA) to evaluate any significant difference in the...
Open Access DOI:10.23937/2469-5831/1510021
Dejian Lai, Ahmed A Arif, Haiyun Xu and George L Delclos
Article Type: Original Research article | First Published: April 29, 2019
Statistical classification analysis has been widely used in many fields. In this article, we applied and compared three different classification procedures: Logistic regression, Fisher''s linear discriminant function and the second order Bahadur representation to two datasets from two surveys on asthma among healthcare professional in Texas. The first dataset contained 102 subjects and the second dataset 2963. The concordance of the classification from the three statistical procedures with possi...
Open Access DOI:10.23937/2469-5831/1510020
Khalid A Salah
Article Type: Research Article | First Published: March 25, 2019
We propose to approximate a model for repeated measures that incorporated random effects, correlated stochastic process and measurements error. The stochastic process used in this paper is the Integrated Ornstein-Uhlenbeck (IOU) process. We consider a Bayesian approach which is motivated by the complexity of the model, thus, we propose to approximate the IOU stochastic process into a continuous spatial model that constructed by convolving a very simple and independent, process with a kernel func...
Open Access DOI:10.23937/2469-5831/1510019
Xiaoyong Wu, Jayesh P Rai, Guohua Yan, Srivastava DK and Shesh N Rai
Article Type: RESEARCH ARTICLE | First Published: March 04, 2019
Assessing the performance of diagnostic tests for repeated binary measurements is very important in clinical trials and diagnostic medicine. The gastric-emptying studies involve 4-hourly measurements of emptying. Empirical results suggest that the gastric emptying results over time are correlated and therefore failure to consider the correlation in statistical measures may not produce satisfactory assessments. If these measurements are highly correlated/associated, early gastric emptying can be ...
Open Access DOI:10.23937/2469-5831/1510018
Hai Zhu, Mary Akosile, Shuqin Zhang, Nils P Johnson, Dejian Lai and Hongjian Zhu
Article Type: Research Article | First Published: July 28, 2018
Right heart catheterization (RHC) is a well-established diagnostic tool for patients with congenital and acquired right heart disease and to actively monitor critically ill patients in the intensive care unit. Notably, previous randomized controlled trials and observational studies provide limited support for the clinical utilization of RHC in critically ill patients. However, traditional statistical methods incorporating propensity scores rely heavily on potentially invalid parametric assumptio...
Open Access DOI:10.23937/2469-5831/1510017
Jingwen Gu, Ao Yuan, Chunxiao Zhou, Leighton Chan and Ming T Tan
Article Type: Research Article | First Published: April 14, 2018
We propose and study a method for partial covariates selection, which only select the covariates with values fall in their effective ranges. The coefficients estimates based on the resulting data is more interpretable based on the effective covariates. This is in contrast to the existing method of variable selection, in which some variables are selected/deleted in whole. To test the validity of the partial variable selection, we extended the Wilks theorem to handle this case. Simulation studies ...
Open Access DOI:10.23937/2469-5831/1510016
Yu-Ting Weng, Yi Tsong, Meiyu Shen and Chao Wang
Article Type: Research Article | First Published: March 15, 2018
The equivalence test in analytical similarity assessment uses a margin of 1.5 times of the standard deviation of a reference product. In the current practice, the standard deviation, estimated from study data, is considered as a fixed constantin the margin....
Open Access DOI:10.23937/2469-5831/1510015
Rand R Wilcox
Article Type: Research Article | First Published: December 22, 2017
Certainly the best-known method for making inferences about p is the Wilcoxon-Mann-Whitney (WMW) test. It is well known, however, that under general conditions, the WMW method uses an incorrect estimate of the standard error. Numerous methods have been derived for dealing with this issue....
Open Access DOI:10.23937/2469-5831/1510014
Ke-Sheng Wang, Ying Liu, Shaoqing Gong, Chun Xu, Xin Xie, Liang Wang and Xingguang Luo
Article Type: Research Article | First Published: December 01, 2017
Alzheimer's Disease (AD), the most common form of dementia, is a chronic neurodegenerative disease. The HECT domain and ankyrin repeat containing E3 ubiquitin protein ligase 1 (HACE1) gene is expressed in human brain and may play a role in the pathogenesis of neurodegenerative disorders....
Open Access DOI:10.23937/2469-5831/1510013
Man Jin and James L Kepner
Article Type: Research Article | First Published: October 09, 2017
For a rare disease, all the patients having the disease constitute a small population, and the standard single-stage hypergeometric test is uniformly most powerful to evaluate the response probability of a specific treatment regimen....
Open Access DOI:10.23937/2469-5831/1510012
Xiaoyong Wu and Shesh N Rai
Article Type: Research Article | First Published: October 07, 2017
Reproducibility of results in simulation studies plays a key role in statistical science. Although P-value occupies a prominent place for determining statistical significance in replicate studies, there is always possibility of extra variability across samples leading to irreproducible results. Recently, Halsey, et al....
Open Access DOI:10.23937/2469-5831/1510011
Gerd K Rosenkranz
Article Type: Research Article | First Published: September 23, 2017
Personalized medicine today is primarily addressing efficacy. Here we investigate and illustrate the role that precision medicine could play in drug safety by supporting the identification of subjects at high risk of harm by an otherwise safe and efficacious treatment. Predicting potential harm requires high sensitivity of a classification rule....
Open Access DOI:10.23937/2469-5831/1510010
Joyce Cheng, Hui Zhang, Shenghui Tang and Rajeshwari Sridhara
Article Type: Original Article | First Published: May 20, 2017
The drug development paradigm in oncology has changed in recent times as developments in science and technology have led to more targeted therapies. Drug products are receiving marketing approvals based on single randomized studies enrolling 100-200 patients, including early phase (phase II) clinical trials....
Open Access DOI:10.23937/2469-5831/1510009
Junshan Qiu and Ram Tiwari
Article Type: Research Article | First Published: June 30, 2016
Missing data are primarily due to dropout which can be categorized into different types based on its relation to the response process. For simplicity, it is generally assumed that the relation between a specific type of dropout and the response process can be described using a single (indicator) random variable. In case of distinct types of dropout, it is natural to use the multinomial indicator variables to model the dropout....
Open Access DOI:10.23937/2469-5831/1510008
Jason JZ Liao
Article Type: Research Article | First Published: December 3, 2015
To develop a biosimilar product, it is necessary to demonstrate biosimilarity between the proposed biosimilar product and the reference product in terms of the purity, potency, efficacy, and safety. In this paper, clinical efficacy data required for establishing biosimilarity are considered. Non-inferiority (NI) and equivalence methods are commonly used for analyzing clinical trials to meet this requirement. The equivalence approach often requires large, costly, and lengthy clinical trials....
Open Access DOI:10.23937/2469-5831/1510007
Michael A. Frolich, Paul Jung and Shannon Starr
Article Type: Research Article | First Published: November 2, 2015
The field of functional magnetic resonance imaging (fMRI) has grown in usage, applications, and complexity. The results of a general linear model (GLM) analysis vary from one investigator to another as they depend on image preprocessing, model choices and physiological assumptions. There is a need for a simple, efficient and consistent analysis method. Methods: We propose the target frequency analysis (TFA) as an intuitive, computationally efficient method to analyze data from block design fMRI ...
Open Access DOI:10.23937/2469-5831/1510006
Haixin Wang and Dawit Aberra
Article Type: Original Article | First Published: October 03, 2015
One of the most important properties in gene expression is the stochasticity. Gene expression process is noisy and fluctuant. In this paper, the noise of gene regulatory networks (GRNs) using polynomial model and S-system model is analyzed by proposed approach on the basis of particle filter. The measurement noise and process noise are analyzed to test noise effects on the synthetic GRNs. The relation among Root Mean Square (RMS) error, measurement noise, and system noise covariance is analyzed....
Open Access DOI:10.23937/2469-5831/1510005
Douglas D Gunzler, James C Spilsbury, Michael Fu, Susannah Rose, Neal V Dawson, Shirley Moore and Thomas E Love
Article Type: Original Article | First Published: September 28, 2015
As institutions and funders expand their efforts toward multi-disciplinary, interdisciplinary, and even transdisciplinary research, there is a substantial need for scientists who can lead such efforts. The traditional image of a leader of transdisciplinary clinical research is a quantitatively savvy clinician conducting research at some point along the continuum from the 'bench to the bedside'. However, this is not the only alternative. Nonclinician scientists can also provide effective leadersh...
Open Access DOI:10.23937/2469-5831/1510004
Ke-Sheng Wang, Yue Pan, Weize Wang and Chun Xu
Article Type: Research Article | First Published: September 9, 2015
The protein tyrosine phosphatase, receptor type, N polypeptide 2 (PTPRN2) gene may play a role in cancer; however, no study has focused on the associations of genetic variants within the PTPRN2 gene with age at onset (AAO) of cancer. Methods: This study examined 220 single nucleotide polymorphisms (SNPs) within the PTPRN2 gene in the Marshfield sample with 716 cancer cases (any diagnosed cancer, excluding minor skin cancer) and 2,848 non-cancer controls. Multiple logistic regression model and li...
Open Access DOI:10.23937/2469-5831/1510003
Emil N. Coman, L. Suzanne Suggs, Maria Coman and Eugen Iordache and Judith Fifield
Article Type: Review Article | First Published: September 4, 2015
We provide a comprehensive review of simple and advanced statistical analyses using an intuitive visual approach explicitly modeling Latent Variables (LV), likely to better illuminate what is assumed in each analytical method and what is actually estimated, by translating the causal relationships embedded in the graphical models in equation form. We recommend the graphical display rooted in the century old path analysis, that details all parameters of each statistical model, and suggest labeling...
Open Access DOI:10.23937/2469-5831/1510002
Kevin Soderholm and Rhonda Magel
Article Type: Research Article | First Published: September 02, 2015
Data from over 2000 patients receiving knee replacement surgery was gathered from a hospital system in the Midwestern United States. The age group that each patient belonged to was noted, under age 65 or 65 years of age and older, as well as their gender. A variety of drugs in each of three drug categories was studied as to their association with total hospital cost, length of stay, prevalence of early readmissions and prevalence of blood transfusions. The drug categories included spinal blocks,...
Open Access DOI:10.23937/2469-5831/1510001
Yorghos Tripodis and Nikolaos Zirogiannis
Article Type: Research Article | First Published: August 28, 2015
We propose a dynamic factor model appropriate for large epidemiological studies and develop an estimation algorithm which can handle datasets with large number of subjects and short temporal information. The algorithm uses a two cycle iterative approach for parameter estimation in such a large dataset. Each iteration consists of two distinct cycles, both following an EM algorithm approach. This iterative process will continue until convergence is achieved. We utilized a dataset from the National...
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