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.

Journal Information

Title: International Journal of Clinical Biostatistics and Biometrics

ISSN: 2469-5831

Editor-in-chief: James Michael Hardin

NLM title abbreviation: Int J Clin Biostat Biom

ISO abbreviation: Int J Clin Biostat Biom

Other titles: IJCBB

Category: Public health/Biological Science

DOI: 10.23937/2469-5831

Peer review: Double blind

Review speed: 3 weeks

Fast-track review: 10 days

Publication format (s): Electronic and print

Publication policy: Open Access; COPE guide

Publication type(s): Periodicals

Publisher: ClinMed International Library

Country of publication: USA

Language: English

Contact email:

Articles Search by   Keyword   |   Journal title   |   Author name   |   DOI


 Open Access DOI:10.23937/2469-5831/1510053

Analyzing the Covariance Structure of Plasma Signaling Proteins in Relation to the Diagnosis of Dementia

Calvin Guan, Rhoda Au, Alvin Ang and Ashis Gangopadhyay

Article Type: Original Research | First Published: 2024/02/12

Numerous studies have shown that individuals with dementia have exhibited activation of inflammatory pathways in their brains. Typically, these studies use traditional and well-established regression methods for data analysis. In this paper, a new approach is introduced that utilizes the analysis of the covariance structure using methods related to the principal component analysis (PCA) theory. Eleven biomarkers related to neuroinflammation were used to determine the association with the onset o...

 Open Access DOI:10.23937/2469-5831/1510052

Statistical Analysis in Clinical Trials Using the Study Data Tabulation Model (SDTM) and the Analysis Dataset Model (ADaM): Effects, Obstacles, and Solutions

Sagar Kumar Patel, Srinivasa Reddy Mukkala, Rachna Patel and Sandeep Bolla

Article Type: Review Article | First Published: 2023/09/25

Proper statistical analysis is the most important thing in clinical trials if a person wants to come to accurate conclusions and make smart decisions about the safety and effectiveness of new medical interventions. The utilization of the Study Data Tabulation Model (SDTM) and the Analysis Dataset Model (ADaM) is imperative in facilitating this process. The Study Data Tabulation Model (SDTM) is a universally accepted and standardized framework utilized to structure and display data obtained from ...

 Open Access DOI:10.23937/2469-5831/1510051

Biostatistical Methodologies in Clinical Trials: An Overview of Recent Developments and Pitfalls

Sagar Kumar Patel, Rachna Patel and Sandeep Bolla

Article Type: Review Article | First Published: August 16, 2023

Biostatistical analysis has emerged as one of the most crucial applications for clinical trial systems. The relevance of statistical analysis in clinical trials cannot be overstated in the advancement of novel pharmaceuticals and therapeutics. Data volumes, including effectiveness and safety summaries, are produced throughout the process of developing and approving novel medicines....

 Open Access DOI:10.23937/2469-5831/1510050

Fitting Birth and Death Queuing Models using Maximum Likelihood Estimation with Application to COVID-19 Pandemic in Sub-Saharan Africa

Nkemnole EB and Kuti OO

Article Type: Research Article | First Published: March 03, 2023

The COVID-19 pandemic has revealed facts about deficiencies in health resource planning of some countries having relatively high case count and death toll. The virus has undergone an observed increase of cases that led to a global pandemic. Many authors have developed different models for predicting or observing the current trend of COVID-19 pandemic. In this study, fitting birth and death models using maximum likelihood estimation (MLE) method with application to COVID-19 in sub-Sahara Africa i...

 Open Access DOI:10.23937/2469-5831/1510049

Hypothyroidism: A Small Clinical Trial Will Quickly Resolve the Combination Therapy Controversy

Timothy A Welborn, AO, PhD, FRCP, FRACP, MBBS and Satvinder S Dhaliwal, PhD, MSc, BSC

Article Type: Letter | First Published: October 23, 2022

Hypothyroidism is an extremely common condition. More than 100 million prescriptions for thyroxine (T4) are processed in the USA each year. T4 is the recommended treatment for hypothyroidism. But 5-15% of patients treated to target with T4 continue to have symptoms. Some of these patients respond dramatically to the addition of triiodothyronine (T3) as first reported 20 years ago....

 Open Access DOI:10.23937/2469-5831/1510048

A New Modified Liu Ridge-Type Estimator for the Linear Regression Model: Simulation and Application

Olasunkanmi J Oladapo, Abiola T Owolabi, Janet I Idowu and Kayode Ayinde

Article Type: Original Research | First Published: July 09, 2022

Several efforts have been made to solve the multicollinearity problem, which arises from correlated regressors in the linear regression model. This is because the Ordinary Least Squares (OLS) Estimator becomes inefficient in the presence of multicollinearity....

 Open Access DOI:10.23937/2469-5831/1510047

Development of a Novel Retrospective Instrument to Gauge the General Well-being Index and Lumbar Specific Disability Index Post Intervention in Lumbar Degenerative Disease

Song Ying Chong, MBBS, Mahmoud Danaee, PhD and Dharmendra Ganesan, FRCS

Article Type: Original Article | First Published: July 04, 2022

The clinical outcome data for patients who had a particular intervention for the lumbar degenerative disease is based on changes in symptomatology. This functional data had been acquired in a prospective manner using standard tools e.g., ODI, RMQ, SF-36 etc. Such data may be lacking in many facilities of developing countries due to various reasons....

 Open Access DOI:10.23937/2469-5831/1510046

Time Based Prediction of Breast Cancer Tumor Recurrence Using Machine Learning

Siddharth Raj Gupta

Article Type: Original Article | First Published: May 06, 2022

An in-depth study using the database from GLOBOCAN, CDC, and WHO health repository highlights the lethality of breast cancer, taking thousands of lives each year. Therefore, timely prediction of cancer can help patients to consult the doctor on time. In the past various studies have successfully predicted the nature of the tumor to be benign or malignant and if the breast cancer tumor will reoccur or not. However, no time-based models have been studied previously. With the help of Machine Learni...

 Open Access DOI:10.23937/2469-5831/1510045

Triple Negative Breast Cancer Prevalence in Indian Patients over a Decade: A Systematic Review

Suvobrata Sarkar and Murtaza Akhtar

Article Type: Systematic Review and Meta-analysis | First Published: January 12, 2022

Triple Negative Breast Cancer (TNBC) is an aggressive variant of breast cancer with penurious prognosis and limited therapeutic options. This subtype is characterised with higher incidence rate among the younger women, aggressive tumour behaviour, with early local recurrence and distant metastasis leading to poor outcomes. In India, majority of prevalence data of TNBC is hospital based from patient treated at tertiary care hospitals or centres ranging from 10% to 43% which is evident from the va...

 Open Access DOI:10.23937/2469-5831/1510044

The Comparison of Family Function and its Related Factors in First-Child Infertile Women and Second-Child Infertile Women after ‘Two-Child’ Policy in China

Tian Qiu, Zhi Ma, Yong Zhao, Wenling Wang, Huimin Jiang, Fengdi Wang, Yuelu Chen, Ting-Li Han, Yang Yang and Lianlian Wang

Article Type: Original Research | First Published: January 09, 2022

The increasing prevalence of infertility rate around the world has seriously impacted individuals, couples and families. This research identifies how infertility influences family functions in China under the newly introduced two-child policy. Specially, we compared family function between first-child infertile (FI) and second-child infertile (SI) women. This study included 572 infertile women of childbearing age, composed with 337 first-child infertile women and 235 second-child infertile women...

 Open Access DOI:10.23937/2469-5831/1510042

The Modeling by Fuzzy Least Squares Regression Approach Relationships between Copper Values in the Soil, Vegetables, Fruits and Human Tissue

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

Determination of Factors Influencing the Activities of PR Interval on the Electrocardiogram (ECG) in an Experiment of the Factorial Type

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

Modeling the Risk Assessment of COVID-19 Pandemic in Bingham University of Nigeria

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

An Application of the Patient Rule-Induction Method to Detect Clinically Meaningful Subgroups from Failed Phase III Clinical Trials

Greg Dyson

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

On the Comparison of Multiple Linear and Interval Regression Models of Apnea-Hypopnea Index in Patients with Obstructive Sleep Apnea Syndrome

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

Comparison of Estimation Method in Diagnostic Meta-Analysis: An Application in Dentistry

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

The Incidence of Tuberculosis in Brazil from 2001 to 2018: Use of Polynomial Regression Combined with a Stochastic Volatility Model

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

Psychophysiological Differences in Patients with/without Schizophrenia: A Comparative Study

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

Multiobjective Optimal Control of the COVID Virus Outbreak

Lakshmi Sridhar

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

Changes in Mobility during COVID-19 as a Response to Government Imposed Restrictions: A Multiple Regression Analysis for the Top Five Populous U.S States

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

A New Two Parameter Biased Estimator for the Unrestricted Linear Regression Model: Theory, Simulation and Application

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

Two-stage Adaptive Biomarker-Targeted Clinical Trial Design: Non-Parametric Bayesian and MLE Approaches

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

Pulmonary Thromboembolism in COVID-19: Proposal for a Scoring System for Diagnosis

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

Bridging Strategies for In Vitro Diagnostic Clinical Trials in a New Region

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

Application of Hierarchical Polynomial Regression Models to Predict Transmission of COVID-19 at Global Level

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

The Basic Four Measures and their Derivates in Dichotomous Diagnostic Tests

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

Factors Influencing Resident Research: Evidence from a 10-Year Cohort

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

Nonparametric Method for Estimation of Controlled Correlations in Studies of VEGF-Hypoxia Relationship

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

A Signal Detection Analysis of World Health Organization’s Pharmacovigilance Database

Yeqian Liu

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

Child Mortality: A Comparative Study of Some Developing Countries in the World

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

A Comparative Study of Three Classification Procedures: Asthma among Healthcare Professionals in Texas

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

An Approximation of a Longitudinal Stochastic Model

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

Correlation Statistic for Assessing a Diagnostic Value Based on a Bivariate Bernoulli Distribution with Application to a Retrospective Single-Center Clinical Study

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

Reassessing the Effectiveness of Right Heart Catheterization (RHC) in the Initial Care of Critically Ill Patients using Targeted Maximum Likelihood Estimation

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

Partial Variable Selection and its Applications in Biostatistics

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

Improved Wald Test for Equivalence Assessment of Analytical Biosimilarity

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

Analogs of the Wilcoxon-Mann-Whitney Test When There is a Covariate

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

Bayesian Cox Proportional Hazards Model in Survival Analysis of HACE1 Gene with Age at Onset of Alzheimer's Disease

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

On Sample Size Calculation for Exact Group Sequential Tests for Rare Disease

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

A Systematic Approach to Increase Reproducibility in Simulation Studies

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

Can We Identify Patients at High Risk of Harm under a Generally Safe Intervention?

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

Inference Based on Small Randomized Oncology Clinical Trials: Is the Observed Treatment Effect True?

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

Hierarchical Bayes Approach for Analysis of Item-Level Missing Data

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

A Constrained Non-inferiority Approach for Assessing Clinical Efficacy to Establish Biosimilarity

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

Target Frequency Analysis of functional MRI Data

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

Noise Analysis of Gene Regulatory Networks Using Particle Filter

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

Training a Nonclinician to Become a Leader in Transdisciplinary Clinical Research: Clinical Observerships

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

Bayesian Survival Analysis of Genetic Variants in PTPRN2 Gene for Age at Onset of Cancer

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

A Review of Graphical Approaches to Common Statistical Analyses. The Omnipresence of Latent Variables in Statistics

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

Drug Treatment Comparison for Total Knee Replacement Surgery

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

Dynamic Factor Analysis for Multivariate Time Series: An Application to Cognitive Trajectories

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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ClinMed Journals Index Copernicus Values

Clinical Medical Image Library: 93.51

International Journal of Critical Care and Emergency Medicine: 92.83

International Journal of Sports and Exercise Medicine: 91.84

International Journal of Womens Health and Wellness: 91.79

Journal of Musculoskeletal Disorders and Treatment: 91.73

Journal of Geriatric Medicine and Gerontology: 91.55

Journal of Infectious Diseases and Epidemiology: 91.55

Clinical Medical Reviews and Case Reports: 91.40

International Archives of Nursing and Health Care: 90.87

International Journal of Ophthalmology and Clinical Research: 90.80

International Archives of Urology and Complications: 90.73

Journal of Clinical Nephrology and Renal Care: 90.33

Journal of Family Medicine and Disease Prevention: 89.99

Journal of Clinical Gastroenterology and Treatment: 89.54

Journal of Dermatology Research and Therapy: 89.34

International Journal of Clinical Cardiology: 89.24

International Journal of Radiology and Imaging Technology: 88.88

Obstetrics and Gynaecology Cases - Reviews: 88.42

International Journal of Blood Research and Disorders: 88.22

International Journal of Diabetes and Clinical Research: 87.97

New Issues


International Journal of Clinical Cardiology

ISSN: 2378-2951 | ICV: 89.24



Obstetrics and Gynaecology Cases - Reviews

ISSN: 2377-9004 | ICV: 88.42



Journal of Hypertension and Management

ISSN: 2474-3690 | ICV: 87.69



International Journal of Diabetes and Clinical Research

ISSN: 2377-3634 | ICV: 87.97



Journal of Infectious Diseases and Epidemiology

ISSN: 2474-3658 | ICV: 91.55