Concise Biostatistical Principles Concepts
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Concise Biostatistical Principles and Concepts
Author: Laurens Holmes, Jr
language: en
Publisher: Laurens Holmes, Jr
Release Date: 2025-03-18
Concise Biostatistical Principles and Concepts, 2nd Edition Clinical medicine or surgery continues to make advances through evidence that is judged to be objectively drawn from the care of individual patients. The natural observation of individuals remains the basis for our researchable questions’ formulation and the subsequent hypothesis testing. Evidence-based medicine or surgery depends on how critical we are in evaluating evidence in order to inform our practice. These evaluations no matter how objective are never absolute but probabilistic, as we will never know with absolute certainty how to treat future patients who were not a part of our study. Despite the obstacles facing us today in an attempt to provide an objective evaluation of our patients, since all our decisions are based on a judgment of some evidence, we have progressed from expert opinion to the body of evidence from randomized controlled clinical trials, as well as cohort investigations, prospective and retrospective. The conduct of clinical trials though termed the “gold standard”, which yields more reliable and valid evidence from the data relative to non-experimental or observational designs, depends on how well it is designed and conducted prior to outcomes data collection, analysis, results, interpretation, and dissemination. The designs and the techniques used to draw statistical inferences are often beyond the average clinician’s understanding. A text that brings hypothesis formulation, analysis, and how to interpret the results of the findings is long overdue and highly anticipated. Statistical modeling which is fundamentally a journey from sample to the application of findings is essential to evidence discovery. The four past decades have experienced modern advances in statistical modeling and evidence discovery in biomedical, clinical, and population-based research. With these advances come the challenges in accurate model stipulation and application of models in scientific evidence discovery. While the application of novel statistical techniques to our data is necessary and fundamental to research, the selection of a sample and sampling method that reflects the representativeness of that sample to the targeted population is even more important. Since one of the rationale behind research conduct is to generate new knowledge and apply it to improve life situations including the improvement of patient and population health, sampling, sample size, and power estimations remain the basis for such inference. With the essential relevance of sample and sampling technique to how we come to make sense of data, the design of the study transcends statistical technique, since no statistical tool no matter how sophisticated can correct the errors of sampling. This text is written to highlight the importance of appropriate design prior to analysis by placing emphasis on subject selection and probability sample, randomization process when applicable prior to the selection of the analytic tool. In addition, it stresses the importance of biological and clinical significance in the interpretation of study findings. The basis for statistical inference, implying the quantification of random error is a random sample. When studies are conducted without random samples as often encountered in clinical and biomedical research, it is meaningless to report the findings with p value. However, in the absence of a random sample, the p-value can be applied to designs that utilize consecutive samples, and disease registries, since these samples reflect the population of interest, and hence representative sample, justifying inference and generalization. Essential to the selection of test statistics is the understanding of the scale of the measurement of the variables, especially the response, outcome or dependent variable, type of sample (independent or correlated), hypothesis, and normality assumption. In terms of the selection of statistical tests, this text is based on the scale of measurement (binary), type of sample (single, independent), and relationship (linear). For example, if the scale of measurement of the outcome variable is binary, repeated measure, and normality is not assumed, the repeated measure logistic regression model remains a feasible model for evidence discovery in using the independent variables to predict the repeated outcome. This book presents a simplified approach to evidence discovery by recommending the graphic illustration of data and normality test for continuous (ratio/interval scale) data prior to statistical test selection. Unlike current text in biostatistics, the approach taken to present these materials is very simple. First, this text uses applied statistics by illustrating what, when, where, and why a test is appropriate. Where a text violates the normality assumption, readers are presented with a non-parametric alternative. The rationale for the test is explained with a limited mathematical formula and is intended in order to stress the applied nature of biostatistics. Attempts have been made in this book to present the most commonly used statistical model in biomedical or clinical research. We believe since no book is complete to have covered the basics that will facilitate the understanding of scientific evidence discovery. We hope this book remains a useful guide, which is our intention in bridging the gap between theoretical statistical models and reality in the statistical modeling of biomedical and clinical research data. As researchers we all make mistakes and we believe we have learned from our mistakes during the past three decades hence the need to examine flaws and apply reality in the statistical modeling of biomedical and research data. We hope this text results in increased reliability in the conduct, analysis,
Concise Biostatistical Principles and Concepts, 2nd Edition
Author: Laurens Holmes, Jr
language: en
Publisher: Laurens Holmes, Jr
Release Date: 2025-03-18
Concise Biostatistical Principles and Concepts - Statistical Reality in Evidence Discovery Clinical medicine or surgery continues to make advances through evidence that is judged to be objectively drawn from the care of individual patients. The natural observation of individuals remains the basis for our researchable questions’ formulation and the subsequent hypothesis testing. Evidence-based medicine or surgery depends on how critical we are in evaluating evidence in order to inform our practice. These evaluations no matter how objective are never absolute but probabilistic, as we will never know with absolute certainty how to treat future patients who were not a part of our study. Despite the obstacles facing us today in an attempt to provide an objective evaluation of our patients, since all our decisions are based on a judgment of some evidence, we have progressed from expert opinion to the body of evidence from randomized controlled clinical trials, as well as cohort investigations, prospective and retrospective. The conduct of clinical trials though termed the “gold standard”, which yields more reliable and valid evidence from the data relative to non-experimental or observational designs, depends on how well it is designed and conducted prior to outcomes data collection, analysis, results, interpretation, and dissemination. The designs and the techniques used to draw statistical inferences are often beyond the average clinician’s understanding. A text that brings hypothesis formulation, analysis, and how to interpret the results of the findings is long overdue and highly anticipated. Statistical modeling which is fundamentally a journey from sample to the application of findings is essential to evidence discovery. The four past decades have experienced modern advances in statistical modeling and evidence discovery in biomedical, clinical, and population-based research. With these advances come the challenges in accurate model stipulation and application of models in scientific evidence discovery. While the application of novel statistical techniques to our data is necessary and fundamental to research, the selection of a sample and sampling method that reflects the representativeness of that sample to the targeted population is even more important. Since one of the rationale behind research conduct is to generate new knowledge and apply it to improve life situations including the improvement of patient and population health, sampling, sample size, and power estimations remain the basis for such inference. With the essential relevance of sample and sampling technique to how we come to make sense of data, the design of the study transcends statistical technique, since no statistical tool no matter how sophisticated can correct the errors of sampling. This text is written to highlight the importance of appropriate design prior to analysis by placing emphasis on subject selection and probability sample, randomization process when applicable prior to the selection of the analytic tool. In addition, it stresses the importance of biological and clinical significance in the interpretation of study findings. The basis for statistical inference, implying the quantification of random error is a random sample. When studies are conducted without random samples as often encountered in clinical and biomedical research, it is meaningless to report the findings with p value. However, in the absence of a random sample, the p-value can be applied to designs that utilize consecutive samples, and disease registries, since these samples reflect the population of interest, and hence representative sample, justifying inference and generalization. Essential to the selection of test statistics is the understanding of the scale of the measurement of the variables, especially the response, outcome or dependent variable, type of sample (independent or correlated), hypothesis, and normality assumption. In terms of the selection of statistical tests, this text is based on the scale of measurement (binary), type of sample (single, independent), and relationship (linear). For example, if the scale of measurement of the outcome variable is binary, repeated measure, and normality is not assumed, the repeated measure logistic regression model remains a feasible model for evidence discovery in using the independent variables to predict the repeated outcome. This book presents a simplified approach to evidence discovery by recommending the graphic illustration of data and normality test for continuous (ratio/interval scale) data prior to statistical test selection. Unlike current text in biostatistics, the approach taken to present these materials is very simple. First, this text uses applied statistics by illustrating what, when, where, and why a test is appropriate. Where a text violates the normality assumption, readers are presented with a non-parametric alternative. The rationale for the test is explained with a limited mathematical formula and is intended in order to stress the applied nature of biostatistics. Attempts have been made in this book to present the most commonly used statistical model in biomedical or clinical research. We believe since no book is complete to have covered the basics that will facilitate the understanding of scientific evidence discovery. We hope this book remains a useful guide, which is our intention in bridging the gap between theoretical statistical models and reality in the statistical modeling of biomedical and clinical research data. As researchers we all make mistakes and we believe we have learned from our mistakes during the past three decades hence the need to examine flaws and apply reality in the statistical modeling of biomedical and research data. We hope this text results in increased reliability in the conduct, analysis
Modern Biostatistical Principles and Conduct
Author: Laurens Holmes, Jr
language: en
Publisher: Laurens Holmes, Jr
Release Date: 2025-03-14
Modern Biostatistical Principles & Conduct - Clinical Medicine and Public/Population Health Assessment Clinical medicine or surgery continues to make advances through evidence that is judged to be objectively drawn from the care of individual patients. The natural observation of individuals remains the basis for our researchable questions’ formulation and the subsequent hypothesis testing. Evidence-based medicine or surgery depends on how critical we are in evaluating evidence in order to inform our practice. These evaluations no matter how objective are never absolute but probabilistic, as we will never know with absolute certainty how to treat future patients who were not a part of our study. Despite the obstacles facing us today in an attempt to provide an objective evaluation of our patients, since all our decisions are based on a judgment of some evidence, we have progressed from expert opinion to the body of evidence from randomized controlled clinical trials, as well as cohort investigations, prospective and retrospective. The conduct of clinical trials though termed the “gold standard”, which yields more reliable and valid evidence from the data relative to non-experimental or observational designs, depends on how well it is designed and conducted prior to outcomes data collection, analysis, results, interpretation, and dissemination. The designs and the techniques used to draw statistical inferences are often beyond the average clinician’s understanding. A text that brings hypothesis formulation, analysis, and how to interpret the results of the findings is long overdue and highly anticipated. Statistical modeling which is fundamentally a journey from sample to the application of findings is essential to evidence discovery. This text, Modern Biostatistics for Clinical, Biomedical and Population-Based Researchers has filled this gap, not only in the way complex modeling is explained but the simplification of statistical techniques in a way that had never been explained before. This text has been prepared intentionally at the rudimentary level to benefit clinicians without sophisticated mathematical backgrounds or previous advanced knowledge of biostatics as applied statistics in health and medicine. Also, biomedical researchers who may want to conduct clinical research, as well as consumers of research products may benefit from the sampling techniques, their relevance to scientific evidence discovery as well a simplified approach to statistical modeling of clinical and biomedical research data. It is with this expectation and enthusiasm that we recommend this text to clinicians in all fields of clinical and biomedical research. One’s experience with biomedical research and how the findings in this arm are translated to the clinical environment signals the need for the application of biological, and clinical relevance of findings prior to statistical inference. The examples provided by the author to simplify research methods are familiar to orthopedic surgeons as well as clinicians in other specialties of medicine and surgery. Whereas statistical inference is essential in our application of the research findings to clinical decision-making regarding the care of our patients, statistical inference without clinical relevance or importance can be very misleading, and meaningless. The authors have attempted to deemphasize the p-value in the interpretation of clinical and biomedical research findings, by stressing the importance of confidence intervals, which allow for the quantification of evidence. For example, a large study due to a large sample size that minimizes variability may show a statistically significant difference while in reality, the difference is too insignificant to warrant any clinical importance. In contrast, a small study as frequently seen in most clinical trials or surgical research may have a large effect size of clinical relevance but not statistically significant at (p > 0.05). Thus, without considering the magnitude of the effect size with the confidence interval, we tend to regard these studies as negative findings, which is erroneous, since the absence of evidence, simply on the basis of an arbitrary significance level of 5% does not necessarily mean evidence of absence.1 In effect, clinical research results, cannot be adequately interpreted without first considering the biological and clinical significance of the data, before the statistical stability of the findings (p-value and 95% Confidence Interval), since the p-value as observed by the authors merely reflects the size of the study and not the measure of evidence. In recommending this text, it is one’s inclination that this book will benefit clinicians, research fellows, clinical fellows, postdoctoral students in biomedical and clinical settings, nurses, clinical research coordinators, physical therapists, and all those involved in clinical research design, conduct, and analysis of research data for statistical and clinical relevance. Convincingly, knowledge gained from this text will lead to our improvement of patient care through well-conceptualized research. Therefore, with the knowledge that no book is complete, no matter its content or volume, especially a book of this nature, which is prepared to guide clinicians on sampling, statistical modeling of data, and interpretation of findings, this book will benefit clinicians who are interested in applying appropriate statistical technique to scientific evidence discovery. Finally, we are optimistic that this book will bridge the gap in knowledge and practice of clinical and biomedical research, especially for clinicians in busy practice who are passionate about making a difference in their patient's care through scientific research initiatives.