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The book is organized so as to address in separate sections first the preparatory topics of medicine (clinical and epidemiological), science in general, and statistics (mathematical); then topics of epidemiological research proper; and, finally, topics of ‘meta-epidemiological’ clinical research. In those two main sections, a further grouping is based on the distraction between objects and methods of study. In this framework, the particular topics are addressed both descriptively and quasi-prescriptively, commonly with a number of explicatory annotations. This book is intended to serve as a handbook for whomever is, in whatever way, concerned with epidemiological or ‘meta-epidemiological’ clinical research. But besides this, it is also intended to serve as a textbook for students in introductory courses on ‘epidemiological’ research – to which end there is a suggested hierarchy of the concepts that might reasonably be covered.
First edition published in 2002. Second edition published in 2008.
This edition is the most updated since its inception, is the essential text for students and professionals working in and around epidemiology or using its methods. It covers subject areas - genetics, clinical epidemiology, public health practice/policy, preventive medicine, health promotion, social sciences and methods for clinical research.
This text offers a comprehensive insight into the methods and principles of epidemological study alongside an analysis of the broad context in which epidemiological work is undertaken.
In the late 1980s, the National Cancer Institute initiated an investigation of cancer risks in populations near 52 commercial nuclear power plants and 10 Department of Energy nuclear facilities (including research and nuclear weapons production facilities and one reprocessing plant) in the United States. The results of the NCI investigation were used a primary resource for communicating with the public about the cancer risks near the nuclear facilities. However, this study is now over 20 years old. The U.S. Nuclear Regulatory Commission requested that the National Academy of Sciences provide an updated assessment of cancer risks in populations near USNRC-licensed nuclear facilities that utilize or process uranium for the production of electricity. Analysis of Cancer Risks in Populations near Nuclear Facilities: Phase 1 focuses on identifying scientifically sound approaches for carrying out an assessment of cancer risks associated with living near a nuclear facility, judgments about the strengths and weaknesses of various statistical power, ability to assess potential confounding factors, possible biases, and required effort. The results from this Phase 1 study will be used to inform the design of cancer risk assessment, which will be carried out in Phase 2. This report is beneficial for the general public, communities near nuclear facilities, stakeholders, healthcare providers, policy makers, state and local officials, community leaders, and the media.
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Concise, fast-paced, intensive introduction to clinical research design for students and clinical research professionals Readers will gain sufficient knowledge to pass the United States Medical Licensing Examination part I section in Epidemiology
Presents information from the field of epidemiology in a less technical, more accessible format. Covers major topics in epidemiology, from risk ratios to case-control studies to mediating and moderating variables, and more. Relevant topics from related fields such as biostatistics and health economics are also included.
The concepts of epidemiology, the science that uses statistical methods to investigate associations between risk factors and disease outcomes in human populations, are developed using examples involving real data from published studies. The relevant statistical methods are developed systematically to provide an integrated approach to observational and experimental studies. After covering basic measurement, study design, and study credibility issues, the author continues with basic statistical methods and techniques for adjusting risk estimates for confounders. Statistical models including logistic regression and the proportional hazards model for survival analysis are explained in detail in the following chapters, concluding with an explanation of the general methods for determining the sample size and power requirements for an epidemiological study. Taking advantage of the power, accessibility and user-friendliness of modern computer packages, the author uses a variety of interesting data sets and graphical displays to illustrate the methods. Epidemiological Research Methods will be of interest to students and research workers who need to learn and appreciate modern approaches to the subject. Without unnecessary emphasis on mathematics or theory, the book will enable the reader to gain a greater level of understanding of the underlying methods than is normally provided in books on epidemiology.