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)

Planning a clinical study is much more than determining the basic study design. Who will you be studying? How do you plan to recruit your study subjects? How do you plan to retain them in the study? What data do you plan to collect? How will you obtain this data? How will you minimize bias? All these decisions must be consistent with the ethical considerations of studying people. This book teaches how to choose the best design for your question. Drawing on their many years working in clinical research, Nancy G. Berman and Robert A. Parker guide readers through the essential elements of study planning to help get them started. The authors offer numerous examples to illustrate the key decisions needed, describing what works, what does not work, and why. Written specifically for junior investigators beginning their research careers, this guide will also be useful to senior investigators needing to review specific topics.

Composed of contributions from an international team of leading researchers, this book pulls together the most recent research results in the field of cancer modeling to provide readers with the most advanced mathematical models of cancer and their applications.Topics included in the book cover oncogenetic trees, stochastic multistage models of carcinogenesis, effects of ionizing radiation on cell cycle and genomic instability, induction of DNA damage by ionizing radiation and its repair, epigenetic cancer models, bystander effects of radiation, multiple pathway models of human colon cancer, and stochastic models of metastasis. The book also provides some important applications of cancer models to the assessment of cancer risk associated with various hazardous environmental agents, to cancer screening by MRI, and to drug resistance in cancer chemotherapy. An updated statistical design and analysis of xenograft experiments as well as a statistical analysis of cancer occult clinical data are also provided.The book will serve as a useful source of reference for researchers in biomathematics, biostatistics and bioinformatics; for clinical investigators and medical doctors employing quantitative methods to develop procedures for cancer diagnosis, prevention, control and treatment; and for graduate students.

Epidemiology has been defined as the study of the distribution and determinants of health states or events in defined populations and its application to the control of health problems. Psychiatric epidemiology has continued to develop and apply these core principles in relation to mental health and mental disorders. This long-awaited second edition of Practical Psychiatric Epidemiology covers all of the considerable new developments in psychiatric epidemiology that have occurred since the first edition was published. It includes new content on key topics such as life course epidemiology, gene/environment interactions, bioethics, patient and public involvement in research, mixed methods research, new statistical methods, case registers, policy, and implementation. Looking to the future of this rapidly evolving scientific discipline and how it will to respond to the emerging opportunities and challenges posed by 'big data', new technologies, open science and globalisation, this new edition will continue to serve as an invaluable reference for clinicians in practice and in training. It will also be of interest to researchers in mental health and people studying or teaching psychiatric epidemiology at undergraduate or postgraduate level.

Highly praised for its broad, practical coverage, the second edition of this popular text incorporated the major statistical models and issues relevant to epidemiological studies. Epidemiology: Study Design and Data Analysis, Third Edition continues to focus on the quantitative aspects of epidemiological research. Updated and expanded, this edition shows students how statistical principles and techniques can help solve epidemiological problems. New to the Third Edition New chapter on risk scores and clinical decision rules New chapter on computer-intensive methods, including the bootstrap, permutation tests, and missing value imputation New sections on binomial regression models, competing risk, information criteria, propensity scoring, and splines Many more exercises and examples using both Stata and SAS More than 60 new figures After introducing study design and reviewing all the standard methods, this self-contained book takes students through analytical methods for both general and specific epidemiological study designs, including cohort, case-control, and intervention studies. In addition to classical methods, it now covers modern methods that exploit the enormous power of contemporary computers. The book also addresses the problem of determining the appropriate size for a study, discusses statistical modeling in epidemiology, covers methods for comparing and summarizing the evidence from several studies, and explains how to use statistical models in risk forecasting and assessing new biomarkers. The author illustrates the techniques with numerous real-world examples and interprets results in a practical way. He also includes an extensive list of references for further reading along with exercises to reinforce understanding. Web Resource A wealth of supporting material can be downloaded from the book’s CRC Press web page, including: Real-life data sets used in the text SAS and Stata programs used for examples in the text SAS and Stata programs for special techniques covered Sample size spreadsheet

This book presents a logical system of critical appraisal, to allow readers to evaluate studies and to carry out their own studies more effectively. This system emphasizes the central importance of cause and effect relationships. Its great strength is that it is applicable to a wide range of issues, and both to intervention trials and observational studies. This system unifies the often different approaches used in epidemiology, health services research, clinical trials, and evidence-based medicine, starting from a logical consideration of cause and effect. The author's approach to the issues of study design, selection of subjects, bias, confounding, and the place of statistical methods has been praised for its clarity and interest. Systematic reviews, meta-analysis, and the applications of this logic to evidence-based medicine, knowledge-based health care, and health practice and policy are discussed. Current and often controversial examples are used, including screening for prostate cancer, publication bias in psychiatry, public health issues in developing countries, and conflicts between observational studies and randomized trials. Statistical issues are explained clearly without complex mathematics, and the most useful methods are summarized in the appendix. The final chapters give six applications of the critical appraisal of major studies: randomized trials of medical treatment and prevention, a prospective and a retrospective cohort study, a small matched case-control study, and a large case-control study. In these chapters, sections of the original papers are reproduced and the original studies placed in context by a summary of current developments.