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With the increasing emphasis on evidence-based practices, there is a greater need for pharmacists to understand clinical research, evaluate scientific findings, and translate evidence to support patient-care decisions. This requires a comprehensive understanding of the principles and practice of drug literature evaluation with a strong grounding in research design and statistical methods. Most available texts emphasize statistical approaches and/or scientific literature evaluation techniques. Although there may be comprehensive books in other health professions, it is challenging to find a pharmacy textbook that covers all critical research design and evaluation elements to translate evidence into practice. We decided to edit this book to provide a balanced approach to the principles of clinical research and statistics for evaluating pharmacy literature to implement evidence-based pharmacotherapy.

Most pharmacy schools offer a course in the pharmacy professional program that covers fundamentals of research design, biostatistics, and evaluation of pharmacy literature, as required by the Accreditation Council for Pharmacy Education (ACPE). Consequently, this book is divided into three sections to provide comprehensive course content to meet and exceed these curriculum standards set by the ACPE. Section 1 of the book covers principles of scientific research with an emphasis on clinical research designs ranging from randomized controlled trials to case reports. Section 2 of the book provides the foundation necessary to understand statistics and to critically evaluate results from statistical analyses reported in the medical literature with a focus on common statistical methods. Section 3 of the book covers principles of evidence-based medicine, drug literature sources and evaluation techniques, and application of evidence to patient care. There are seven chapters in each section of the book.

Chapter 1 defines basic, applied, clinical, and translational research, and describes the steps in scientific research and evidence-based medicine. Chapter 2 explains the guiding ethical principles in clinical research and discusses the regulatory framework governing clinical research. Chapter 3 provides the basics of designing clinical research, with an emphasis on common clinical research designs and methodologies. Chapter 4 discusses the design considerations associated with randomized controlled trials, including common clinical designs and analytical framework. Chapters 5 and 6 provide observational approaches for conducting clinical research. Chapter 5 describes case-control and cohort designs and includes a discussion of common biases and analytical approaches to minimize such biases. Chapter 6 provides an overview of cross-sectional studies, pre- and post-observational studies, ecological studies, and time series evaluations. Chapter 7 presents the key steps in designing a case report and case series studies along with tools to critically evaluate these designs.

Chapter 8 discusses the summarizing, organizing, and presenting functions of statistics, commonly referred to as descriptive statistics, and also introduces the different kinds of data that are collected in clinical research. Chapter 9 provides the general foundation for applying basic tools of statistical inference, focusing on the related mechanisms of estimation and hypothesis testing. Given that many studies in the drug literature involve the comparison of two or more groups, Chapter 10 discusses commonly used statistical procedures that are used to answer research questions involving group comparisons; in addition, it describes the statistical methods for assessing the correlation between two variables. Chapters 11 and 12 provide an overview of regression analysis methods that can be used to account and/or adjust for variables that cannot be handled at the design stage of an experiment. Chapter 11 describes simple linear and multiple regression approaches to address a number of research problems, such as confounding and effect modification. Chapter 12 introduces logistic regression and Cox regression methods to analyze binary and time-to-event outcomes, respectively. Chapter 13 introduces the statistical principles underlying sample size calculation. Chapter 14 presents the elements of the systematic review process and describes meta-analysis as a method to quantitatively synthesize evidence from studies identified in a systematic review.

Chapter 15 identifies the steps involved in evidence-based medicine along with the discussion of its strengths and limitations. Chapter 16 discusses the sources and use of primary, secondary, and tertiary literature to identify clinical evidence for evidence-based medicine. Chapters 17, 18, and 19 discuss approaches to appraise published primary literature for patient care. Chapter 17 provides a stepwise approach to appraise published literature with an emphasis on evaluating the study objectives, methods and design, statistics, results, and discussion. Chapter 18 describes the key considerations for evaluating methodological rigor in randomized controlled trials using an example. Chapter 19 describes and applies formal criteria to evaluate observational studies using an example. Chapter 20 discusses general principles of applying evidence to patient care with an emphasis on evidence from clinical trials and practice guidelines. Finally, Chapter 21 describes the general format of a journal club and examines the characteristics of an effective journal club.

This book is designed for professional pharmacy (PharmD) students. Instructors teaching principles of research and drug literature evaluation can design the professional course primarily based on this book or can supplement this book with research articles. The contents of the book can be delivered in one or two semesters. Chapters are written by expert authors specializing in pharmacy practice and research. Each chapter includes the following elements:

  • Learning Objectives present the chapter's desired outcomes to the reader.

  • Key Terminology helps the reader quickly identify critical new terms.

  • Review Questions allow readers to apply what has been learned in the chapter and assess their understanding of the content.

  • Online Resources direct students to web sites relevant to the content.

The chapters are designed to provide the knowledge base and application techniques for research design and drug literature evaluation. In addition to figures and tables, numerous pharmacy examples and case studies are provided to aid student learning. Additional readings from pharmacy journals and a drug literature evaluation project can improve the critical thinking skills of pharmacy students. The online sources and chapter references can be used to supplement the content. This book can also be an excellent resource for students in residency and fellowship training programs. In addition, this book can be beneficial to pharmacy practitioners and professionals, especially those involved in training students, residents, and fellows.

We would greatly appreciate feedback from students and faculty for future editions. All knowledge is considered as work in progress, including the contents of this book.

—March 2014

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