This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

Public health researchers and clinicians regularly work with people who have suffered physical and mental trauma. Knowing how to conduct a study or treat a patient while navigating deep emotional issues requires special skills and overall awareness of how trauma can impact the process and outcomes of participating in research and/or receiving health care. This book presents a diverse array of case examples from scholars of health-related topics, focusing on biographical narrative as a window into understanding key needs in trauma informed scholarship and medicine. Exploring stories from people of varied backgrounds, experiences, and contexts can help professionals within and beyond the academic research and clinical care spheres create rewarding experiences for patients. Negotiating the Emotional Challenges of Conducting Deeply Personal Research in Health will be of interest to public health practitioners, educators and researchers as well as students.

Acacias: The Genus Acacia (sensu lato) is an evidence-based treatment of this super genus, through the eyes of a clinical pharmacognosist and integrative medicine specialist. The book begins with antiviral activity, revealing within the five genera of Acacia s.l., pharmacological properties and pharmacologically active compounds. Profiles of prominent species within these genera, including photographs, accompany the narrative of current research and traditional usage into antibacterial, antifungal, anticancer, antidiabetic, metabolic syndrome ameliorative, and psychotherapeutic potential. Features: Comprehensive treatment of the entire Acacia sensu lato genus. Aids ethnopharmacological prospectors of new sources of novel botanically-based medicines for modern metabolic and psychiatric diseases. Illuminates the presence of psychedelic simple substituted tryptamines in trees and their medical and psychotherapeutic potential. Acacias: The Genus Acacia (sensu lato) provides a unique and comprehensive coverage of one of the most interesting and diverse genera of trees, firmly entrenched in the Levant, Africa, Australia, the Far East, and the New World. The influence of these genera on pharmacy and industry (especially through gum arabic, wildcrafted in Africa from Senigallia senigallia), human consciousness, the advent and development of religions, planetary ecology, botanical therapeutics, and the emergence of psychedelic medicine reflects both the history of our species and the transformative promise of tomorrow.

The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

This book provides candidates with an easy-to-use exam-oriented text that covers most aspects of critical appraisal. It presents concepts in a user-friendly format, particularly for the benefit of those who find epidemiological and statistical concepts rather migraine-inducing.

Undue Risk is an unprecedented and chilling history of the use of human subjects in atomic, biological and chemical warfare experiments by the US Government from World War II to the present. Jonathan Moreno, a senior researcher on the President's special commission, goes where few researchers have gone before, exploring secret government documents which reveal a plethora of government experiments.
Now available in paperback, with a new afterword, this exciting read covers recent objections by US military personnel to required anthrax vaccinations and new developments in government policies on experiments involving vulnerable human subjects.

This inspirational text will appeal to those both starting research projects and those wanting to understand how research can be used in everyday working practice. It brings together expertise from a wide range of areas and makes research easy and accessible. The practical workbook style is easy to use and shows the whole process from design to dissemination and application. Those working in primary healthcare teams and the new organisations supporting them will find it essential reading. Primary Care Research series is aimed at developing the knowledge, expertise and skills of all practitioners in primary care. Each book is based on contributions from experts in their field and is supported by practical facts, personal insight, support and advice. They enable all primary care practitioners to realise the potential of exploring information used in everyday working practice. Other books in the Primary Care Research series: Wilson: Research Approaches in Primary Care Mathers: Statistical Analysis in Primary Care

An understanding of each of the critical components of the funding process is key to meeting the challenges posed by the increasingly intense competition for research funds. This book is a vital tool for those who want to build and maximize their grant support. Although many publications provide valuable information about proposal preparation, few cover the full spectrum of issues--from planning through execution--in the funding process. The book leads off with a discussion of the relationship between researchers and the funding environment, features of good short- and long-range funding plans, characteristics of funding organizations in terms of funding power, mission, and priorities, and the manner in which funding information is disseminated. Succeeding chapters focus on the actual development of the many different types of opportunities--research projects, multicomponent research programs, career development and training programs, and small business innovation research. These chapters emphasize conceptualizing an idea, optimizing the researcher-sponsor match, and testing the concept for competitiveness. Further chapters deliver strategies for translating research ideas into written proposals, preparing administrative sections and communicating with a sponsor. The final chapters are dedicated to the outcomes of the proposal process: reviews, rebuttals, and resubmissions; and to progress reports and future proposals for maintaining and building on funding. Flowcharts, examples, and summary tables are used throughout the text to highlight key points.

Animal Models in Orthopaedic Research is a reference book of the major animal models used in the study of orthopaedic conditions and in the in vivo study of biomaterials. Use of animal models provides important knowledge about pathological conditions that can eventually lead to the development of more effective clinical treatment of diseases in both humans and animals. Directed primarily toward surgeons, investigators, research fellows, graduate students, and those working in orthopaedic or biomaterial research, this book is intended to serve as a basis for a literature search before embarking on a detailed research project.
This book is the result of the editors' own quest for information about research methodology and the use of animal models in orthopaedic and biomaterial research. Concise, inclusive, and practical, this work:

Provides the only single-volume reference for stability requirement in all major markets Discusses all aspects of stability testing, including ICH stability guidelines Supports the text with real-world examples In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials provides a concise presentation of the principles applied in this area. It details the concepts behind randomization and methods for designing and analyzing trials and also includes information on meta-analysis and specialized designs, such as cross-over trials, cluster-randomized designs, and equivalence studies. This latest edition features new and revised references, examples, exercises, and a new chapter dedicated to binary outcomes and survival analysis. It also presents numerous examples taken from the medical literature, contains exercises at the end of each chapter, and offers solutions in an appendix. The author uses Minitab and R software throughout the text for implementing the methods that are presented. Comprehensive and accessible, Introduction to Randomized Controlled Clinical Trials is well-suited for those familiar with elementary statistical ideas and methods who want to further their knowledge of the subject.

Phage Display in Biotechnology and Drug Discovery, Second Edition provides a comprehensive view of the impact and promise of phage display in drug discovery and biotechnology. Building on the success of its previous edition, the book discusses current theories, principles, and methods in the field and demonstrates applications for peptide phage display, protein phage display, and the development of novel antibodies. The book provides readers with an overview of the amazing breadth of the impact that phage display technology has had on the study of proteins in general as well as the development of proteins. It will be a valuable resource for those interested in using phage display and recombinant antibodies in basic research and drug discovery. Key Features: Describes the basic principles of phage display and the methods and systems that have been developed for key applications Outlines applications for peptide phage display in the development of vaccines and high- throughput screens as well as the exploration of protein-protein interactions and enzyme substrate characteristics Details the use of phage display in the engineering of protein stability, the identification and mapping of protein-protein interactions, and the development of catalysts Provides broad coverage of the impact of phage display technology on the development of protein therapeutics Presents expert opinions on future challenges in the field

This volume's purpose is to describe concepts and methods concerning assessment of health-related quality of life (HRQOL) in children and adolescents with a special focus on chronic health conditions. The impetus for this book came from a recognition of the increasing importance of HRQOL assessments in the evaluation of treatment outcomes and the need to increase the utilization of HRQOL assessments in research and clinical applications with a range of pediatric populations. The need to develop a volume that describes new research and clinical applications concerning this topic stemmed from several recent developments. There is a continuing need for evaluations of the efficacy of medical treatments for children and adolescents, including those with chronic health conditions.
To address these critical unmet needs in the field of HRQOL assessment, and to advance scientific methods and clinical applications in this field, a conference was held at Case Western Reserve University. The conference set out to summarize current information concerning the development and implementation of measures of HRQOL assessment, to identify and consider key conceptual and methodological issues in research concerning the measurement of HRQOL, and to recommend priorities to advance the state-of-the-art in research and clinical applications of QOL assessment in children and adolescents with chronic health conditions. This volume summarizes and synthesizes the information that was presented by the conference participants in a series of lively discussions and chapters that were based on the presentations.

This volume's purpose is to describe concepts and methods concerning assessment of health-related quality of life (HRQOL) in children and adolescents with a special focus on chronic health conditions. The impetus for this book came from a recognition of the increasing importance of HRQOL assessments in the evaluation of treatment outcomes and the need to increase the utilization of HRQOL assessments in research and clinical applications with a range of pediatric populations. The need to develop a volume that describes new research and clinical applications concerning this topic stemmed from several recent developments. There is a continuing need for evaluations of the efficacy of medical treatments for children and adolescents, including those with chronic health conditions.
To address these critical unmet needs in the field of HRQOL assessment, and to advance scientific methods and clinical applications in this field, a conference was held at Case Western Reserve University. The conference set out to summarize current information concerning the development and implementation of measures of HRQOL assessment, to identify and consider key conceptual and methodological issues in research concerning the measurement of HRQOL, and to recommend priorities to advance the state-of-the-art in research and clinical applications of QOL assessment in children and adolescents with chronic health conditions. This volume summarizes and synthesizes the information that was presented by the conference participants in a series of lively discussions and chapters that were based on the presentations.

This volume describes important medical discoveries, from the introduction of the first antibiotic to the present, where serendipity, intuition, coincidence, or laboratory accident played an important role in bringing a discovery to light. Although chance is the principal determinant, the book emphasizes other factors, such as economic and political exigencies and being in the right place at the right time.

This volume collates articles investigating antioxidant, oxidant and free radical research. It examines the role of such research in health and disease, particulary with respect to developing greater understanding about the many interactions between oxidants and antioxidants, and how such substances may act as natural protectants and /or natural toxicants.

In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design. Its main aims are to introduce the theoretical framework and algorithms, discuss the range of validity, strengths and limitations of each methodology, and present applications to real world problems in the drug discovery arena. Special emphasis has been given to the emerging and most pressing methodological challenges in in silico drug discovery and design. The book assumes a basic knowledge of physical principles and molecular modeling. Particular attention has been paid to outline the underlying physico-chemical foundation of the methods described, thus providing the necessary background to avoid a "black-box" approach. In each self-contained chapter, this is presented together with the latest developments and applications, and the challenges that lie ahead. Assembling a unique team of experts to weigh in on the most important issues influencing modern computational drug discovery and design, this book constitutes both a desktop reference to academic and industrial researchers in the field, and a textbook for students in the area of molecular modeling and drug discovery. Comprised of 18 chapters and divided into three parts, this book: Provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design Outlines the underlying physico-chemical foundation of the methods described Presents several applications of computational methods to real world problems in the drug design field Helps to avoid a "black-box" approach to in silico drug discovery Constitutes an actual textbook for students in the area of molecular modeling and drug discovery Gives the reader the adequate background to face the current challenges of the field In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications describes the theoretical framework, methods, practical applications and case examples relevant to computer-aided drug lead discovery and design. This text will surely aid in understanding the underlying physical foundation of computational tools and their range of application, thus facilitating the interpretation of simulation results.

If we will ever achieve Paul Ehrlich's "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos," those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology. The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity. The book's ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.

This unique reference provides concise, single-source coverage of the clinical, research, and therapeutic aspects of dermatological problems associated with bacteria, fungi, and viruses.
Introduces many novel antifungal, antibacterial, and antiviral agents
Highlighting the molecular biology as well as risk - benefit ratios of new diagnostic and treatment modalities, Cutaneous Infection and Therapy
evaluates the role of antimicrobial soaps in personal hygiene and research on preoperative skin preparation and infection rates
discusses reasons for the reduced risk of infection using occlusive wound dressings
explains the epidemiology, presentation, pathophysiology, and treatment of athlete's foot and fungal diseases of the scalp
presents new oral antifungals for the treatment of onychomycosis
examines the advantages and disadvantages of preparations to treat superficial fungal infections
addresses oral candidiasis in HIV infection and the resistance to antifungal therapy in AIDS patients
reviews the patterns of candidiasis in children and current approaches to antifungal therapy
covers the epidemiology, implications, and management of herpes in pregnant women and newborns
and much more

A guide to nursing and health care, this book aims to take more account of health care professionals outside nursing and pay more attention to qualitative research and increased consideration of how to develop reliability and validity in research tools.

Animal experimentation is one of the most controversial areas of debate on animal rights. Biomedical research is at the hard edge of these debates: it throws up fundamental questions of moral value - of whether human life is more important than that of animals. Much experimentation is defended by its apparent success in terms of increasing medical knowledge. This study investigates whether biomedical research using animals is, in fact, scientifically justified. The authors show that in scientific terms - using the models that scientists themselves use - these claims are exaggerated, or even false. They argue that we need to reassess our use of animals and, indeed, rethink the standard positions in the debate. Their analysis reveals why research using animals might be a source of hypotheses about human biomedical phenomena, yet would never prove or establish anything about this phenomena.

Precision Medicine in Neurodegenerative Disorders, Part Two, Volume 193 deals with the "How" in the reconfiguration of our approach to slow the progression of those suffering from diseases of accelerated brain aging. This second Handbook of Clinical Neurology volume offers a rethinking of the animal models on which therapies are tested; outlines the progress and expected changes in biological subtyping efforts using lysosomal, endosomal, mitochondrial, immune dysregulation, and inflammatory mechanisms of disease pathophysiology; and the growing role of microbiome in shaping disease and as a future target of therapeutic efforts. The volume separates the potentially disease-modifying neurorescue and neurorestoration, (e.g., gene therapy and cell replacement therapy) from true precision medicine -matching the biology of those affected with the mechanism of the intervention of interest. Specific chapters are dedicated to the promise and challenges of extracellular vesicles for both diagnosis and treatment, the growing application of digital measures and other evaluations of clinical response, the nuts and bolts of novel adaptive clinical trial designs, and the regulatory changes needed to facilitate drug development for disease-modification purposes.

The germfree animal is reared in the laboratory to be bacteria free; its counterpart, the gnotobiotic animal, is exposed to select microorganisms. The need for such an animal model for use in biomedical studies was first expressed by Pasteur in the late 1800s. Subsequent development of germfree and gnotobiotic animals led to an explosion of studies on the effects of microflora and its components on the physiology and metabolism of the host. Germfree and Gnotobiotic Animal Models brings together the most notable points of early and recent studies and gives reference to the most pertinent literature.

This book provides an in-depth description and discussion of different multi-modal diagnostic techniques for cancer detection and treatment using exact optical methods, their comparison, and combination. Coverage includes detailed descriptions of modern state of design for novel methods of optical non-invasive cancer diagnostics; multi-modal methods for earlier cancer diagnostic enhancing the probability of effective cancer treatment; modern clinical trials with novel methods of clinical cancer diagnostics; medical and technical aspects of clinical cancer diagnostics, and long-term monitoring. Biomedical engineers, cancer researchers, and scientists will find the book to be an invaluable resource. Introduces optical imaging strategies; Focuses on multimodal optical diagnostics as a fundamental approach; Discusses novel methods of optical non-invasive cancer diagnostics.