A Concise Guide to Observational Studies in Healthcare


Book Description

A Concise Guide to Observational Studies in Healthcare provides busy healthcare professionals with an easy-to-read introduction and overview to conducting, analysing and assessing observational studies. It is a suitable introduction for anyone without prior knowledge of study design, analysis or conduct as the important concepts are presented throughout the text. It provides an overview to the features of design, analyses and conduct of observational studies, without using mathematical formulae, or complex statistics or terminology and is a useful guide for researchers conducting their own studies, those who participate in studies co-ordinated by others, or who read or review a published report of an observational study. Examples are based on clinical features of people, biomarkers, lifestyle habits and environmental exposures, and evaluating quality of care.




Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide


Book Description

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)




Observational Studies in a Learning Health System


Book Description

"Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine's Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies. Observational Studies in a Learning Health System is the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients"--Publisher's description.




Observational Studies in a Learning Health System


Book Description

Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine\'s Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies. Observational Studies in a Learning Health Systemis the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients.




Guidelines for Reporting Health Research


Book Description

Guidelines for Reporting Health Research is a practical guide to choosing and correctly applying the appropriate guidelines when reporting health research to ensure clear, transparent, and useful reports. This new title begins with an introduction to reporting guidelines and an overview of the importance of transparent reporting, the characteristics of good guidelines, and how to use reporting guidelines effectively in reporting health research. This hands-on manual also describes over a dozen internationally recognised published guidelines such as CONSORT, STROBE, PRISMA and STARD in a clear and easy to understand format. It aims to help researchers choose and use the correct guidelines for reporting their research, and to produce more completely and transparently reported papers which will help to ensure reports are more useful and are not misleading. Written by the authors of health research reporting guidelines, in association with the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, Guidelines for Reporting Health Research is a helpful guide to producing publishable research. It will be a valuable resource for researchers in their role as authors and also an important reference for editors and peer reviewers.




A Concise Guide to Clinical Trials


Book Description

Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies




Essential Concepts in Clinical Research


Book Description

This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods. Written by leaders in the field of clinical research who have published extensively with authorship of hundreds of articles in medical journals. The authorship includes one of the three authors of the CONSORT guidelines for the reporting of randomized controlled trials. The book presents the essential concepts to a wide array of topics including randomized control trials, descriptive studies, cohort studies, case-control studies, bias, and screening tests. The book utilises a readable and humorous prose style, lightening what can be a difficult area for clinical readers. Derived from decades of teaching clinical research in seminar settings the book will empower clinicians to make sense of, and critically appraise, current medical research and will enable researchers to enrich the quality of their work. The updated new edition includes six new chapters: Surrogate endpoints Limitations of observational epidemiology Participant recruitment Practicalities of double-blinding Randomized trials in the context of a prospective meta-analysis Reporting studies in medical journals: CONSORT




Design of Observational Studies


Book Description

An observational study is an empiric investigation of effects caused by treatments when randomized experimentation is unethical or infeasible. Observational studies are common in most fields that study the effects of treatments on people, including medicine, economics, epidemiology, education, psychology, political science and sociology. The quality and strength of evidence provided by an observational study is determined largely by its design. Design of Observational Studies is both an introduction to statistical inference in observational studies and a detailed discussion of the principles that guide the design of observational studies. Design of Observational Studies is divided into four parts. Chapters 2, 3, and 5 of Part I cover concisely, in about one hundred pages, many of the ideas discussed in Rosenbaum’s Observational Studies (also published by Springer) but in a less technical fashion. Part II discusses the practical aspects of using propensity scores and other tools to create a matched comparison that balances many covariates. Part II includes a chapter on matching in R. In Part III, the concept of design sensitivity is used to appraise the relative ability of competing designs to distinguish treatment effects from biases due to unmeasured covariates. Part IV discusses planning the analysis of an observational study, with particular reference to Sir Ronald Fisher’s striking advice for observational studies, "make your theories elaborate." The second edition of his book, Observational Studies, was published by Springer in 2002.




Registries for Evaluating Patient Outcomes


Book Description

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. 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.




Demystifying Research for Medical and Healthcare Students


Book Description

DEMYSTIFYING RESEARCH FOR MEDICAL & HEALTHCARE STUDENTS All healthcare students need to understand research methods to be able to understand research articles and to actively engage in research where necessary. Most clinical programs include research training within their courses, and many students are required to undertake an assessed research project—both at undergraduate and postgraduate levels. Breaking down the jargon barriers of research methods, and designed for those new to the world of research, Demystifying Research is a straightforward and highly accessible guide to fundamental research methods, approaches, and skills. This student-friendly resource describes quantitative and qualitative research approaches, mixed research methods, research ethics and governance, research skills and more. Step-by-step, students learn to appraise research in scholarly articles, design a project, and conduct research in the lab, in clinical practice, and other real-life situations. Technical jargon and classic research are explained in plain English, while relevant theory is illustrated through relatable examples of research in practice. Designed to make learning about research easy, this valuable guide: Explains basic research methods in a direct and engaging style Breaks research methods down into manageable, easy-to-digest pieces Defines what research is, and provides an overview of its methods and methodologies Covers all key areas of research, including observational and experimental approaches, and clinical trials Includes real-life examples of successful student research projects Features a companion website containing lecture slides available to download in PowerPoint Demystifying Research is a must-have for undergraduate and postgraduate medical, nursing, other healthcare and social sciences students, as well as professionals looking to refresh their knowledge.