A practical guide to understanding and navigating the unique challenges faced by physicians and other professionals who wish to undertake research in the ED or other acute care setting.

 Focusing on the hyper-acute and acute care environment and fulfilling two closely-related needs:

1)the need for even seasoned researchers to understand the specific logistics and issues of doing research in the ED; and2)the need to educate clinically active physicians in research methodology.

This new text is not designed to be a complex, encyclopedic resource, but instead a concise, easy-to-read resource designed to convey key need-to-know information within a comprehensive framework. Aimed at the busy brain, either as a sit-down read or as a selectively-read reference guide to fill in knowledge gaps, chapters are short, compartmentalized, and are used strategically throughout the text in order to introduce and frame concepts. This format makes it easy - and even entertaining - for the research novice to integrate and absorb completely new (and typically dry) material.

The textbook addresses aspects of feasibility, efficiency, ethics, statistics, safety, logistics, and collaboration in acute research. Overall, it grants access for the seasoned researcher seeking to learn about acute research to empathically integrate learning points into his or her knowledge base.

As the ED is the primary setting for hyper-acute and acute care, and therefore a prime site for related clinical trial recruitment and interventions, the book presents specific logistical research challenges that researchers from any discipline, including physicians, research nurse coordinators, study monitors, or industry partners, need to understand in order to succeed.

Kama Z. Guluma, MD, is an Associate Professor of Emergency Medicine and the Research Education Coordinator in the UC San Diego Health Systems Department of Emergency Medicine. He is a board-certified and clinically active Emergency Physician with over 10 years of hands on experience in clinical and basic science research, specifically with regards to acute stroke. He has served -- and currently serves as a Principal Investigator in NIH? funded clinical trials, and has published both clinical and pre-clinical research manuscripts. He has been a member of the NIH Stroke Progress Review Group, a national panel convened by the National Institutes of Neurological Diseases and Stroke (NINDS) to identify and outline national research priorities in acute stroke. He is also a reviewer for theAnnals of Emergency Medicine,Internal and Emergency Medicine, and theJournal of Emergency Medicine.

Michael P. Wilson, PhD, MD, is an Attending Physician in the UC San Diego Health Systems Department of Emergency Medicine, as well as Director of the Department of Emergency Medicine Behavioral Emergencies Research lab. He is a board certified and clinically active Emergency Physician, and brings a "cross-trained" perspective, having received his PhD in Cognitive Neuroscience. He has published numerous articles on both Emergency Medicine research and behavioral emergencies, sits on numerous journal editorial boards, and is a reviewer for both theJournal of Emergency Medicine andWestern Journal of Emergency Medicine.

Stephen Hayden, MD, is a Professor in the UC San Diego Health Systems Department of Emergency Medicine, is the previous Director of Residency Training and currently serves as Dean of Graduate Medical Education. He is a board-certified and clinically active Emergency Physician, has lectured nationally on evidence-based medicine, and is editor-in-chief of theJournal of Emergency Medicine.

List of contributors, ix

Part 1: Getting ready: Preparing for your research study

1 Aspects of research specific to acute care, 3
Jarrod M. Mosier and Peter Rosen

2 Aspects of feasibility in research, 7
Kama Z. Guluma

3 How do I formulate a research question?, 13
Michael P. Wilson

4 Evidence?]based medicine: Finding the knowledge gap, 17
Eddy Lang and Zubair Bayat

5 How to carry out an efficient literature search, 21
Aleksandr Tichter, Louise Falzon, and Peter Wyer

6 What do I need to know to get started with animal and basic science research?, 31
George J. Shaw

7 The IRB process: How to write up a human studies protocol, 37
Christian Tomaszewski

8 Ethics in research: How to collect data ethically, 45
Nas Rafi and Brian Snyder

9 Safety in research: How to ensure patient safety?, 53
Robert Grover and Vicken Y. Totten

Part 2: Getting it done: Doing your research study

10 How to design a study that everyone will believe: Minimizing bias and confounding, 61
Michael Witting

11 How to design a study that everyone will believe: An overview of research studies and picking the right design, 65
Julian Villar, Jennifer Lanning, and Robert Rodriguez

12 How to design a study that everyone will believe: Random selection and allocation of patients to treatment conditions, 71
Katie L. Tataris, Mary Mercer, and Prasanthi Govindarajan

13 How to design a study that everyone will believe: Surveys, 79
Edward M. Castillo and Gary M. Vilke

14 How to design a study that everyone will believe: Retrospective reviews, 85
Jonathan Auten and Paul Ishimine

15 How to design a study that everyone will believe: Prehospital studies, 93
Christopher Kahn

16 How to design a study that everyone will believe: Ethical concepts for special populations in emergency research, 97
Kimberly Nordstrom

17 How to design a study that everyone will believe: Industry studies, 105
Richard F. Clark and Alicia B. Minns

18 How to design a study that everyone will believe: Prospective studies, 115
Gary Gaddis

19 How to design a study that everyone will believe: effectiveness, safety, and the intention to treat, 121
Ashleigh Campillo, Christopher J. Coyne, and Juan A. Luna

20 How to design a study that everyone will believe: Emergency department operations and systems, 129
Vaishal Tolia

21 How to design a study that everyone will believe: The challenges of doing international research, 133
Vicken Y. Totten

22 The development of clinical prediction rules, 139
Benton R. Hunter and Christopher R. Carpenter

23 Testing the safety and efficacy of devices: Device safety, as well as obtaining an IDE (investigational device exemption) from the FDA, 149
Sean?]Xavier Neath

24 Privacy in research: How to collect data safely and confidentially, 155
Gary M. Vilke and Edward M. Castillo

25 How do I establish a research assistant program?, 161
Judd E. Hollander

26 How to complete a research study well and in a minimum of time: The importance of collaboration, 167
Austin Hopper and Michael P. Wilson

Part 3: Getting it out there: Analyzing and publishing your study

27 Eliminating common misconceptions to enable intelligent use of biostatistics: How can a novice use statistics more intelligently?, 175
Gary Gaddis

28 Basic statistics: sample size and power: How are sample size and power calculated?, 183
Manish Garg, Richard Harrigan, and Gary Gaddis

29 Basic statistics: Means, P values, and confidence intervals, 191
Daniel del Portal and Richard Harrigan

30 Basic statistics: Assessing the impact of therapeutic interventions with odds-ratios, relative risk, and hazard ratios, 199
Jesse J. Brennan and Edward M. Castillo

31 Basic statistics: Assessing the impact of a diagnostic test; choosing a gold standard, sensitivity, specificity, PPV, NPV, and likelihood ratios, 205
Stephen R. Hayden

32 Advanced biostatistics: Chi?]square, ANOVA, regression, and multiple regression, 213
Gary Gaddis

33 Can I combine the results of this study with others? An introduction to systematic reviews, 223
Brian H. Rowe

34 How to write a scientific paper for publication, 231
Stephen R. Hayden

35 How do I make reviewers happy? The review process: What do reviewers look for in a manuscript? What is the review process?, 239
David J. Karras and Jacob W. Ufberg

36 How do I write a grant?, 247
Zachary D.W. Dezman and Jon Mark Hirshon

37 How to make an academic career: Developing a successful path in research, 253
Deirdre Anglin and Michael Menchine

Glossary, 259

Index, 267