Doing Research in Emergency and Acute Care

Making Order Out of Chaos
 
 
Wiley-Blackwell (Verlag)
  • erschienen am 2. März 2016
  • |
  • 288 Seiten
 
E-Book | ePUB mit Adobe DRM | Systemvoraussetzungen
978-1-118-64347-1 (ISBN)
 
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; and 2) 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.
1. Auflage
  • Englisch
  • New York
  • |
  • Großbritannien
John Wiley & Sons
  • 7,97 MB
978-1-118-64347-1 (9781118643471)
111864347X (111864347X)
weitere Ausgaben werden ermittelt
  • Intro
  • Title page
  • Table of Contents
  • List of contributors
  • PART 1: Getting ready: Preparing for your research study
  • CHAPTER 1: Aspects of research specific to acute care
  • Responsibility of the academic physician
  • Asking the right questions
  • Challenges with acute care research
  • Where do I start?
  • Roadblocks, errors, and things to avoid
  • CHAPTER 2: Aspects of feasibility in research
  • Safety considerations
  • Expertise and infrastructure
  • Compliance with study procedures
  • "Recruitability"
  • Sustainability considerations
  • References
  • CHAPTER 3: How do I formulate a research question?
  • Characteristics of an interesting question
  • Making a question interesting
  • Time and resources to answer a question
  • Translating a question into a hypothesis
  • Ethical concerns
  • References
  • CHAPTER 4: Evidence-based medicine: Finding the knowledge gap
  • Evidence synthesis/systematic reviews
  • Structured critical appraisal
  • Knowledge translation
  • Conclusion
  • References
  • CHAPTER 5: How to carry out an efficient literature search
  • Part I: Surveying the research landscape
  • Part II: The deep dive
  • Summary
  • References
  • CHAPTER 6: What do I need to know to get started with animal and basic science research?
  • Laboratory space
  • Equipment and supplies
  • Choosing the right model
  • Laboratory workers
  • Mentors and collaborators
  • Funding
  • "So you want to do a single preclinical study?" An approach for the ad hoc investigator
  • References
  • CHAPTER 7: The IRB process: How to write up a human studies protocol
  • Introduction
  • Key issues
  • Conclusion
  • References
  • CHAPTER 8: Ethics in research: How to collect data ethically
  • The philosophical foundation of experimental research
  • Historical case studies that have shaped how human research is conducted
  • The establishment of the Belmont Principles
  • The ethical standards to which we are held today
  • The Institutional Review Board
  • Summary
  • References
  • CHAPTER 9: Safety in research: How to ensure patient safety?
  • How do we protect patients in our studies?
  • Adverse events
  • FDA reporting requirements
  • Data safety monitoring plans and data safety monitoring boards
  • Clinical trial monitors, contract research organizations, and clinical research associates
  • References
  • Further reading
  • PART 2: Getting it done: Doing your research study
  • CHAPTER 10: How to design a study that everyone will believe: Minimizing bias and confounding
  • Bias
  • Confounding
  • References
  • CHAPTER 11: How to design a study that everyone will believe: An overview of research studies and picking the right design
  • Introduction
  • Overview of study designs
  • Randomized controlled trials
  • Cohort studies
  • Case-control studies
  • Cross-sectional studies
  • Case series
  • Meta-analyses
  • Conclusion
  • References
  • CHAPTER 12: How to design a study that everyone will believe: Random selection and allocation of patients to treatment conditions
  • Why conduct a randomized control trial?
  • Planning a clinical trial
  • The planning phase
  • The preparatory phase
  • Recruitment phase
  • The patient follow-up and termination phase
  • The analysis phase
  • Ethical aspects of research
  • References
  • CHAPTER 13: How to design a study that everyone will believe: Surveys
  • Overview of survey methodology
  • Administration
  • Survey methods
  • Technology and surveys
  • Time to develop your survey
  • Survey questions
  • Survey layout and respondent interaction
  • Final steps
  • Further reading
  • CHAPTER 14: How to design a study that everyone will believe: Retrospective reviews
  • Why are retrospective reviews held in a negative light?
  • With the existing bias against chart reviews, why spend the time?
  • What are the limitations to retrospective review?
  • Designing a believable retrospective study
  • References
  • CHAPTER 15: How to design a study that everyone will believe: Prehospital studies
  • External validity
  • Sample size (Power)
  • Methodology
  • Informed consent
  • Patient outcomes
  • Relevance
  • A few parting thoughts
  • References
  • CHAPTER 16: How to design a study that everyone will believe: Ethical concepts for special populations in emergency research
  • Introduction
  • Primer on ethics
  • Application of concepts
  • Conclusion
  • References
  • CHAPTER 17: How to design a study that everyone will believe: Industry studies
  • Introduction
  • Coming up with a question
  • Types of industry studies or clinical trials
  • Developing methods
  • Getting started with industry-sponsored research funding
  • Data safety monitoring boards
  • Material safety transfer agreements
  • Compensation
  • Publication
  • Pitfalls
  • Conflicts of interest
  • IRB issues
  • Recruiting patients
  • Summary
  • References
  • CHAPTER 18: How to design a study that everyone will believe: Prospective studies
  • Introduction
  • Observational studies
  • Cohort studies
  • Randomized control study designs with a placebo group
  • Randomized clinical trials without a placebo group
  • Epilogue
  • Summary
  • References
  • CHAPTER 19: How to design a study that everyone will believe: Effectiveness, safety, and the intention to treat
  • Real world issues that occur in clinical research
  • Which came first: The efficacy or the effectiveness study and what is the difference anyway?
  • So your patient is a no-show for the rest of the study. Now what? Intention-to-Treat Analysis
  • The good the bad and the ugly: Pros and cons of intention-to-treat analysis
  • Filling in the blanks: Types of missing data and techniques for replacing missing data points
  • Summary
  • References
  • CHAPTER 20: How to design a study that everyone will believe: Emergency department operations and systems
  • Studying operations and flow in an acute care setting
  • Benchmarking
  • Informatics
  • Improving operations-based research
  • Conclusion
  • References
  • CHAPTER 21: How to design a study that everyone will believe: The challenges of doing international research
  • Quality work
  • "Inter-nation-al" means between and among nations
  • Ethics
  • Be respectful
  • Applicability
  • Readers? What readers?
  • Summary
  • References
  • CHAPTER 22: The development of clinical prediction rules
  • What is a clinical decision instrument?
  • Choosing a CDI focus
  • Developing a CDI: Research methods
  • Advanced topics
  • References
  • CHAPTER 23: Testing the safety and efficacy of devices: Device safety, as well as obtaining an IDE (investigational device exemption) from the FDA
  • Step one: Protect your invention
  • Step two: Innovate
  • Step three
  • Step four
  • Step five: Obtain reimbursement for your device
  • Obtaining an IDE (Investigational Device Exemption) from the FDA
  • Summary
  • References
  • CHAPTER 24: Privacy in research: How to collect data safely and confidentially
  • Overview
  • What is HIPPA?
  • Informed consent and impact on privacy
  • Protected health information and anonymity
  • Protecting and storing the data
  • Futher reading
  • CHAPTER 25: How do I establish a research assistant program?
  • What is an research assistant program and why do I need one?
  • Why do you need an academic associate program?
  • What does an academic associate program cost my department?
  • What do other research faculty get out of it?
  • What do research faculty have to do in return for use of the academic associates?
  • What do non-research faculty get out of it?
  • Sounds great. How do I establish an academic associates program?
  • How many students do you take?
  • What exactly is the curriculum?
  • Are you really crazy enough to have classes and examinations for volunteers?
  • How do students sign up, get trained and supervised?
  • Once created, where do you find students?
  • How many clinical studies can you conduct at the same time?
  • Can the academic associates do more than just collect data in the ED?
  • What do the students get out of it?
  • References
  • CHAPTER 26: How to complete a research study well and in a minimum of time: The importance of collaboration
  • Working with your team
  • The collaborator standing next to you
  • The collaborator down the hall
  • Dirty jobs: Assigning authorship
  • References
  • PART 3: Getting it out there: Analyzing and publishing your study
  • CHAPTER 27: Eliminating common misconceptions to enable intelligent use of biostatistics: How can a novice use statistics more intelligently?
  • Recognizing types of data [1]
  • Describing data [6]
  • Statistical inference, random sampling, bias and error [1]
  • Matching the type of data to the appropriate inferential statistical test [8, 9]
  • Summary
  • References
  • CHAPTER 28: Basic statistics: sample size and power: How are sample size and power calculated?
  • The purpose of sample size and power calculations
  • Important definitions relevant to sample size and power calculations
  • What is power?
  • Factors influencing sample size and power
  • When should you perform a sample size calculation?
  • How do you perform a sample size and power calculation when testing for a possible difference between groups?
  • How do you perform a sample size and power calculation when undertaking an equivalence or non-inferiority trial?
  • Summary
  • References
  • CHAPTER 29: Basic statistics: Means, P values, and confidence intervals
  • Outlining your study
  • Describing your sample
  • Comparing groups
  • Accounting for chance
  • The problem with P values
  • Confidence intervals: Another statistical weapon
  • Interpreting confidence intervals
  • Application to clinical research
  • References
  • CHAPTER 30: Basic statistics: Assessing the impact of therapeutic interventions with odds-ratios, relative risk, and hazard ratios
  • Hypothetical study example
  • What is relative risk?
  • What is an odds ratio?
  • Which one should I use?
  • Time as a factor: What is a hazard ratio?
  • How do you interpret statistical significance?
  • Final thoughts
  • Further reading
  • CHAPTER 31: Basic statistics: Assessing the impact of a diagnostic test
  • choosing a gold standard, sensitivity, specificity, PPV, NPV, and likelihood ratios
  • Test results when two outcomes are possible
  • Sensitivity and specificity
  • Positive and negative predictive value
  • Accuracy of a diagnostic test
  • Likelihood ratio
  • Likelihood ratio for dichotomous test results
  • Rules of thumb [1]
  • Likelihood ratios for interval or continuous data
  • References
  • CHAPTER 32: Advanced biostatistics: Chi-square, ANOVA, regression, and multiple regression
  • Introduction
  • Chi-square testing [1]
  • Analysis of variance (ANOVA) [3]
  • Regression [4-6]
  • Multiple regression [5, 6]
  • References
  • CHAPTER 33: Can I combine the results of this study with others? An introduction to systematic reviews
  • Patient scenario
  • Introduction
  • Terminology
  • How do you start?
  • Methods: What are the keys to a "good" systematic review?
  • Where can you find good SR evidence?
  • Conclusions
  • Acknowledgements
  • References
  • CHAPTER 34: How to write a scientific paper for publication
  • Introduction
  • How do you choose a journal to submit to?
  • Rules of the road from an editor's perspective
  • Use a clear writing style
  • Section-by-section considerations
  • Conclusion
  • References
  • Appendix 34.1
  • CHAPTER 35: How do I make reviewers happy? The review process: What do reviewers look for in a manuscript? What is the review process?
  • Introduction
  • Part 1: What to expect when submitting: A step-by-step guide to the review process
  • Part 2: Bullet-proofing your manuscript
  • Part 3: Responding to the decision
  • Summary
  • Further reading
  • CHAPTER 36: How do I write a grant?
  • Introduction
  • General definitions
  • Getting started
  • The importance of grant application instructions
  • Writing the research plan
  • The budget and budget justification
  • Ethical considerations
  • Appendix 36.1 Gantt Chart
  • Appendix 36.2 Additional resources
  • CHAPTER 37: How to make an academic career: Developing a successful path in research
  • Fellowship training: Is it necessary?
  • Mentorship
  • It is not a "niche": Choosing a research focus
  • Profile of activities
  • Challenges
  • References
  • Glossary
  • Index
  • End User License Agreement

List of contributors


Deirdre Anglin, MD, MPH
Professor of Emergency Medicine
Department of Emergency Medicine, Keck School of Medicine of University of Southern California, Los Angeles, CA, USA

Jonathan Auten, DO
Assistant Professor of Military and Emergency Medicine
F Hebert School of Medicine, Uniformed Services University of Health Sciences, Bethesda, MD;
Attending Physician,
Department of Emergency Medicine, Naval Medicine Center, San Diego, CA, USA

Zubair Bayat
Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

Jesse J. Brennan, MA
Senior Research Scientist
Department of Emergency Medicine, University of California San Diego, San Diego, CA, USA

Ashleigh Campillo, BS
UCSD Department of Emergency Medicine Behavioral Emergencies Research (DEMBER) laboratory, University of California, San Diego, CA, USA

Christopher R. Carpenter, MD, MSc
Associate Professor
Department of Emergency Medicine, School of Medicine;
Director of Evidence Based Medicine
Washington University in St Louis, St. Louis, MO, USA

Daniel del Portal, MD, FAAEM
Assistant Professor of Clinical Emergency Medicine
Temple University School of MedicinePhiladelphia, PA, USA

Edward M. Castillo, PhD, MPH
Associate Adjunct Professor
Department of Emergency Medicine, University of California San Diego, San Diego, CA, USA

Richard F. Clark, MD, FACEP
Professor of Emergency Medicine
Director, Division of Medical Toxicology
UCSD Medical Center, San Diego, CA, USA

Christopher J. Coyne, MD
Clinical Research Fellow
UCSD Department of Emergency Medicine, UC San Diego Health System, San Diego, CA, USA

Zachary D.W. Dezman, MD, MS
Clinical Instructor
Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, MD, USA

Louise Falzon, BA, PGDipInf
Information Specialist
Center for Behavioral Cardiovascular Health, Columbia University Medical Center, NY, USA

Gary Gaddis, MD, PhD
St. Luke's/Missouri Endowed Chair in Emergency Medicine
St. Luke's Hospital of Kansas City;
Professor of Emergency Medicine
University of Missouri-Kansas City School of Medicine, MO, USA

Manish Garg, MD
Professor, Emergency Medicine
Senior Associate Residency Program Director
Assistant Dean for Global Medicine
Temple University Hospital and School of Medicine, Philadelphia, PA, USA

Kama Z. Guluma, MD
Clinical Professor of Emergency Medicine and Research
Education Coordinator, UC San Diego Health SystemsDepartment of Emergency Medicine, CA, USA

Prasanthi Govindarajan, MD, MAS
Associate Professor of Emergency Medicine-Medical Center Line
Stanford University Medical CenterStanford, CA, USA

Robert Grover, MD, MPH
PGY-2
Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA

Richard Harrigan, MD
Professor of Emergency Medicine
Temple University Hospital and School of Medicine, Philadelphia, PA, USA

Stephen R. Hayden, MD
Professor in the UC San Diego Health Systems
Department of Emergency Medicine, CA, USA

Jon Mark Hirshon, MD, MPH, PhD
Professor
Department of Emergency Medicine and Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA

Judd E. Hollander, MD
Associate Dean for Strategic Health Initiatives
Sidney Kimmel Medical College;
Vice Chair, Finance and Healthcare Enterprises
Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA

Austin Hopper, BS
Department of Emergency Medicine Behavioral Emergencies Research laboratory (DEMBER), UC San Diego Health System, San Diego, CA, USA.

Benton R. Hunter, MD, MSc
Assistant Professor of Clinical Emergency Medicine
Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN, USA

Paul Ishimine, MD
Director, Pediatric Emergency Medicine Fellowship Training Program
USCD/Rady Children's Hospital, San Diego;
Director, Pediatric Emergency Medicine
UC San Diego Health System;
Clinical Professor of Emergency Medicine and Pediatrics
University of California, San Diego School of Medicine
UC San Diego Health System, Department of Emergency Medicine, San Diego, CA, USA

Christopher Kahn, MD, MPH
Associate Professor of Clinical Emergency Medicine
Division of Emergency Medical Services and Disaster Medicine, Department of Emergency Medicine, University of California, San Diego, CA, USA

David J. Karras, MD
Professor of Emergency Medicine
Assistant Dean for Clinical Education Integration
Associate Chair for Academic Affairs
Department of Emergency Medicine, Temple University School of Medicine, Philadelphia, PA, USA

Eddy Lang, MDCU
Acting Zone Clinical Department Head and Interim Faculty Department Head
Department of Emergency Medicine, University of Calgary, Calgary, AB, Canada

Jennifer Lanning, MD, PhD
Resident
Department of Emergency Medicine, University of California San Francisco, San Francisco General Hospital, CA, USA

Juan A. Luna, MA, BA
California State University San Marcos, CA, USA

Michael Menchine, MD, MPH
Associate Professor of Emergency Medicine
Department of Emergency Medicine, Keck School of Medicine of University of Southern California, Los Angeles, CA, USA

Mary Mercer, MD, MPH
Assistant Clinical Professor of Emergency Medicine
University of California San Francisco;
Director of Performance Improvement and EMS Base Hospital Medical Director
Department of Emergency Medicine, San Francisco General Hospital, San Francisco, CA, USA

Alicia B. Minns, MD
Assistant Clinical Professor of Emergency Medicine
Fellowship Director, Division of Medical Toxicology
UCSD Medical Center, San Diego, CA, USA

Jarrod M. Mosier, MD
Director EM/Critical Care;
Assistant Professor Emergency Medicine, Department of Emergency Medicine;
Assistant Professor Internal Medicine, Department of Medicine, Section of Pulmonary Critical Care, Allergy and Sleep
University of Arizona, Tucson, AZ, USA

Sean-Xavier Neath, MD, PhD
Assistant Clinical Professor of Medicine
Department of Emergency Medicine, University of California, San Diego, CA, USA

Kimberly Nordstrom, MD, JD
Medical Director, Psychiatric Emergency Services, Denver Health Medical Center;
Assistant Professor of Psychiatry, University of Colorado School of Medicine Denver, CO, USA;
President, American Association for Emergency Psychiatry Bloomfield, CT, USA

Nas Rafi, MD
Biomedical Ethics Fellow
Assistant Clinical Professor of Emergency Medicine
UCSD Emergency Department, San Diego, CA, USA

Robert Rodriguez, MD, FAAEM
Professor of Emergency Medicine
Department of Emergency Medicine, University of California San Francisco, San Francisco General Hospital, CA, USA

Peter Rosen, MD
Senior Lecturer, Emergency Medicine, Harvard University Medical School
Attending Physician, Beth Israel Deaconess Medical Center
Boston, MA, USA;
Visiting Professor Emergency Medicine, University of Arizona School of Medicine;
Professor Emeritus Emergency Medicine, University of California San Diego School of Medicine

Brian H. Rowe, MD, MSc, CCFP(EM), FCCP
Scientific Director, Emergency Strategic Clinical Network, AHS;
Tier I Canada Research Chair in Evidence-based Emergency Medicine;
Professor, Department of Emergency Medicine
University of Alberta, Edmonton, AB, Canada

George J. Shaw, MD, PhD
Associate Professor
Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA

Brian Snyder, MD
Biomedical Ethics Fellowship Director
Clinical Professor of Emergency Medicine,
UCSD Emergency Department, San Diego, CA, USA

Katie L. Tataris, MD, MPH
Assistant Professor of MedicineSection of Emergency Medicine
University of ChicagoEMS Medical Director, Chicago South EMS System Chicago, IL, USA

Aleksandr Tichter, MD, MS
Assistant Professor of Medicine
Columbia University Medical Center, NY, USA

Vaishal Tolia, MD, MPH, FACEP
Associate Clinical ProfessorAssociate Medical DirectorDirector of ED ObservationAttending in Emergency Medicine & Hospital MedicineDepartment of Emergency Medicine, University of California, San Diego Health System, San Diego, CA, USA

Christian Tomaszewski, MD, MS, MBA, FACEP, FACMT, FIFEM
Professor of Clinical Emergency Medicine;
Medical Director, Department of Emergency Medicine;
Attending in Medical Toxicology and Hyperbarics
University of California San Diego Health System, San Diego, CA, USA

Vicken Y. Totten, MD, MS
Institutional Director for Research
Kaweah Delta Health Care District, Department of Emergency Medicine, Visalia, CA, USA

Jacob W. Ufberg, MD
Professor and Residency Director
Department of Emergency Medicine, Temple University School of Medicine, Philadelphia, PA, USA

Gary M. Vilke, MD, FACEP, FAAEM
Professor of Clinical Emergency Medicine
Medical Director, Risk Management, UC San Diego Health System
Director, Clinical Research for Emergency...

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