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Index
Cover
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
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