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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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