Translational Cardiology

1st Edition - January 20, 2025
Imprint: Academic Press
Editors: Jeffrey A. Bakal, Michael Gibson, Adam E.M. Eltorai
Language: English
Paperback ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 7 9 0 - 2
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 8 6 1 0 - 6

Translational Cardiology provides a cardiology-specific instructional guide to translational medical research that will serve as a practical, step-by-step roadmap for taking a biom… Read more

Purchase options

BLOOM INTO SPRING SAVINGS

Save up to 25% on books and eBooks!

Shop now

Institutional subscription on ScienceDirect

Request a sales quote

Translational Cardiology provides a cardiology-specific instructional guide to translational medical research that will serve as a practical, step-by-step roadmap for taking a biomedical device, potential therapeutic agent, or research question from idea through demonstrated clinical benefit. Fundamentally, the volume aims to help bridge the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in cardiology, this book provides a clear process for understanding, designing, executing, and analyzing clinical and translational research.

Title of Book
Cover image
Title page
Table of Contents
Handbook for Designing and Conducting Clinical and Translational Research
Copyright
Contributors
List of section editors
Preface
Part I. Introduction
Chapter 1. Translational cardiology: Introduction
Introduction
Conclusions
Chapter 2. Translational process
What is translational cardiology?
The importance of translational research in cardiology
Bridging the gap
Accelerated innovations
Personalized medicine
Big data and AI in translational cardiology
Challenges in translational cardiology
The future of translational process
Integration with technology, collaboration, and patient-centric research
Chapter 3. Scientific method
Key points
Why it matters
Steps of the scientific method
Scenario 1: Hypothetico-deductive question
Scenario 2: Hypothetico-inductive question
Sample observational study
Getting started
Pitfalls
Examples of the scientific method
Example 1
Example 2
Example 3
Additional resources and readings
Chapter 4. Basic research
Key points
Why it matters
Chapter text
Cell biology and biochemistry
Sequencing
Immunology
Imaging
Major areas of current investigation
Get started
Pitfalls to avoid
Real-world example
Part II. Pre-clinical: Discovery & development
Chapter 5. Overview of preclinical research in cardiovascular diseases
Why it matters
From in vitro research to animal models
In vitro research
Characteristics of animals frequently used
Care of the animals: Nutrition, cages, environmental/infectious risks
Experiments in translational cardiovascular research
Areas of improvement
Chapter 6. What problem are you solving?
Key points
Introduction
The problem
Types of problems
New pathophysiology?
Repurposing existing agents?
New technology empowering new delivery?
Improving existing therapies and combinations
How to ask the right research questions
Potential pitfalls
Resources additional reading
Chapter 7. Types of structural interventions
Key points
Why it matters
Aortic valve disease
Anatomical
Coronary artery disease
Long-term management
Mitral valve disease
Primary MR
Secondary MR
Tricuspid valve
Importance of the heart team
Chapter 8. Drug discovery
Key points
Introductory section
Target identification
Target optimization and preclinical phase
Clinical studies
Conclusion
Get started
Potential pitfalls
Examples of HTS drug discovery
Resources
Chapter 9. Drug testing
Key points
Introduction
Get started
Major areas of current investigation
Budgetary considerations and how to fund this stage
Potential pitfalls
Examples of …
Resources
Chapter 10. Device testing
Key points
Why does it matter?
Introduction
Medical device safety, efficacy, and regulation in the United States
Safety and effectiveness
Medical device reporting
Medical device classification
How to choose the proper classification
Safety and efficacy data for medical device approval
Pathways to medical device approval
Investigational device exemption
Early feasibility studies
Pivotal studies
Budget considerations
Funding opportunities for device approval
Conclusion
Get started
Pitfalls to avoid
Chapter 11. Diagnostic discovery
Key points
Introductory section/why it matters
Get started
Potential pitfalls
Prototyping
Disciplines and common lab methods/techniques
Major areas of current investigation
Examples of …
New pan-amyloid detector
Transient endothelial dysfunction induced by mental stress
Computed tomography-based fractional flow reserve
Resources
Chapter 12. Diagnostic testing
Key points
Introduction
Evaluation of diagnostic tests
Real-world examples
Coronary artery calcium score
Natriuretic peptides
Potential pitfalls
Regulatory process
Get started
Resources
Chapter 13. Other product types
Key points
Introduction
FDA overview
Regulated and not regulated products
Human food and supplements
Human drugs
From creation to the market (drugs and devices)
Medical devices
Biologics
Electronic radiation products
Cosmetics
Veterinary products
Tobacco products
Get started
Potential pitfalls
Cardiovascular real-world examples of products regulated by the FDA
Resources: Additional reading, consultants, contractors
Chapter 14. Procedural technique development
Key points
Why does it matter?
Introduction
General approach to procedural technique development
Preprocedural medications and care
Surgical preparation and anesthesia
Surgical procedure
Follow-up procedures
Postoperative medications and care
Euthanasia
Necropsy and tissue harvest
A step-based approach
Step 1: Do the research
Step 2: Refine the procedure
Step 3: Pilot study
Step 4: Performing the complete study
Clinical procedures
Pitfalls to avoid
Getting started
Examples of additional resources
Chapter 15. Behavioral intervention
Key points
Introduction
Methodologies
Animal models
Computational models
Stages of behavioral intervention
Get started
Potential pitfalls
Real world examples
Additional resources for the reader
Part III. Clinical: Fundamentals
Chapter 16. Introduction to clinical research: What is it? Why is it needed?
Key points
Why it matters?
Introduction
Regulatory approval
Observational or interventional research
Randomized controlled trials
Observational studies
Get started
Pitfalls to avoid
Chapter 17. The question: Types of research questions and how to develop them
Key points
Why it matters?
Selecting the appropriate research question
Appropriate data and study design
Appropriate statistical methods
Get started
Pitfalls to avoid
Chapter 18. Study population: Who and why them?
Key points
Why it matters?
Introduction
Size and power
Sampling
Inclusion and exclusion criteria
Sex
Race and ethnicity
Elderly and comorbidities
Pitfalls to avoid
Getting started
Chapter 19. Introduction to clinical research: What data are being collected and why?
Key points
Why it matters?
Introduction
Choosing appropriate variables
Data sources and study populations
Data analysis
The choice of outcome type
Get started
Pitfalls to avoid
Resources/Further reading
Chapter 20. Optimizing the question: Balancing significance and feasibility
Key points
Why it matters?
Introduction
Research questions
Developing an optimized research question
PICO
FINER
Pitfalls to avoid
Part IV. Statistical principles
Chapter 21. Common issues in analysis
Key points
Introductory section/why it matters
Misunderstood concepts in statistical analysis
Examples of common misconceptions in translational cardiology
Limitations by study design
Observational studies
Appropriate and overstepping conclusions
Examples
Potential pitfalls
Get started
Consultants/cocontractors
Chapter 22. Basic statistical principles
Key points
Introduction: Why it matters
Confidence intervals
P-values
Confusion matrix
Sensitivity
Specificity
Positive and negative predictive values
Precision and recall
Accuracy
Incidence
Prevalence
Quantifying risk
Potential pitfalls
Examples of terms
Resources
Chapter 23. Distributions
Key points
Introductory section/why it matters
The normal distribution
Characteristics and properties
Standardization and Z-scores
Applications in translational cardiology research
The binomial distribution
Definition, components, and parameters
Implementation in translational cardiology research
The Poisson distribution
Attributes
The probability mass function in the Poisson distribution
Its use in translational cardiology research
The exponential distribution
Features and elements
Probability density function in the exponential distribution
Relationship between the Poisson and exponential distribution
Applications in translational cardiology research
Get started
Potential pitfalls
Additional reading
Consultants/contractors
Chapter 24. Hypothesis and error types
Introduction
Hypothesis
P-value approach of hypothesis testing
Types of error
Type I error (α)
Type II error (β)
Chapter 25. Power of the study
Key points
The importance of power in clinical and translational research
Establishing a context for power by introducing hypothesis testing
A high-level intuition of how these errors can be committed
Exploring type I errors to understand type II errors and power
What is statistical power and how can we optimize for it?
Standards for power in clinical and translational research: Introducing sensitivity
Example
Chapter 26. Regression
Key points
Definition and types of regression models
Mathematical basics
Statistical assumptions
When to use regression
Examples
Linear regression for continuous outcomes
Logistic regression for dichotomous/binary outcomes
Poisson regression for discrete outcomes
Get started
Potential pitfalls
Resources
Chapter 27. Continuous variable analyses: Student's t-test, Mann–Whitney U test, Wilcoxon signed-rank test
Key points
Chapter introduction
Comparing continuous variables when data is normally distributed
Comparing continuous variables when data is not normally distributed
Chapter 28. Categorical variable analyses: Chi-square test, Fisher's exact test, Mantel-Haenszel test
Key points
Introduction
Chi-square test
Fisher's exact test
Mantel–Haenszel test
Chapter 29. ANOVA in statistics
Key points
Analysis of variance
The grand mean and the Sum of Squares Between
The Sum of Squares Within
ANOVA in clinical and translation studies—The basic principles and caveats
One-way versus two-way ANOVA
Inflation of type I errors
Post hoc analysis
Potential pitfalls
Example 13
Example 25
Example 36
Resources
Chapter 30. Correlation
Key points
Introduction
Get started
Correlation
Pearson's correlation coefficient
Spearman's rank correlation coefficient
Other notable correlation coefficients
Correlation interpretation
Potential pitfalls
Real-world examples
Resources
Chapter 31. Statistical bias
Selection bias
Recall bias
Confounding bias
Lead time bias
Other biases
Chapter 32. Basic science statistics
Introduction
Basic concepts
Types of data
Descriptive statistics
Inferential statistics
Central tendency and dispersion
Measures of central tendency
Measures of dispersion
Hypothesis testing
Chapter 33. Sample size
Key points
Get started
Sample size calculation
Study design
Hypotheses
Primary study endpoint
Effect size and clinically meaningful difference
Power analysis
Time-to-event endpoints
Examples of sample size calculations from clinical trials
Chapter 34. Statistical software
Introduction
Statistical Package for the Social Sciences
R and R studio
Stata
SAS and JMP
Other software
Part V. Clinical: Study types
Chapter 35. Design principles: Hierarchy of study types
Key points
Introduction
Observational and experimental studies
Hierarchy of evidence
Systematic review and meta-analysis
Randomized control trial
Cohort study
Case-control study
Cross-sectional study
Survey
Case series
Chapter 36. Case series: Design, measures, and classic examples
Key points
Introduction
Importance of case series
Design of case series
Case selection
Literature review
Ethical considerations
Data collection
Analysis and interpretation
Writing the report
Get started
Potential pitfalls
Classic examples
Case series on early COVID-19 outbreak in China
An unusual outbreak of Kaposi's sarcoma leading to discovery of AIDS
Case series of “fatty degeneration of the viscera, of unknown cause” in children
Conclusion
Resources
Chapter 37. Case control study: Design, measures, and classic examples
Key points
Introduction
Design of case-control studies
Case selection
Selection of control
Measures
Risk ratio versus odds ratio
Report writing
Get started
Potential pitfalls
Classic examples
Smoking and lung cancer: Doll and Hill 1950
Modifiable risk factors and coronary heart disease—Yusuf et al. 2004
Diethylstilbestrol and vaginal cancer—Herbst et al
Conclusion
Resources
Chapter 38. Cohort study: design, measures, and classic examples
Key points
Introduction
Definition
Clinical questions addressed by cohort studies
Subtypes of a cohort study
Nested case control study
Get started
Measurements
Relative risk
Advantages of a cohort study design
Disadvantages of a cohort study design
Pitfalls to avoid in a cohort study
Confounding variables
Loss to followup
Examples of cohort studies in cardiovascular medicine
Conclusion
Chapter 39. Cross-sectional studies
Key points
Introduction
Design
Sample size calculation
Sampling methods
Measures
Prevalence calculation
Prevalence odds ratio
Prevalence ratio
Modeling in analytical studies
Get started
Potential pitfalls
Classic examples
National Health and Nutrition Examination Survey
The European Youth Heart Study
ECHOES study: Quality of life among heart failure patients
Conclusion
Chapter 40. Longitudinal studies: design, measures, and classic examples
Key points
Introduction
Strengths and limitations
Types of longitudinal studies
Reporting longitudinal data
Potential pitfalls
Classic examples
Resources and additional reading
Chapter 41. Understanding meta-analysis
Key points
Introduction to meta-analysis
Methods and results
Discussion
Get started
Potential pitfalls
Examples
Resources
Chapter 42. Cost-effectiveness study: Design, measures, classic example
Introduction
Benefits
Steps
Setting clear baseline, appropriate outcomes, and duration
Decision and cost analysis
Cost-effectiveness analysis
Average cost-effectiveness ratio
Incremental cost-effectiveness ratio
Interpreting results
Uncertainty handling
Decision making
Cost-effectiveness thresholds
Limitations
Chapter 43. Diagnostic test evaluation: Design, measures, classic example
Key points
Introduction
Diagnostic test evaluation: Design4–11
Define the objective
Choose the study design
Select the comparator
Define outcomes
Sample size calculation
Ethical considerations
Data collection and analysis
Interpretation and reporting
Post-market surveillance
Test-treatment threshold
Diagnostic test evaluation: Measures12–14
Diagnostic test evaluation: Classic example
Chapter 44. Reliability study
Key points
Introduction and definition
Designing a study
Chapter 45. The state of database studies and future research
Introduction
Types of database studies
Overview of big data
Advantages of big data
Limitations of big data
Highlights of big data
Registries extracted from big data
Statistical analysis: Linear regression and propensity match
Example of database registry
Future directions
Chapter 46. Surveys and questionnaires
Introduction
First step
Second step
Third step
Fourth step
Fifth step
Sixth step
Seventh step
Eighth step
Ninth step
Tenth step
Pitfalls
Chapter 47. Qualitative methods and mixed methods in translational cardiology research
Key points
Introduction
Qualitative methods
Example
Advantages of qualitative methods6–12
Limitations of qualitative methods6–12
Mixed methods
Examples
Advantages of mixed methodology in research17–24
Challenges of mixed methodology17–24
Future directions
Part VI. Clinical trials
Chapter 48. Clinical trials
Definitions
Motivation to perform clinical trials
Types of randomization
Simple randomization
Blocked randomization
Response-adaptive randomization
Blinding
Equipoise
Advantages
Limitations
Designing phase III clinical trial
Chapter 49. Nonrandomized controlled clinical trials
Definition
Advantages
Limitations
Designing a nonrandomized trial
Estimating the causal effect
Chapter 50. Historical controlled studies
Definition
Advantages
Limitations
Design of a historically controlled trial
Methods to improve the study design
Chapter 51. Crossover studies
Definition
Advantages
Limitations
Designing crossover studies and examples
Reporting and analysis
Chapter 52. Withdrawal trials (randomized discontinuation trials)
Introduction
Definitions
Advantages
Limitations
Designing a withdrawal clinical trial
Pitfalls
Chapter 53. Factorial study design
Introduction
Definition
Advantages
Limitations
Designing factorial design and examples
Pitfalls of factorial design
Analysis of factorial trials
Chapter 54. Group allocation
Key points
Introduction
Choosing the best randomization method
Research team
Funding
Chapter 55. Hybrid design
Key points
Action items
Pitfalls
Chapter 56. Large, pragmatic trials
Key points
Getting started
Pitfalls
Additional resources
Chapter 57. Equivalence and noninferiority trials: Design, measures, and classic example
Key points
Introductory section/why it matters
Equivalence trials
Significance, benefits, and limitations
Statistical considerations
Noninferiority
Significance, benefits, and limitations
Statistical considerations
Differences between equivalence and noninferiority
Biocreep
Assay sensitivity
Constancy assumption
Budget considerations
Getting started with an equivalence or noninferiority study
Recognizing a knowledge gap, asking the research question, and deciding on the study design
Choosing the active control
Choosing the noninferiority/equivalence margin
Sample size calculation, statistical analysis, and missing data
Potential pitfalls
Real-world examples
Example 1—Equivalence trial
Example 2—Noninferiority trial
Example 3—Noninferiority trial
Resources
Chapter 58. Adaptive designs
Key points
Introduction
Get started
Efficiency in resource utilization
Real-time responsiveness
Enhanced patient-centric approach
Accelerated drug development
Optimized statistical rigor
Ethical considerations
Subtypes of adaptive design trials
Potential pitfalls
Limited experience
Inflated type I error
Operational challenges
Communication challenges
Examples of …
Resources
Chapter 59. Blinding: Who? and how?
Introduction
Who should be blinded in a research study?
How do we blind?
Chapter 60. Phases of clinical trials
Phase 0
Phase I
Phase II
Phase III
Phase IV
Chapter 61. The IDEAL framework
Key points
Introduction
The IDEAL Framework and Recommendations
Pre-IDEAL (stage 0)—Exploration of early concepts
Recommendations for the pre-IDEAL stage6
Real-world example of the pre-IDEAL stage
Idea (stage 1)—First-in-human use
Recommendations for stage 1 (idea)6
Real-world example of stage 1 study
Development (stage 2a)—Stabilization of the technique
Recommendations for stage 2a6
Real-world example of stage 2a study
Exploration (stage 2b)—Bridge to a pivotal trial
Recommendations for stage 2b6
Real-world example of stage 2b study
Assessment (stage 3)—Pivotal study/RCT
Recommendations for stage 36
Real-world example of stage 3 study
Long-term study (stage 4)—Identifying rare and later outcomes
Recommendations for stage 46
Real-world example of stage 4 study
Get started
Potential pitfalls—How IDEAL may help avoid common mistakes in surgical evaluation
Additional reading
Part VII. Clinical: Preparation
Chapter 62. Patient perspectives
Key points
Introduction
Understanding the patient's perspective
Patient-reported outcomes
Patient advocacy groups
Examples of successful patient engagement efforts
Barriers to patient involvement in research
Chapter 63. Budgeting
Key points
Introduction
Developing a reasonable budget
Facilities and administrative costs
Direct costs
Personnel
Equipment
Travel
Materials and services
Consultants
Consortiums/subawards
Timeline
Detailed versus modular budgets
Final tips
Chapter 64. Ethics and review boards
Key points
Introduction
Clinical research versus clinical practice
Ethics and clinical research
History of ethics in clinical research
Research ethics codes and regulations
Ethical framework for clinical research
Ethics in randomized controlled trials
Institutional review boards
Chapter 65. Regulatory considerations for new drugs and devices
Key points
Introduction
FDA drug approval
Expedited programs
FDA device approval
Common pathways for device approval
PMA
Premarket notification (501k)
Exempt
Humanitarian device exemption
DeNovo pathway
Expanded access
Issues with drug and device approval process
Chapter 66. Funding approaches
Key points
Introduction
How to obtain funding
Public agencies
Private agencies
How to write a grant proposal
Common pitfalls
Chapter 67. Conflict of interest
Key points
Introduction
Examples of conflicts of interest
Chapter 68. How to do subject recruitment?
Importance of appropriate subject recruitment
Identifying recruitment targets
Subject recruitment phase and reducing barriers
Key points
Chapter 69. Data management
What is research data, and why should we manage it?
Data management plans
Online data management plan tools
Principles of data collection, cleaning, and formatting
Data storage: Where and for how long?
Data security and privacy
Data sharing and publication
Conclusion
Chapter 70. Quality control in translational research
Key points
Introductory section
Get started
Auditing and monitoring
Checklist for assessing quality practices in a quality management plan
Types of visits/auditing
Potential pitfalls: Preparing for a quality control visit
How to conduct a successful quality visit
Chapter 71. Research in acute care settings
Introduction
Get started
Timing
Informed consent
Ethical concerns
Potential pitfalls
Funding
Chapter 72. Special populations
Introductory section/Why it matters
Potential pitfalls
Get started
Examples of ...
Standard research team personnel
Resources
Chapter 73. Report forms: Harm and quality of life
Key points
Introduction
The burdens of harm
The underlying reasons for harm
Adverse event classification systems in cardiology
Strategies for mitigating harm in cardiology
The importance of quality of life
Evaluating the quality of life in cardiology
Conclusions
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 74. Subject adherence
Introduction
Get started
Nonadherence and its consequences
Assessing adherence
Increasing adherence
Intention to treat versus per-protocol
Conclusions
Chapter 75. Intuitive survival analysis
Key points
Why it matters?
Introduction
Censoring
Types of censoring
Right censoring
Left censoring
Interval censoring
Truncation
Types of truncation
Methods used to estimate survival
Kaplan–Meier method
Life-table method
Hazard function
Comparing survival curves
Regression analysis
Cox (proportional hazards) regression
Parametric regression
Competing risks
Random survival forests
Get started
Pitfalls to avoid
Chapter 76. Monitoring committee in clinical trials
Key points
Introduction
Definition and purpose
Roles and responsibilities
Ethical considerations
Challenges and solutions
Early termination of clinical trials for futility
Conclusions
Get started
Potential pitfalls
Examples of …
Resources
Part VIII. Regulatory basics
Chapter 77. FDA overview
Key points
Purpose and overview
Introduction
The big picture
Why it matters
Introduction to the FDA
History
Modern day drug/device approval process
FDA branches and divisions
Office of the Commissioner
The four directorates: FDA's field offices
Office of Medical Products and Tobacco
Office of Foods and Veterinary Medicine
Office of Global Regulatory Operations and Policy
Office of Operations
Navigating FDA in translational medicine
Regulatory principles
What is an FDA guidance?
When it goes wrong
Get started
Potential pitfalls
Examples
Resources
Chapter 78. IND/New Drug Application
Key points
Introduction
Is an IND required?
The IND filing process
The NDA filing process
FDA resources
Financing
Get started
Additional resources
Chapter 79. Regulatory basics of medical device regulation
Key points
Why it matters
Regulatory basics of medical device regulation
Products considered medical devices
Regulation of a medical devices
Where medical devices are regulated
Device classification
Clinical data collection
Medical devices classification
Premarket notification—510(k)
De Novo submission
Premarket approval
Humanitarian device exemption
Breakthrough Device Designation
Q-submissions/presubmissions
Three common presubmission missteps
Getting started
Predictability
Precedent
Additional resources
Chapter 80. Digital health technologies in clinical trials—Regulatory basics
Key points
Introduction—Why it matters?
Regulatory advances for DHT-enabled clinical trials
DHT trials—From study design to clinical translation
Remote patient monitoring and real-world data with DHTs
Equitable participation in DHT-enabled clinical trials—Regulatory perspectives
Concluding remarks
Get started
Pitfalls to avoid
Chapter 81. A short overview of the orphan drugs development
Introduction
Process/pathway
Common challenges
Budgetary considerations and funding options
Conclusions
Additional reading
Chapter 82. Regulatory, product development, resources, and financial challenges associated with creating and commercializing combination products
Key points
Why it matters
Introduction
FDA guidance for early development of innovative combination products
Real-world examples of the path to regulatory approval for combination products
Get started
Pitfalls: Classic examples of failure modes include the following
Conclusions
Chapter 83. CMC and GxP—Cardiology
Key points
Introductory section/why it matters
CMC session
IND and NDA6
CMC section challenges5
Good Practices
Summary
Get started
Potential pitfalls
Resources
Chapter 84. Non-US regulatory
Key points
Introduction/why it matters
North America (Canada)
China
Europe
Japan
Africa
Asia and Australia
Latin America
International Council for Harmonisation of technical requirements for pharmaceuticals for human use
Get started
Potential pitfalls
Examples
Chapter 85. Postmarket drug safety monitoring
Key points
Introductory section/why it matters
Introduction
Data collection
Active surveillance
FDA's Sentinel Initiative
Manufacturer inspections
Supplemental applications
Drug advertisements
Generic drugs
Potential pitfalls in the postmarket surveillance of drug safety
Real world examples of product recalls published by the FDA
Additional resources
Get started
Chapter 86. Postmarket medical device safety monitoring
Key points
Introduction
Manufacturer and User Facility Device Experience
Product performance reports
Postapproval studies
Postmarket surveillance for coverage and payment
Manufacturer inspections
The future of postmarket surveillance
The impact of post market device monitoring: Three real world examples
Case study 1—Transcatheter aortic valve replacement: A postmarket success story
Case study 2—Fidelis and Riata implantable cardioverter-defibrillator leads
Case study 3—NC Trek RX and NC Traveler RX coronary dilation catheters
Key takeaways
Pitfalls to avoid
Get started
Resources and further reading
Part IX. Clinical implementation
Chapter 87. Implementation research
Key points
Introductory section/why it matters
Implementation research and how it fits into the translational process
Potential pitfalls
Theoretical basis of implementation research in cardiology
Diffusion of innovations theory
Reach, effectiveness, adoption, implementation, and maintenance framework
Consolidated framework for implementation research
Chapter 88. Design and analysis
Get started/objects
Key points
Introductory section/why it matters
Most common experimental clinical research methodologies
Experimental clinical study types
Implementation science: Objectives and commonly used methodologies
Example #1: A pragmatic effectiveness-implementation trial and implementation fidelity
Example #2: TAVR and the successful use of “Change infrastructure” cluster strategy to gather evidence of external validity
Example #3: Measuring implementation success through mixed-methods research
Measurement challenges
Dissemination
Potential pitfalls
Resources
Chapter 89. Mixed methods research
Key points
Introductory section/why it matters
Examples of …
Explanatory studies
Exploratory studies
Convergent studies
Get started
Potential pitfalls
Resources
Chapter 90. Population and setting specific implementation
Key points
Introduction
Sex specific risk factors for cardiovascular disease
Gender bias in cardiovascular care
Race specific risk factors for heart failure
Racial disparities in cardiovascular research
Rural–urban disparities in cardiovascular health
Socioeconomic factors in cardiovascular health
Conclusion
Potential pitfalls
Examples of implementation
Chapter 91. Guideline development
Key points
Why it matters
Development of clinical practice guidelines
Validity
Process
Identifying topics
Action statements
Evidence profiles
Recommendation grades
Designing clinical research for guidelines via grade
Current major areas of focus
Examples of recent guidelines
Budgetary considerations
How to fund this stage
Get started
Pitfalls
Additional resources and readings
Part X. Public health
Chapter 92. Public health
Key points
Background: Why it matters
Population health and the role of public health research in the translational process
Major areas of focus
Health promotion: Population-based cardiovascular disease prevention and management
Health services research: Elucidating and tackling healthcare disparities
Environmental health: Intersection between climate change and cardiovascular medicine
Global health: Leaving no patient behind
Getting started
Budgetary and funding considerations
Pitfalls to avoid
Conclusion
Additional resources
Books
Articles
Websites
Chapter 93. Epidemiology
Key points
“Why it matters?”
Introduction
Step 1: Defining the question
Step 2: Choosing the optimal study design
Step 3: Conducting and interpreting the analysis
“Get started”
Chapter 94. How to ask the right public health research questions
Key points
Introduction
Qualitative research
Quantitative research
Chapter 95. Population- and environmental-specific considerations
Key points
Why it matters?
Unique considerations of environmental factors on cardiovascular health, public health, and the economy
Personal, social, and natural domains of the human environment affecting CVD risk
Air pollution
Noise pollution
The interplay of social determinants of health with environmental pollutants
Lessons learned from the COVID-19 era
Successful approaches
Pitfalls to avoid
Chapter 96. Law, policy, ethics
Key points
Introduction
Law
Siracusa Principles1
Policy
Public health ethics 2011, Jonathan Anomaly
Ethics
Chapter 97. Healthcare institutions and system
Introduction/why it matters
Get started
Key points
Potential pitfalls
Examples of …
Resources
Pharmaceutical and insurance companies
Insurance
Healthcare providers
Patients
Government
Chapter 98. Public health institutions and systems
Introduction/why it matters
Get started
Key points
Potential pitfalls
Examples of …
Resources
Governmental agencies
Nongovernmental agencies
Part XI. Practical resources
Chapter 99. Presenting data
Manuscript
Introduction
Methods
Results
Graphs
Discussion
Conclusion
Presenting data on social media
Common pitfalls to avoid
Resources: Additional reading, consultants, contractors
Chapter 100. Manuscript preparation
Key points
“Why it matters?”
“Get started”
Pitfalls to avoid
Resources
Chapter 101. Promoting research
Key points
Why it matters?
Utilizing research databases
Measures of research impact
Journal-level measures of research impact
Article-level measures of research impact
Individual measures of academic productivity
Promoting research through social media
Get started
Chapter 102. Research versus quality improvement
Key points
Why it matters
Performance metrics and balancing metrics: Ensuring quality improvement benefits patients
Quality versus process versus performance improvement: Words matter
PDSA versus PDCA versus DMAIC: Frameworks matter
A DIY framework for quality improvement: DMARITSCR
Define the problem
Measure performance
Analyze to understand the root cause of variation and defects
Research to learn how others have addressed the issue and what best practice is
Identify process changes that would address root causes and implement best practice and hypothesize how this will affect performance and balancing metrics
Test your hypothesis by implementing your process change—Use process metrics
Study: Analyze data and draw conclusions
Control the improved process
Report your results
Chapter 103. The importance of teams
Key point
Why it matters
Project management
Project initiation
Project planning
Project execution/monitoring
Project closure
Team dynamics
DiSC
Myers Briggs Type Indicator
Get started
Potential pitfalls
Resources
Chapter 104. Patent basics
Key points
Why it matters?
Introduction
Options to protect intellectual property
Patent
Intellectual property protection in cardiology
Patents
Building a portfolio
Prior art search
Patentability assessment
Freedom to operate
Path to protection
Initial patent filing
International phase
National phase
Budgetary considerations
Communication of intellectual property
Lab notebooks
Nondisclosure agreements
Public disclosure
Technology transfer
Getting started
Establishing ownership of work
University technology transfer offices
Pursuing commercialization
Patent attorney
Pitfalls to avoid
Late or no use of a lab notebook
The fine line of filing
The breadth of your claim
Chapter 105. Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR)
Key points
What is the National Institutes of Health?
NIH grants: An introduction
The need for NIH grants
Small Business Innovative Research
Small Business Technology Transfer
Get started: Phases of the programs
Key differences between SBIR and STTR grants, as adapted from the NIH website7
Examples of when to use SBIR8
Examples of when to use STTR
Eligibility requirements
Application requirements
Resources
Glossary
Index

Jeffrey A. Bakal

Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes.

Affiliations and expertise

Division General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton Alberta, Canada

Michael Gibson

C. Michael Gibson, M.S., M.D. is an interventional cardiologist, cardiovascular researcher and educator who pioneered our understanding of the "open artery hypothesis" as well our understanding of the importance of restoring flow downstream in the capillary bed in the "open microvasculature hypothesis" in heart attack. Gibson has been a leading investigator in trials of thrombolytic agents, glycoprotein 2b3a inhibitor agents, thienopyridines, factor Xa inhibitors, lipid lowering agents and new devices. Gibson was named one of the world's most widely published and cited scientists of past decade in 2014 by Thomson Reuters.

For years, Gibson has been chosen as one of Boston's Top Doctors & U.S. News & World Report also lists Gibson as one of America's top doctors. He has held numerous leadership positions in medicine including positions as a Coronary Care Unit Director, a Cardiac Catheterization Laboratory Director, a Chief of Cardiology and as a Vice Chairman of Medicine.

Affiliations and expertise

Beth Israel Deaconess Medical Centre, USA

Adam E.M. Eltorai

Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

Affiliations and expertise

Harvard Medical School, Boston, MA, USA

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Translational Cardiology

Purchase options

BLOOM INTO SPRING SAVINGS

Institutional subscription on ScienceDirect

Jeffrey A. Bakal

Michael Gibson

Adam E.M. Eltorai

Related books