Translational Interventional Radiology

1st Edition - April 5, 2023
Imprint: Academic Press
Editors: Adam E.M. Eltorai, Tao Liu, Rajat Chand, Sanjeeva P. Kalva
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 2 3 0 2 6 - 8
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 2 3 0 5 5 - 8

Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidenc… Read more

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Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidence-based medicine and applies these principles to the design of translational investigations in Interventional Radiology. The reader will come to fully understand important concepts including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in Interventional Radiology, and know what is needed for successful collaboration. Further, this reference is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps aspiring investigators navigate challenging considerations in study design and implementation. This book provides valuable discussions of the critical appraisal of published studies in Interventional Radiology, elucidating the evaluation of the quality with respect to measuring outcomes and making effective use of all types of evidence in patient care. In short, this practical guide will be of interest to every medical researcher and interventional radiologist who has ever had a good clinical idea but not the knowledge of how to test it.

Cover image
Title page
Table of Contents
Handbook for designing and conducting clinical and translational research
Copyright
List of contributors
Preface
Part I. Introduction
Chapter 1. Translational process
Key points
Chapter 2. Scientific method
Key points
Why it matters?
Observation
Question
Hypothesis
Experiment
Analysis
Conclusion
Get started
Potential pitfalls
Real-world examples
Chapter 3. Basic science research
Introduction to basic science research
The scientific method of inquiry
Translating basic science research
Barriers to research
Conclusion
Part II. Pre-clinical: discovery and development
Chapter 4. Overview of preclinical research
Key points
What is preclinical research?
Why it matters?
Preclinical research models
Get started
Designing in vivo experiments
Hypothesis and effect size
Experimental unit and sample size
Outcome data and measurements
Reducing biases in preclinical studies
Real-world examples
Resources
Chapter 5. Defining the problem to solve
Key points
Why it matters?
Step 1
Chapter 6. Types of problems
Key points
Introduction (why it matters)?
Intersection of interventional oncology and immuno-oncology
Drug repurposing
Technology and device development
Get started
Chapter 7. Types of interventions
Key points
Why it matters?
Types of interventions
Real-world examples
Potential pitfalls
Get started
Additional resources
Chapter 8. Drug discovery
Chapter 9. Drug safety in vitro, in vivo, harm, toxicity, dosing, good laboratory practices
Introduction
Preclinical studies: in vitro and in vivo
Clinical studies: clinical trials
Dosing
Toxicity
Medication harm
Good laboratory practice
Resources
Characterization
Rules
Results
Quality assurance
Summary
Chapter 10. Device discovery
Chapter 11. Device prototyping: Iterative refinement, optimization process
Why it matters?
Customer requirements and technical benchmarking
Types of prototypes
Iterative design
Prototype fidelity
Real-world examples
Get started
Chapter 12. Device classification
Key points
Why it matters?
Device classification: basics1–4
Regulatory basics1–5
Device classification: process1–3
Special device classifications23,25
Conclusion
Get started
Chapter 13. Device testing: Safety and efficacy
Key points
Why it matters?
Get started
Potential pitfalls
Real-world examples
Additional resources
Chapter 14. Diagnostic testing
Why it matters?
Overview
Sensitivity and specificity: measures of diagnostic accuracy
Regulatory classification
How are IVD products classified?
Budgetary considerations and how to fund this stage
Chapter 15. Regulatory process: Discussion of FDA history, organization, and regulatory purview and application process
Background
What does the FDA do?
Combination products
FDA approved: what does it mean and what is covered?
FDA structure and review
Drug approval process
Orphan drug status
Device approval process
IR-related FDA regulated products
Chapter 16. Procedural technique development
Key points
Why it matters?
Overview
Preclinical considerations
Methodologies
Stages of procedure technique development
Get started
Potential pitfalls
Real-world examples
Resources: additional reading
Chapter 17. Behavioral interventions
Summary
Introduction
Step 1: Define the problem and where it is happening
Step 2: Understand the drivers of problem behavior
Step 3: Design interventions with stakeholders in mind
Step 4: Assess feasibility and effectiveness in the real world
Conclusion
Potential pitfalls
Part III. Clinical: fundamentals
Chapter 18. Introduction to clinical research: What is it? Why is it needed?
Key points
What is it and why it matters?
Observational studies
Interventional studies
Who is involved in clinical research?
Regulatory body
Funding
What are clinical trials?
Get started
Chapter 19. The question: Types of research questions and how to develop them
Real-world example
Get started
Potential pitfalls
Chapter 20. Study population: Who and why them?
Potential pitfall, real-world example: sample selection—the “how” and “why” of choosing the study population
Real-world example: probabilistic sampling
Potential pitfalls: nonprobabilistic sampling
Get started
Chapter 21. Outcome measurements: What data is being collected and why?
Potential pitfalls
Real-world examples
Potential pitfalls
Real-world examples and potential pitfalls
Get started
Chapter 22. Optimizing the question: Balancing significance and feasibility
Key points
Why it matters?
Real-world examples: defining a value proposition to guide clinical strategy
Real-world examples: constructing a clinical strategy
Real-world examples: understanding the significance of clinical outcomes
Feasibility considerations
Potential pitfalls: less is more
Get started and resources
Part IV. Statistical principles
Chapter 23. Common issues in analysis
Chapter 24. Everyday statistics for the clinician
What is significance?
What is precision and what is accuracy? Why does this matter for my research?
What are sensitivity and specificity? How can i use these properties to explain what a positive and negative test mean?
How do incidence and prevalence change my positive predictive values and negative predictive values?
How do I quantify risk? What formulas should I use? What pitfalls should I be aware of?
Chapter 25. Distributions
Key points
Appendix of equations
Chapter 26. Hypotheses and types of error
Key points
Chapter 27. Power
Key points
Chapter 28. Regression analysis: Applications to radiological research and recent examples
Key points
Introduction
Linear and generalized linear models
Regression analysis for time-to-event data
Tree-based regression methods
Unstructured data and analysis methods
Association, causation, and prediction
Examples of recent studies
Chapter 29. t-test
Key points
Why it matters?
Introduction
Inferential statistics and T-distribution
Assumptions for a t-test
Key differences between a t-test and z-test
One-sample t-test
Independent sample t-test
Paired t-test
Conclusion
Get started
Chapter 30. Chi square
Key points
Why it matters?
Introduction
Nonparametric methods, chi-square distribution, and R×C tables
Assumptions and limitations of a chi-square test
Chi-square test for goodness of fit
Chi-square test of independence
Chi-square test for equality of proportions
Conclusion
Get started
Chapter 31. Analysis of variance
Key points
Why it matters?
Introduction
Calculation and interpretation
Examples in interventional radiology
Post hoc analysis
Alternatives
Get started
ANOVA pitfalls
Chapter 32. Correlation
Key points
Introduction
Correlation
Correlation coefficient
Coefficient of determination
Regression model analysis
Interventional radiology examples
Get started
Chapter 33. Biases
Key points
Why it matters?
Introduction
Bias before the study investigation
Selection bias
Bias during investigation
Bias after study investigation
Conclusion
Get started
Chapter 34. Basic science statistics
Parametric and nonparametric tests
Conclusion
Part V. Clinical: study types
Chapter 35. Design principles: Hierarchy of study types
Key points
Why knowing hierarchy of study types matters
The hierarchy of studies: introduction to study design
Going beyond the pyramid: modified hierarchy of studies
From evidence to recommendations: clinical guidelines and strengths of recommendations
Conclusion
Get started, step by step evaluation
Chapter 36. Case series: Design, measures, and classic example
Key points
Why it matters?
Get started
Potential pitfalls
Examples of case series
Resources
Chapter 37. Case-control study: Design, measures, classic example
Key points
Why it matters?
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 38. Cohort study: Design, measures, classic example
Design
Measures
Types of cohort studies
Cohort study advantages and disadvantages
Methods
Classic example
Chapter 39. Cross-sectional study: Design, measures, classic examples
Key points
Why it matters?
Benefits and limitations
Design
Measurement
Examples
Get started
Chapter 40. Longitudinal study: Design, measures, and classic example
Study design
Measures
Benefits
Potential pifalls
Real-world example
Get started
Standard research team personnel and roles
Budgetary considerations and funding options
Resources
Chapter 41. Clinical trials: Design, measures, classic example
Introduction and history
Clinical trial
Subtypes
The multiphases of clinical trials
Design
Benefits (advantages)
Limitation (downside)
How to improve future clinical trials
Conclusion
Chapter 42. Meta-analysis: Design, measures, classic example
Key points
Background
Designing and conducting a meta-analysis
Certainty of the evidence
Update
Get started
Potential pitfalls
Real-world example
Resources
Chapter 43. Cost-effectiveness analysis: Design, measures, classic example
Introduction
Definition of CEA
Indications of CEA
Goals of CEA
Required measures for CEA
Conduct of a CEA study
Final word
Chapter 44. Diagnostic test evaluation
Sensitivity and specificity
Positive and negative predictive value
Likelihood ratios
Receiver operating characterisic curve
Other commonly used metrics
Summary
Classical example
Chapter 45. Reliability study: Design, measures, and classic example
Introduction
Types of reliability measures
Designing a reliability study: get started
Chapter 46. Surveys and questionnaires: Design, measures, and classic example
Key points
Potential pitfalls: what is survey research
Real-world examples
Survey design
Piloting the study
Analytical method
Reporting data
Summary
Get started
Resources
Chapter 47. Qualitative methods and mixed methods
Potential pitfalls
Real-world examples
Get started
Part VI. Clinical trials
Chapter 48. Randomized control: Design, measures, and classic example
Key points
Why it matters?
Why randomized control trials are the best?
What can you test with a randomized control trial?
How to formulate a research question?
How to conduct an RCT?
Random allocation
Other complications
How to report a randomized controlled trial?
Chapter 49. Nonrandomized controlled trials
Introduction
Nonrandomized controlled studies
Real-world examples: interventional radiology studies that used nonrandomized controlled trials
Get started
Potential pitfalls
Resources
Chapter 50. Historical control: Design, measures, and classic example
Definition of historical control
Sources of historical control
Advantages of the historical control study
Disadvantages of the historical control study and how to overcome
Types of historical controls
Samples of historical control study design
Chapter 51. Cross-over: Design and measures with classic example
Study structure
Chapter 52. The withdrawal design
Key points
Why it matters?
Fundamental components of the withdrawal study
Benefits and limitations
Example 1
Get started
Chapter 53. Factorial design
Key points
Why it matters: introduction
Benefits of factorial design
Limitations of factorial design
Factorial design—a step-by-step guide
Potential pitfalls
Real-world examples
Get started
Resources
Chapter 54. Group allocation: Design, measures, classic examples
Key points
Chapter 55. Large, pragmatic: Design, measures, and classic examples
Key points
Definition of a pragmatic clinical trial
Benefits and limitations of PCTs
Steps to design a pragmatic study
Standard research team personnel and roles
Budgetary considerations and funding pathways
Get started5,16
Potential pitfalls
Resources
Chapter 56. Equivalence and noninferiority: Design, measures, and classic example
Key points
Why it matters?
Get started
Potential pitfalls
Example
Examples of noninferiority and equivalence trials in the literature for further reference:
Resoures
Chapter 57. Adaptive: Design, measures, and classic example
Key points
Introduction
Get started
Potential pitfalls
Examples
Conclusion
Chapter 58. Randomization
Key points
Introduction
Get started
Potential pitfalls
Examples
Conclusion
Resources
Chapter 59. Blinding: Who and how?
Key points
Introduction: importance of blinding and impact on findings
Deciding who to blind
Hierarchy of blinding studies for interventional trials
Double-blinded studies
Complete blinded studies
Single-blinded studies
Open-label studies
How to blind effectively
Detailed reporting
Conclusion
Potential pitfalls
Chapter 60. Multicenter considerations
Key points
Introduction
Planning phase
Project development stage
Execution phase
Dissemination phase
Challenges
Get started
Chapter 61. Registries
Summary
Introduction
Definition
Benefits and limitations
Get started
Financing a registry
Potential pitfalls
VIRTEX SIR data registry
Real-world examples
Chapter 62. Phases of clinical trials
Key points
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 63. The IDEAL framework
Key points
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 64. Studies to assess AI methodology in clinical research
Key points
Introduction
Angiography-based machine learning
Clinical modeling
Trainee education
Budgetary considerations and how to fund this stage
Implementation of AI research
Conclusions
Chapter 65. Patient perspectives
Key points
Definitions
Why it matters?
Introduction
The patient pathway in IR
Measuring patient perspectives
Using PROs for selecting treatments
Future PRO considerations in IR
Conclusions
Get started
Potential pitfalls
Real-world examples
Resources
Part VII. Clinical: preparation
Chapter 66. Meaningful outcome measurements
Key points
Why it matters?
Characteristics of outcome measures
Real-world examples: clinically meaningful outcome measures
Real-world examples: surrogate outcome measures: often more feasible, sometimes less valid
Real-world examples: patient-reported outcome measures
Choosing the right outcome measures to support translation
Get started
Potential pitfalls
Resources
Chapter 67. Sample size
Key points
Introduction
Get started
Potential pitfalls
Examples
Conclusion
Resources
Chapter 68. Budgeting
Chapter 69. Ethics and review boards
Why it matters?
Ethical principles
Review boards
Special considerations for IR research
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 70. Regulatory considerations for drugs and devices seeking FDA approval or off-label uses
Key points
Medical device approval
Off-label use of medical devices
Emergency situations and compassionate use
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 71. Funding approaches
Key points
Why it matters?
Get started
Chapter 72. Subject recruitment: Where, when, and how
Real-world examples
Study protocol phase
Real-world examples and potential pitfalls: recruitment strategies
Real-world examples and potential pitfalls: study conduct phase: recruitment and retention
Real-world examples and potential pitfalls: study follow-up period
Get started
Resources
Chapter 73. Data management
Key points
Introduction
Get started
Discussion/potential pitfalls/ examples
Conclusion
Chapter 74. Quality control in IR translational research
Key points
Why does quality management matter?
Who deals with quality management?
Where and when is quality control applicable?
How is quality control conducted?
Quality management systems
Lean
Six Sigma
Real-world examples
Chapter 75. Statistical software
Key points
Why it matters?
Overview of common statistical software packages
Comparison of statistical software (Tables 75.2 and 75.3)
Get started
Real-world examples
Chapter 76. Report forms: Harm and quality of life
Key points
Background
Why do errors happen
Adverse event classification systems in interventional radiology
How to mitigate harm in IR
The value of quality of life
Different types of PROMs
The role of PROMs in IR research
Conclusions
Get started
Potential pitfalls
Real-world examples
Chapter 77. Subject adherence
Key points
Introduction
Causes of nonadherence
Detection and prevention of nonadherence
Addressing nonadherence
Get started
Potential pitfalls
Chapter 78. Monitoring committee in clinical trials
Key points
Who serves on monitoring committees
When to use a monitoring committee
Data monitoring committee responsibilities
Real-world examples
Get started
Potential pitfalls
Resources
Part VIII. Regulatory
Chapter 79. The FDA: An overview of their role
Key points
Why it matters?
FDA history
What does the FDA regulate?
How is the FDA organized?
How this relates
Get started
Chapter 80. Investigational new drugs
Key points
Why it matters?
Overview1,2
Process/pathways1,3–12
Budgetary considerations and how to fund
Get started
Potential pitfalls
Chapter 81. New drug application process
Key points
Why it matters?
History of the NDA
Investigational new drug submission
NDA submission
Abbreviated new drug application submission
Cost of filing an NDA
Get started
Chapter 82. Medical device pathways
Key points
Why it matters?
Device classification
Device pathways
Special considerations
Get started
Chapter 83. Radiation-emitting electronic products
Ionizing radiation
Radiation safety
Monitoring radiation exposure
Regulation
Budgetary considerations
Conclusion
Chapter 84. Combination products
Key points
Why does it matter?
Examples of common combination products used in radiologic interventions
Overview of FDA approval of combination products
Get started
Potential pitfalls
Chapter 85. Cosmetics
Overview of cosmetics in IR regulatory basics
Process/pathways
Components
Examples
Common challenges
Budgetary considerations
How to fund
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 86. CMC and GxP
Key points
Chemistry, manufacturing, and controls
Components of CMC: section 312.121
Common challenges: CFR 312.231
Real-world examples in interventional radiology
Strategies for CMC application
Good “x” practices
Get started
Potential pitfalls
Resources
Chapter 87. Non-US regulatory
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 88. Postmarketing drug safety monitoring
Key points
Supplemental applications
INDs for marketed drugs
Manufacturer inspections
Drug advertising
Generic drugs
Reporting problems
Active surveillance
Get started
Chapter 89. Postmarket device safety monitoring
Key points
Introduction
Get started
Potential pitfalls
Discussion/examples
Conclusion
Part IX. Clinical implementation
Chapter 90. Implementation research in interventional radiology
Key points
Why it matters?
Translational science: background
Barriers to implementation
Areas of current research
Real-world examples
Endovascular arteriovenous fistula creation
Budgetary considerations
Potential pitfalls
Get started
Chapter 91. Implementation research: Design and analysis
Summary
Introduction
Step 1: Define the problem and where it exists
Step 2: Identify viable implementation strategies
Step 3: Develop appropriate research questions
Step 4: Define measurable outcomes
Step 5: Designing the study
Conclusion
Potential pitfalls
Chapter 92. Mixed methods research
Key points
Introduction and definition
The research paradigms
Types of MMR
Advantages of MMR
Potential drawbacks of MMR
Examples from published medical literature
Conclusion
Potential pitfalls
Get started
Chapter 93. Population- and setting-specific implementations
Introduction
Setting and implementation
Population and implementation
Conclusion
Potential pitfalls
Examples
Resources/additional readings
Get started
Part X. Public health
Chapter 94. Public health research
Key points
What is public health?
Public health research
Converting translational research into public health outcomes
Applications of interventional radiology to public health
Public health research and interventions
Resources
Chapter 95. Epidemiology
Key points
Objectives
Introduction
Chapter text
Real-world examples epidemiology in interventional radiology
Potential pitfalls within epidemiological research
Data sources
Get started
Chapter 96. Good questions
Chapter 97. Translational interventional radiology: Population and environmental-specific considerations
Chapter 98. Ethics, policy, and law
Key points
Introduction
Basic and preclinical research
Clinical practice
Conclusion
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 99. Healthcare institutions and systems
What is the role of healthcare organizations?
What are the different types of healthcare organizations?
Who pays for healthcare?
The Beveridge model6
The Bismarck model6
The National Health Insurance model6
The out-of-pocket (fee for service) model6
The special case of the United States
The government sector covers two different populations
Market place insurance for working population
Preferred provider organizations
Exclusive provider organization
Health maintenance organization
Point of service9
The role of the radiologist within the healthcare system
Chapter 100. Public health institutions and systems
Introduction
The public health system of the United States
How can radiology help public health?
How can public health help radiology?
Conclusion
Part XI. Practical resources
Chapter 101. Presenting data
Key points
Why it matters?
Basic concepts
Presentation of categorical variables
Presentation of continuous variables
General consideration for table design
General consideration for graphical presentation
Get started
Real-world examples
Chapter 102. Manuscript preparation
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 103. Research team: Standard personnel and roles
Key points
Introduction
Chapter
Get started
Potential pitfalls
Real-world examples
Resources
Chapter 104. Patent basics
Key points
Why it matters?
Copyrights
Trademarks
Trade secrets
Patent
Types of medical patents
How to get started: the process of obtaining a patent
Chapter 105. Venture pathways
Bullet-point summary of the chapter
Get started
Chapter 106. Small business innovation research/small business technology transfer (SBIR/STTR)
Introduction
About the SBIR/STTR initiatives
Distinguishing between SBIR/STTR
Basic eligibility requirements
Application components
Application review
Application acceptance
Currently accepted IR projects/ real world examples
Potential pitfalls
Get started
Resources
Chapter 107. Sample forms and templates
Key points
Why it matters?
Grant proposals
Institutional review board protocols
Budgets
Consort diagram
Manuscript formatting
Practical tools
Get started
Potential pitfalls
Real-world examples
Resources
Appendix 1: example of a grant proposal research plan
Appendix 2: IRB protocol template for biomedical research
Glossary
Index

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

Tao Liu

Dr Liu obtained his PhD in Biostatistics from the University of Pennsylvania. Dr Liu is Associate Professor of Biostatistics and Director of the Brown ARCH Data and Statistics Core. He also is a faculty member at the biostatistics core of the Lifespan/Boston/Brown Center for AIDS Research (CFAR), Brown Data Science Initiative (DSI), Advance-Clinical Translational Research (Advance-CTR) and an affiliated faculty member for the AMPATH Biostatistics and Data Program. His research interests are in the area of health data science and include clinical decision making, incomplete data problems, causal inference, diagnostic testing, and design of clinical trials.

Affiliations and expertise

Associate Professor of Biostatistics and Director of the Brown ARCH Data and Statistics Core, Brown University, USA

Rajat Chand

Dr. Rajat Chand is an Early Specialization in Interventional Radiology (ESIR) Resident at the John H. Stroger, Jr. Hospital of Cook County in Chicago, Illinois, USA. He is currently an International Outreach Chair for the Society of Interventional Radiology – Resident, Fellow, and Student section. Prior to that, he was a Communications Chair for the Society of Interventional Radiology – Resident, Fellow, and Student section and a Pediatric Service Line Chair for the Society of Interventional Radiology – Resident, Fellow, and Student section.

Affiliations and expertise

Department of Radiology, University of North Carolina Medical Center, University of North Carolina School of Medicine, Chapel Hill, NC, United States

Sanjeeva P. Kalva

Sanjeeva Kalva, MD is the chief of Interventional Radiology in the Department of Radiology at Massachusetts General Hospital. He is a world-renowned expert in minimally invasive approaches to treating liver cancer. Dr. Kalva trained as an interventional radiologist in India where he served on the faculty at Kovai Medical Center and Hospital in Coimbatore. In 2004, he completed a research fellowship at Harvard Medical School followed by a fellowship in vascular and interventional radiology at Massachusetts General Hospital. He served on the faculty at Harvard Medical School and Massachusetts General Hospital until 2013 when he became the chief of Interventional Radiology at UT Southwestern Medical Center in Dallas, Texas. Dr. Kalva has published multiple research papers and book chapters in the peer-reviewed literature. His research focuses on the effectiveness of minimally invasive procedures to treat liver cancer, venous thromoboembolism, portal hypertension, varicose veins and pulmonary vascular disease including arteriovenous malformations. Dr. Kalva has won several awards for his work in interventional radiology including the Outstanding Performance Award and the Dr. Athanasoulis Award for Excellence in Teaching, both at Massachusetts General Hospital. He is an active member of a number of professional associations including the Radiological Society of North America and the American College of Radiology and has also been named a fellow of the Society of Interventional Radiology.

Affiliations and expertise

Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Translational Interventional Radiology

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Adam E.M. Eltorai

Tao Liu

Rajat Chand

Sanjeeva P. Kalva

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