Kooperativer Bibliotheksverbund

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Format: 1 online resource (600 pages)

ISBN: 9780128230558

Series Statement: Handbook for Designing and Conducting Clinical and Translational Research Series

Content: 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. Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within interventional radiology Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation Details discussions of the critical appraisal of published studies in interventional radiology, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care.

Note: Front Cover -- Translational Interventional Radiology -- Handbook for designing and conducting clinical and translational research -- Translational Interventional Radiology -- Copyright -- Contents -- List of contributors -- Preface -- I - Introduction -- 1 - Translational process -- Key points -- References -- 2 - Scientific method -- Key points -- Why it matters? -- Observation -- Question -- Hypothesis -- Experiment -- Analysis -- Conclusion -- Get started -- Potential pitfalls -- Real-world examples -- Question -- Hypothesis -- Experiment -- References -- Additional reading -- Further reading -- 3 - Basic science research -- Introduction to basic science research -- The scientific method of inquiry -- Translating basic science research -- Barriers to research -- Conclusion -- References -- II - Pre-clinical: discovery and development -- 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 -- References -- Additional reading -- 5 - Defining the problem to solve -- Key points -- Why it matters? -- Step 1 -- Case 1: Prostate artery embolization -- Case 2: Inferior vena cava (IVC) filters -- Case 3: Arterial gene transfer -- Step 2 -- Case 1: Prostate artery embolization -- Case 2: IVC filters -- Case 3: Arterial gene transfer -- Step 3 -- Case 1: Prostate artery embolization -- Case 2: IVC filters -- Case 3: Arterial gene transfer -- Step 4 -- Case 1: Prostate artery embolization -- Case 2: IVC filters -- Case 3: Gene therapy -- Step 5 -- Case 1: Prostate artery embolization -- Case 2: IVC filters -- Case 3: Gene therapy -- Get started. , References -- 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 -- References -- 7 - Types of interventions -- Key points -- Why it matters? -- Types of interventions -- Drugs -- Tools and devices -- Laboratory analysis and IR -- IR procedures -- Ablation-thermal ablation -- Ablation-cryoablation -- Angiogram/angiography -- Angioplasty and stent insertion -- Fluid drainage -- Chemoembolization -- Embolization -- Image-guided biopsy -- Inferior vena cava filters -- Shunt placement (TIPS) -- Thrombolysis -- Thrombectomy -- Percutaneous drainage -- Telehealth and telesurgery -- Behavioral change -- Palliative -- Real-world examples -- Potential pitfalls -- Get started -- Additional resources -- References -- 8 - Drug discovery -- References -- 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 -- References -- 10 - Device discovery -- References -- 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 -- References -- 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 -- References -- Further reading -- 13 - Device testing: Safety and efficacy -- Key points. , Why it matters? -- Get started -- Potential pitfalls -- Real-world examples -- Additional resources -- References -- 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 -- References -- 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 -- Premarket notification 510(k) -- Premarket approval -- Investigational device exemption -- Humanitarian device exemption -- De novo classification requests -- IR-related FDA regulated products -- References -- 16 - Procedural technique development -- Key points -- Why it matters? -- Overview -- Preclinical considerations -- Methodologies -- Live animal models (in vivo) -- Ex vivo models -- Simulation -- In vitro models -- Virtual animal models -- Stages of procedure technique development -- Stage 0: innovation-proof of principle -- Stage 1: development-refinement, definition, and early adoption -- Stage 2: exploration-dissemination -- Stage 3: assessment-comparison with existing treatments -- Stage 4: long term-surveillance, quality control, and improvement -- Get started -- Potential pitfalls -- Real-world examples -- Resources: additional reading -- References -- 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 -- References -- III - Clinical: fundamentals -- 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 -- References -- 19 - The question: Types of research questions and how to develop them -- Real-world example -- Get started -- Potential pitfalls -- Resources -- References -- 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 -- Resources -- References -- 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 -- Resources -- References -- 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 -- References -- IV - Statistical principles -- 23 - Common issues in analysis -- References -- Further reading -- 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? -- References -- 25 - Distributions -- Key points -- Appendix of equations -- 26 - Hypotheses and types of error -- Key points -- Further reading -- 27 - Power -- Key points -- References -- 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 -- References -- Further reading -- 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 -- References -- 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 -- References -- 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 -- References -- 32 - Correlation -- Key points -- Introduction -- Correlation -- Correlation coefficient -- Coefficient of determination -- Regression model analysis -- Interventional radiology examples -- Get started -- References -- 33 - Biases. , Key points.

Additional Edition: Print version: Eltorai, Adam E. M. Translational Interventional Radiology San Diego : Elsevier Science & Technology,c2023 ISBN 9780128230268

Language: English