Foundations of Clinical Research Applications to Practice 3rd Edition by Leslie G Portney, Mary P Watkins ISBN 0131716409 9780131716407

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ISBN 10: 0131716409 
ISBN 13: 9780131716407
Author: Leslie G Portney, Mary P Watkins

Foundations of Clinical Research: Applications to Practice, 3/e provides the foundations that are necessary for finding and interpreting research evidence across all healthcare professions. This book has been revised to reflect the most current changes in the field of clinical research in rehabilitation and medicine, including the growing emphasis on evidence-based practice (EBP) that has become central to all of health care and the new vocabulary that is being integrated into research and practice across disciplines. There is also a new chapter on systematic reviews and meta-analysis as well as expanded content related to clinical decision making, including likelihood ratios, pretest and posttest probabilities, minimally important change and number needed to treat.

Foundations of Clinical Research Applications to Practice 3rd Table of contents:

Part 1: Introduction to Clinical Research

1. Introduction to Clinical Research

   • Definition and Importance of Clinical Research
   • The Role of Clinical Research in Evidence-Based Medicine
   • The Evolution of Clinical Research and Its Impact on Healthcare

2. The Research Process in Clinical Practice

   • Steps in the Research Process: From Idea to Publication
   • Research Design and Its Applications in Clinical Settings
   • Understanding Clinical Research Protocols

3. Ethical and Regulatory Issues in Clinical Research

   • Ethical Considerations: Informed Consent, Privacy, and Confidentiality
   • Institutional Review Boards (IRB) and Ethics Committees
   • Regulatory Agencies: FDA, EMA, and Other Governing Bodies
   • Protection of Human Subjects in Clinical Research

Part 2: Research Design and Methodology

4. Types of Clinical Research Designs

   • Observational vs. Experimental Studies
   • Cross-Sectional, Case-Control, and Cohort Studies
   • Randomized Controlled Trials (RCTs): Design, Implementation, and Analysis
   • Systematic Reviews and Meta-Analyses

5. Clinical Trials and Study Protocols

   • Phases of Clinical Trials (I, II, III, IV)
   • Design and Conduct of Clinical Trials
   • Randomization, Blinding, and Control Groups
   • Sample Size Calculation and Power Analysis

6. Qualitative Research in Clinical Practice

   • Purpose and Methods of Qualitative Research
   • Interviews, Focus Groups, and Case Studies
   • Analyzing Qualitative Data
   • Integration of Qualitative and Quantitative Data

7. Measurement and Data Collection in Clinical Research

   • Types of Variables: Independent, Dependent, and Confounding Variables
   • Measurement Tools and Instruments: Reliability and Validity
   • Data Collection Methods: Surveys, Interviews, Observational Tools
   • Monitoring and Auditing in Clinical Trials

Part 3: Data Analysis and Interpretation

8. Basic Statistical Concepts in Clinical Research

   • Descriptive vs. Inferential Statistics
   • Measures of Central Tendency and Dispersion
   • Probability, Confidence Intervals, and P-Values
   • Statistical Significance and Clinical Significance

9. Advanced Statistical Methods

   • Regression Analysis: Linear and Logistic Regression
   • Survival Analysis: Kaplan-Meier Curves and Cox Proportional Hazards Model
   • Multivariable Analysis and Adjusted Models
   • Handling Missing Data and Statistical Assumptions

10. Evaluating Research Results

    • Interpreting Statistical Results in Clinical Context
    • Understanding Bias, Confounding, and Effect Modification
    • Sensitivity, Specificity, and Predictive Values
    • Reporting Results in Clinical Practice

Part 4: Translating Research into Practice

11. Evidence-Based Medicine (EBM) and Clinical Practice

    • Principles of Evidence-Based Practice
    • Levels of Evidence and Hierarchies in Clinical Research
    • Applying Research Findings to Patient Care
    • Barriers to Implementation and Strategies for Overcoming Them

12. Translational Research and Its Impact on Clinical Practice

    • Moving from Bench to Bedside: The Translational Research Process
    • T1, T2, T3, and T4 Translational Phases
    • Challenges in Translational Research
    • Case Studies in Translational Medicine

13. Clinical Guidelines and Decision-Making

    • Developing Clinical Guidelines Based on Research Evidence
    • Critical Appraisal of Clinical Guidelines
    • Using Research to Inform Clinical Decision-Making
    • Implementing Evidence into Clinical Workflow

14. Patient-Centered Research and Care

    • Incorporating Patient Preferences and Values into Clinical Research
    • Shared Decision-Making Models
    • Patient-Reported Outcomes and Quality of Life Measurements

Part 5: Special Topics in Clinical Research

15. Pharmacology and Clinical Research

    • Pharmacokinetics and Pharmacodynamics in Clinical Trials
    • Adverse Drug Reactions and Drug Safety Monitoring
    • Personalized Medicine and Pharmacogenomics

16. Research in Special Populations

    • Clinical Research in Pediatrics, Geriatrics, and Women’s Health
    • Ethnic and Cultural Considerations in Clinical Research
    • Research in Vulnerable Populations: Pregnant Women, Prisoners, etc.

17. Global Health and Clinical Research

    • Conducting Research in Low-Resource Settings
    • Ethical Issues in Global Health Research
    • International Collaboration and Regulatory Challenges

18. Big Data and Clinical Research

    • Use of Electronic Health Records (EHRs) and Health Databases in Research
    • Data Mining, Machine Learning, and AI in Clinical Research
    • Ethical and Legal Issues in Big Data Research

Part 6: Writing and Publishing Clinical Research

19. Writing and Presenting Clinical Research

    • Structuring a Research Paper: Introduction, Methods, Results, and Discussion
    • Writing for Different Audiences: Researchers, Clinicians, and Policymakers
    • Preparing Research Abstracts and Posters
    • Oral and Poster Presentations

20. Publication and Dissemination of Research

    • Peer Review Process and Submission to Scientific Journals
    • Strategies for Getting Published in High-Impact Journals
    • Ethical Considerations in Publishing (Authorship, Plagiarism, Conflicts of Interest)
    • Disseminating Research Findings to the Public and Clinical Communities

Part 7: Advanced Topics in Clinical Research

21. Quality Assurance and Control in Clinical Research

    • Ensuring High Standards in Clinical Research
    • Audits, Monitoring, and Data Verification
    • Addressing Research Integrity and Reproducibility
    • Good Clinical Practice (GCP) and International Guidelines

22. Grant Writing and Funding for Clinical Research

    • Identifying Funding Sources for Clinical Research
    • Writing a Research Grant Proposal
    • Budgeting and Financial Management in Research
    • Ethical Considerations in Research Funding

23. Future Directions in Clinical Research

    • Emerging Trends in Clinical Research Methodology
    • The Role of Technology and Innovation in Clinical Trials
    • Precision Medicine and Its Impact on Clinical Research
    • The Future of Research in Clinical Practice

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