Strengthening Research Capabilities Professor John B. Kaneene DVM, MPH, PhD, FAES, FAVES Center for Comparative Epidemiology Michigan State University

1. Laboratory and Related Facilities 2. Critical Mass of Research Faculty 3. Opportunities for Further Training of Faculty 2 Six Pillars of Research Capabilities

4. Ability to Compete for Extramural Grants 5. Ability to Design, Implement, and Analyze Research Projects 6. Ability to Contribute to the Scientific Literature and Different Stakeholders 3 Six Pillars of Research Capabilities (cont.)

 Focus of Different Types of Grants 1. Research 2. Development 3. Research + Development 4 Ability to Compete for Extramural Grants

 Focus of Different Types of Grants 1. Research Grants  Hypothesis-Driven 2. Development Grants  Demonstrate High Impact  Demonstrate Sustainability 5 Types of Grants

3. Combined Development and Research Grants  Hypothesis-driven research to generate programs that are High Impact and Sustainable 6 Types of Grants (cont.)

 Examples of Types of Grants 1. Research Grants  Does interaction of livestock, wildlife and humans increase the probability of brucellosis in rural communities? 7 Types of Grants

 Examples of Types of Grants 2. Development Grants  Impact of increasing rural veterinarians and veterinary technicians on:  Animal and Human Health  Livestock Productivity 8 Types of Grants (cont.)

 Examples of Types of Grants 3. Combined Development and Research Grants  Demonstrating the impact of student-led action research on the milk quality, safety and economic performance of the dairy value chain in Western Uganda 9 Types of Grants (cont.)

 Overall Goal  The goals of this short course is to provide the trainee with the fundamental concepts and methods for:  Designing research studies  Implementing studies  Analyzing results from research studies  Publishing results 10 Ability to Design, Implement, and Analyze Research Projects

 After completing the short course, the trainee will be able to:  Develop an overall problem statement relating to the research topic of interest  State the underlying overall question  Articulate a hypothesis or hypotheses of the study 11 Course Objectives

 After completing the short course, the trainee will be able to :  State the objectives and specific aims of the study  Explain the general issues relating to any research study 12 Course Objectives (cont.)

 After completing the short course, the trainee will be able to :  Describe the different types of study designs:  Indications  Strengths  Limitations 13 Course Objectives (cont.)

 After completing the short course, the trainee will be able to :  Design, implement, and analyze data from a research study  Provide a rationale and strategies for publishing results from a research study 14 Course Objectives (cont.)

 Steps involved in conducting a research study  Types of study designs  General issues relating to any study design 15 Course Outline

 Provide a Problem Statement  State the Overall Question  Formulate the Hypothesis(es)  State Objectives and Specific Aims  Design the Study 16 Steps in Conducting a Research Study

 Implement the Study  Analyze the Data  Interpret Results  Publish the Study Results 17 Steps in Conducting a Research Study (cont.)

 Formulate the Hypothesis/Hypotheses  Based on Analytical Approach  Simple association between factors  Direction, Magnitude  Does not imply cause-effect relationship  Cause-effect relationships  Direction, Magnitude  Dependent variables (outcomes)  Independent variables (risk factors) 18 Conducting a Research Study

 Formulate the Hypothesis/Hypotheses  Research hypothesis: Testable statement of relationship between factors  Statistical hypothesis  H 1 : Relationship exists  H 0 : Relationship does not exist (Null hypothesis) 19 Conducting a Research Study

 Design the Study  Types of Studies  Experimental  Observational  Study design must be able to address the study hypothesis(es) 20 Conducting a Research Study

 Descriptive Studies: Hypothesis testing - NO  Analytical Studies: Hypothesis testing – YES  Experimental Studies: Controlled  Observational Studies: Not controlled 21 Types of Study Designs

Observational Studies Experimental Studies Cross-Sectional (survey) Prospective Retrospective Hybrid Laboratory Based Controlled Field Trials Analytical (Explanatory) Studies 22 Randomized Clinical Trials

1. Ethical and Humane Considerations 2. Standard Operating Procedures 3. Validity and Biases 4. Sample Size and Power Consideration 5. Statistical Approaches 23 General Issues Relating to All Study Designs

1. Ethical and Humane Considerations  Basic Ethical Principles (Belmont Report, 1979)  Respect for the Subject  Autonomy  Protection for subjects 24 General Issues Relating to Study Design

1. Ethical and Humane Considerations  Basic Ethical Principles (Belmont Report, 1979)  Beneficence  Maximize benefits and minimize harms  Justice  Fairness in distribution of benefits and/or risks 25 General Issues Relating to Study Design

 Respect for the Subject  Informed Consent  Potential Risk  Potential Benefits  Confidentiality 26 General Issues Relating to Study Design: Meeting Ethical and Humane Considerations

 Beneficence  Minimize Risks and Maximize Benefits  Stopping Rules  Justice  Randomization  Blinding 27 General Issues Relating to Study Design: Meeting Ethical and Humane Considerations

2. Standard Operating Procedures (SOPs)  Study protocols  Standardized methodology for use by study investigators  Best Practices: internationally-accepted standard procedures  Procedure Manuals 28 General Issues Relating to Study Design

3. Validity and Biases  Accuracy and Precision  Validity  Biases  Confounding 29 General Issues Relating to Study Design

 Biases that affect Validity  Selection Bias  Information Bias  Confounding General Issues Relating to Study Design: Validity and Biases 30

4. Sample Size and Power Considerations  Importance of Sample Size Determination  Sufficient Statistical Power for Valid Inferences in hypothesis testing  Conservation of Resources 31 General Issues Relating to Study Design

 What is Statistical Power?  The probability that you find a statistically significant difference when it exists  The difference is of a certain magnitude 32 General Issues Relating to Study Design: Sample Size and Power Considerations

 Valid Inference = Avoiding error  Type I error (α)  Finding difference when none exists  Incorrectly reject H 0  Type II error (β)  Finding no difference when difference exists  Incorrectly accept H 0 33 General Issues Relating to Study Design: Sample Size and Power Considerations

34  Statistical Considerations for Sample Size Determination  Significance  Probability that differences d.t. random chance  = Type I error (α)  Power  Probability of correctly identifying differences  = 1 - Type II error (1 – β)

General Issues Relating to Study Design: Sample Size and Power Considerations  Sources for assumptions  Literature review  Biologically significant differences  Difference between groups is biologically/clinically important  Pilot studies 35

5. Approach for Statistical Analysis  State hypotheses & significance level  Determine types of data to be used  Select and conduct appropriate statistical test(s)  Interpret results 36 General Issues Relating to Study Design