DPT 7343 Research Design & Analysis - Comprehensive Notes
Course overview
DPT 7343: Research Design & Analysis with Dr. Jason Jakiela (Fall 2025). This course is designed to equip students with the essential skills to effectively transition research into pragmatic evidence-based practice (EBP) and enhance clinical decision-making. The focus is on understanding the entire research pipeline from question formulation to dissemination and practical application.
Core framework: The Research Process outlines five main sequential steps, critical for systematic inquiry:
Identify the research question: This foundational step involves pinpointing a clear, answerable question, often derived from identified gaps in existing literature or clinical observations.
Design the study: Crafting a methodology that is appropriate to answer the research question, including selecting the study population, intervention, comparison, and outcome measures.
Implement the study: Executing the designed research protocol, which includes obtaining ethical approvals, recruiting participants, and collecting data.
Analyze data: Systematically processing, interpreting, and drawing conclusions from the collected data using appropriate statistical or qualitative methods.
Disseminate findings: Sharing the research results with the scientific community and relevant stakeholders through various platforms to inform practice and generate further inquiry.
Key themes integrated across the course, emphasizing a holistic understanding of research:
Translational research: Bridging the gap between basic scientific discoveries and their application in clinical practice and patient outcomes.
EBP and evidence sources: Understanding how to integrate the best available research evidence with clinical expertise and patient values for optimal care.
Research ethics and regulatory compliance: Adhering to ethical principles and regulations governing human subjects research, including mandatory CITI training and Institutional Review Board (IRB) processes to ensure participant safety and rights.
Study design types and their applications: Differentiating between various quantitative and qualitative designs (e.g., experimental, observational, descriptive) and understanding their strengths and limitations for specific research questions.
Statistical literacy and interpretation: Developing the ability to understand, apply, and critically interpret statistical analyses relevant to clinical research, moving beyond mere calculation to meaningful clinical implications.
Research dissemination and implementation in practice: Learning effective strategies to share research findings (e.g., presentations, publications) and facilitate their uptake into clinical environments.
Textbook and materials
Required textbook: Foundations of Clinical Research: Applications to Evidence-Based Practice, 4th Edition, authored by Leslie G. Portney. This text serves as a comprehensive guide for the theoretical and practical aspects of clinical research.
Accessibility: The full text is conveniently available for free to enrolled students through the WSSU library, ensuring all students have access to core readings.
Assessments and grading (as announced in the syllabus)
Exams: Two comprehensive examinations, each contributing 20 ext{ extbf{a%}} to the final grade, totaling 40 ext{ extbf{a%}}. These exams assess understanding of core concepts, study designs, statistical principles, and ethical considerations covered in the course.
Journal Club discussions: Five active discussions, collectively accounting for 20 ext{ extbf{a%}}. Students will lead and participate in critically appraising published research articles, fostering skills in evidence evaluation and scholarly discourse.
Statistics assignments: Five assignments, each worth 4 ext{ extbf{a%}}, cumulatively making up 20 ext{ extbf{a%}}. These assignments are designed to build proficiency in statistical software, rationale for method selection, and the interpretation of statistical results in a research context.
IRB assignment / CITI training: One multi-part assignment, comprising 20 ext{ extbf{a%}}. This assignment guides students through the process of developing an IRB proposal and completing required CITI Human Subjects Protections training, crucial for conducting ethical research. The final, revised version of the IRB proposal is due on December 1st.
Overall assessment summary:
Exams (x2, each 20 ext{ extbf{a%}}): 40 ext{ extbf{a%}}
Journal Club Discussions (x5): 20 ext{ extbf{a%}}
Statistics Assignments (x5, each 4 ext{ extbf{a%}}): 20 ext{ extbf{a%}}
IRB Assignment / CITI Training: 20 ext{ extbf{a%}}
Course schedule and topics (overview by week)
Week 1 (8/18/2025): Introduction to the course, foundational concepts of Translational Research, principles of Evidence-Based Practice (EBP), Research Ethics, CITI training requirements, and an overview of the Institutional Review Board (IRB) process.
Week 2 (8/25/2025): Focusing on the initial stages of research, including formulating a precise Research Question, conducting effective Literature Searches, strategies for Choosing a Sample, and ethical Recruitment methods.
Week 3: Labor Day (no class) – a break in the scheduled instruction.
Week 4 (9/1/2025): Delving into data quality, covering Principles of Measurement, assessing Reliability (consistency), Validity (accuracy), and various aspects of Design Validity (internal and external).
Week 5 (9/8/2025): Exploring core Research Design elements, the importance of Controls in experimental studies, fundamentals of Hypothesis Testing, and characteristics of Descriptive Research.
Week 6 (9/15/2025): In-depth study of Experimental Designs, various Observational Designs, and the structure and methodology of Clinical Trials.
Week 7 (9/22/2025): Examining Quasi-Experimental Designs, Single Subject Designs for individual cases, and the methodologies of Qualitative Research.
Week 8 (9/29/2025): Comprehensive topics on evidence synthesis: Systematic Reviews & Meta-Analyses, and practical approaches to Evaluating Research Reports critically.
Exam 1: Scheduled for 10/20/2025 from 1-4 PM, covering material from Weeks 1-8.
Week 9 (10/6/2025): Introduction to Descriptive Statistics, Foundations of Statistical Inference, and an Overview of Statistical Software commonly used in research.
Week 10 (10/13/2025): Focus on Analysis of Variance (ANOVAs) and various Multiple Comparisons techniques used to interpret differences between groups.
Week 11 (10/27/2025): Exploring Correlation for assessing relationships between variables, Chi-Square tests for categorical data, and an introduction to Non-Parametric statistical methods.
Week 12 (11/3/2025): Specific statistical applications in clinical practice, including Diagnostic Accuracy, and statistical measures of Reliability and Validity.
Week 13 (11/10/2025): Advanced statistical topics: Regression analysis for prediction, Risk assessment (e.g., odds ratios, relative risks), and Multivariate statistical techniques.
Exam 2: Date not explicitly stated in the transcript but occurs within the Weeks 13–14 window, covering post-Exam 1 material.
Week 14 (11/17/2025): Practical application of research writing, covering how to structure a Research Proposal, Methods section, Results section, full Paper, and Poster presentations.
Week 15 (11/24/2025): Research Group Presentation & Formation, where students will present nascent research ideas and form collaborative groups.
Week 16 (12/1/2025): Dedicated to Research Group Meetings and the official commencement of IRB & CITI Training work; Journal Club meetings continue.
Reading assignments by week (Chapters listed from Portney’s Foundations of Clinical Research):
Week 1: Ch 1, 2, 5, 7
Week 2: Ch 3, 6, 13
Week 3: n/a
Week 4: Ch 8, 9, 10, 15
Week 5: Ch 11, 12, 20
Week 6: Ch 14, 16, 19
Week 7: Ch 17, 18, 21
Week 8: Ch 36, 37
Week 9: n/a (this week likely focuses on software introductions/practice)
Week 10: Ch 22, 23, 24
Week 11: Ch 25, 26
Week 12: Ch 27, 28, 29
Week 13: Ch 32, 33
Week 14: Ch 30, 31, 34
Week 15: n/a (likely for group work and presentations)
Week 16: Ch 35, 38
The research process (five steps)
This core framework guides all systematic inquiry in clinical research:
Identify the research question:
This initial step is crucial for defining the scope and purpose of the study. It typically begins with a thorough literature review to identify existing knowledge, pinpoint gaps in that knowledge, and justify the necessity of a new study.
The literature review also helps in selecting the most appropriate methodology and provides a theoretical framework for interpreting future findings.
Key elements determined in this step using frameworks like PICOTS include: the specific Population/condition, the Intervention/exposure/risk factor, the Comparison group (if applicable), the measurable Outcome variables, the optimal study Design and statistical approaches, and potential Limitations.
Design the study:
This step involves selecting a research design that is best suited to answer the identified research question while maximizing validity and minimizing bias.
For instance, if the question involves comparing a 12-week strength program against usual care for knee osteoarthritis in adults, a Randomized Controlled Trial (RCT) might be chosen for its ability to establish cause-and-effect relationships.
The design phase culminates in the development of a detailed research proposal, which is essential for securing funding and, critically, for submission to the Institutional Review Board (IRB) for ethical approval.
Considerations like Efficacy (can it work in ideal conditions?) versus Effectiveness (does it work in real-world practice?) are paramount, influencing study context and generalizability. The ICF model (which frames health in terms of functioning and disability, and contextual factors) is often used here to ensure comprehensive and patient-centered outcomes.
Implement the study:
This is the execution phase where the research plan is put into action. It involves obtaining ethical approval, participant recruitment, data collection, and adherence to the established protocol.
Strict adherence to the study design is critical to maintain the integrity and validity of the research.
Analyze the data:
Once data collection is complete, this step involves systematically processing, analyzing, and interpreting the findings. It typically includes data cleaning, statistical analysis (for quantitative data), or thematic analysis (for qualitative data).
Results should be interpreted objectively, and analysis is generally held until after study completion to prevent researcher bias from influencing data collection or participant interaction.
Disseminate findings:
The final step involves sharing the study results with the wider scientific and clinical communities. This can occur through various channels such as presentations at conferences, scientific abstracts, poster sessions, peer-reviewed journal publications, or even popular media outlets.
Clinicians then appraise the applicability of these findings, considering factors like the potential benefit versus risk, feasibility within their practice setting, associated costs, and alignment with patient preferences and values, thereby closing the loop for evidence-based practice.
Completion of one study often leads to the identification of new research questions, fostering a continuous cycle of inquiry.
PICOTS framework for research questions
The PICOTS framework provides a structured approach to formulating clear and comprehensive research questions:
Population: Describes the specific group of individuals being studied, including their condition, demographics, and any specific inclusion/exclusion criteria.
Intervention: Details the specific exposure, risk factor, diagnostic test, or therapeutic intervention being investigated.
Comparison: (If appropriate) Specifies the alternative intervention or control condition to which the intervention is compared (e.g., usual care, placebo).
Outcome: Identifies the measurable result(s) or effect(s) that the intervention is expected to influence.
Time: Defines the duration over which the intervention or observation occurs, or when the outcome will be measured (e.g., 12 weeks, 3 months).
Study Design: (Optional but highly recommended) Specifies the type of research design used (e.g., RCT, cohort study) to best answer the question.
Example: In adults with knee OA (Population), does a 12-week strength training program (Intervention) versus usual care (Comparison) improve pain and function (Outcome) over 3 months (Time) in a Randomized Controlled Trial? (Study Design).
Efficacy vs. Effectiveness (EBP context)
These terms differentiate the conditions under which an intervention's benefits are observed, and their distinction is critical for applying research to practice:
Efficacy: Refers to the benefit of an intervention compared to a control group under ideal, highly controlled laboratory or clinical trial conditions. Studies evaluating efficacy typically boast high internal validity, meaning the observed effects are confidently attributable to the intervention.