Presentation # 1 - Introduction to EBM. Research Porcess and Questions. Ethical considerations. .pptx

Introduction to EBM. The research Question.

1. Introduction to Evidence-based Medicine Research Methods and Research Questions

2. What’s Research? Research is a systematic process of inquiry aimed at generating new knowledge or confirming existing knowledge through scientific methods. It is the foundation of evidence-based medicine (EBM) .

3. The Research Process

4. Introduction to Evidence-Based Practice Evidence-based medicine integrates: Best available research evidence (from high-quality studies). Clinical expertise (provider’s experience and skills). Patient values and preferences (patient-centered care). EBM is the use of the best available evidence from research, clinical expertise, and patient values and preferences to make clinical decisions. Importance: Enhances patient care, improves outcomes, and supports informed decision-making.

5. Types of Research Basic Research Applied Research Driven by curiosity to expand knowledge Designed to solve practical problems Examples: What are electrons composed of? How do slime molds reproduce? What is the genetic code of the fruit fly? Examples: Improve agricultural crop production Treat or cure a specific disease Improve the energy efficiency of cars

6. Types of Research Quantitative : Structured, numerical, large samples (e.g., surveys, experiments). Qualitative : Exploratory, small samples, open-ended (e.g., interviews, focus groups).

7. Quantitative Research Qualitative Research Objective Measures and quantifies variables Explores concepts, meanings, experiences Data Type Numerical, structured data Non-numerical, textual or visual data Data Collection Surveys, experiments, structured observations Interviews, focus groups, open-ended surveys Sample Size Large, statistically representative Small, purposive or theoretical sampling Analysis Approach Statistical, mathematical analysis Thematic, content, discourse analysis Outcome Generalizable findings, statistical conclusions Rich, contextualized insights, deeper understanding Examples Clinical trials, epidemiological studies, surveys Case studies, ethnographic research, narrative analysis

8. Types of Research Primary – Original studies such as randomized controlled trials (RCTs), cohort studies, case-control studies, and qualitative research. Secondary – Synthesizing existing studies, such as systematic reviews, meta-analyses, and clinical guidelines.

9. ANATOMY OF RESEARCH: THE STUDY PLAN DESIGN COMPONENTS PURPOSE Research question(s) What question(s) will the study address? Background and significance Why are these questions important? Design Type of study How is the study structured? Participants Selection criteria Sampling design Who are they, and how will they be selected? Variables Predictor variables Confounding variables Outcome variables What measurements will be made? Statistical issues Hypotheses Sample size Analytic approach How large is the study, and how will it be analyzed?

10. The Research Question The study’s objective (addresses the uncertainty about a problem). Research starts with a broad inquiry and is refined into a concrete, specific question . Broad question: Does caffeine affect cognitive function? Needs further focus; break it into specific key aspects to build the research protocol. Refined questions: How does caffeine affect short-term memory in adults? How does caffeine affect reaction time in shift workers? What’s the relationship between caffeine and exam score in students?

11. EXAMPLES OF CLINICAL RESEARCH DESIGNS TO FIND OUT WHETHER CAFFEINE CONSUMPTION REDUCES THE RISK OF DEMENTIA EPIDEMIOLOGIC DESIGN KEY FEATURE EXAMPLE Observational Designs Cross-sectional study A group examined at one point in time The investigator interviews a group of participants about current and past caffeine intake and correlates results with scores on a test of cognitive function. Cohort study A group (usually without the outcome) identified at the beginning of the study and followed over time The researcher measures caffeine consumption in a group of participants with normal cognitive function and examines them at follow-up visits to see if those who consume caffeine are less likely to develop dementia. Case-control study Two groups selected based on the presence or absence of an outcome The researcher compares past caffeine intake in a group of people with dementia (the “cases”) with that in a group with normal cognitive function (the “controls”). Clinical Trial Design Randomized blinded trial Two groups created by a random process and a blinded intervention The researcher randomly assigns participants with normal cognitive function to receive caffeine supplements or a placebo that is identical in appearance and then follows both treatment groups for several years to observe the incidence of dementia.

12. Formulating a Research Question PICO Framework: P atient/Population I ntervention/Treatment C omparison O utcome FINER Criteria: F easible (practical, fundable) I nteresting (engaging for researchers) N ovel (adds new knowledge) E thical (meets IRB standards) R elevant (clinically significant)

13. What Type of Question are You Asking? Therapy/ Inter vention: Does the treatment work? How effective is the intervention? Diagnosis: What is the ability of the test to predict the likelihood of a disease? Etiology/Harm: What is the cause of the problem? What is the harmful effect of an intervention or exposure? Prognosis: What is the future course of the patient?

14. What Type of Study do you Need?

15. Therapy/Intervention In adults with type 2 diabetes (P), how does intermittent fasting (I) compare to a standard calorie-restricted diet (C) in improving glycemic control and weight loss (O) over six months (T)? P: Adults with type 2 diabetes I: Intermittent fasting C: Standard calorie-restricted diet O: Glycemic control and weight loss over six months

16. Diagnosis In adults at risk for Alzheimer's disease, how does cerebrospinal fluid (CSF) tau protein measurement compare to amyloid PET imaging in predicting future cognitive decline? P: Adults at risk for Alzheimer's disease I: Cerebrospinal fluid (CSF) tau protein C: Amyloid PET imaging O: Prediction of future cognitive decline

17. Etiology/Harm In long-term smokers, how does smoking more than 20 cigarettes per day compare to smoking fewer than 10 cigarettes per day in increasing the risk of developing lung cancer? P: Long-term smokers I: Smoking more than 20 cigarettes per day C: Smoking fewer than 10 cigarettes per day O: Increased risk of developing lung cancer

18. Prognosis In patients with early-stage Parkinson’s disease, how does the presence of REM sleep behavior disorder compare to its absence in predicting the progression to severe motor impairment within five years? P: Patients with early-stage Parkinson’s disease I: Presence of REM sleep behavior disorder C: Absence of REM sleep behavior disorder O: Progression to severe motor impairment within five years

19. Background and Significance Designing a meaningful research requires understanding the research filed. The goal is contributing with new knowledge (or perspective) that enhances understanding or impacts clinical practice. Experts and existing literature are sources of insight. Identify what is known and what remains uncertain. Reveals problems with prior studies (limitations, inconsistencies). Defines how the study will address these gaps. Modify the question based on findings and discussions.

20. Human Subjects Research: Ethical considerations

21. Ethical Considerations in Research Historical cases Tuskegee study, Nazi experiments, research with prisoners → Led to the Belmont report. Belmont principles : Respect for persons → Informed consent Beneficence → Minimize harm, maximize benefits Justice → Fair participant selection

22. The Institutional Review Board (IRB) Ensures risks are minimized and reasonable. Protects confidentiality (HIPAA). Reviews research design and ethical compliance. Vulnerable Populations Protections Children, prisoners, pregnant women. Address power imbalances & social disadvantages.

23. Ethical Responsibilities of Investigators Scientific Misconduct : Fabrication, falsification, plagiarism. Conflicts of Interest : Transparency in funding, authorship, and compensation. Informed Consent : Disclosure of p otential risks and benefits, p rocedures of the study, voluntary participation and a lternative to participation.

24. Practical Exercise Identify PICO elements in an assigned paper. Determine the type of research question or problem addressed (diagnosis, therapy/intervention, etiology/harm, or prognosis.