Community Scientist Academy Session 2 Study and Intervention Design

Welcome and Introductions Community Scientist Academy (CSA) Team 5:30 Kate Stewart Nicki Spencer Rachel Hale

Welcome and Introductions Make notes of your answers to these questions on your index card: What was most interesting to you that we discussed in last week’s session? What was the most important thing you learned? (If you weren’t here, tell us your name, how you learned of the CSA and why you decided to participate) We have 30 seconds each to tell us your name and answer the questions. Nicki will be timing us!!!

TIMER 30 SECONDS

Community Scientist Academy Purpose: To increase awareness and understanding of research and to increase participation in multiple aspects of the research process. Overview: Session 1: Research Process, Types, and Partnerships Session 2:Study and Intervention Design Session 3: Implementation, Analysis and Dissemination Session 4: Basics of Research Funding Session 5: UAMS and TRI Research Involvement Opportunties Session 6: Graduation Celebration and Next Steps ORIGINAL WORDING: Purpose: To increase awareness and understanding of research and participation in multiple aspects of the research process. Camille 5:46

DISCLAIMER This is just a broad introduction to whet your appetite! It’s not in-depth or exhaustive

Study Design Types of Study Designs Descriptive / observational (non-experimental) Quasi-experimental Experimental

Study Design Descriptive/observational (non-experimental) Purpose: To accurately describe or depict the people being studied. Types: Observational, Case Study, Survey No comparison or control group Examples: Studies documenting death rates Disparities in quality of care Differences in access to care or use of services

Study Design Quasi-experimental Purpose: To study the effect of an intervention (e.g. drugs, procedures, health services, education, policy change, etc.) Looks for differences over time (by taking a series of measurements before and after) and/or between groups Examples: Hand-washing before and after adding sanitizer by the doors of half of the patients Impact of community health workers on cost using secondary data

Study Design Experimental Randomized Controlled Trial Random assignment (e.g., flip a coin, etc.) to either control or intervention group Considered most rigorous design or “gold standard”

Is random assignment used? Yes No Randomized controlled trial Is there a comparison group or multiple measurements? Yes No Quasi-experimental Descriptive non-experimental

Randomized Controlled Trials Exercise Watch the videos During the video, use your index card to note things you want to ask about afterwards.

Randomized Controlled Trials Exercise Example https://youtu.be/Wy7qpJeozec Why is randomization important? https://www.youtube.com/watch?v=V_GIjFw6RZE What is clinical trial? https://www.youtube.com/watch?v=R4AUGdT3DE8

Study Design DEBRIEF What questions do you have? My questions for you: Why is it important to randomly assign patients to receive the treatment being tested? Why are drugs tested in phases?

Guest Presentation - Researcher L. Joseph Su, PhD, MPH Professor, Department of Epidemiology Fay W. Boozman College of Public Health, UAMS Co-Director, Cancer Prevention and Population Science, W. P. Rockefeller Cancer Institute, UAMS

BREAK – 5 minutes

REVIEW How is Research Defined?

REVIEW How is Research Defined? A systematic (organized, planned) process used to develop or contribute to generalizable knowledge. ORIGINAL TEXT: A systematic (organized, planned) process used to develop or contribute to generalizable knowledge.

Break into three groups and answer your assigned questions. REVIEW Break into three groups and answer your assigned questions. Group 1 How are patient centered outcomes research and community-based participatory research different from traditional research? Why have CBPR and PCOR become more popular approaches to research in recent years? Group 2 Describe the different parts of the research process. What, if anything, about the process was confusing or interesting to you? Group 3 What is the IRB and what is its role? What was the most interesting thing you learned from Ms. Killebrew?

REVIEW Find your group (Either here, next door, or in the hall room.) Spend 5-10 minutes discussing the answer to your assigned question. Make notes on the flip chart paper. Also list any questions or comments you have. Pick someone to report to the rest of the group.

Report Out and Discussion 3 minutes each group

Steps in the Research Process Define the research question Identify the PROBLEM Devise a PLAN ACT To implement your plan OBSERVE Collect and analyze your data REFLECT And share Study Design, Develop Study Methods, Instruments Dissemination Write grants, obtain funding, write study protocol, obtain IRB approval Study Implementation

Institutional Review Boards (IRB) Researchers must submit their studies for IRB review IRB determines if activities require review Research must be approved before activities can start Studies not meeting ethical standards are denied approval IRB also monitors approved studies to assure they are conducted ethically Kate ORIGINAL WORDING: IRB determines if activities require review Researchers must submit their studies for IRB review Research must be approved before activities can start Studies not meeting ethical standards are denied approval IRB also monitors approved studies to assure they are conducted ethically

Examples of Types of Research Basic research – studies of the body’s cells and molecules – to find out how they function. Clinical studies: Testing medications or procedures in patients or healthy volunteers Reviewing medical records Lab studies of blood or other human tissue Survey research – phone, in person, completed by yourself Health services research – studies about healthcare quality, access, and cost Community-based interventions – healthy eating, exercise, etc. Kate Basic research – for example basic research on cancer might look at the role of different molecules in starting or stopping cancer.

Traditional versus Participatory Research Community-Based Participatory Research (CBPR) CBPR is a collaborative research approach that is designed to ensure and establish structures for participation by communities affected by the issue being studied, representatives of organizations, and researchers in all aspects of the research process to improve health and well-being through taking action, including social change. Kate – 5 minutes Viswanathan M, et al. 2004 ARHQ Evidence Report 99: Community-based Participatory Research: Assessing the Evidence accessed on 9/2/09 at Http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.44133.

Traditional versus Patient Centered Outcomes Research (PCOR) Helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options. Kate

Collect and analyze your data How are CBPR and PCOR Different? We do all the steps together. Including Identifying the problem Identify the PROBLEM Devise a PLAN ACT To implement your plan OBSERVE Collect and analyze your data REFLECT And share

Collect and analyze your data How are CBPR and PCOR Different? We do all the steps together. Including Identifying the problem Identify the PROBLEM Devise a PLAN ACT To implement your plan OBSERVE Collect and analyze your data REFLECT And share Ideally, researchers and community members, patients, families, or others affected by the issue develop a partnership before you start the process!

Debrief & Wrap-up Any questions