syllabus – understanding and interpreting human studies

Understanding and Interpreting Human Studies
INTD 381

Gehlbach, Stephen H. Interpreting the Medical Literature, McGraw-Hill, Amherst, Mass 2006.

There will be a Sakai site on Web4Students associated with this course, and you must be able to access it. Articles will be put up on the site for you to read online or download. It will be enable interaction for project selection.

Class times and schedule:
Class meets from 9:30 to 12:30

Course Summary: Studying people using scientific tools can actually help us and those around us to change behavior wisely and adjust our attitudes to better agree with the way the world operates. This course will introduce some of the key principles in the design of human studies primarily through reading and analyzing studies others have done. It is a challenge to study people. People are unfortunately – or fortunately – “messy”! By reading and interpreting studies of humans, we can make better decisions for ourselves and those we care about. To do that well, we need to know the limitations of the conclusions we can reach given the data presented. This course also addresses the ethical reasons to do research, and ethical concerns both in doing research and interpreting it. There will also be an opportunity to practice designing human research.

This is an introductory course – we will work towards the following goals:
1) Be able to read a scientific paper on a human study, especially a medical study, and
a. identify key issues in study design
b. identify some fatal flaws
c. identify some of what you can and cannot conclude from the study
2) Through the reading of papers on human studies be able to identify some of the key factors involved in clinical and human research so that you can:
a. Begin to apply the results – personally and professionally
b. Design human research yourself or with others.
3) Identify some of the key ethical issues in doing human studies and presented when reading about the research of others
4) Apply the results of some specific research studies studied in class to your own life in practical ways.

Class attendance and participation is crucial
Missing even a single class is a real problem in this course. You are getting 3 hours credit for this course, so missing one class is like missing a week of class in the normal semester. Assignment materials will be handed out, and presentations and discussions cannot be made up easily. If you do miss a class it is your responsibility to obtain notes from someone in the class. The text is not a substitute for class participation.

a) Assigned reading. Keep notes on assigned reading. Keeping up with assigned reading is very important and it may also be evaluated by pop quiz or individualized class discussion assessment.
b) Specific project assignments. Make sure these are completed in accordance with the instructions, and submitted on time. Late assignments will not get full credit, and are a real problem as class discussion of assignment material happens the day it is due.
c) You are expected to spend substantive time outside class reading assigned materials and working on projects. The more you put into this course, the more you will get out of it.

Project Assignments:
The following are preliminary descriptions of these assignments. These will be presented in more detail, and possibly refined, as the class develops.

1) Project one
a. Summary – What was the central study question? Explain for the non-expert
b. Terms for Project one: Use these terms to examine the study
* Confounding
* Types of study: More important to describe the architecture of it than to name: Cross sectional, Intervention – (Experimental),Retrospective (Case control – or comparative sample),Variations, Prospective (followup or longitudinal)
* Definitions
* Measurement
* Classifications
* Outcomes
* Selection issues – Bias? Sample? Random?
c. What are the implications for action of this study? What limits keep it from being helpful for action? Discuss strengths and limitations.

2) Second project: Design a study
Think of a question you would like to answer about humans – be specific and clear
Design a study to answer that question.
What kind of study will work best: intervention, cross-sectional, retrospective, prospective, combo
What measures will you use… for each of the variables
How reliable are your measures?
Is there any way to make them more reliable?
How do they connect to the construct of interest- so they enable your study to be useful
How will you “control” the study so that you investigate your question, and not something else?
How will you select your sample?
Think about the various issues we have discussed to date in study design and incorporate them into your study plan.
This assignment will be critiqued by your peers in class.
You will also hand in a hard copy.

3) Final project:
I would suggest that you pick this published study early on in the class, and be collecting your info all along on it.
Take a question that you are interested in answering about human beings that might have practical application to your life or those you care about. Pick something specific.
Pick one original study on the topic in a peer-reviewed medical or social science journal.
Describe the study: Type, selection, measurements, likelihood of having false positive or false negative results…see Gehlbach readings and class notes for prompts for various additional points.
Use what you learned from feedback from project one to improve this project write-up. This project should be in more depth, as you will now know more.
Given the results, what would you advise regarding action and why?
Look at various problems in the study that limits what you can conclude?
Class presentation and hard copy to hand in.
Weighting of assignments:
There will be no final exam in this course
30% Project 1
30% Project 2
40% Project 3