Section outline

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  • Monday, August 4, 2014, 9:00 AM - 10:15 AM

    Lecture: The Research Question

    Introduction to the course; components ("anatomy") of a research protocol and "physiology" of research; examples from Dr. Newman's neonatal jaundice research.

    Faculty:  Tom Newman

    Location:      HSW 302

    • Session Slides:

    • Epi 150.03 Introduction 2014 File
    • Newman Lecture 1 Intro to Research and Research Questions for 1-month DCR 2014-0730 File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading:

      DCR-4: Chapter 1: The Anatomy and Physiology of Clinical Research

      DCR-4: Chapter 2: Conceiving the Research Question

    • Errata for DCR-3 as of July 18, 2012 File

    • Optional Reading:

    • Newman 2003 Stories Statistics BMJ File
      Not available unless: Your ID number contains 02

    • Assignment: Assignment one (due at the start of class)

  • Monday, August 4, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Andrew Avins, Dejana Braithwaite, Amy Hsu, Sara Kalkhoran, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot


    Location:      Avin S-180, Braithwaite S-168, Hsu U-460, Kalkhoran C-417, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online

    • Session Slides:

    • Assignment:

      Download and review full assignment below. Most important:

        1. Read Chapters 1 & 2 of DCR-4
        2. Choose a research question.
        3. Identify and meet with your mentor
        4. Bring a hard copy of a 1-sentence version of your Research Question and a 1/2 to 3/4 page Significance section to class.
        5. Use a citation management program for the references. Take a class if needed.

    • ASSIGNMENT ONE 2014.dueWeekOne.080414 File

    • Assignment Due Date:

      Assignment 1, to be completed before August 5

      Assignment 2 due August 7 at Noon

  • Wednesday, August 6, 2014, 9:00 AM - 10:15 AM

    Lecture: Subjects and variables

    Target and accessibile populations; inclusion and exclusion criteria; balancing feasibility and generalizability; sampling; types of variables and measurements; and maximizing precision and accuracy.

    Faculty:  Doug Bauer

    Location:      HSW 302

    • Session Slides:

    • CTSI OLL BAUER.2 File

    • Required Reading:

      DCR-4 Chapter 3: Choosing the Study Subjects

      DCR-4 Chapter 4: Planning the Measurements

    • How do we know what we know? This is a 52 minute recorded lecture by Tom Newman URL
      Not available unless: Your ID number contains 02

    • Assignment Due Date:  

      Final  version of assignment two due electronically at noon on August 7.

  • Wednesday, August 6, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Andrew Avins, Dejana Braithwaite, Amy Hsu, Sara Kalkhoran, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot


    Location:  Avin S-180, Braithwaite S-168, Hsu U-460, Kalkhoran C-417, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online

    • Assignment:

      Download and review full assignment below. Most important:

        1. Read chapters 3 and 4 of DCR-4.
        2. Compose an outline of your study.
        3. Include a more detailed "Study Subjects" and “Variables” section.
        4. Make an appointment to meet with your mentor.
        5. Watch TN's presentation "How do we know what we know?"

    • ASSIGNMENT TWO 2014.dueWeekOne.080714 File

    • Assignment Due Date:  Assignment 2 due August 7 at Noon

  • Monday, August 11, 2014, 9:00 AM - 10:15 AM

    Lecture: Sample size and power

    An introduction to the concepts and information needed to estimate sample sizes for various types of studies.

    Faculty: Steve Cummings

    Location:      HSW 302

    • Sample Size lecture File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading:

      DCR-4 Chapter 5: Getting Ready to Estimate Sample Size

      DCR-4 Chapter 6: Estimating Sample Size and Power

  • Monday, August 11, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of Assignment Three

    Faculty: Andrew Avins, Dejana Braithwaite, Valerie Flaherman, Amy Hsu, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot


    Location:      Avin S-180, Braithwaite S-168, Hsu U-460, Flaherman C-417, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online

    • Assignment:

              Download and review full assignment below. Most important:

        1. Read Chapters 5 & 6 of DCR-4.
        2. Improve your protocol.
        3. Bring a sample size calculation.

    • ASSIGNMENT THREE 2014.dueWeekTwo.081414.doc File

    • Assignment Due Date: August 14th, 2014 at NOON

  • Wednesday, August 13, 2014, 9:00 AM - 10:15 AM

    Lecture: Causality/Clinical trials

    Drawing causal inference; chance, bias, and confounding; pros and cons of observational studies and randomized controlled trials; examples from the diabetes literature.

    Faculty:  Deborah Grady

    Location:      HSW 302

    • Session Slides:

    • Causal Inference 0814 Students File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading:

      DCR-4 Chapter 9: Enhancing Causal Infernence in Observational Studies

      DCR-4 Chapter 10: Designing a Randomized Blinded Trial

      DCR-4 Chapter 11: Alternative Trial Designs and Implementation Issues

    • Assignment Due Date: 

      Final version of assignment 3 due electronically August 14 at Noon.

  • Wednesday, August 13, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of Assignment Three

    Faculty: Andrew Avins, Dejana Braithwaite, Valerie Flaherman, Amy Hsu, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot


    Location:  Avin S-180, Braithwaite S-168, Hsu U-460, Flaherman C-417, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online


  • Monday, August 18, 2014, 9:00 AM - 10:15 AM

    Lecture: Observational study design

    Classification of observational studies: sampling scheme and time frame; structure, advantages and disadvantages of major observational designs; importance of sampling scheme in studies of diagnostic test accuracy; practice naming designs.

    Faculty: Margaret Handley

    Location:  HSW 302

    • MH DCR Lecture File

    • Required Reading:

      DCR-4 Chapter 7: Designing a Cohort Study

      DCR-4 Chapter 8: Designing Cross-Sectional and Case Control Studies

    • Optional Reading:

      DCR-4 Chapter 12, 13, 14

  • Monday, August 18, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Andrew Avins, Arpi Bekmezian, Dejana Braithwaite, Amy Hsu, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot


    Location:  Avin S-180,Bekmezian C-417, Braithwaite S-168, Hsu U-460, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online


    • Assignment:

              Download and review full assignment below. Most important:

        1. Have a clear, detailed understanding of exactly how at least one predictor and one outcome variable for their study will be (or was) measured or be aware that they do not have such an understanding and have a plan to acquire it
        2. Have experience providing tips to colleagues
        3. Be able to list and explain the advantages and disadvantages of basic observational study designs, including case-control, cross-sectional and cohort studies
        4. Be able to propose a logical (if not feasible) alternative design for their research question

    • ASSIGNMENT FOUR 2014.due WeekThree.082114 File

    • Assignment Due Date:  August 21, 2014 at 12 noon

  • Wednesday, August 20, 2014; 9:00 AM - 10:15 AM

    Lecture: Questionnaires and qualitative methods

    Development of questionnaires; adapting existing instruments or items vs creating new ones; pretesting to identify ambiguities.

    Faculty:  Miriam Kuppermann

    Location:      HSW 302

    • Kuppermann DCR 8/20/14 File

    • Required Reading:

      DCR-4 Chapter 15: Designing Questionnaires and Interviews

      DCR-4 Chapter 16: Data Management

    • Final Exam Due Date: Final Protocol Due 5pm, Monday, August 25.

  • Wednesday, August 20, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of Assignment Four

    Faculty: Andrew Avins, Arpi Bekmezian, Dejana Braithwaite, Amy Hsu, Sara Kalkhoran, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot



    Location:  Avin S-180, Bekmezian C-417, Braithwaite S-168, Hsu U-460, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online

  • Monday, August 25, 2014; 9:00 AM - 10:15 AM

    Lecture: Statistics for life

    Biostatistic pearls. How to interpret P values. Standard error versus Standard deviation. Confidence intervals. Adjustment in multivariable analyses.

    Faculty:  Charles McCulloch

    Location:      HSW 302

    • DCR Lecture Biostat 2014 File

    • Required Reading:

      DCR-4 Chapter 5: Underlying Statistical Principles (starting on page 46)

    • Assignment: Download and review full assignment below.  Most important:

      1.  Review Chapters 5 (Statistics principles section) & 15 (Questionnaire Design) of DCR-4

      2.  Bring your own study questionnaire to section if you have one and be prepared to discuss pros and cons

      3.  Say goodbyes

      4.  No additional written assignment due this week (apart from study protocol)

    • Assignment Due Date:

      Only final protocol due today 8/25/14.  No other written assignment.

  • Monday, August 25, 2014, 10:30 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of questionnaires.

    Faculty: Andrew Avins, Arpi Bekmezian, Dejana Braithwaite, Amy Hsu, Sara Kalkhoran, Helen Kim, Nicole Ling, Kala Mehta, Eleni Linos, Diana Naranjo, Jonathan Singer, Betty Smoot


    Location:      Avin S-180, Bekmezian C-417, Braithwaite S-168, Hsu U-460, Kim S-174, Ling C-517, Mehta S-172, Naranjo S 170, Singer S-178, Smoot S-176, Linos Online

  • Wednesday, August 27, 2014, 10:00 AM - 1:00 PM

    Final Peer Review Sessions

    Faculty: TBA

    Location: TBA