Section outline

  • Collapse all Expand all

  • Monday, August 3, 2015, 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:

    • Newman Lecture 1 Intro and Research Questions for 1 month DCR 2015-0730 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
    • Errata for DCR-4 as of 2014-0817 File

    • Optional Reading:

    • Newman 2003 Stories Statistics BMJ File
      Not available unless: Your ID number contains 02
    • Newman 2006 NEJM Outcomes of TB 25 or more File
    • Newman 1991 AJDC Direct Bili LEJN-2 File

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

  • Monday, August 3, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong


    Location:      Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot S-157, Wong Online

    • 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 2015.dueWeekOne.080315 File

    • Assignment Due Date:

      Assignment 1, to be completed before August 4

      Assignment 2, due August 6 at Noon

  • Wednesday, August 5, 2015, 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:

    • Bauer subjects measurements 7.15 File

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

    • 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 6.

  • Wednesday, August 5, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong

    Location:  Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot S-157, Wong 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 2015.dueWeekOne.080615 File

    • Assignment Due Date:  Assignment 2 due August 6 at Noon

  • Monday, August 10, 2015; 9:00 AM - 10:15 AM

    Lecture: Study Designs

    Faculty:  Kirsten Bibbins-Domingo

    Location:      HSW 302

    • Session Slides:

    • KBD DCR Lecture Slides 8-10-15.kbd File

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

    • Required Reading:

      DCR-4 Chapter 7: Designing Cross-Sectional and Cohort Studies

      DCR-4 Chapter 8: Designing Case-Control Studies

  • Monday, August 10, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of Assignment Three

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong

    Location:  Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot CL220, Wong Online

    • Assignment:

              Download and review full assignment below. Most important:

        1. Read Chapters 7 and 8 of DCR-4 (and either 12,13 or 18 depending on your study).
        2. Have a clear, detailed understanding of exactly how at least one predictor and one outcome variable for your study will be (or was) measured
        3. Have experience providing tips to colleagues
        4. Be able to list and explain the advantages and disadvantages of basic observational study designs, including case-control, cross-sectional and cohort studies
        5. Be able to propose a logical (if not feasible) alternative design for your research question

    • ASSIGNMENT THREE 2015.due WeekTwo.081315 File

    • Assignment Due Date: August 13, 2015 at NOON

  • Wednesday, August 12, 2015, 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 0815 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 13th at Noon.

  • Wednesday, August 12, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of Assignment Three

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong

    Location:  Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot CL-220, Wong Online


    • Assignment:

      Download and review full assignment below.  Most important:

      1. Read chapters 9, 10 and 11 in DCR-4.  You would have previously read chapters 7 and 8 of DCR-4 (and either 12,13 or 18 depending on your study).
      2. Have a clear, detailed understanding of exactly how at least one predictor and one outcome variable for your study will be (or was) measured
      3. Have experience providing tips to colleagues
      4. Be able to list and explain the advantages and disadvantages of basic observational study designs, including case-control, cross-sectional and cohort studies
      5. Be able to propose a logical (if not feasible) alternative design for your research question

    • ASSIGNMENT THREE 2015.due WeekTwo.081315 File

    • Assignment Due Date:  Assignment 3 due for discussion in section today.  Due electronically August 13th at Noon to Section Leader

  • Monday, August 17, 2015, 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

    • Session Slides:

    • Sample Size for Medical Students 2015 to post 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 17, 2015, 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

    • Session Slides:

    • MH DCR Lecture File

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

    • 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 17, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong

    Location:  Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot S-157, Wong Online


    • Assignment:

              Download and review full assignment below. Most important:

        1. Provide a contrasting point of view to the traditional view that studies with <80% power are not worthwhile
        2. Be very comfortable with the 1-sentence study plan summary
        3. Have justified the decisions/assumptions you used to estimate your sample size
        4. Know how to use a sample size calculator and the tables in the book to estimate sample size, given the decisions and assumptions you justified

    • ASSIGNMENT FOUR 2015.dueWeekThree.082015 File

    • Assignment Due Date:  August 20, 2015 at Noon

  • Wednesday, August 19, 2015; 9:00 AM - 10:15 AM

    Lecture: Introduction to Statistics

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

    Faculty:  Michael Kohn

    Location:      HSW 302

    • Session Slides:

    • Mostly Harmless Statistics for Clinical Research File

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

    • Required Reading:

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

  • Wednesday, August 19, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of Assignment Four

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong

    Location:  Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot S-157, Wong Online

     

    • Assignment:

       Download and review full assignment below. Most important:

        1. Provide a contrasting point of view to the traditional view that studies with <80% power are not worthwhile
        2. Be very comfortable with the 1-sentence study plan summary
        3. Have justified the decisions/assumptions you used to estimate your sample size
        4. Know how to use a sample size calculator and the tables in the book to estimate sample size, given the decisions and assumptions you justified

    • ASSIGNMENT FOUR 2015.dueWeekThree.082015 File

    • Assignment Due Date:  August 20, 2015 at Noon

  • Monday August 24, 2015; 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

    • Session Slides:

    • Kuppermann DCR 081815 File

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

    • 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 24, 2015.

  • Monday, August 24, 2015, 10:15 AM - 12:00 PM (Times and dates for online sessions may differ)

    Small Group Discussion Section

    Discussion of questionnaires.

    Faculty: Dejana Braithwaite, Beth Cohen, Kristen Kangelaris, Diana Naranjo, Daniel West, Veeral Ajmera, Sarah Averbach, Ben Chaffee, Sulggi Lee, Kala Mehta, Betty Smoot, Jenise Wong

    Location:  Braithwaite S-178, Cohen S-168, Kangelaris S-170, Naranjo S-174, West S-176, Ajmera S-172, Averbach U-456, Chaffee U-458, Lee U-460, Mehta S-180 Smoot S-157, Wong Online

  • Wednesday, August 26, 2015, 10:00 AM - 1:00 PM

    Final Peer Review Sessions

    Faculty: TBA

    Location: TBA