THE DESIGN AND ANALYSIS OF CLUSTER RANDOMIZED TRIALS Syllabus

223.690.01 | AY 2013-2014 - 4th Term | 2 Credit(s)
T 3:30:00 PM
  • Contact Information
    Faculty
    Lawrence Moulton
  • Course Learning Objectives

    Upon successfully completing this course, students will be able to:

    • Identify when a cluster randomized trial may be preferable to an individually randomized trial.
    • Determine optimal design strategies for enabling estimation of efficacy and effectiveness parameters of interest.
    • Conduct and interpret statistical analyses appropriate to these designs.
  • Course Description

    Covers the major concepts and methods in the design and analysis of trial in which the unit of randomization is a group of participants. Focuses on design: discusses unmatched, matched, stepped wedge, and other approaches, with particular attention paid to randomization and sample size considerations. Presents a variety of methods for the analysis of these correlated-outcomes studies. Includes special aspects of infectious disease interventions.

    Additional Faculty Notes:

    Course Format:

     

    The course will be mainly in lecture format, with a brief break in the middle of each double-period session.  The last 1 to 1.5 sessions will be devoted to student presentations.  Only a few students, selected by lottery, will be presenting.

     

    Course Policies:

             Auditors:   auditors may attend, but I expect them to attend at least half the sessions.  If we are assigned a small room, those registered for course credit will have preferential seating.

    ·         Attendance: I think you will have a hard time figuring out my slides unless you attend.  Students will be responsible for all material covered in class, whether or not the material exists in an assigned or recommended reading or in the slide set.

    ·         No credit will be given for late homework assignments.  Homework will be due in the CoursePlus Drop Box 5 minutes before the class begins at which it is due.

    ·         Use of cell phones/laptops during class: I do not care what you do with these as long as I cannot hear them.  Please note that you are paying as much for each class session as you would for an opera ticket.  If I hear such a device, I will not continue teaching until the owner is identified and the device is turned off.  A second offense will mean banishment for the remainder of that class session.  I have a hard enough time keeping my train of thought!

    ·         Course reading information (students are required to complete readings before class sessions, etc.)

    ·         Group work guidelines: All homework is expected to be completed on an individual basis.  For the final project, students may bounce ideas off each other, but will submit their individual projects.

    ·         Grades will be determined as follows:  60% for 5 homework sets, 40% for the final project.

    ·         Final Project:  Students will be expected to write a 6-10 page description of a proposed cluster randomized trial.  It will include the following: 

    Main question to be answered

    Rationale for a cluster randomized trial

    Description and defense of the design:

       -Study population

       -Unit of randomization

       -Randomization plan

       -Sample size/power justification

    Planned statistical analyses

     

       INSTEAD of this, a few students will be randomly selected to give 12-minute class presentations of their study, touching on the most interesting of the above points.  This will be followed by 12 minutes of class discussion.

     

    ·         Disability Support Services

    I often do not always speak loudly.  If you cannot hear me, please let me know. 

    If you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Career Services and Disability Support: dss@jhsph.edu, 410-955-3034, or Room E-1140

    • Academic Ethics Code

    The code, discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class: https://my.jhsph.edu/Resources/PoliciesProcedures/ppm/PolicyProcedureMemoranda/Students_01_Academic_Ethics.pdf

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University’s mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Intended Audience
    Advanced doctoral students, many of whom will have already had a course in clinical or field trials. Primarily from the Global Disease Epidemiology and Control Program in the Department of International Health; also drawing from Epidemiology, Mental Health, and PFRH.
  • Methods of Assessment
    60% weekly exercises, 40% short project paper outlining a new trial with critical features and options discussed.
  • Prerequisites
    Biostatistics 621, 622, 623, 624 or equivalent sequence.
  • Required Text(s)

    Additional Faculty Notes:

    REQUIRED:

    Hayes , R.J. and Moulton , L.H. ( 2009 ) Cluster Randomised Trials , Chapman & Hall .

    Note: this book can be downloaded chapter-by-chapter from Welch Library.  I believe it would be a violation of copyright and Welch guidelines for one person to download it and give it to another person, but I am not sure; so beware!

     

    RECOMMENDED:

    Eldridge, S, Kerry, S. (2012) A Practical Guide to Cluster Randomised Trials in Health Services Research, First Edition.

    John Wiley & Sons, Ltd.
     
    Donner , A. and Klar , N. ( 2000 ) Design and Analysis of Cluster Randomised Trials in Health Research ,
    Arnold , London .
     
    Murray , D.M. ( 1998 ) Design and Analysis of Group Randomised Trials , Oxford University Press ,
    New York .
  • Course Schedule

    Please see the course Session for a full list of dates and items for this course.

  • Academic Ethics Code

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Course Format

    Additional Faculty Notes:

    Course Format:

     

    The course will be mainly in lecture format, with a brief break in the middle of each double-period session.  The last 1 to 1.5 sessions will be devoted to student presentations.  Only a few students, selected by lottery, will be presenting.

     

    Course Policies:

             Auditors:   auditors may attend, but I expect them to attend at least half the sessions.  If we are assigned a small room, those registered for course credit will have preferential seating.

    ·         Attendance: I think you will have a hard time figuring out my slides unless you attend.  Students will be responsible for all material covered in class, whether or not the material exists in an assigned or recommended reading or in the slide set.

    ·         No credit will be given for late homework assignments.  Homework will be due in the CoursePlus Drop Box 5 minutes before the class begins at which it is due.

    ·         Use of cell phones/laptops during class: I do not care what you do with these as long as I cannot hear them.  Please note that you are paying as much for each class session as you would for an opera ticket.  If I hear such a device, I will not continue teaching until the owner is identified and the device is turned off.  A second offense will mean banishment for the remainder of that class session.  I have a hard enough time keeping my train of thought!

    ·         Course reading information (students are required to complete readings before class sessions, etc.)

    ·         Group work guidelines: All homework is expected to be completed on an individual basis.  For the final project, students may bounce ideas off each other, but will submit their individual projects.

    ·         Grades will be determined as follows:  60% for 5 homework sets, 40% for the final project.

    ·         Final Project:  Students will be expected to write a 6-10 page description of a proposed cluster randomized trial.  It will include the following: 

    Main question to be answered

    Rationale for a cluster randomized trial

    Description and defense of the design:

       -Study population

       -Unit of randomization

       -Randomization plan

       -Sample size/power justification

    Planned statistical analyses

     

       INSTEAD of this, a few students will be randomly selected to give 12-minute class presentations of their study, touching on the most interesting of the above points.  This will be followed by 12 minutes of class discussion.

     

    ·         Disability Support Services

    I often do not always speak loudly.  If you cannot hear me, please let me know. 

    If you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Career Services and Disability Support: dss@jhsph.edu, 410-955-3034, or Room E-1140

    • Academic Ethics Code

    The code, discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class: https://my.jhsph.edu/Resources/PoliciesProcedures/ppm/PolicyProcedureMemoranda/Students_01_Academic_Ethics.pdf

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University’s mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Disability Support Services
    If you are a student with a documented disability who requires an academic accommodation, please contact the Office of Student Life Services at 410-955-3034 or via email at dss@jhsph.edu.