DESIGN AND CONDUCT OF COMMUNITY TRIALS Syllabus

223.664.01 | AY 2013-2014 - 3rd Term | 4 Credit(s)
TTh 1:30:00 PM
  • Contact Information
    Faculty
    Joanne Katz
    Luke Mullany
    Alain Labrique
  • Course Learning Objectives

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

    • formulate a research question and design a trial
    • describe the methods used to conduct a trial, and the types of data analysis required to answer the research question
  • Course Description

    In this course students will (1) critically review the community trials literature, and (2) develop, identify and justify a randomized community trial design appropriate to answer a set of specific research aims. Different types of randomized study designs appropriate for community (as opposed to clinical) trials are discussed. Topics include critical review of the community trials literature, formulation of specific aims, selection of study designs and appropriate study populations, estimation of sample size, methods for allocation of interventions or treatments, grantsmanship and budgeting, community participation, consent procedures, ethical and cultural considerations, specification of key outcomes, Safety and Monitoring Boards, data management, analyses and publication of results. These methods apply in many settings, but emphasis is placed on issues that are unique to developing country and resource constrained environments.

    Additional Faculty Notes:

    Field trials in low-income countries are needed to assess potentially useful new interventions and to develop more effective disease control strategies. This course uses the principles of randomized clinical trials to discuss the design and methods for conducting community trials in resource poor environments.

  • Intended Audience
    MPH, MSPH and PhD students

    Additional Faculty Notes:
    This course is intended for students who want to know how to design, write grant proposals and conduct community-based randomized trials.

  • Methods of Assessment

    Student evaluation based on exercises, oral presentations and a group project (proposal to conduct a community based randomized trial).

    Additional Faculty Notes:

    Student grades will be based on specific aims for group project (5%), a sample size exercise (10%), a draft consent form (15%), a written literature critique (20%), one oral presentations (5%), attendance at the final group presentations (5%), and a group project (40%).

  • Prerequisites

    140.621, 140.622, 140.623 concurrently, or 140.651-653 340.602 or 340.608 highly recommended but not required

    Additional Faculty Notes:
     

  • Required Text(s)

    Additional Faculty Notes:

    "Field Trials of Health Interventions in Developing Countries: A Toolbox", edited by Peter G. Smith and Richard H. Morrow, 2nd edition, Macmillan Education Ltd, London, 1996. (available in Liliienfeld library and there may be a limited number at JHMI book store). In addition, I have been able to secure copies directly from Peter Smith in London. These will be on sale in W5009 at the purchase cost and shipping from the UK totalling $24 (see my assistant Brenda Casey, bcasey@jhsph.edu to purchase).

  • 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.

  • Welcome Message

    Welcome to the website for Design and Conduct of Community Trials for the year 2013-14. At this website we will post the course schedule, some reading materials, exercises, and power point lectures. We look forward to meeting and working with all of you.

  • Course topics

    The course will consist of lectures that largely follow the content of the recommended text (“Field Trials of Health Interventions in Developing Countries: A Toolbox” see below). In addition to lectures, the course uses active learning with a sample size exercise, a draft of a consent form, a short written critique of a published trial, a group oral presentation of 10 minutes duration with a 10 minute question/answer session, and a group project of a written research proposal due at the end of the course. Some class time will be allotted to group work with the instructors available to provide advice on the group projects, exercises and critiques, as well as to answer questions arising from the lectures. Some sessions will include hands on demonstrations and discussions.

  • Course Objectives(from old syllabus)

    At the end of this course, you should be able to formulate a research question and design a randomized community trial to address that question, describe the methods used to conduct a trial and the types of data analysis required to answer the research question. As part of these skills, you will write a research proposal for a community trial, along with a budget, and critically assess published trials.

  • 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.