STUDY PROTOCOL

Dr. Jim teWaterNaude
School of Public Health
UCT Faculty of Health Sciences
jim@cormack.uct.ac.za.

LEARNING OUTCOMES

At the end of this module you will be able to:
  • write the framework of a research protocol and find your own research question, and,
  • state the research question clearly.

Note: You may see the Power Point presentation used at the lecture.

Research and research (study) protocol:

Research may be defined as the process of asking and answering a question.

The reason for having a study plan or protocol is efficiency. You want to be able to do the intended study quickly, cheaply, easily and ethically, and with no major oh-my-gosh-I-didn’t-think-of-that moments..What follows here are three examples of protocol outlines:

Example 1: (This is the preferred style, as found in Hulley et al.)
Element Purpose
1. Research questions What questions will the study address?
2. Significance (background) Why are these questions important?
3. Design
   Time frame
   Epidemiologic approach		 How is the study structured?
4. Subjects
   Selection criteria
   Sampling design		 Who are the subjects and how will they be selected?
5. Variables
   Predictor variables
    Confounding variables
    Outcome variables		 What measurements will be made?
6. Statistical issues
   Hypotheses
   Sample size
   Analytic approach		 How large is the study and how will it be analyzed?

Hulley explains the process in familiar terms:

Anatomy of research (What it is made of) Physiology of research (how it works)
  • Research question
  • Significance
  • Design
  • Subjects
    • Population
    • Sample size
  • Variables
    • Predictor
    • Outcome
 Using measurements in a sample to draw inferences about phenomena in a population
Example 2. Major headings in a protocol (Medical Research Council approach)

Here, the major headings of the study, starting with the title, all the way down to the appendices (if any) are set out, to be fleshed out as the study progresses:

Title: Investigators, institutional affiliations and qualifications
Summary/Abstract
1. Introduction
   - Literature review; Motivation for the study (problem); Purpose;
   - Specific objectives; Implementation objectives
2. Methods:
   Definition of terms; Study design; Study population and sampling; Measurements; Pilot studies
3. Logistics and time schedule:
   Responsibilities of investigators and of staff; Time schedule
4. Data management and analysis
5. Resources:
   - Available resources; Budget and budget motivation
6. Ethical and legal considerations
7. Reporting of results
8. Appendices.

Example #3. Components of a research proposal (According to Shi)

This is similar to the above example (#2)

A. Title page.
B. Table of contents.
C. Abstract.
D. Project Description

  1. Introduction.
  2. Problem statement and significance.
  3. Goals and objectives.
  4. Methods and procedures.
  5. Evaluation.
  6. Dissemination.
E. References
F. Budget and Justification
G. Human Subjects
H. Appendices

Main protocol elements:

The above protocol outlines have these as main elements:

In order to understand these, we need to revisit some epidemiology…

What is "epidemiology"?

Epidemiology is:

What do we mean by "distribution and determinants"?

Distribution is the "‘What" (the disease), plus the "when" and the "where" as well as the "‘who" of the disease, described by TIME + PLACE + POPULATION. The "what", "when", "where" and "who" questions are addressed by descriptive studies.

Determinants is the "‘Why", which equals the "causes" or "risk factors". We want to know what the disease is associated with, or what its cause(s) may be. This is addressed by analytic studies and interventive studies.

What do we mean by "population"?

A population may be defined as “a group sharing certain common characteristics”. A population does not have to consist of people, although it usually does. A population may consist of records, institutions, farms or events, but this is fundamental: the population needs to be clearly defined and specified.