The research question and protocol development
This section contains
the following:
Introduction
At the center of any research study is the question. Research
questions that lead to the conduct of pragmatic randomised controlled
trials often come through reflection on current practice and the desire
to improve patient care or through the highlighting of gaps in the
research evidence through systematic reviews of literature
One of the biggest challenges of developing an appropriate
question is stating it clearly and fully and then developing
this
into a protocol to undertake the desired research study.
The protocol gives written evidence for the necessity and feasibility
of a research study and provides a detailed plan of the investigation.
It gives a description of the aims, objectives, trial design,
methods,
statistical considerations and organisation of a trial and is
a
reference o be used through out the conduct of a
trial. A
comprehensive guide to the development of a protocol is detailed in the
Trial Protocol
Tool (TPT).
The TPT which is in English and Spanish is a tool that supports the
production of a high quality research protocol. It provides a checklist
of issues that should be considered when writing a protocol, examples
of how these issues have been addressed by other researchers, a library
of full protocols and teaching materials. It also provides access to
related websites.
Back to top
Things to
consider when formulating your research question and writing a
protocol
- Have a clear and concise research question
that is
relevant to patients and includes the experimental intervention,
comparison intervention as well as the key outcomes.
- Consider whether this will be a single or
multi-centre
trial. The advantages and disadvantages of each of these
approaches are included in the TPT.
- What is the overall plan and purpose of the
trial?
- Have a flow chart of the schedule of the
trial.
- Clearly state the trials aims and
objectives.
- The objectives should be for measurable
outcomes. For this the author should consider using the PICOT method.
- Consider publishing your protocol.
Back to top
Additional resources
This checklist was developed by Dave Sackett for the 3rd
Edition of
Clinical Epidemiology; A Basic Science for Answering Questions about
Health Care, published by Lippincott, Williams &
Wilkins in
2005.
This checklist comes from the ICH Guidelines for Good Clinical
Practice in the conduct of clinical trials.
The Guideline is an international ethical and scientific
quality
standard for designing, conducting, recording and reporting trials that
involve the participation of human subjects.
This site provides useful advice on how to ask a research question by
using the PICOT method.
Back to top
This page was last updated September 2008