Biomedical Engineering Reference
In-Depth Information
Design and Methods
This section contains a description of the study being proposed. It includes
the following:
• Restatement of the study aims: Even though the study aims were
expressed earlier in section a, this repetition helps the reader bring the
study back into focus.
• Overview of the study design: To give the reader the “big picture,” this
should establish the overall evaluation approach being employed as
described in Chapter 2 of this topic and the type of study as discussed in
Chapter 3. If a field study is proposed, it is important to explain how the
study will fit into its patient care, research, or educational environment.
If the study is objectivist, explain whether the design is descriptive, com-
parative, or correlational—and why this choice was made. Provide an
overview of the study groups and the timing of the intervention. If the
study is subjectivist, include an overview of the data collection strategies
and procedures that will be employed.
• Study details: For objectivist studies, this part must include specific infor-
mation about participants and their sampling/selection/recruitment;
investigative procedures with a clear description of the intervention (the
information resource and who will use it, in what forms); description of
the independent and dependent variables; how each of the variables will
be measured (the instrumentation, with reliability/validity data if not pre-
viously reported); a data analysis plan (what statistical tests in what
sequence); and a discussion of sample size, which in many cases will
include a formal power analysis. Samples of any data collection forms, or
other instruments, should be provided in an appendix to the proposal.
For subjectivist studies, the study details include the kinds of data that
will be collected (who is anticipated to be interviewed, the types of doc-
uments that will be examined, the types of activities that will be
observed); how will study documents be maintained and by whom; and
the plan for consolidating and extracting patterns and themes from the
data. The reader of the proposal, if conversant with subjectivist methods,
will understand that many of the ideas expressed in this section may
change as the study unfolds.
• Project management plan: For evaluations, it is important to describe
the study team and its relation to the resource development team and
how decisions to modify the study, should that be necessary, will be made.
The “playing field” figure, and related concepts introduced in Chapter 2
of this volume, may be instructive in determining the content of this
section.
• Communication/reporting plan: For evaluations, it is important to explain
the report(s) to be developed, by whom, and with whom they will be
shared in draft and final form. The techniques of reporting are discussed
later in this chapter.
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