After reading chapter 29, answer the following question.
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Read a qualitative nursing study. If a different investigator had gone into the field to study the same problem, how likely is it that the conclusions would have been the same? How transferable are the research findings?
Chapter 29
Feasibility Assessments and Pilot Tests of Interventions Using Mixed Methods
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Question #1
Tell whether the following statement is true or false:
The terms pilot study and feasibility study are interchangeable.
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Answer to Question #1
False
Often, the terms pilot study and feasibility study are used interchangeably. Recently, however, some experts are drawing a distinction between the two.
A feasibility study is research completed prior to a main intervention study to test specific and discrete aspects of an emerging intervention or the anticipated trial.
A pilot study is an investigation designed to test the feasibility of, and to support refinements of, the protocols, methods, and procedures to be used in a larger scale trial of an intervention.
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Basic Issues in Piloting Interventions
Feasibility study
Tests specific and discrete aspects of an emerging intervention
Using a fairly simple design
Pilot study
A small-scale version of a full trial
Assesses an entire set of procedures for implementing
Evaluates an intervention
Ideally involves a randomized design
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Feasibility Study
Completed prior to a main intervention study
Tests specific and discrete aspects of an emerging intervention or the anticipated trial
Does not focus on the outcome of interest
Typically does not use a randomized design
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Overall Purpose of Pilot Work
Goal is to avoid a costly full-study failure.
Questionable as to whether it should be used to test a hypothesis
Sample size is too small.
Typically 30-40 subjects
Pilot study results are meant to inform the decision about whether to
Move forward with a full trial
Make revisions that require an additional pilot
Abandon the project altogether
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Question #2
Tell whether the following statement is true or false:
An external pilot is a stand-alone study, whereas an internal pilot is an early phase of a larger trial.
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Answer to Question #2
True
An external pilot is a stand-alone study, the findings from which inform the design and implementation of a full randomized control trial. An internal pilot is an early phase of a large trial, the findings from which are typically used to make adjustments to sample size projections.
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Objectives and Criteria in Pilot Work
Stated at the onset of study
Focus on the
Process
Resources
Management issues
Scientific issues
Retention
Ethics
Recruitment
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Scientific-Related Objectives
Focuses on the substantive aspects of the intervention
Safety and tolerability
Clinical significance
Preliminary evidence of efficacy
Clinical significance
Focuses on the methodologic aspects of a trial
Randomization
Sample size (computed with confidence intervals [CIs])
Fidelity
Instruments
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Mixed Method Designs
Especially well suited for a pilot study.
Quantitative data can be used to assess whether feasibility criteria were met.
Qualitative data can elucidate
Why they were not met
How the intervention of study protocols could be improved
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Lessons from Pilot Work
Lessons learned
Major product provides
Information from which protocols for a full trial can be created
If interventions have been found to be feasible, acceptable, and promising
List of proposed outcomes
The findings will be published so that others can benefit from learning about both the successes and the failures
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Critical Appraisal of Feasibility and Pilot Studies
Provides descriptions of sample characteristics, design elements, and instruments
Intervention theory and development of the intervention
References should be provided to any previously published papers on intervention development
Researchersâ description of the pilot objectives, the criteria used to make decisions about feasibility, and the methods associated with feasibility assessments
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Question #3
What term is used to identify practical information about the real-life application of a pilot study?
Responder analysis
Exit interview
Lessons learned
Statement of purpose
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Answer to Question #3
C
A major product from pilot work is a description of âlessons learnedâ that informs the final protocols for a full trial as well as providing information about the usefulness and achievability of the proposed intervention(s) in the âreal world.â
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