Nursing Research DQ 13

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Chapter 28

Feasibility Assessments and Pilot Tests of Interventions Using Mixed Methods

Question

Tell whether the following statement is true or false:

The terms pilot study and feasibility study are interchangeable.

Answer

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.

Feasibility and Pilot Studies

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

Feasibility Study

Completed prior to a main intervention study
Tests specific and discrete aspects of an emerging intervention or the anticipated trial
Do not focus on the outcome of interest
Typically do not use a randomized design

Pilot Study

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

Question

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.

Answer

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.

Pilot Study Objectives

Stated at the onset of study
Focus on the:
Process
Resources
Management issues
Scientific issues

Scientific Objectives

Focuses on the substantive aspects of the intervention
Safety and tolerability
Clinical significance
Preliminary evidence of efficacy
Focuses on the methodologic aspects of a trial

Randomization

Sample size

Fidelity

Instruments

Preliminary Effect Size Estimates

Often computed with confidence intervals (CIs)
CIs need not be as stringent as in full study results.

Resulting Decisions

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

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

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.

Critiquing Feasibility and Pilot Studies

Provides descriptions of sample characteristics, design elements, instruments
Intervention theory and development of the intervention
References should be provided to any previously published papers on intervention development.
Researchers’ description of the pilot objectives, the criteria used to make decisions about feasibility, and the methods associated with feasibility assessments

Question

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

Answer

A major product from pilot work is a description of “lessons learned” that inform the final protocols for a full trial as well as providing information about the usefulness and achievability of the proposed intervention(s) in the “real world.”