Feasibility Assessments and Pilot Tests of Interventions Using Mixed Methods

Chapter 29 Feasibility Assessments and Pilot Tests of Interventions Using Mixed Methods

Question #1

Tell whether the following statement is true or false:

The terms pilot study and feasibility study are interchangeable.

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.

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

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

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

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.

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.

Objectives and Criteria in Pilot Work

Stated at the onset of study

Focus on the

Process

Resources

Management issues

Scientific issues

Retention

Ethics

Recruitment

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

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 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

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

Researchers’ description of the pilot objectives, the criteria used to make decisions about feasibility, and the methods associated with feasibility assessments

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

Answer to Question #3

A major product from pilot work is a description of “lessons learned” 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 “real world.”

Feasibility Assessments and Pilot Tests of Interventions Using Mixed Methods

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