Course material

1. Qualitative Nursing Study Discussion: Feasibility Assessments
Qualitative Nursing Study Discussion: Feasibility Assessments ON Qualitative Nursing
Study Discussion: Feasibility AssessmentsRead a qualitative nursing study. If a different
investigator had gone into the field to study the same problem, how likley is it that the
conclusions would have been the same? How transferable are the research’s
findings? attachment_1attachment_2attachment_3Unformatted Attachment
PreviewChapter 28 Feasibility Assessments and Pilot Tests of Interventions Using Mixed
Methods Copyright © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins Question
Tell whether the following statement is true or false: The terms pilot study and feasibility
study are interchangeable. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams
& Wilkins 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 refinements of, the
protocols, methods, and procedures to be used in a larger scale trial of an intervention.
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Feasibility Study • Completed prior to a main intervention study • Tests
specific and discrete aspects of an emerging intervention or the anticipated trial •
Qualitative Nursing Study Discussion: Feasibility AssessmentsDo not focus on the outcome
of interest • Typically do not use a randomized design Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins 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. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins 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

2. projections. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Pilot
Study Objectives • Stated at the onset of study • Focus on the: – Process – Resources –
Management issues – Scientific issues Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Preliminary Effect Size Estimates • Often computed with confidence intervals (CIs)
– CIs need not be as stringent as in full study results. Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters
Kluwer Health | Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins 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. Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Question What term is used to identify practical
information about the real-life application of a pilot study? A. Responder analysis B. Exit
interview C. Lessons learned D. Statement of purpose Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Answer C 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.” Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Chapter 27 Qualitative Nursing Study Discussion: Feasibility
AssessmentsDeveloping Complex Nursing Interventions Using Mixed Methods Research
Copyright © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins Question Tell
whether the following statement is true or false: Nursing intervention research refers to a
distinctive process of developing, implementing, testing, and disseminating nursing
interventions. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins
Answer True Nursing intervention research refers to a distinctive process of developing,
implementing, testing, and disseminating nursing interventions—particularly complex
interventions. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins
Nursing Intervention Research • Distinctive process • Developing, implementing, testing,

3. and disseminating nursing interventions • Particularly complex interventions Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Complex Intervention •
Number of components • Number of outcomes targeted • Number and complexity of
behaviors required • Time needed for the full intervention to be delivered Copyright ©
2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Framework Phases • Phase 1:
Strong development efforts at the onset • Phase 2: Pilot tests of the intervention • Phase 3:
Controlled trial to assess efficacy • Phase 4: Assess effectiveness of interventions in real-
world clinical settings Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Question Tell whether the following statement is true or false: Studies to assess
effectiveness of interventions in real-world clinical settings (Phase 4) are common in
nursing. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Answer
False Studies to assess effectiveness of interventions in real-world clinical settings (Phase
4) are rare in nursing. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Framework • Idealized model • Process rarely linear • Mixed methods research
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Question Tell
whether the following statement is true or false: An important product during Phase 2 is a
carefully conceived intervention theory from which the design of the intervention flows.
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Answer False An
important product during Phase 1 is a carefully conceived intervention theory from which
the design of the intervention flows. Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Phase 1 • Conceptualization and in-depth understanding of the problem
and the target population • Intervention theory • Resources for developing an evidence-
based intervention and intervention strategies – Systematic reviews – Descriptive research
– Consultation with experts – Discussion with team Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins Intervention Theory • Content • Dose and intensity •
Timing • Outcomes to target and when to measure them • Setting • Agents • Mode of
delivery • Individualization Copyright © 2017 Wolters Kluwer Health | Lippincott Williams
& Wilkins Phase 2 • Preliminary interventions tested • Simple quasi-experimental design •
Pilots – Qualitative components – Recruitment and retention Copyright © 2017 Wolters
Kluwer Health | Lippincott Williams & Wilkins Pilot Study • Feasibility of more rigorous
testing • Lessons – Refine the intervention – Improve its acceptance and appeal – Enhance
delivery Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Question
Tell whether the following statement is true or false: A mixed methods approach can
strengthen the test of the intervention during the Phase 2 controlled trial. Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Answer False A mixed methods
approach can strengthen the test of the intervention during the Phase 3 controlled trial.
Qualitative Nursing Study Discussion: Feasibility AssessmentsThe inclusion of qualitative
components can shed light on intervention fidelity, variation in effects, clinical significance,
and interpretive ambiguities. Copyright © 2017 Wolters Kluwer Health | Lippincott
Williams & Wilkins Mixed Methods • Appropriate for all phases • Phase 1 QUAL has priority.
• Phases 2 and 3 QUAN is usually dominant. Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins Chapter 28 Feasibility Assessments and Pilot Tests of
Interventions Using Mixed Methods Copyright © 2012 Wolters Kluwer Health | Lippincott

4. Williams & Wilkins Question Tell whether the following statement is true or false: The
terms pilot study and feasibility study are interchangeable. Copyright © 2017 Wolters
Kluwer Health | Lippincott Williams & Wilkins 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 refinements of, the protocols, methods, and procedures to be used in a larger scale trial
of an intervention. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins 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 Copyright © 2017 Wolters Kluwer
Health | Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins 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
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins 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. Copyright © 2017 Wolters
Kluwer Health | Lippincott Williams & Wilkins 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. Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Pilot Study Objectives • Stated at the
onset of study • Focus on the: – Process – Resources – Management issues – Scientific issues
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins 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 Copyright © 2017
Wolters Kluwer Health | Lippincott Williams & Wilkins Preliminary Effect Size Estimates •
Often computed with confidence intervals (CIs) – CIs need not be as stringent as in full
study results. Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins
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 Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins 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
Copyright © 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins Lessons Learned
• Major product provides: – Information from which protocols for a full trial can be created

5. – 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. Copyright © 2017 Wolters Kluwer Health |
Lippincott Williams & Wilkins 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 Copyright © 2017 Wolters Kluwer Health | Lippincott Williams
& Wilkins Question What term is used to identify practical information about the real-life
application of a pilot study? A. Responder analysis B. Exit interview C. Lessons learned D.
Statement of purpose Copyright © 2017 Wolters Kluwer Health | Lippincott Williams &
Wilkins Answer C 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.” Copyright
© 2017 Wolters Kluwer Health | Lippincott Williams & Wilkins …Qualitative Nursing Study
Discussion: Feasibility Assessments