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Qualitative Nursing Study Feasibility Assessments.docx
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
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