Pilot Tests of Interventions.docx
- 1. Assignment: Pilot Tests of Interventions Assignment: Pilot Tests of Interventions ON Assignment: Pilot Tests of Interventionsattachment_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 • 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
- 2. 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 • Assignment: Pilot Tests of InterventionsOften 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 Developing 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, 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
- 3. 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 | Assignment: Pilot Tests of InterventionsLippincott 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. The 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 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
- 4. 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 • Assignment: Pilot Tests of InterventionsA 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 – 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 • Assignment: Pilot
- 5. Tests of InterventionsProvides 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 …Assignment: Pilot Tests of Interventions