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ASPIRE CLASS 1: Conceiving the Research Idea

Learn how to write research questions that meet PICO and FINER criteria, formulate objectives and hypotheses, and select outcome measures. Discover an efficient process for reviewing articles and managing references.

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ASPIRE CLASS 1: Conceiving the Research Idea

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  1. ASPIRE CLASS 1: Conceiving the Research Idea • Katie Derington, PharmD • Outcomes Research Fellow in Ambulatory Care • Kaiser Permanente Colorado & University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences

  2. Learning Objectives ASPIRE Class 1: Conceiving the Research Idea • Write a research question that meets PICO & FINER criteria • Formulate primary and secondary objectives • Formulate study hypotheses and select outcome measures for each objective • Use a well-written study question to survey primary literature • Identify an efficient process for reviewing articles and managing references

  3. Where Do Research Questions Come From?

  4. Where Do Research Questions Come From? • Clinical practice • Literature • Institutional and clinical problems

  5. Example Research Questions • How effective is a clinical pharmacy service in managing patients with diabetes? • Why do HMO patients take their prescriptions to outside (out of plan) pharmacies? • What are the benefits of Medication Management? • Why don’t patients pick up their new bisphosphonate prescriptions?

  6. Components of a good research question PICO • Population • Intervention • Comparison Group • Outcome

  7. FINER Quality of a good research question • Feasibility • Interesting • Novel • Ethical • Relevant

  8. Example Question Does a home blood pressure monitoring program improve hypertension control?

  9. Quality/Completeness Check: PICO Does a home blood pressure monitoring program improve hypertension control? • Population • Intervention • Comparison • Outcome

  10. Quality/Completeness Check: PICO Does a home blood pressure monitoring program improve hypertension control? • Population—adult pts with a HTN diagnosis and uncontrolled HTN • Intervention—Pharmacist-managed HBPM program • Comparison—adult pts meeting inclusion criteria but not enrolled in program • Outcome—systolic BP

  11. Revised Question Does a pharmacist-managed home blood pressure monitoring program (I) reduce blood pressure to a greater extent (O) in hypertensive patients with uncontrolled BP (P) compared to similar patients receiving usual care (C)?

  12. Quality Check: FINER • Feasibility • Interesting • Novel • Ethical • Relevant

  13. Elements of a Research Protocol Objectives Background Design Research Question Population Analytical Plan Procedures

  14. Objectives, Hypotheses, and Outcomes • Objective: • Whatyou want to learn • Outcome • Howyou plan to measure it • Specific • Hypothesis • What results do you expect?

  15. Study Objectives (Study Aims) • What the study will achieve • Guides thinking, study design, analysis, and reporting • Serves as outline for organizing later sections • Methods section should parallel • Can have multiple objectives • Not too many! • Use strong verbs

  16. Study Outcome(s) • This is the specific thing you are going to measure for each objective

  17. Study Outcome(s) Is this specific enough as a study outcome? “The primary outcome of the study was patient satisfaction.”

  18. Study Hypothesis • Definition: prediction of the relationship between one or more factors and the problem under study • More specific than objectives and allow you to statistically evaluate the objective • Guides how to conduct the statistics

  19. Study Hypothesis • Most appropriate for intervention/evaluative studies • Difficult for descriptive/exploratory studies • At least 1 hypothesis for each objective • can have more than 1 • Simple, specific, and stated in advance • Stated as null or alternative • Statistical analysis based on null hypothesis

  20. Study Objectives: Example Question: Does a pharmacist-managed home blood pressure monitoring program reduce blood pressure to a greater extent in hypertensive patients with uncontrolled BP compared to similar patients receiving usual care? • Primary Objective: • Secondary Objective:

  21. Study Objectives: Example Question: Does a pharmacist-managed home blood pressure monitoring program reduce blood pressure to a greater extent in hypertensive patients with uncontrolled BP compared to similar patients receiving usual care? • Primary Objective: Establish effectiveness of pharmacist-managed HBPM program on blood pressure outcomes • Secondary Objective: Determine patient satisfaction with pharmacist-managed HBPM program

  22. Outcome: Example Primary Objective: Establish effectiveness of pharmacist-managed HBPM program on blood pressure outcomes

  23. Outcome: Example Primary Objective: Establish effectiveness of pharmacist-managed HBPM program on blood pressure outcomes • Systolic blood pressure • Diastolic blood pressure • Time to blood pressure goal

  24. Hypothesis Example Primary Objective: Establish effectiveness of pharmacist-managed HBPM program on blood pressure outcomes Primary Outcome: Systolic blood pressure Null: Alternative:

  25. Hypothesis Example Primary Objective: Establish effectiveness of pharmacist-managed HBPM program on blood pressure outcomes Primary Outcome: Systolic blood pressure Null: There will be no difference in systolic blood pressure in those managed in the pharmacist HBPM program and usual care groups. Alternative: Systolic blood pressure will be lower in those managed using the pharmacist HBPM program compared to usual care.

  26. Blood Pressure Example Summary • Question: Does a pharmacist-managed home blood pressure monitoring program increase the proportion of hypertensive patients with uncontrolled BP who achieve their target blood pressure compared to similar patients receiving usual care? • Primary Objective: Establish effectiveness of pharmacist-managed HBPM program on blood pressure outcomes • Primary Outcome: Change in systolic blood pressure • Hypothesis: Systolic blood pressure will be lower in those managed using the pharmacist HBPM program compared to usual care.

  27. Elements of a Research Protocol Objectives Background Design Research Question Population Analytical Plan Procedures

  28. Researching Background: Goals • Understand what is known • Find the unknown • Learn how others have approached this problem • Guide your research question, methods, outcomes, etc.

  29. General Search Strategies • Tips to insure a high-quality, • systematic search: • Use at least two databases • Check references of studies meeting inclusion criteria • Check with content experts to make sure relevant studies are not missed • Search for ‘gray’ literature • Avoid limiting searches by date • Come up with a process for reference management (manual or software assisted) • Record search history • Start with your PICO question(s) • Establish preliminary search terms/themes • Establish inclusion and exclusion criteria

  30. Free Resources for Reference Management • EndNote Web Version: Register for free access (1 year) • Mendeley (https://www.mendeley.com/) • Manual management

  31. EndNote Web Resource Pros Cons It’s only free for 1 year The interface is not that intuitive Not all functionality is available work computers • It’s free(ish) • It enables you to maintain a comprehensive electronic reference list • It’s widely accessible

  32. Mendeley Pros Cons May not have access on work computers !! Caution using pre-populated fields Relies on you to enter information correctly • Free • Links to PubMed and other literature sources • Plug-in for browsers allow you to add references as you search • Plug-in for Microsoft Word makes it easy to use • Relatively intuitive/easy • Share libraries with other Mendeley users • Search function

  33. Manual Reference Management Pros Cons • Free • Not vulnerable to IT issues • It’s like retro, man

  34. During the Literature Search • Be organized! • Add references to your reference manager • Write down things to look up later

  35. Sample Evidence Summary

  36. Once You Have References… • Determine which should be included (relevant) • Devise a scheme for routinely updating reference list • Detail references in your protocol, posters, and manuscript

  37. Assessing Quality of Studies • Appropriate study design • Application of appropriate statistical testing • Identification of bias and conflicts of interest • Meaningful synthesis of results • Appropriate conclusions drawn • Various published quality assessment tools are available (email me if you are interested)

  38. In summary… • Start with a good PICO question • Think about your objectives, outcomes, and hypotheses before and during your literature search • Consult with content experts • Be systematic about finding, reviewing, and storing references • Use free resources to your advantage

  39. Assignment • Begin background literature review for your study • Prepare a 5-10 min presentation for your small group session including draft versions of the following: • Your research question (use FINER and PICO criteria) • Primary and secondary objectives • A hypothesis and study outcome(s) for each objective Please bring the above with you to the first class KPCO Central Support Services: 16601 E Centretech Parkway, Aurora CO

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