ASPIRE CLASS 1: Conceiving the Research Idea

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