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 Class 1: Conceiving the Research Idea
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
Could be a problem you regularly encounter in practice, or a question that comes up in reading literature, or institutional issues or concerns, such as meeting quality objectives (JCACHO in the hospital, HEDIS in managed care)

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
Components of the question

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

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
Prob-
Pop- who?
Int- pharmacist-managed HBPM program
Comparison- pts enrolled vs not enrolled ; pre and post NOT a good comparison here!
Outcome- BP control; change in SBP

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
Prob-
Pop- who?
Int- pharmacist-managed HBPM program
Comparison- pts enrolled vs not enrolled ; pre and post NOT a good comparison here!
Outcome- BP control; change in SBP

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
Feas—non-interventional, so Q is getting data– Pt identification? (Administrative) Characteristics? (Administrative) Beliefs? (Survey)
Also—enough subjects?
Technical expertise?
Cost and duration?
Scope?
Interesting– real patient problem
Novel– Confirms or refutes or extends previous findings; Provides new findings
Ethical–
Relevant– to scientific knowledge; to future research directions—could lead to designing a successful intervention

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

14. Objectives, Hypotheses, and Outcomes
What you want to learn
Outcome
How you 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
Outlines what the study will achieve
Multiple objectives is ok, but make sure one is primary and others are secondary/tertiary
Limit number to keep your study focused

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.”
This needs to be much more specific. Include:
Satisfaction with what?
How is satisfaction being measured?
At what time point are we interested in 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
Not usually possible for descriptive studies
Example of more than 1: BP outcomes in general, BP outcomes in specific subgroup

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
What would be an appropriate outcome for this objective?

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
Probably need to be more specific than this:
Comparator groups?
Time points?

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.
Important to note that there can be multiple ways to word an alternative hypothesis

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
Background
Population
Design
Objectives
Procedures
Analytical Plan
Research Question

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 (
Manual management

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

32. Mendeley Pros Cons May not have access on work computers
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
May not have access on work computers
!! Caution using pre-populated fields
Relies on you to enter information correctly

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
Study N
Design
Inclusion criteria
Intervention
Comparator
Outcomes
Median follow-up
Chacon, 2011
675
RCT
>18 years
KP member
Normal
Renal
function
Bloodletting
Leeches
Syncope
30 days

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 ( 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
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