1. ASPIRE CLASS 1: Conceiving the Research Idea
Sarah J. Billups, PharmD, BCPS, Clinical Pharmacy Specialist Samuel Johnson, PharmD, BCPS (AQ Cardiology), Clinical Pharmacy Specialist

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. What Makes a Good Research Question?
PICO
Population
Intervention
Comparison Group
Outcome
Components of the question

7. What Makes 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—achieving target 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 increase the proportion of hypertensive patients with uncontrolled BP who achieve their target blood pressure compared to similar patients receiving usual care?

12. Why don’t patients pick up their new bisphosphonate prescriptions?
Example Question #2
Why don’t patients pick up their new bisphosphonate prescriptions?

13. Quality/ Completeness Check: PICO
Why don’t patients pick up their new bisphosphonate prescriptions?
Population
Intervention
Comparison
Outcome
Prob-
Pop-women only? Adults only? What’s a bisphosphonate? (oral vs parenteral) What’s a “new” Rx? What does “picked up” mean?
Int-not for this question; could develop a service to address this problem, but that’s a later step
Comparison-who to compare to?
Outcome-list of reasons? Patient characteristics? Pt beliefs about bisphosphonates? About osteoporosis? Pt $ constraints?

14. Quality/ Completeness Check: PICO
Why don’t patients pick up their new bisphosphonate prescriptions?
Population—adult women who don’t purchase an oral bisphosphonate Rx within 90 days of its being written
Intervention— N/A
Comparison—patients who DO purchase their Rx…
Outcome—questionnaire responses
Prob-
Pop-women only? Adults only? What’s a bisphosphonate? (oral vs parenteral) What’s a “new” Rx? What does “picked up” mean?
Int-not for this question; could develop a service to address this problem, but that’s a later step
Comparison-who to compare to?
Outcome-list of reasons? Patient characteristics? Pt beliefs about bisphosphonates? About osteoporosis? Pt $ constraints?

15. Revised Question
How do beliefs about osteoporosis and bisphosphonates differ between adult women with new prescriptions for oral bisphosphonates who do versus do not purchase their medication within 90 days of its being ordered?

16. 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

17. What does the ‘C’ stand for in PICO ?
Knowledge Check
What does the ‘C’ stand for in PICO ?
Cohort
Context
Confounder
Comparison Group
Components of the question

18. What does the ‘C’ stand for in PICO ?
Knowledge Check
What does the ‘C’ stand for in PICO ?
Cohort
Context
Confounder
Comparison Group
Components of the question

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

20. Objectives, Hypotheses, and Outcomes
What you want to learn
Hypothesis
What results do you expect?
Outcome
How you plan to measure it
Specific

21. 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 follow parallel sequence
Can have multiple objectives; designate a primary and remainder as secondary or tertiary
Not too many!
Outlines what the study will achieve
Limit number to keep your study focused

22. Study Objectives: Example
Compare concerns about medication cost between patients with and without primary nonadherence (defined as those who did versus did not purchase a new bisphosphonate prescription within 90 days of its being written).

23. Study Hypothesis
Definition: prediction of the relationship between one or more factors and the problem under study
More specific than objectives and are amenable to explicit statistical evaluation
Guides how to conduct the statistics as the type of data collected/analyzed should be clear

24. 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

25. Example
Objective:
Compare concerns about prescription cost between patients with and without primary non-adherence.

26. Example Hypothesis: Alternative:
Patients with primary non-adherence will have more concern about prescription costs than adherent patients
Null:
Patients with and without primary non-adherence will have the same level of concern about prescription costs

27. Study Outcome(s) This is the specific thing you are going to measure
In this study, we are using a telephone questionnaire and asking patients to respond to the question “How concerned are you about the cost of this medication?” with “very, somewhat, a little, or not at all”

28. Example
Outcome:
The proportion of patients in each group who express that they are “very” or “somewhat” concerned about prescription cost in response to a telephone survey
NOTE:

29. Objective, Hypothesis, and Outcome
Example 2
Objective:
To identify the incidence of bisphosphonate primary non-adherence over a 3 month period
Hypothesis:
Outcome:
Among patients with a new oral bisphosphonate prescription written between August 1 and October 31, 2012, the percent who do not purchase it within 90 days

30. Knowledge Check
Components of the question

31. Classify the following statement :
Knowledge Check
Classify the following statement :
High school students given two samples of cola will express a preference for Pepsi over Coke.
Study Objective
Null Hypothesis
Alternative Hypotheses
Study Outcome
Components of the question

32. Classify the following statement :
Knowledge Check
Classify the following statement :
High school students given two samples of cola will express a preference for Pepsi over Coke.
Study Objective
Null Hypothesis
Alternative Hypotheses
Study Outcome
Components of the question

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

34. Researching Background: Goals
Understand what is already known about the subject and where there are holes
Learn how others have approached this problem
Reveal limitations or holes in the existing literature

35. Building the Background
Broad statement of topic
Review relevant published literature
Outline gaps in the literature and why these gaps are important
End with research question/purpose statement
What is known? What is not known? Why do I care?

36. 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
Establish inclusion and exclusion criteria

37. Free Resources for Reference Management
PubMed: Register for a free NCBI Account
EndNote Web Version: Register for free access (1 year)
Manual management: Hey, whatever works!

38. PubMed Resources Pros Cons It’s free It’s easy to access
Most people are familiar with it
It doesn’t include gray literature
Access to most full-texts requires you to use a PC with a KPCO IP address

39. EndNote Web Resource Pros Cons It’s free
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 on KP PCs

40. Manual Reference Management
Pros
Cons
It’s free ;)
Not vulnerable to IT issues ;)
It’s like retro, man

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

42. 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)

43. 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

44. Sample Evidence Table More detailed than evidence summary
May be used to fuel a SR and meta-analysis
Screenshot example(s)

45. In summary… Start with a good PICO question
Record your search history, consult with content experts
Devise a systematic way to review and store references (and stick to it ;)
Use free online resources to your advantage
Recognize opportunities for ST and meta-analysis
Evidence synthesis
Development of guidelines or consensus statements

46. Class 1 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 come prepared with the above items
Kaiser Permanente Central Support Services