1. ASPIRE Workshop 3: Choosing Your Study Design and Population
Hope everyone is doing well and that your research projects are progressing as you had expected!
So, today’s sessions are primarily focused on coming up with your study design and entry criteria.
Kari L Olson, PharmD, FCCP, BCPS

2. Workshop 3 Assignment
Give a 5-10 min presentation of the following to your small group:
Study design and setting
Study population
inclusion and exclusion criteria
Be prepared to discuss generalizability and validity of your selection criteria
So, in your small group sessions…..
Recap with everyone your revised study question/objectives to be sure everyone is on the same page. Probably good idea to share with your small groups some of the discussions you’re had with your site teams to share with your small groups rationale for the direction you’re taking your project.
Then you will……
Small groups/mentors should focus on key elements in these areas mentioned here.

3. Study Designs: Recap April 29, 2018
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4. To examine the association between glucocorticoid use and VTE
Randomized, controlled trial
Case series
Case-control study
Cross-sectional study
Background:
Excess endogenous cortisol has been linked to venous thromboembolism (VTE) risk, but whether this relationship applies to exogenous glucocorticoids remains uncertain
Answer: C
JAMA INTERNAL MEDICINE 2013;173:
April 29, 2018
| © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.

5. To determine the impact of smoking on lung cancer rates
Randomized, controlled trial
Case-control study
Cross-sectional study
Cohort study
Retrospective or prospective
Answer: C
Rates include time, so you would need to design this to be longitudinal
Would you do this prospectively or retrospectively?

6. Randomized, controlled trial Cross-sectional study Case report
To describe sub-therapeutic linezolid concentrations in a patient with morbid obesity
Randomized, controlled trial
Cross-sectional study
Case report
Pre/Post study
Answer: C

7. Randomized, controlled trial Cross-sectional study
To determine the cardiovascular risk factor knowledge among patients with diabetes in a diabetes education program
Randomized, controlled trial
Cross-sectional study
Retrospective, longitudinal cohort study
Pre/Post study
Answer: B

8. To determine the efficacy of combined teriparatide and denosumab with both agents alone on bone mineral density in women with osteoporosis
Randomized, controlled trial
Case-controlled study
Cross-sectional study
Cohort study
Osteoporosis medications increase bone-mineral density (BMD) and lower but do not eliminate fracture risk. The combining of anabolic agents with bisphosphonates has not improved efficacy. We compared combined teriparatide and denosumab with both agents alone.
Answer: A
Discuss efficacy vs. effectiveness
Are there any questions about any of this? Things you are still unclear about that would be beneficial for the large group to hear?
Lancet 2013;382:50-56.

9. Study Question
Among patients with Type 2 DM likely to benefit from statin therapy, will an intervention involving a letter, a pre-ordered statin prescription, and pharmacist counseling increase the proportion of patients on statins compared to no intervention?

10. PRIMARY Objective, Hypothesis, and Outcome
Primary Objective: To evaluate whether the intervention will increase the proportion of patients with DM who purchase a statin compared to usual care
Hypotheses: More patients in the intervention group will purchase a statin compared to usual care.
Primary Outcome: % of patients who purchase a statin within 3 months of the receiving the intervention

11. Possible Study Designs
Pre/Post study
Randomized, controlled trial
Cohort study
Prospective or retrospective
Quasi-experimental study
Other study?
Pre/post study: this is a very common method of assessment in pharmacy-practice-based studies as it is easy, fairly quick
What are some problems with this design however?
B. Randomized, controlled

12. Study Inclusion and Exclusion Criteria
Inclusion Criteria
Age between years
Diabetes Mellitus Type 2
Total cholesterol >135 mg/dL
No statin purchases within prior year
KPCO member
Exclusion Criteria
ALT > 60 or SCr >2.0 within past year
Prior CPK >2x ULN within past 2 years
Non-English reader
No baseline cholesterol labs
Receiving therapy with fibrates or cyclosporine within past 90 days
Hospice/palliative care
Writing techniques: do not “label pts” with their disease or condition.
Pts have the disease but are not ….
When writing these, no need to place something that is in the inclusion criteria also in exclusion criteria:
Age,
As you are working through these, you need to think about how you are going to “operationalize” these things.
What do I mean by that?
Additionally, you want to think about the balance b/w internal validity and external validity

13. Intervention Intervention will be
A letter explaining:
The benefits/risks of statins
Information on the statin ordered for them
How to pick-up the prescription
When to come in for follow-up labs
Who to call with questions/concerns
Usual Care is the healthcare a patient normally would receive
Orders for simvastatin 40 mg qd and appropriate labs will be entered for each pt in the intervention group
F/u labs will be reviewed and triaged by clinical pharmacy specialist at each clinic
Monthly reports of patients due for labs will be provided to CPS who will call patients to come for as needed.

14. Internal Validity External Validity Confounding Bias
Discussion
Internal Validity External Validity Confounding Bias
A confounder is a third variable that can make it appear (sometimes incorrectly) that an observed exposure is associated with an outcome.
In other words, a confounder is an unobserved exposure associated with the exposure of interest and is a potential cause of the outcome of interest.
Confounders lead to bias that distorts the magnitude of the relationship between two factors of interest.
Conditions for a Factor to be a Potential Confounder:
Must be a risk factor for the outcome (disease)
Must be associated with the exposure.
Must not be an intermediate step in the causal path
Should not be a surrogate for exposure
Many types of bias have been discussed but can be reduced to two broad types of bias:
Selection bias - Concern is that patients have different probability of being selected according to exposures or outcomes of interest
Information bias - Collection of erroneous study data

15. http://www.ASPIREKPCO.WEEBLY.COM April 29, 2018
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