1. Special Issues in Measurement
By Design Approach

2. Experimental Study The Intervention (exposure) What is it
What is the active ingredient
What is the biological mechanism with which the
active ingredient produces the desired outcome
What are the inactive ingredients and are they inactive
Is it standard for all or tailor-made
Is it specified in enough detail to be reproducible
Our Intervention

3. Intervention Description if the Same Study was Observational
Our Cohort Study
Our Case-Control Study

4. Experimental Study Our Study Compliance
What are the likely problems with compliance
Who (or what group) is more likely to have these problems
How will compliance be assured, maximized and measured
Cross-overs and/or selective drop-outs
Our Study

5. Exposure “Adherence” if the Same Study was Observational
Our Cohort Study
Our Case-Control Study

6. Experimental Study Co-intervention
What are the likely co-interventions
Who are the most likely to seek out co-interventions
How will the co-intervention affect your results
How will you measure co-interventions
Our Study

7. Co-Intervention Assessment if the Same Study was Observational
Our Cohort Study
Our Case-Control Study

8. Experimental Study Blinding How will you measure blinding Intervention
Outcome
Analysis
Our Study

9. Experimental Study Outcome What is it
Biological link to Intervention ingredient
When measured (science: in relation to outcome)
How will you measure outcome
Our Study

10. Effect of Physician Management Ability on Asthma Control
1996 Cohort
1996
1997
1998 X
05/20/97
Patient A’s Visit to the Study MD
1-year Baseline Assessment Period
05/20/96
11/20/96
1-year Outcome Assessment Period
05/20/985
03/1/975
03/15/98
Patient B’s Visit to the Study MD
Baseline Assessment Period
Outcome Assessment Period
09/15/98
1999
09/15/97
09/15/99
Example a.
Example b.
: Respiratory-related Visits to Study MDs
: Other Visits to Study MDs
: 6-Month Out of Control Evaluation
: 1-year Asthma Status Evaluation
x : First Day of Billing

11. Outcome Assessment if the Same Study was Observational
Our Cohort Study
Our Case-Control Study