Special Issues in Measurement By Design Approach

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

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

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

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

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

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

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

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

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

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