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Epidemiology: 6) Disease Outcomes


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Common reasons why a surrogate endpoint may fail
1)D variable not relevant (whiteness of teeth and lung cancer).
2)D variable relevant but extreme value may confer poor health.
3)Procedures to change D have other adverse (worse) effects.
Issues associated with measuring D
Correct measurement procedures.
How well executed.
Diagnostic criteria
Involve expert.
Have definitive case definition
Disease onset timeing
Index date: time of onset - should be explicitly outlined
Identifying Death
1)State vital records
2)National vital records
3)National death index
4)Medicare enrollment
5)Interview follow-up
Issues for using death
1)Quality of code of death on death certificate.
2)Determine time of disease onset
3)Relevance to study question
Identify Diseases leading to medical care
1)Provider records
Key issues of medical care and disease
1)Access to records
3)Exposure influece decision to diagnose/treat
4)Appropriate severity level
Misclssification of D can
Incorrectly classify non-cases of D (False pos - Poor PPV or Specificity).
Fail to detect true D (Sensitivity).
Nondifferential misclassification
false positive can bias towards null
Differential Misclassification
False negative: Bias AWAY from the null

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