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UseCase ClinicalResearch.doc
Title |
Specific toxicities; adverse events, hypoglycemia of various diabetic therapies |
Description |
The study will concentrate not only on how much the blood sugar levels are controlled but also on methods of controlling sugar levels. The study will explore specific clinical outcomes and adverse events associated with diabetes therapies, such as heart failure, renal disease, liver dysfunction, polyps, weight gain, etc. |
Assumptions |
Sufficient amount of data to provide the ability to do a power analysis. |
Cohort Selection |
Patients with diabetes with flexibility in defining cohort to include different combinations of number, frequency and duration of diagnosis codes, relevant lab parameters, and the intensity and duration of medications.
|
Preconditions |
Availability of sufficiently complete data to perform the primary and associated secondary analyses. These data include effect modifiers and outcomes, but also elements, including comorbidities and demographics that could be used as stratifiers to adjust for confounding.
|
Post conditions |
Dataset suitable for applicable analysis. The dataset needs to be in a structured format that can be studied and plugged into the analytical software. A data dictionary will be provided to define the variables for analysis |