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Fragile X Clinic Pharmacological Database

This project will collect retrospective data in order to establish a research database containing pharmacological parameters from medical records of patients of the Fragile X Clinic at Kennedy Krieger Institute. The database is to be used for management and storage of pharmacological data for the purposes of research. Specifically, we intend to use the database to gather data about the Clinic's practice (e.g., which treatments work and how is being tolerated), presentations at conferences, publication(s), and possible grant applications. In the future, we will submit applications to ask specific research questions utilizing the dataset.

The database will contain the following patient information: a patient identification number (a unique code that is not used for any other purpose and is not derived from another identifier) - the code will be a random number identifier, and this code will not be directly traceable to the patient name or other identifying information. No master list will be kept connecting the random number identifier to participant data in the original record, current age (in months), gender, ethnicity, current living arrangement, the name of the medication the patient has been prescribed and the age of onset it was prescribed, the indication of the medication, the initial dose of the medication that was prescribed to the patient, the maintenance dose of the medication (i.e., the amount of drug required to keep a desired mean steady-state concentration in the tissues) and duration of the period (age range in months), the dosage of the medication required to produce clinically significant behavioral changes in the patient (including blood levels when appropriate: i.e., lithium carbonate, valproic acid, carbamazepine, risperidone), the length of time on the medication to produce clinically significant changes in the patient, scores of parent behavioral checklists (i.e., Aberrant Behavior Checklist, Child Behavior Checklist, Conners Parents and Teachers) reflecting a clinical progress, and clinician’s impression of a clinical progress (i.e., improved, no change, worse). If available, we will gather basics scores of adaptive functions test (i.e., Vineland). The database will be de-identified and not contain any links back to the original dataset (as stated in our HIPAA Form 4 waiver).

As for the tolerance medication monitoring, for all medications, we will record values of standard nursing assessment obtained during each visit: vital signs (i.e., blood pressure, pulse, temperature), weight, heights, body mass index, head circumference. For some medications (i.e., antipsychotics, mood stabilizers and anticonvulsants, selective serotonin reuptake inhibitors), we will record available laboratory values (CBC: white cell count, platelets, hemoglobin, hematocrit, MCV; serum electrolytes; standard liver function test such as AST, ALT, total, direct and indirect bilirubin, albumin, and total protein; thyroid profile, standard urine analysis, diabetes screen indices such as glucose, insulin and hemoglobin A1c, and lipid profile). We will record any side effects experienced by the patient while taking the medication whether there are related or unrelated to the laboratory values, reasons for discontinuing use of the medication, precautions taken prior to onset, the degree of the Clinic involvement (i.e., was the medication prescribed and/or managed by the physicians at the Fragile X Clinic at Kennedy Krieger Institute). We will also gather data and record any therapies (i.e., behavioral psychology, occupational, speech and language, physical).

Bradley L. Schlaggar, M.D., Ph.D., Named President and CEO of Kennedy Krieger Institute

We’re thrilled to welcome Bradley L. Schlaggar, M.D., Ph.D., to the Kennedy Krieger family as our next President and CEO.

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