Clinical therapeutics
-
Clinical therapeutics · May 2008
Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial.
The measurement of spasticity as a symptom of neurologic disease is an area of growing interest. Clinician-rated measures of spasticity purport to be objective but do not measure the patient's experience and may not be sensitive to changes that are meaningful to the patient. In a patient with clinical spasticity, the best judge of the perceived severity of the symptom is the patient. ⋯ The measurement of the symptom of spasticity using a patient-rated 0-10 NRS was found to be both reliable and valid. The definitions of CID and MCID will facilitate the use of appropriate responder analyses and help clinicians interpret the significance of future results.
-
Clinical therapeutics · May 2008
In vitro stability of two formulations of recombinant activated factor VIIa reconstituted in inappropriate solvents or at inappropriate volumes.
Recombinant activated factor VIIa (rFVIIa) is indicated for on-demand treatment of bleeding and the prevention and treatment of surgical bleeding in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The currently approved single-use formulation of rFVIIa is freeze dried and is stable for up to 3 years when stored at 2 degrees C to 8 degrees C (36 degrees F-46 degrees F). A new formulation has been developed that is stable for up to 2 years when stored at temperatures up to 25 degrees C (77 degrees F). This formulation does not require refrigerated storage and does not have to be brought to room temperature before use. Both formulations must be reconstituted before use. The original formulation is reconstituted with sterile water for injection (SWFI), whereas the new formulation is reconstituted with a solvent containing histidine. ⋯ Based on the results of these experiments, the 2 rFVIIa products should be reconstituted using the appropriate solvent at the correct volume.