A multidimensional approach to the assessment of clinical validity in a study on CCVD treatment: dihydroergocristine versus placebo.
An example of multidimensional assessment procedure applied to the study of treatment effects in a type of pathological aging is presented in this paper. Data discussed here come from a clinical trial performed to evaluate the effects of an ergot derivate, dihydroergocristine, in CCVD memory deficits. The multidimensional assessment procedure consisted of behavioral, clinical, and psychometric measures aimed to identify both the results related to drug activity (experimental validity), and the implications that these eventual drug-induced changes have on the everyday life patients' competence (clinical validity). 97 out-patients (both sexes were represented), with a mean age of 61.21 y (SD 7.29), who suffered from mild to moderate chronic cerebro-vascular disturbances were included in this double-blind study only when they met rigid inclusion criteria. The experimental period was 12 weeks. Results indicate a pattern of convergent, statistically significant, changes which evidence how treatment-associated memory changes are accompanied by an improvement of emotional and physical well being and by a modification of behavioral structure which is characterized by greater efficiency and greater responsiveness to stimuli.
D000368:Aged; D002561:Cerebrovascular Disorders / Q000188:drug therapy* / Q000523:psychology; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004088:Dihydroergotoxine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008569:Memory Disorders / Q000188:drug therapy*; D008606:Mental Processes / Q000187:drug effects; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales
D004088:Dihydroergotoxine