Documentation of an instrument for assessment of subjective CNS-related symptoms during cardiovascular pharmacotherapy

Abstract

The aim of this work was to develop and initiate the documentation of an instrument for the assessment of subjective CNS-related symptoms occurring during cardiovascular pharmacotherapy. The self-applied questionnaire developed for minor symptom evaluation (MSE profile) includes 24 items and uses a visual analogue scale to record symptoms. Three different studies were performed using a total of 86 healthy volunteers. Based on a subjective grouping followed by principal component analysis to confirm the grouping, three dimensions-contentment (eight items), vitality (five items), and sleep (three items)-were formed. The Cronbach's alpha coefficient, used to evaluate the internal consistency of these dimensions, was found to be 0.90, 0.88, and 0.85, respectively. To validate the MSE profile, the subjective symptoms of two classes of drugs with well-known symptom profiles, a nonselective, beta-blocker (propranolol) and a benzodiazepine (oxazepam), were compared in placebo-controlled randomized double-blind crossover studies. The obtained results indicate that the symptom profiles were different but were compatible with the previously reported effects of these compounds. It can be concluded that the MSE profile is practical, useful, and sensitive enough to also detect subtle drug-induced effects.

Cost-effectiveness of self-monitoring of blood glucose in patients with type 2 diabetes mellitus managed without insulin

“…27 We generated cost-effectiveness acceptability curves for the reference case, as well as for alternative testing frequencies and test strip prices, to illustrate the probability that the self-monitoring of blood glucose is cost-effective across a range of decision-makers' willingness-to-pay thresholds. 28 …”

Assessment of Health-Related Quality of Life in Migraine

“…In the case of subjective symptoms, there is no suitable measurable standard with which the results obtained can be directly compared. Indirect validation methods therefore have to be used (2,17). The patient's answers are usually compared with other variables which may be assumed to measure the same phenomena, partly or completely.…”

“…Visual analogue scales consist of a straight line which joins two extremes, usually 100 mm long, on which the patient marks the severity of a certain symptom or level of well-being. For this type of assessment, the VAS technique has often proved to be both more sensitive and more practical than the Likert scale for registration of subjective symptoms (9,17).…”

CNS‐related subjective symptoms during treatment with beta 1‐ adrenoceptor antagonists (atenolol, metoprolol): two double‐blind placebo controlled studies.

“…The MSE-profile, was used to assess subjective experiences (Dahlof et al, 1989). The questionnaire was answered in the volunteers' normal environment the day before start of active treatment (day 0) and at days 3, 7 and 14.…”

“…The MSE-profile has been designed especially for registration of subtle changes in subjective symptoms considered to be CNSrelated (Dahlof et al, 1989). The MSE-profile contains 24 items and uses a visual analogue scale (VAS).…”