Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group.

OBJECTIVES: To investigate the knowledge about randomized clinical trials and the attitude towards clinical research among Danish outpatients and to examine the relationships between outpatient demographic variables and knowledge and attitude. SETTING: Outpatients (n = 415) were recruited from four departments at a university hospital in Copenhagen. METHODS: The participants answered an 18 item multiple choice test evaluating knowledge about randomized clinical trials and a 32 item Likert format questionnaire evaluating attitudes towards clinical research in general and randomized clinical trials. Assessment of scales for knowledge and attitudes was performed using Rasch analysis and Cronbach's alpha. Associations between demographic variables, knowledge score and attitude score were examined using analysis of variance. RESULTS: Mean age for all outpatients was 46 years (range 18-88 years); 251 (60%) were females. A total of 27 outpatients (7%) had previously participated in a randomized clinical trial. Mean knowledge score (number of correct answers out of a maximum of 17) was 7.9 (SD 3.1). Patients in the younger age groups and patients with longer education had significantly higher knowledge scores (p < 0.001). The effect of age group (estimated increase in knowledge score relative to the group 60-89 years) was: 18-29 years 1.2 (SE 0.4); 30-39 years 2.0 (SE 0.4); and 40-59 years 1.6 (SE 0.4). The effect of education (estimated decrease in knowledge score relative to patients with > 12 years of education) was: < 7 years 3.4 (SE 0.4); and 8-11 years 2.0 (SE 0.3). Mean total attitude score was 74.8 (SD 14.8) on a scale from 0-128. Compared to female patients, male patients had an estimated 5.1 points (SE 1.5) higher attitude score (p < 0.001). There was a weak but significant positive association (r = 0.38; p < 0.001) between the knowledge score and the total attitude score. CONCLUSION: Among Danish outpatients knowledge about randomized clinical trials is better in the younger age groups and in individuals with longer education. Overall, better knowledge was associated with a more positive attitude towards clinical research. The question is whether it is possible by simple means to increase knowledge about clinical research and whether an increase in knowledge may positively affect the attitude towards clinical research in individual patients.

Bacteria-induced IgE-mediated histamine release: examination of patients with chronic bronchitis (CB) during acute exacerbations.

Twelve patients hospitalized with acute exacerbations of chronic bronchitis (CB) and infected in the lower respiratory tract with H. influenzae (HI) or Streptococcus pneumoniae (SP) were examined. Bacteria, isolated from the expectorate caused an IgE-mediated histamine release from the patient's own blood leukocytes, indicating that all were sensitized to their own bacteria. Sensitization was only observed in some of the patients when tested with a standard panel of HI or SP obtained from other patients, indicating the importance of using the patient relevant bacterial antigenic determinants. No sensitization was found in twelve controls. The patients showed cellular hyperreactivity to HI and SP, i.e. the releasability was higher than in the control group. The cellular hyperreactivity was not dependent on sensitization since it was also found against the non-infecting species. Both sensitization and cellular hyperreactivity may contribute to the aggravation of the disease.