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1.  Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study 
Spontaneous reporting of adverse drug reactions (ADRs) is an important method for pharmacovigilance, but under-reporting and poor quality of reports are major limitations. The aim of this study was to evaluate if repeated one-page ADR information letters affect (i) the reporting rate of ADRs and (ii) the quality of the ADR reports.
All 151 primary healthcare units in the Region Västra Götaland, Sweden, were randomly allocated (1:1) to an intervention (n = 77) or a control group (n = 74). The intervention consisted of one-page ADR information letters administered at three occasions during 2008 to all physicians and nurses in the intervention units. The number of ADR reports received from the 151 units was registered, as was the quality of the reports, which was defined as high if the ADR was to be reported according to Swedish regulations, that is, if the ADR was (i) serious, (ii) unexpected, and/or (iii) related to the use of new drugs and not labelled as common in the Summary of Product Characteristics. A questionnaire was administered to evaluate if the ADR information letter had reached the intended recipient.
Before the intervention, no significant differences in reporting rate or number of high quality reports could be detected between the randomization groups. In 2008, 79 reports were sent from 37 intervention units and 52 reports from 30 control units (mean number of reports per unit ± standard deviation: 1.0 ± 2.5 vs. 0.7 ± 1.2, P = 0.34). The number of high quality reports was higher in intervention units than in control units (37 vs. 15 reports, 0.5 ± 0.9 vs. 0.2 ± 0.6, P = 0.048). According to the returned questionnaires (n = 1,292, response rate 57%), more persons in the intervention than in the control group had received (29% vs. 19%, P < 0.0001) and read (31% vs. 26%, P < 0.0001) an ADR information letter.
This study suggests that repeated ADR information letters to physicians and nurses do not increase the ADR reporting rate, but may increase the number of high quality reports.
PMCID: PMC3182972  PMID: 21899766
2.  Adhesion of the probiotic bacterium Lactobacillus plantarum 299v onto the gut mucosa in critically ill patients: a randomised open trial 
Critical Care  2005;9(3):R285-R293.
To achieve any possible positive effect on the intestinal mucosa cells it is important that probiotics adhere tightly onto the intestinal mucosa. It has been shown in healthy volunteers that Lactobacillus plantarum 299v (Lp 299v) (DSM 9843), a probiotic bacterium, given orally in a fermented oatmeal formula adheres onto the intestinal mucosa, but whether this also occurs in critically ill patients is unknown.
After randomisation, nine enterally fed, critically ill patients treated with broad-spectrum antibiotics received an oatmeal formula fermented with Lp 299v throughout their stay in the intensive care unit; eight patients served as controls. Biopsies of the rectal mucosa were made at admission and then twice a week, and the biopsies were analysed blindly.
Four patients in the control group were colonised with Lp 299v at admission but thereafter all their biopsies were negative (Lp 299v is an ingredient in a common functional food, ProViva®, in Sweden). Of the treated patients none was colonised at admission but three patients had Lp 299v adhered on the mucosa from the second or third biopsy and in the following samples.
This study shows that Lp 299v could survive the passage from the stomach to the rectum and was able adhere onto the rectal mucosa also in critically ill, antibiotic-treated patients.
PMCID: PMC1175894  PMID: 15987403

Results 1-2 (2)