While many anecdotal case reports have described the development of convulsions during treatment with fluoroquinolone antibiotics with or without nonsteroidal anti-inflammatory drugs (NSAIDs), whether signals of convulsion-inducing effects may be detected in a spontaneously reporting adverse event database remains unknown. The aim of the present study was to analyze the adverse events of convulsion for 11 fluoroquinolone antibiotics using the Japanese Adverse Drug Event Report (JADER) database. Our analysis showed that reporting odds ratios (RORs) of convulsion calculated for patients receiving ofloxacin, moxifloxacin, levofloxacin, ciprofloxacin or pazufloxacin without NSAIDs were significantly (the lower limits of 95％CI>1.0)) elevated. In addition, RORs calculated for patients receiving levofloxacin or garenoxacin concomitantly with NSAID were significantly elevated. RORs of convulsion for patients receiving levofloxacin without NSAIDs were significantly elevated only in elderly patients (60 to 79 and ≥80 years), while RORs for patients receiving levofloxacin with NSAIDs were significantly elevated not only in elderly patients (60 to 79 and ≥80 years) but also in younger adults (20 to 59 years). In conclusion, various fluoroquinolone antibiotics may have different convulsion-inducing effects and susceptibility to potentiation by NSAIDs. The effect of aging on the convulsion-inducing potential of levofloxacin may differ in the presence or absence of NSAIDs. Further studies using other adverse drug event databases compiled in different populations are required to confirm the present findings.
The proportion of individuals using health foods and dietary supplements has been increasing recently. Serious adverse events, such as severe hepatic dysfunction, have been associated with Chinese dietary foods. Nevertheless, adverse events are rarely reported to the Japanese regulatory authorities. The resulting lack of information makes early detection and prevention of adverse events difficult.
In this study, we investigated the trends in health food-related adverse events using a long-term database managed by the Tokyo Metropolitan Government. We extracted and analyzed the following information: (1) reporters (physicians or pharmacists), (2) cases of adverse events, and (3) health foods suspected to be related.
Out of 260 cases of adverse events associated with health food consumption, 153 cases were reported by physicians and 107 cases by pharmacists. Annual trends revealed that the number of cases peaked in 2006 and 2007. With regard to the purpose of consumption, physicians tended to report health maintenance, health improvement, and treatment; whereas pharmacists most frequently reported treatment. Compared to cases reported by pharmacists, those reported by physicians trended be more severe.
In conclusion, our results demonstrated the importance of accumulating case reports in order to identify trends in health food-associated adverse events.
Background: There is a lack of information to create an effective instruction strategy for clinical research coordinators (CRCs). This study aimed to develop a scale that evaluates the level of expertise of CRCs.
Methods: The original scale was developed including 96 items based on items reviewed by several researchers and the results of a pilot survey. The original scale was distributed to 12 CRCs who attended a training program at an academic society to investigate its test-retest reliability. The original scale was also distributed to another group of CRCs at medical institutes or site management organizations in order to perform exploratory factor analysis and confirmatory factor analysis.
Results: The interclass correlation coefficient of the whole scale was 0.957 through the first survey of 12 CRCs. Exploratory factor analysis by the maximum-likelihood approach with promax rotation indicated 4 factors, i.e., knowledge, attitude, management skill and basic, from 90 items. Cronbach's α of the whole scale was 0.984, and those of the subscales were 0.943〜0.979. Regarding fit indexes, chi-square value was 35732.138 (p<0.01), Goodness of Fit Index (GFI) was 0.449, Adjusted GFI (AGFI) was 0.423, and Root Mean Square Error of Approximation (RMSEA) was 0.091 from the results of confirmatory factor analysis.
Conclusion: The scale that evaluates the level of expertise of CRCs that we developed is reliable and valid although there was an issue regarding fitness of the model.