The Relation between Metacognition and Mental Health Status among First-Year Medical Students at Several Months after Admission / 医学教育

Background / Purpose: The aim of this study was to analyze the relationship between metacognition and mental health among first-year Japanese medical students at several months after admission.　Method: A questionnaire survey was conducted on first-year medical students at a private medical university. We used the Adults' Metacognition Scale to measure metacognition and the Japanese version of the 12-item General Health Questionnaire (GHQ-12) to measure mental health status.　Results: The data from 80 students were analyzed. The total metacognition score and the subscale monitoring score were negatively correlated with the GHQ-12 total score and were significantly different between the poor mental health group and the good mental health group. 　Discussion: The results suggest that students in poor mental health status were considered to have weak metacognition, especially monitoring.

Weekend and off-hour effects on the incidence of cerebral palsy: contribution of consolidated perinatal care

OBJECTIVE@#This study estimated the effects of weekend and off-hour childbirth and the size of perinatal medical care center on the incidence of cerebral palsy.@*METHODS@#The cases were all children with severe cerebral palsy born in Japan from 2009 to 2012 whose data were stored at the Japan Obstetric Compensation System for Cerebral Palsy database, a nationally representative database. The inclusion criteria were the following: neonates born between January 2009 and December 2012 who had a birth weight of at least 2000 g and gestational age of at least 33 weeks and who had severe disability resulting from cerebral palsy independent of congenital causes or factors during the neonatal period or thereafter. Study participants were restricted to singletons and controls without report of death, scheduled cesarean section, or ambulance transportation. The controls were newborns, randomly selected by year and type of delivery (normal spontaneous delivery without cesarean section and emergency cesarean section) using a 1:10 case to control ratio sampled from the nationwide Japan Society of Obstetrics and Gynecology database.@*RESULTS@#A total of 90 cerebral palsy cases and 900 controls having normal spontaneous delivery without cesarean section were selected, as were 92 cerebral palsy cases and 920 controls with emergent cesarean section. A significantly higher risk for cerebral palsy was found among cases that underwent emergent cesarean section on weekends (odds ratio [OR] 1.72, 95% confidence interval [CI] 1.06-2.81) and during the night shift (OR 2.29, 95% CI 1.30-4.02). No significant risk was found among normal spontaneous deliveries on weekends (OR 1.63, 95% CI 0.97-2.73) or during the quasi-night shift (OR 1.26, 95% CI 0.70-2.27). Regional perinatal care centers showed significantly higher risk for cerebral palsy in both emergent cesarean section (OR 2.35, 95% CI 1.47-3.77) and normal spontaneous delivery (OR 2.92, 95% CI 1.76-4.84).@*CONCLUSION@#Labor on weekends, during the night shift, and at regional perinatal medical care centers was associated with significantly elevated risk for cerebral palsy in emergency cesarean section.

Comparison of video-assisted thoracoscopic surgery and intrapleural urokinase as an initial treatment for parapneumonic effusion and thoracic empyema

Introduction: The treatment of complicated parapneumonic effusion [PPE] and thoracic empyema [TE] is controversial; and the choice of treatment after confirming the failure of simple drainage remains unclear. The purpose of this study was to compare the outcomes of intrapleural urokinase [UK] administration and video-assisted thoracoscopic surgery [VATS] as initial treatment options for PPE and TE

Materials and Methods: We retrospectively reviewed and compared the data of 20 patients with PPE and TE diagnosed between January 2010 and December 2012 at our hospital, dividing them on the basis of the initial treatment into a video-assisted thoracoscopic surgery [VATS] group [n=9] and UK group [n=11]

Results: Age was the only statistically different parameter between both groups [P=0.025]; with the mean age of the VATS and UK groups being 64 and 76 years, respectively. There was no significant difference in the duration of drainage or success rate between the UK or VATS groups. Although no statistically significant differences [P=0.20] were observed, duration of hospital stay was longer in the UK group [21 and 28 day for VATS and UK, respectively]

Conclusion: VATS for PPE and TE may shorten the duration of hospital stay. However, UK administration may be used for selective patients because it is considered to yield outcomes similar to VATS

Future Post-Approval Clinical Trials : From “Post-Marketing Clinical Trials” to “Post-Approval Clinical Trials” / 薬剤疫学

As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.

Current Status and Future Prospects of Post-Marketing Clinical Trials / 薬剤疫学

Good Post-Marketing Surveillance Practice (GPMSP) defines “post-marketing clinical trials” as industry-initiated studies constituting a part of Post-Marketing Surveillance (PMS). Post-marketing clinical studies play the role of gathering further information on appropriate drug use. This is why the proper conduct of medically required post-marketing clinical trials would facilitate the proposal of new treatments with improved efficacy and/or safety over existing therapies, thereby contributing to the promotion of EBM and to the advance of healthcare. In the case of anticancer drugs, in particular, post-marketing clinical trials are of great importance, because they also serve as Phase III studies. In reality, however, pharmaceutical companies are not very active in conducting these studies because of the many issues involved. To solve or alleviate these problems, the Japan Pharmaceutical Manufacturers Association and COTEC are making aggressive efforts.