鈍的外傷による心停止患者における脊柱固定と生存退院との関連

京都大学0048新制・課程博士博士(社会健康医学)甲第21700号社医博第91号新制||社医||10(附属図書館)京都大学大学院医学研究科社会健康医学系専攻(主査)教授 今中 雄一, 教授 佐藤 俊哉, 教授 小池 薫学位規則第4条第1項該当Doctor of Public HealthKyoto UniversityDFA

Impact of the Clinical Trials Act on Noncommercial Clinical Research in Japan: An Interrupted Time-series Analysis

Background: The number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry. Methods: An interrupted time-series design was used in the analysis, which was conducted from April 2015 to March 2019. We collected data for studies registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network. Results: In total, 35, 811 studies were registered; of these, 16, 455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new studies after CTA enforcement decreased significantly by 15.0 (95% confidence interval [CI], −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) studies from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical studies, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors. Conclusions: The number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety

Around ten percent of most recent Cochrane reviews included outcomes in their literature search strategy and were associated with potentially exaggerated results: A research-on-research study

[Objectives] To assess the proportion of the recent Cochrane reviews that included outcomes in their literature search strategy, how often they acknowledged these limitations, and how qualitatively different the results of outcomes included and not included in the search strategy were. [Design and Setting] We identified all the Cochrane reviews of the interventions published in 2020 that used a search strategy connecting outcome terms with “AND.” Reviews were defined as acknowledging the limitations of searching for outcomes if they mentioned them in the discussion. We compared the characteristics of outcomes included and not included in the search strategy. [Results] Of the 523 Cochrane reviews published in 2020, 51 (9.8%) included outcomes in their search strategy. Only one review acknowledged it as a limitation. Forty-seven (92%) assessed outcomes not included in the search strategy. Outcomes included in the search strategies tended to include a larger number of studies and show their effects in favor of the intervention. [Conclusions] Around ten percent of the recent Cochrane reviews included outcomes in their search, which may have resulted in more outcomes significantly in favor of the intervention. Reviewers should be more explicit in acknowledging the potential implications of searching for outcomes

Upper limb muscle atrophy associated with in-hospital mortality and physical function impairments in mechanically ventilated critically ill adults : a two-center prospective observational study

Background: Lower limb muscle atrophy is often observed in critically ill patients. Although upper limb muscles can undergo atrophy, it remains unclear how this atrophy is associated with clinical outcomes. We hypothesized that this atrophy is associated with mortality and impairments in physical function. Methods: In this two-center prospective observational study, we included adult patients who were expected to require mechanical ventilation for > 48 h and remain in the intensive care unit (ICU) for > 5 days. We used ultrasound to evaluate the cross-sectional area of the biceps brachii on days 1, 3, 5, and 7 and upon ICU discharge along with assessment of physical functions. The primary outcome was the relationship between muscle atrophy ratio and in-hospital mortality on each measurement day, which was assessed using multivariate analysis. The secondary outcomes were the relationships between upper limb muscle atrophy and Medical Research Council (MRC) score, handgrip strength, ICU Mobility Scale (IMS) score, and Functional Status Score for the ICU (FSS-ICU). Results: Sixty-four patients (43 males; aged 70 ± 13 years) were enrolled. The Acute Physiology and Chronic Health Evaluation (APACHE) II score was 27 (22–30), and in-hospital mortality occurred in 21 (33%) patients. The decreased cross-sectional area of the biceps brachii was not associated with in-hospital mortality on day 3 (p = 0.43) but was associated on days 5 (p = 0.01) and 7 (p < 0.01), which was confirmed after adjusting for sex, age, and APACHE II score. In 27 patients in whom physical functions were assessed, the decrease of the cross-sectional area of the biceps brachii was associated with MRC score (r = 0.47, p = 0.01), handgrip strength (r = 0.50, p = 0.01), and FSS-ICU (r = 0.56, p < 0.01), but not with IMS score (r = 0.35, p = 0.07) upon ICU discharge. Conclusions: Upper limb muscle atrophy was associated with in-hospital mortality and physical function impairments; thus, it is prudent to monitor it

Cordierite gneiss from the Wanni Complex, Sri Lanka: Petrology, phase equilibria modeling and U-Pb zircon geochronology

The Tenth Symposium on Polar Science/Ordinary sessions: [OG] Polar Geosciences, Wed. 4 Dec. / Entrance Hall (1st floor), National Institute of Polar Researc

The impact of continuity correction methods in Cochrane reviews with single-zero trials with rare events: A meta-epidemiological study.

Meta-analyses examining dichotomous outcomes often include single-zero studies, where no events occur in intervention or control groups. These pose challenges, and several methods have been proposed to address them. A fixed continuity correction method has been shown to bias estimates, but it is frequently used because sometimes software (e.g., RevMan software in Cochrane reviews) uses it as a default. We aimed to empirically compare results using the continuity correction with those using alternative models that do not require correction. To this aim, we reanalyzed the original data from 885 meta-analyses in Cochrane reviews using the following methods: (i) Mantel-Haenszel model with a fixed continuity correction, (ii) random effects inverse variance model with a fixed continuity correction, (iii) Peto method (the three models available in RevMan), (iv) random effects inverse variance model with the treatment arm continuity correction, (v) Mantel-Haenszel model without correction, (vi) logistic regression, and (vii) a Bayesian random effects model with binominal likelihood. For each meta-analysis we calculated ratios of odds ratios between all methods, to assess how the choice of method may impact results. Ratios of odds ratios <0.8 or <1.25 were seen in ~30% of the existing meta-analyses when comparing results between Mantel-Haenszel model with a fixed continuity correction and either Mantel-Haenszel model without correction or logistic regression. We concluded that injudicious use of the fixed continuity correction in existing Cochrane reviews may have substantially influenced effect estimates in some cases. Future updates of RevMan should incorporate less biased statistical methods

Excellent mechanical and corrosion properties of austenitic stainless steel with a unique crystallographic lamellar microstructure via selective laser melting

We first developed a unique “crystallographic lamellar microstructure” (CLM), in which two differently oriented grains appear alternately, in a 316L stainless steel specimen via selective laser melting technology. The CLM was composed of major 〈011〉 grains and minor 〈001〉 grains aligned along the build direction, which stemmed from vertical and approximately ±45° inclined columnar cells formed in the central and side parts of melt-pools, respectively. The development of CLM was found to largely improve the material properties via the strengthening of the product, simultaneously showing superior corrosion resistance to commercially obtained specimens.Sun S., Ishimoto T., Hagihara K., et al. Excellent mechanical and corrosion properties of austenitic stainless steel with a unique crystallographic lamellar microstructure via selective laser melting. Scripta Materialia, 159, 89. https://doi.org/10.1016/j.scriptamat.2018.09.017