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Publications (3)4.72 Total impact

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    ABSTRACT: In a longitudinal clinical study to compare two groups, the primary end point is often the time to a specific event (eg, disease progression, death). The hazard ratio estimate is routinely used to empirically quantify the between-group difference under the assumption that the ratio of the two hazard functions is approximately constant over time. When this assumption is plausible, such a ratio estimate may capture the relative difference between two survival curves. However, the clinical meaning of such a ratio estimate is difficult, if not impossible, to interpret when the underlying proportional hazards assumption is violated (ie, the hazard ratio is not constant over time). Although this issue has been studied extensively and various alternatives to the hazard ratio estimator have been discussed in the statistical literature, such crucial information does not seem to have reached the broader community of health science researchers. In this article, we summarize several critical concerns regarding this conventional practice and discuss various well-known alternatives for quantifying the underlying differences between groups with respect to a time-to-event end point. The data from three recent cancer clinical trials, which reflect a variety of scenarios, are used throughout to illustrate our discussions. When there is not sufficient information about the profile of the between-group difference at the design stage of the study, we encourage practitioners to consider a prespecified, clinically meaningful, model-free measure for quantifying the difference and to use robust estimation procedures to draw primary inferences.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 06/2014;
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    ABSTRACT: The present study aimed to determine the ability of the revised International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) classification of lung adenocarcinoma to predict patient survivals and driver gene alterations. A reclassification of 904 surgically resected adenocarcinomas was performed. The results were statistically analyzed to examine the correlation between the classification and overall survival (OS) using Cox regression analyses, and integrated discrimination improvement (IDI) analyses. The 5-year OS rates for adenocarcinomas in situ (AIS) or minimally invasive adenocarcinoma (MIA) were 98%. Five-year OS rates of Lepidic-, acinar-, papillary-, micropapillary-, and solid-predominant adenocarcinomas was 93%, 67%, 74%, 62%, and 58%, respectively. The IDI estimates revealed that classification of ADC into the 7 subgroups had a higher estimated (0.0175) than did the combined histological grouping (AIS+MIA, lepidic+acinar+papillary, micropapillary+solid+others) (0.0111). Epidermal growth factor receptor mutations, KRAS gene mutations, and anaplastic lymphoma kinase gene alterations were statistically prevalent in papillary-predominant (P=0.00001), invasive mucinous (P=0.00001), and micropapillary- and acinar-predominant (P=0.00001) adenocarcinomas, respectively. The new classification reflects disease prognosis, and was also associated with driver gene alterations.
    Lung cancer (Amsterdam, Netherlands) 07/2013; · 3.14 Impact Factor
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    ABSTRACT: To investigate glucose regulation in young adults with very low birth weight (VLBW; <1500 g) in an Asian population. Cross-sectional observational study. A general hospital in Hamamatsu, Japan. 111 young adults (42 men and 69 women; aged 19-30 years) born with VLBW between 1980 and 1990. Participants underwent standard 75 g oral glucose tolerance test (OGTT). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were glucose and insulin levels during OGTT and risk factors for a category of hyperglycaemia defined as follows: diabetes mellitus, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and non-diabetes/IGT/IFG with elevated 1 h glucose levels (>8.6 mmol/l). The secondary outcomes were the pancreatic β cell function (insulinogenic index and homeostasis model of assessment for beta cell (HOMA-β)) and insulin resistance (homeostasis model of assessment for insulin resistance (HOMA-IR)). Of 111 young adults with VLBW, 21 subjects (19%) had hyperglycaemia: one had type 2 diabetes, six had IGT, one had IFG and 13 had non-diabetes/IGT/IFG with elevated 1 h glucose levels. In logistic regression analysis, male gender was an independent risk factor associated with hyperglycaemia (OR 3.34, 95% CI 1.08 to 10.3, p=0.036). Male subjects had significantly higher levels of glucose and lower levels of insulin during OGTT than female subjects (p<0.001 for glucose and p=0.005 for insulin by repeated measures analysis of variance). Pancreatic β cell function was lower in men (insulinogenic index: p=0.002; HOMA-β: p=0.001), although no gender difference was found in insulin resistance (HOMA-IR: p=0.477). In male subjects, logistic regression analysis showed that small for gestational age was an independent risk factor associated with hyperglycaemia (OR 33.3, 95% CI 1.67 to 662.6, p=0.022). 19% of individuals with VLBW already had hyperglycaemia in young adulthood, and male gender was a significant independent risk factor of hyperglycaemia. In male young adults with VLBW, small for gestational age was associated with hyperglycaemia.
    BMJ Open 01/2012; 2(1):e000327. · 1.58 Impact Factor