Quality of life (QOL) evaluated by patients themselves has become one of the important outcomes in clinical practice as well as clinical trials. Recently clinicians have attempted to gather QOL evaluation data in their clinical practice setting and integrate the findings into the medical decision-making process. To date, several multidimensional generic questionnaires consisting of multiple domains such as functional, physical, mental and social well-being, have been developed and utilized for generic QOL evaluation in clinical trials, especially in the oncology area. To develop a well-constructed and valid QOL questionnaire, its psychometric characteristics such as reliability, validity, responsiveness and feasibility must be adequately assessed in the research setting.
In clinical trials, QOL data are generally measured in a longitudinal fashion and there are two prominent embarrassing statistical problems : one is the multiplicity due to replication (in time) of statistical tests and the other is the occurrence of missing data due to a variety of reasons. Non-random missing data which occurs because of any reasons related to a patient's present status and/or future prognosis possibly leads to bias and misinterpretation of the results of a trial. To solve the multiplicity problem, the repeated-measures ANOVA-type data analysis or summarization of a repeated measures into an appropriate summary measure can be applied. Missing data can be prevented to some extent by allocating/training coordinators at each participating institute and establishing a communication network between a data center and participating institutes. However, missing data will occur inevitably due to the deterioration of a patient's physical status in the area of life threatening diseases suchas advanced cancer or other diseases with poor prognosis. Although several statistical approaches to cope with missing data even including non-random one have been proposed, there is no single complete analytical solution that can handle the non-random missing problem. The best remedy would be to collect information about reasons why the missing data occurred so that we can identify the missing mechanism and take it into account in a statistical analysis. A so-called “sensitivity analysis” of comparing the results of several analytical methods suchas different imputation techniques or newly proposed ideas would also be a useful approach. The QALY (Quality Adjusted Life Year) used the idea of weighting life time by utility evaluated by patients themselves and is coined for incorporating a patient's judgment into the treatment selection. Ultimately, an assessment of QOL should be utilized for “individualized” or “tailor-made” treatment and statistical methodology should be developed further for gathering, analyzing and utilizing QOL data.

As is evident from the Oriental Medical phrase “the mind and body are one”, the body and mind are thought to mutually influence each other. Based on this assumption, the authors studied the psychotropic effects of Kampo formulas that are commonly used for physical disorders. The effects were rapid and remarkable. However, just as individual Kampo formulas are effective for specific organs, the effect of each formula was found to be limited to a certain mental state. Since each mental state was thought to correspond to one of the elements in the Five Element theory there were five mental states identified, i. e.: 1. Will, 2. Anxiety, 3. Irritation, 4. Manic mood, 5. Sociability. Tonifying Kampo formulas seemed to affect two states, one of which was suppressed. The Mutually Destructive Aspects (Sokoku) of the Five Element theory was useful in explaining this. Further studies were made of the psychotropic effects of one Kampo formula, Hachimi-jio-gan. The results indicated that Hachimi-jio-gan had the mutually opposing psychotropic effects of facilitating the will and suppressing the irritation. From these results and the study of various other Kampo formulas, it was suggested that the Mutually Destructive Aspects of the Five Element theory may be useful in gaining an understanding of their psychotropic effects.
In this study, since we were afraid that the psychotropic effects of Hachimi-jio-gan might be due to the presence of Aconiti Tuber, it was removed from the formula, along with the Cinnamomi Cortex. The effects of the remaining formula, Rokumi-gan, were then studied. Twelve patients suffering mainly from depressive neurosis were given Rokumi-gan, and the five mental states evaluated. The states affected were thought to be the loss of will and irritation. After two weeks (four weeks), the efficacy rates were 66.7% (91.7%) and 66.7% (83.3%), but after four weeks, slight mood deterioration (depression) was seen in five of the twelve cases.
Long administration of such tonifying formulas seemed to bring about another improvement without the two mental states. From these findings and a summary of the results obtained from this stuby, the Mutually Creative Aspects (Sosei) of the Five Element theory seems to be useful after the 2-4 week point. In addition, from the study of many formulas, the psychotropic effect of Aconiti Tuber was thought to be a tonifyer of the Five element. Some observations were also made concerning the mutual relationship between the Yin/Yang Deficient/Excessive table and the Five Element theory.
*1 The Five Element theory: In ancient China, the universe was thought to consist of five elements. Mental states were also considered to correspond to the five elements. The five elements are: Wood (Moku), Fire (Ka), Earth (Do), Metal (Kon) and Water (Sui).
*2 The Mutually Destructive Aspect of the Five Element theory: The five elements were thought to have a special relationship. Wood suppresses Earth, Fire suppresses Metal, Earth suppresses Water, Metal suppresses Wood and Water suppresses Fire. This relationship keeps the universe in balance.

Severe fever with thrombocytopenia syndrome (SFTS) is an emerging disease endemic in East Asia. Transmitted to other organisms by infected ticks, the SFTS virus (SFTSV) and is endemic to Nagasaki in western Japan. However, epidemiological information regarding SFTSV in Nagasaki ticks has not been available to date. In this study, we began by examining the sensitivities of SFTSV gene detection by real-time RT-PCR and virus isolation in cultured cells and mice. These methods could detect SFTSV in the samples containing more than 4 × 10⁰ ffu. Next, we attempted to isolate SFTSV and to detect viral gene in 2,222 nymph and adult ticks collected from May to August 2013 among seven regions of Nagasaki. However, neither virus isolation nor viral gene detection were confirmed in the tick pools. SFTSV positivity rates are considered to be very low in ticks, and viral loads are also very limited. Further investigations increasing the number of ticks and including larval samples as well as improved detection methods, may be required to find SFTSV-positive ticks in this region.

Severe fever with thrombocytopenia syndrome (SFTS) is an emerging disease that is endemic in East Asia. The SFTS virus (SFTSV) is transmitted to other organisms by infected ticks and is endemic to Nagasaki in western Japan. However, epidemiological information regarding SFTSV in Nagasaki ticks has not been elucidated. In this study, we first examined the sensitivities of SFTSV gene detection by real-time RT-PCR and virus isolation in cultured cells and mice. These methods could detect SFTSV in the samples containing more than 4 × 10⁰ ffu. Next, we attempted to isolate SFTSV and to detect viral gene in 2,222 nymph and adult ticks collected from May to August 2013 among seven regions of Nagasaki. However, neither virus isolation nor viral gene detection were confirmed in those tick pools. SFTSV positivity rates are considered very low in ticks and viral loads in ticks are also very limited. Further investigation by increasing the number of ticks and including larval samples in the investigation, as well as improved detection methods, may be required to find SFTSV-positive ticks in this region.

The primary aim of this study was to compare the ratios of specialized palliative care use to all cancer death using 2 methods: 1) total number of patients who received either of specialized palliative care services (unadjusted), and 2) number of patients after adjustment of potentially duplicated counts (adjusted). The research team obtained patient list from all specialized palliative care services, and counted the number of the patients who received any specialized palliative care services. The ratio of adjusted value to unadjusted value was 0.59, and had large region differences.Unadjusted values had, although overestimated, essentially similar trends in changes by year and differences in the regions. In conclusion, total number of patients who received either of specialized palliative care services could be simple and feasible indicator to roughly determine the activity of specialized palliative care services, but exact number of the patients who received specialized palliative care services should be determined on the basis of the patient lists without duplicated counts.

Purpose and Methods: Infection and neoplastic fever is one of the common complication in patients with advanced cancer. To develop a novel method to differentiate neoplastic fever from infection, we performed a retrospective study of hospitalized terminally ill cancer patients at Seirei Hospice from April 2009 to August 2011. Results: We identified a consecutive sample of 12 patients with neoplastic fever and 12 patients with infection as a control. We extracted demographic data, laboratory data, vital signs and symptoms from medical charts. We found significant differences in difference in C-reacive protein value between afebrile and febrile period (p＜0.001), difference of white blood cell count between afebrile and febrile period (p=0.0017), percentages in neutrophil counts (p=0.023), percentages in lymphocyte counts at base line (p=0.011) and the presence of delirium (p=0.012). Conclusion: These findings suggest that we might differentiate neoplastic fever from infection with common laboratory data and their longitudinal change.

Ceftriaxone is one of the easily administrative antibiotics, but little is known about their role in palliative care settings. The aim of this study is to show the effect and the safety of ceftriaxone subcutaneous infusion to infection among advanced cancer patients. Consecutive patients who received ceftriaxone subcutaneous infusion at the Seirei Hospice from January 2013 to January 2014 were enrolled in this retrospective analyses. Primary outcome was the response rate of ceftriaxone, determined by improvement of symptoms within 3 days of ceftriaxone use. Secondary outcomes are inflammatory site reaction, and a comparison of the response rate between ceftriatone and other antibiotics. Among a total of 100 admitted patients, 10 patients used ceftriaxone subcutaneous infusion (4 for urinary tract infection, 4 for pneumonia, 2 for soft tissue infection). The response rate was 70% (95% confidence interval, 39－89). There was no inflammatory symptom at the insertion site observed. For comparisons, 16 patients used other antibiotics with the response rate of 74% (51－88).In conclusion, subcutaneous infusion of ceftriaxone can be useful in the treatment of infections of end－of－life cancer patients, and randomized controlled trial is promising.

The primary aim of this study was to collect the views of physicians and nurses in the regions where community-based palliative care intervention trial, the OPTIM-study, was performed. A content analysis of free comments of the questionnaire survey was conducted. Questionnaires were mailed to 1,763 physicians and 3,156 nurses after the intervention, and 706 and 2,236 responses were obtained, respectively. A content analysis identified 327 free comments from physicians and 737 from nurses. As favorable effects, the categories [Multidisciplinary teams and community networks were established] [Home-based care is widespread] [Medical knowledge and skills are acquired just as those involved in palliative care] emerged. The main effects of the community palliative care program included the establishment of multidisciplinary teams and community networks, development of home-based care, and increasing knowledge, skills, and awareness about palliative care.