Compared with the increase of cancer patients, there is insufficiency number of beds at palliative care unit(abbreviated to PCU)and hospice. To utilize them as medical resource efficiently, it is necessary to assess the condition of patients and to decide the order of admission fairly and impartially. The appropriate way of decision is also a prerequisite of the facility criterion of hospice by the Ministry of Health, Labour and Welfare and one of the evaluation items of palliative care by Japan Council for Quality Health Care. Many PCUs and hospices declare that a conference for the hospitalization judgment is held regularly, although few hospitals disclose the process of decision and its criteria of the order of priority. We made a checklist for the judgment of hospice admission in which the needs of hospitalization are converted to the numerical value in terms of patient's willingness, condition, context and prognosis. The checklist was introduced in our PCU in September 2012. In 2013 fiscal year, the conference for the judgment of PCU admission was held almost once a week(51 times)and the total number discussed were 403 cases(7.9 cases per one conference)and those who were actually hospitalized were 187 patients. The imbalance shows the necessity of the fair and impartial decision.

  In this report, we introduce the importance of a system for sharing information about cancer molecular-targeted medicines from trial to the clinic by the department of knowledge education research, department of breast surgical oncology, department of cardiovascular internal medicine and department of dermatology at St. Luke’s International Hospital in Japan.  At present, information regarding the side effect(s) of a study drug does not reach doctors who are not members of the department in charge of the clinical trial.  The reason for this is because clinical trials are conducted under the legal constraints of GCP (Good clinical practice), and while safety information about any adverse events (side effects) is reported, it is limited to the level of an Institutional Review Board.  When there was an enquiry about a known side effect that had occurred to patients taking molecular-target medicine from a doctor who was not a member of the department in charge of the clinical trial, it became clear that information regarding the clinical trial medicine and non-approved medicine was not reaching the clinic.  We developed an original reporting system for such information that would offer the information using the same format as the clinical trial itself, as well as the department in which the side effect was treated, to resolve the problem of access to side effect information outside of the clinical trial itself.  We show that the reporting of such information leads to resolution of this problem.  We believe that this will relieve the patient and contribute to the clinical trial as well as to the department that deals with such side effects.

Over 40 years, Post-maketing surveillance (PMS) studies have been conducted as a legal obligation in Japan. Though the contribution of these studies to the better use of the drug has been acknowledged, there are criticisms that these PMS studies have been stereotyped and need to be improved. The ICH-E2E guideline entitled as "Pharmcovigilance Planning", agreed in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been implemented in the concerned countries. The legislation of the guideline in Japan in 2005 seems to have urged drug companies and regulatory agency to review the current PMS practices in contrast with the today's highest scientific standard. We investigated the theoretical and practical aspects of pharmacoepidemiology required when the drug company evaluates safety specification prior to developing the pharmacovigilance plan and designs a PMS study along the lines stipulated in the ICH-E2E guideline. To meet this end, we evaluated the profiles of the drug, summarized "Important identified risks", "Important potential risks" and "Important missing information" to be identified and examined the pharmacovigilance plan suggested by the regulatory agency and that proposed and implemented by the drug company. We examined those aspects for 6 new products selected from 168 drugs newly approved during the period between January 2004 and October 2006. In 5 of 6 cases, we judged that the use of a comparator group would have been appropriate to asses the association between the drug and adverse events of interest. In addition, in one half (3) of 6 cases, it would have been preferable to use the database for the patient registration and/or other types of databases. The issues of relevant legislation and the infrastructure and funding for the investigations needed to develop a desirable study design and conduct a good pharmacoepidemiology study are however beyond a single company's capacity and should be set as a national strategy. The issues of post-marketing safety in the nation is becoming more and more important as the data in the countries outside Japan are being used more often for the processes of marketing authorization application of a new drug and its approval. It is urgent to secure the practice of pharmacoepidemiology to achieve the effective post-approval pharmacovigilance studies.

We have performed mass surveys for colorectal cancer by using an immunological fecal occult blood test (OC Hemodia) since April, 1987. In this report, we evaluated the mass survey protocol, and investigated the upcoming problems and measures.
The total number of examinees for six years until March, 1993 was 172, 474. The persons needed detailed examination amounted to 6, 952 (4.0%) and the persons received the detailed examination, 4, 706 (67.7%). A total of 144 colorectal cancer cases (detection rate: 0.08%, 153 lesions) were discovered, 93 cases (64.6%) were in their early stage. 101 cases (66.0%) of 153 lesions were early cancer, and 71 cases (70.3%) were cured by endoscopic polypectomy.
The detection rate of colorectal cancer was higher in males than females. In particular, the finding rate for males 50 years old and above was extremely high. We strongly recommend that the elderly people should receive a mass survey. Moreover, it is important to offer the opportunity for detailed examination to the persons who don't receive them. That might raise the detection rate.
It was found that detailed examination has left much room for improvement in terms of methodology. Some medical institutions performed only fecal occult blood testing. They are require d to raise the understanding of mass surveys for colorectal cancer. Collaboration with the medical institutions that are capable of detailed examination and care is indispensable to raise the accuracy of examination.
On the basis of the results in 1992, we calculated the diagnostic accuracy of immunological fecal occult blood test. The sensitivity of the one-day-method was 70.8%, the specificity, 97.0%, and the positive predictive value 2.1. The sensitivity of the two-days-method was 86.7%, the specificity, 95. 3%, and the positive predictive value, 2.7, and was better than the one-day-method.
These findings suggest that the carcinomas, negative to the occult blood test, still exist in a high frequency rate. Therefore, we should perform mass surveys by the two-days-method every year, in order to improve the evaluation of the mass survey method for colorectal cancer.

BACKGROUND/OBJECTIVES: This study aimed to examine the association of Japanese schoolchildren's involvement in at-home meal preparation with food intake and cooking skill. SUBJECTS/METHODS: We included 1,207 fifth-grade children aged 10-11 years and one parent of each child. A cross-sectional survey was used to collect data on involvement in at-home meal preparation. Correspondence analysis was used to classify involvement in at-home meal preparation into three groups: food-related activities (cooking only or with other activities such as shopping, table-setting, clean up, and dishwashing), non-food-related activities (table-setting and/or clean up), and no (helping) activities. Food intake was assessed using a food frequency questionnaire. Logistic regression models were used to examine involvement in at-home meal preparation associations. RESULTS: The sample consisted of 1,207 fifth-grade children. Vegetable intake was lower in the no (helping) activities group than the food-related activities group (95% CI; boys: 1.2, 5.1, girls: 2.0, 8.9). Fewer children in the non-food-related activities group reported they were able to make a portion of their meals compared with the food-related activities group (95% CI; boys: 1.6, 3.5; girls: 1.5, 3.2). CONCLUSIONS: Children in the food-related activities group showed more favorable food intake and cooking skills than children in the no (helping) activities or non-food-related activities group.
Asian Continental Ancestry Group* ; Child ; Cooking* ; Cross-Sectional Studies ; Eating ; Female ; Humans ; Logistic Models ; Meals* ; Parents ; Vegetables

BACKGROUND/OBJECTIVES: This study aimed to examine the association of Japanese schoolchildren's involvement in at-home meal preparation with food intake and cooking skill. SUBJECTS/METHODS: We included 1,207 fifth-grade children aged 10-11 years and one parent of each child. A cross-sectional survey was used to collect data on involvement in at-home meal preparation. Correspondence analysis was used to classify involvement in at-home meal preparation into three groups: food-related activities (cooking only or with other activities such as shopping, table-setting, clean up, and dishwashing), non-food-related activities (table-setting and/or clean up), and no (helping) activities. Food intake was assessed using a food frequency questionnaire. Logistic regression models were used to examine involvement in at-home meal preparation associations. RESULTS: The sample consisted of 1,207 fifth-grade children. Vegetable intake was lower in the no (helping) activities group than the food-related activities group (95% CI; boys: 1.2, 5.1, girls: 2.0, 8.9). Fewer children in the non-food-related activities group reported they were able to make a portion of their meals compared with the food-related activities group (95% CI; boys: 1.6, 3.5; girls: 1.5, 3.2). CONCLUSIONS: Children in the food-related activities group showed more favorable food intake and cooking skills than children in the no (helping) activities or non-food-related activities group.
Asian Continental Ancestry Group* ; Child ; Cooking* ; Cross-Sectional Studies ; Eating ; Female ; Humans ; Logistic Models ; Meals* ; Parents ; Vegetables