Study protocol for J-SUPPORT 1604 (J-FORCE): a randomized, double blind, placebo-controlled Phase III study evaluating olanzapine (5 mg) plus standard triple antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy.

The Guidelines of the Japan Society of Clinical Oncology recommend standard triple antiemetic therapy with aprepitant, a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone for patients receiving highly emetogenic chemotherapy. Recently, a Phase III study demonstrated the significance of adding of olanzapine (10 mg) to standard triple antiemetic therapy. Olanzapine is associated with somnolence, and we have previously conducted a randomized Phase II study to evaluate the efficacy and safety of 10 mg and 5 mg olanzapine. Lower dose of olanzapine reduced the incidence of somnolence. Therefore, we conducted a randomized, double blind, placebo-controlled, Phase III study to evaluate the efficacy of olanzapine (5 mg) combined with standard triple antiemetic therapy for cisplatin-based highly emetogenic chemotherapy. This study initiated in Feb 2017. A total of 690 patients are planned to be enrolled over a period of 2 years. This study has been registered at the UMIN Clinical Trials Registry as UMIN000024676.

[Education and enlightenment on point of care testing (POCT) and trainee physicians' wishes in handy blood glucose monitors: based on a questionnaire survey].

Devices for point of care testing (POCT) and self-monitoring of blood glucose (SMBG) have their own characteristics and understanding them is desirable for appropriate use. However, it is hard to say that all medical care prodivers, who measure blood glucose levels with them, understand the characteristics today. The POCT guidelines recommended education and enlightenment of physicians for appropriate use of POCT devices and documented that it was important to educate and enlighten trainee physicians in particular, who would be instructor doctors in the future. All first-year trainee physicians (72 physicians), who worked at the clinical laboratory in our hospital in 2005 and 2006 as rotator physicians in training, were asked to measure blood glucose with a POCT-compatible blood glucose monitor and a questionnaire survey was carried out. The necessity and the importance of the inspection were experienced, and the understanding level of POCT of the trainee physicians who finished clinical training in an indispensable department was higher than that of an inexperienced trainee physicians for clinical training.

[Approval of additional management fee in medical insurance and its change].

An additional management fee was approved in 1996 due to the efforts of the Japanese Association of Clinical Pathology. This particular fee was increased after revisions, markedly contributing to the revenue of the departments of clinical laboratory in hospitals. In the revision of medical insurance fees, a marked reduction in medical costs with an increase in medical insurance for the elderly is performed. For this cost reduction, laboratory tests for which a reduction can be easily achieved may become targets. Regarding the activity of clinical laboratory physicians in terms of medical insurance fees, laboratory and physiological tests should be evaluated according to each item. The prospective payment system mainly employing diagnostic procedure combination (DPC) was introduced primarily at university and large hospitals.

[Activity of clinical laboratory physicians in national health insurance].

As places of activity of clinical laboratory physicians in national health insurance, there are committees of the Japan Medical Association and the Social Insurance Union of Societies Related to Internal Medicine. In 1996, additional management fee was approved due to the efforts of the then President Kinya Kono, and subsequently, fees were increased after every revision, markedly contributing to the income at the department of clinical laboratory in hospitals. Another activity of clinical laboratory physicians is work in the Social Insurance Union of Societies Related to Internal Medicine and that Related to Surgery toward the 2006 revision of medical insurance fees. The former union presented a request paper in cooperation with each scientific society for the revision of medical insurance fees, and clinical laboratory physicians played the central role in summarizing requests associated with laboratory tests. We describe the contents of the request paper for the 2006 revision of medical insurance fees presented by this union. In the previous revisions (2004), after the Ministry of Health, Labour, and Welfare counseled with the Japan Medical Association, the Central Social Insurance Medical Council made the final decisions. In the future, the power of the Ministry of Health Labour, and Welfare may increase. In activities of clinical laboratory physicians in medical insurance fees, clinical laboratory tests and physiological function tests should be evaluated according to each items, and the income/expenditure balance should be improved. In the 2006 revision of medical insurance fees, a marked reduction in medical costs for the increase in medical insurance for the elderly is expected. For this reduction, laboratory tests for which a reduction is easy may become targets. The government reported the principle that reimbursement in 2006 will be reduced by 2-5% to put the brakes on the rise in national medical costs due to the aging of society. The prospective payment system mainly by the diagnosis procedure combination (DPC) is performed mainly at university hospitals at present, and attention is paid to its future progress.

[Clinical evaluation of ECG at the onset subjective symptoms using real-time analysis electrocardiograph (event recorder)].

Examination of patient complaining of palpitation, chest pain and chest discomfort is usually performed by 12-lead electrocardiograph. However, the recording time is short and there are few opportunities to capture an ECG demonstrating conditions during subjective symptoms. To investigate the cause, we need to obtain an ECG during subjective symptoms. Thus, we frequently use a Holter ECG, which can be recorded for 24 hours. However, some patients have a low frequency of subjective symptoms, which may not appear during a 24-hour examination. We used a real-time electrocardiograph (Event Recorder CG-6106 made by Card Guard Scientific Survival Limited) as a monitor during subjective symptoms. Thereafter, ECG findings at the onset of subjective symptoms could be analyzed in 30 patients who did not have a clear cardiac disease. In this examination, arrhythmia was recorded in 25 of 30 cases. Although in these cases ECG during subjective symptoms could not be captured even when Holter examination was performed several times ECG during subjective symptoms was captured using an Event Recorder. This method using an Event Recorder is simple and convenient, moreover, is considered very useful for investigation of subjective symptoms. In the future, the use of an Event Recorder for heart-health-care in the daily life of healthy people and/or cardiac disease patient is highly anticipated.

[The assessment of arteriolosclerosis by serum lipids data, and carotid ultrasonography and pulse wave velocity, and its evaluation as a tool for preventive medicine: II. Carotid ultrasonography and pulse wave velocity for hyperlipemia and diabetes mellitus].

We studied the test results of carotid ultrasonography and pulse wave velocity against a sample of hyperlipemia and diabetes mellitus. Sixty four hyperlipemia samples (HL), 85 diabetes mellitus samples (DS), and 27 complicated samples (CS) were compared with 56 healthy samples (HS). Hyperlipemia samples were selected from cholesterol under 300 mg/dl, and neutral fat under 300 mg/dl. Diabetes mellitus samples were selected from fasting plasma glucose (FBS) under 200 mg/dl. Samples from severe conditions with various disease were excluded. Ratio over 1.1 mm intima-media thickness (IMT) was 0% in HS, 48% in HL, 40% in DS and 33% in CS. PWV value was max 1896cm/s in CS. There was no significant correlation within IMT, serum lipid(Total Cholesterol, Neutral Fat, HDL-Cholesterol, LDL-Cholesterol) and FBS. For early treatment or accurate diagnosis of arteriosclerosis in hyperlipemia or diabetes mellitus patients, who are at high risk of developing arteriosclerosis, to vital function tests (carotid ultrasonography and pulse wave velocity) should be performed, in addition to normal blood tests.

[Laboratory information and consultation service with a ordering system].

We built a laboratory information system that does not require resident medical technologists or medical doctors. The laboratory information system used the following two methods. In the first method, the receiver of questions/complaints/consultations about laboratory tests used e-mail carried by an ordering system. In the second method, the Web utilized a laboratory test information retrieval system by intranet. As for e-mail inquirers, doctors made up 76.7%(46/60), and other types of job were office workers 11.7% (7/60), nurses 8.3%(5/60), and pharmacists 3.3%(2/60). The question(consultation) contents were test methods 30.0%, demands/complaints 28.3% for ordering, specimen saving requests 13.3%, consultations 11.7%, and other 16.7%. Since introducing this system, compared to previously telephone inquiries have by about 60% decreased, and basic questions such as reference intervals or containers have decreased even more. The system operates 24 hours a day and dose not increase the current workload, thus allowing the accumulation of a laboratory information system.