Verification of the Usefulness of an Assessment and Risk Control Sheet that Promotes Management of Cancer Drug Therapy.

Background: Proper management of adverse events is crucial for the safe and effective implementation of anticancer drug treatment. Showa University Hospital uses our interview sheet (assessment and risk control [ARC] sheet) for the accurate evaluation of adverse events. On the day of anticancer drug treatment, a nurse conducts a face-to-face interview. As a feature of the ARC sheet, by separately describing the symptoms the day before treatment and the day of treatment and sharing the information on the medical record, it is possible to clearly determine the status of adverse events. In this study, we hypothesized that the usefulness and points for improvement of the ARC sheet would be clarified by using and evaluating a patient questionnaire. Methods: This study included 174 patients (144 at Showa University Hospital (Hatanodai Hospital) and 30 at Showa University Koto Toyosu Hospital (Toyosu Hospital) who underwent pre-examination interviews by nurses and received cancer chemotherapy at the outpatient center of Hatanodai and Toyosu Hospital. In the questionnaire survey, the ARC sheet's content and quality, respondents' satisfaction, structural strengths, and points for improvement were evaluated on a five-point scale. Results: The patient questionnaire received responses from 160 participants, including the ARC sheet use group (132 people) and the non-use group (28 people). Unlike the ARC sheet non-use group, the ARC sheet use group recognized that the sheet was useful to understand the adverse events of aphthous ulcers (p = 0.017) and dysgeusia (p = 0.006). In the satisfaction survey questionnaire, there was a high sense of security in the pre-examination interviews by nurses using the ARC sheet. Conclusions: The ARC sheet is considered an effective tool for comprehensively evaluating adverse events. Pre-examination interviews by nurses using ARC sheets accurately determined the adverse events experienced by patients with anxiety and tension due to confrontation with physicians.

Validating a Markov model of treatment for hepatitis C virus-related hepatocellular carcinoma.

OBJECTIVE: We created and validated a Markov model to simulate the prognosis with treatment for HCV-related hepatocellular carcinoma (HCC) for assessment of cost-effectiveness for alternative treatments of HCC. METHOD: Markov state incorporated into the model consisted of the treatment as a surrogate for HCC stage and underlying liver function. Retrospective data of 793 patients from three university hospitals were used to determine Kaplan-Meier survival curves for each treatment and transition probabilities were derived from them. RESULTS: There was substantial overlap in the 95% CIs of the Markov model predicted and the Kaplan-Meier survival curves for each therapy. The predicted survival curves were also similar with those from the nationwide survey data supporting the external validity of our model. CONCLUSIONS: Our Markov model estimates for prognosis with HCC have both internal and external validity and should be considered applicable for estimating cost-effectiveness related to HCC.

A prospective randomized trial of either famotidine or omeprazole for the prevention of bleeding after endoscopic mucosal resection and the healing of endoscopic mucosal resection-induced ulceration.

BACKGROUND: It has been reported that inhibitors of gastric acid secretion prevent bleeding after endoscopic mucosal resection for mucosal gastric neoplasm. However, uncertain whether an histamine2-receptor antagonist or proton-pump inhibitor is more effective. AIM: To evaluate prospectively the effectiveness of famotidine or omeprazole for ulcer management after endoscopic mucosal resection. METHODS: From July 2003 to October 2004, 57 patients were randomly assigned to famotidine or omeprazole for the management of endoscopic mucosal resection. Both drugs were given intravenously for the first 2 days, thereafter by mouth. The bleeding rates after endoscopic mucosal resection, the effects on the healing of endoscopic mucosal resection-induced ulceration, and cost-benefits were compared. RESULTS: Twenty-eight patients received famotidine and 29 received omeprazole. No significant difference was observed between the two groups in patient characteristics. The bleeding rates after endoscopic mucosal resection were not significantly different (18% vs. 14%) between the groups. Similarly, no differences were seen in the size of the endoscopic mucosal resection-induced ulceration at 1, 30 and 60 days after resection between groups. The total costs of anti-secretory agents demonstrated a significant cost-benefit to those treated with famotidine (10,420 yen vs. 17,782 yen). CONCLUSIONS: Famotidine is suggested as a better alternative to omeprazole for the management of endoscopic mucosal resection, as it showed a clear cost-benefit, and the healing results after endoscopic mucosal resection were similar for the two treatment strategies.

Crystal structure of alkaline cellulase K: insight into the alkaline adaptation of an industrial enzyme.

The crystal structure of the catalytic domain of alkaline cellulase K was determined at 1.9 A resolution. Because of the most alkaliphilic nature and it's highest activity at pH 9.5, it is used commercially in laundry detergents. An analysis of the structural bases of the alkaliphilic character of the enzyme suggested a mechanism similar to that previously proposed for alkaline proteases, that is, an increase in the number of Arg, His, and Gln residues, and a decrease in Asp and Lys residues. Some ion pairs were formed by the gained Arg residues, which is similar to what has been found in the alkaline proteases. Lys-Asp ion pairs are disfavored and partly replaced with Arg-Asp ion pairs. The alkaline adaptation appeared to be a remodeling of ion pairs so that the charge balance is kept in the high pH range.

Effects of physical training and mental practice of in-clothes swimming: assessment by physiological parameters.

PURPOSE: This study examined whether a short-term physical or mental training reduces the physiological load and perceived exertion of the in-clothes swimming. METHODS: The study included 24 male inter-collegiate competitive swimmers with no previous experience of the in-clothes swimming. Prior to the training, the subjects performed 200-meter swimming with two styles of swimming, namely the crawl and elementary backstroke, and the degree of perceived exertion in the Borg scale, heart rate, and blood lactic acid level were determined. Following this baseline determination, the subjects were divided into 4 groups with 6 individuals each. These four groups were Group A "in-clothes training", Group B "image training", Group C "swimsuit training", and Group N "no training". Group A and C were lectured on the in-clothes swimming and practiced 7.5 min-long in-clothes swimming per day for a week with the two swimming styles, with Group A subjects wearing daily clothes and Group C subjects in swimsuits. Group B received 15 min of nonphysical mental practice primarily through viewing video recording of swimming performance everyday for a week. No training was given to Group N. At the completion of the training session, the subjects underwent the 2nd 200-meter swimming, and the physiological parameters were determined. RESULTS: The 1st in-clothes swimming load test showed that the elementary backstroke swimming resulted in significantly lower values of heart rate, blood lactic acid level, and perceived exertion than the crawl. For Group N, no difference was observed in the physiological parameters between the 1st and 2nd load test with either the elementary backstroke or crawl. Upon the 2nd in-clothes load test with the elementary backstroke, all three parameters were lower for Group A, B, and C than those seen for the 1st load test, and these differences were statistically significant, except for blood lactic acid in Group A. The 2nd in-clothes load test with the crawl showed that both heart rate and blood lactic acid were lower than those of the 1st load test for all three groups, with the differences in heart rate and blood lactic acid in Group A and that in blood lactic acid in Group B reaching the statistic significance. With respect to perceived exertion, the Borg score determined after the in-clothes load test with the crawl was significantly reduced for Group A, B, and C. The score after the in-clothes load test with the elementary backstroke was significantly reduced only for Group A. CONCLUSION: The elementary backstroke, when practiced in-clothes, imposes a relatively less physiological load. The present training methods can reduce physiological load and/or perceived exertion of the in-clothes swimming. Thus, both image training and swimsuit swimming are equally effective as a training method of the in-clothes swimming.

Industrialization, class structure, and social mobility in postwar Japan.

This study examines intergenerational class mobility in Japan using cross-national comparisons with Western nations and cross-temporal comparisons of five national surveys conducted in postwar Japan. Cross-national comparisons highlight the similarity in relative mobility pattern between Japan and Western nations and at the same time the Japanese distinctiveness in absolute mobility rates especially regarding the demographic character of the Japanese manual working class. The results of cross-temporal comparisons of mobility pattern report some systematic trends in total mobility, inflow and outflow rates, reflecting the Japanese experience of late but rapid industrialization. The pattern of association between class origin and class destination, however, was stable in postwar Japan. It is therefore the combination of distinctive absolute mobility rates and similar relative mobility rates that characterizes the Japanese mobility pattern in comparison with the Western experience. Furthermore, Japan's distinctive pattern of postwar social mobility is characterized by a combination of rapidly changing absolute mobility rates and comparatively stable relative mobility rates.

[A study on the appropriate time point for the assessment of Helicobacter pylori eradication--evaluation from the re-positive rate of H. pylori after successful eradication and delayed decrease of 13C-urea breath test levels].

We attempted to evaluate the appropriate time point for the assessment of Helicobacter pylori eradication after treatment. One hundred and nine patients with gastroduodenal diseases were enrolled this study. All of them were received proton pomp inhibitor based triple therapy and diagnosed as eradication of H. pylori infection at initial assessment. They were followed up over six months. The diagnosis of H. pylori eradication was determined by rapid urease test, culture, histology and 13C-urea breath test (UBT), and the initial assessment of the eradication was performed on 31-90 days after finishing eradication therapy. Re-appearance rate of H. pylori after initial diagnosis of eradication was 4.6% (5/109), and the mean follow-up period of them was 16.3 months. The time period of initial assessment of eradication in these 5 patients were 35, 37, 42, 49 and 60 days after treatment, respectively. On the other hand, there were 6 patients who were diagnosed as failed of eradication therapy by 13C-UBT, and being success at following period. All of the 13C-UBT levels of these 6 patients were less than 10/1000 and were decreased within negative range subsequently. The time periods of initial diagnosis of these patients except one were within 2 months after treatment. It was concluded that the assessment time of H. pylori eradication should be performed over 2 months after eradication therapy.

Opportunistic discovery of occult disease by use of test panels in new, symptomatic primary care outpatients: yield and cost of case finding.

BACKGROUND: Diagnostic test panels have been advocated by the Japan Society of Clinical Pathology for evaluation of presenting complaints of new outpatients in primary care medicine. The tests have additional potential utility for opportunistic finding of asymptomatic diseases, but data are lacking on the number of new conditions identified by the test panels and on the cost per identified case. METHODS: We studied 540 new, symptomatic patients at the Comprehensive Medicine Clinics of National Defense Medical College during 1991-1997. All underwent testing with the "Essential Laboratory Tests" panel (2) [ELT(2) panel]. This panel includes hematologic tests, urinalysis, total protein, C-reactive protein, albumin, cholesterol, triglycerides, glucose, urea nitrogen, creatinine, uric acid, serum protein fractionation, six enzymes, and optional tests, including x-rays, electrocardiogram, and fecal occult blood. RESULTS: The ELT(2) panel uncovered 276 additional diagnoses of asymptomatic disease or abnormal health status. The most frequent occult condition was hyperlipidemia (100 cases) followed by liver dysfunction (53 cases). Clinical efficiency of the panel (occult diseases/patient) varied depending on the category of tentative initial diagnosis, with the highest efficiency in patients with cardiovascular disease. We created smaller panels by combining 11 basic tests [called the ELT(1) baseline panel] with one or more additional tests from the ELT(2) and analyzed their cost-effectiveness. Addition of four tests (total cholesterol, alanine aminotransferase, glucose, and uric acid) improved both clinical efficiency (0.41 occult disease/patient) and economic efficiency [ 2372 yen (approximately $22.50 US)/occult disease] at a cost-effectiveness of 177 yen per incremental case of occult disease. Addition of further tests decreased cost-effectiveness. CONCLUSIONS: Although the ELT(2) panel has supplemental utility for opportunistic screening of some significant, occult diseases and conditions, universal utilization of the full panel is not supported by the cost-effectiveness found in this study.

[A cost-effectiveness analysis of a pre-visit testing system for new outpatients in primary care medicine].

We evaluated cost-effectiveness parameters of common diagnostic test panels advocated by the Japan Society of Clinical Pathology in order to determine the validity of pre-visit testing of these test panels for new outpatients with some defined symptoms. The "Essential Laboratory Tests(ELT) (2)" panel was universally applied to 540 new outpatients who visited the Comprehensive Medicine Clinics in the National Defense Medical College and its affiliated hospital. A "useful result(UR)", the unit of usefulness of the ELT, was assigned by assessing the impact of its results on physician's diagnosis- or decision-making. Patients were classified into 7 major symptom groups according to their chief complaint, and clinical effectiveness(UR/patient), economic efficiency(cost/UR) and cost-effectiveness(delta cost/delta UR) were analyzed in each patient group. Clinical effectiveness ranged from 1.38(renal/urinary tract symptoms) to 0.27 UR/patient(neurological symptoms) with a cost disparity from yen 1,222 to yen 5,946/UR between these patient groups. Substantial decreases in clinical effectiveness were demonstrated in all patient groups with the ELT(1)-testing alone in a simulation study; however, cost-effectiveness parameters still remain in excellent values in the renal/urinary tract symptom and infection/inflammation-related symptom groups(1.13 and 0.77 UR/patient at a cost of yen 836 and yen 1,181/UR, respectively). The addition of some ELT(2)-specific test items such as AST, ALT to the ELT(1) baseline panel improved clinical effectiveness of the ELT(1) in lassitude/exhaustive symptom group at a minimal cost increment. This study verified the validity of the ELT(1) as a panel for pre-visit testing in patients with renal/urinary tract symptoms and infection/inflammation-related symptoms, but not in those with other symptoms.

[Assessment of brain cell function using 123I-IMP SPECT of cerebral blood flow and visual evoked potential by photic stimulation in normal and demented elderly subjects].

Cerebral blood flow was quantitatively measured using 123I-IMP SPECT by photic stimulation and visual evoked potential (VEPs) in normal and dementia subjects: 8 with Alzheimer-type dementia, 9 with cerebrovascular dementia and 7 normal elderly subjects were divided into the three groups based on the Clinical Dementia Rating (CDR) grade: Group I (CDR 0), Group II (CDR 0.5-1), Group III (CDR 2-3). The 123I-IMP SPECT measurement was conducted at rest with the eyes closed and also during photic stimulation. VEPs were measured simultaneously. The results reveal prolongation of the P2 latency of the VEPs prolonged in accordance with the increasing severity of the dementia, and quantitative cerebral blood flow was lower in Group II and Group III than in Group I at rest, while during photic stimulation it significantly increased in Group I and II, but showed no change in Group III. The results suggest that quantitative measurement of cerebral blood flow using 123I-IMP SPECT by photic stimulation may enable more detailed assessment of brain cell function.

Common diagnostic test panels for clinical evaluation of new primary care outpatients in Japan: a cost-effectiveness evaluation.

BACKGROUND: The Japan Society of Clinical Pathology (JSCP) has developed a guideline for common diagnostic test utilization in new primary care outpatients. To determine the scientific and economic validity of the JSCP panel testing system, we analyzed cost-effectiveness parameters of test panels advocated. METHODS: The "Essential Laboratory Tests" panel (2) [ELT(2) panel], a package of common diagnostic tests added to the ELT(1) baseline health-status screening panel, was applied to 540 new outpatients who visited the Comprehensive Medicine Clinics in an academic medical center during 1991 to 1997. A "useful result" (UR) of testing was defined as a finding that contributed to a change in a physician's diagnosis- or decision-making, relating to a "tentative initial diagnosis" (TID) obtained from history and physical examination alone. RESULTS: Clinical usefulness was demonstrated in 259 patients with ELT(2), in whom 398 URs were generated. Clinical effectiveness (UR/TID) ranged from 1.65 (hematological) to 0.088 (neurological disease), with a cost disparity from yen1251 ( approximately $10) to yen23 037 ( approximately $200) per UR. A total of 1137 tests generated URs. We further assessed the clinical effectiveness and economic efficiency (cost/UR) of ELT(1) and restructured panels. Use of the ELT(1) alone generated 244 URs in 167 patients. The poor efficiency of the ELT(1) panel was markedly improved with the addition of certain ELT(2)-specific tests in liver/pancreatobiliary, metabolic/endocrine, and cardiovascular disease groups. CONCLUSIONS: A wide disparity in the utility of ELT panels in different patient groups does not support the JSCP recommendation of their routine use for new outpatients. Selective test combinations should be used in selected patient groups.

Assessment of resectability of pancreatic carcinoma by color Doppler sonography.

This study was undertaken to evaluate the role of color Doppler sonography in the preoperative assessment of vascular involvement in patients with pancreatic carcinoma. Twenty-six pancreatic carcinomas were investigated with color Doppler sonography and angiography, and the results of these examinations were compared with those of surgical findings. Color Doppler sonography was more sensitive than angiography in depicting vascular involvement of carcinoma. Thus, it seems rational to perform a preoperative assessment in suspected pancreatic carcinoma patients initially with color Doppler sonography to improve patient management.

Experimental assessment of endoscopic mucosectomy with a cap-fitted panendoscope.

BACKGROUND AND STUDY AIMS: The use of a cap-fitted panendoscope is one method of carrying out endoscopic mucosectomy in the esophagus, stomach, and large intestine. The purpose of this study was to determine the optimal volume of physiological saline for submucosal injection, the rate of mucosal extension after saline injection, the initial size of the resected mucosal specimen, and the most appropriate heights for the fitted caps used in the colon and in the rectum, respectively. METHODS: Endoscopic mucosectomies using cap-fitted panendoscopes were carried out on resected surgical specimens from ten patients with colorectal cancer. RESULTS: It was necessary to inject 12 ml of saline under the mucosa to prevent perforation. Submucosal saline injection extended the mucosa by 1.4 +/- 0.2 times. A cap with a height of 7 mm is suitable for performing mucosectomy in the colon safely, while both 7 mm and 10 mm caps can be used in the rectum. The initial size of the resected mucosal specimens obtained with both caps was 12-20 mm (mean 14 mm) in diameter, with no significant differences. As the sizes of resected mucosal specimens reported in the past have been obtained after submucosal saline injection, it appears that larger specimens can be resected with the cap-fitted panendoscope than with conventional methods. CONCLUSIONS: The conditions under which endoscopic mucosectomy using the cap-fitted panendoscope can be performed safely in the colon and the rectum were suggested by this experimental study using resected specimens. A saline injection of 12 ml under the mucosa is necessary to prevent perforation. A cap with a height of 7 mm is the most suitable size for the colon, while both 7 mm and 10 mm caps can be used in the rectum.

Preoperative mediastinoscopic assessment of N factors and the need for mediastinal lymph node dissection in T1 lung cancer.

The significance of preoperative N factor assessment in T1 lung cancer and the need for mediastinal node dissection in T1 N0 M0 cases were investigated. The results of mediastinoscopy were evaluated in patients with T1 adenocarcinoma or squamous cell carcinoma who underwent preoperative mediastinoscopy and thoracotomy from 1971 to 1991 (n = 164). Mediastinoscopy gave true negative results in 90% of patients, false negative in 1%, and true positive in 9%. The 5-year survival was 90% for patients with T1 N0 M0 disease who underwent nonradical dissection (n = 64) and 70% for those who underwent radical dissection (n = 61), indicating that the prognosis was significantly better (p < 0.05) with nonradical dissection. Distant metastasis was a common cause of death, and no death was related to local recurrence, whether nonradical or radical dissection had been performed. The results strongly suggest that preoperative mediastinoscopy and intraoperative node sampling are sufficient for assessment of N factors in T1 lung cancer. The possible relation between immunologic functional changes associated with mediastinal lymph node dissection and the prognosis in patients without evidence of positive lymph nodes should be clarified by a prospective randomized study.

Nutritional assessment of a group of Japanese elementary school children in Tokyo: with special emphasis on growth, anemia, and obesity.

Anthropometric data, nutrient intake data, and blood biochemical parameters were analyzed for 66 elementary school children living in Tokyo, Japan, and their nutritional status was evaluated focusing on three problems: (1) zinc nutriture and growth, (2) anemia with iron deficiency, and (3) lipid nutriture and obesity. The subjects' mean energy and protein intakes met the recommended levels for Japanese children. However, their zinc intake levels were inadequate at 7.2, 8.3, and 8.5 mg in grades 2 (mean age: 8 yr), 4 (10 yr), and 6 (12 yr), respectively. Mean serum zinc concentration was 0.82 +/- 0.15 microgram/ml; the percentages of subjects who showed serum zinc concentration lower than 0.68 microgram/ml, the lower limit of the normal serum zinc concentration, were 28.6, 15.4, and 5.0% in grades 2, 4, and 6, respectively. These serum zinc concentrations indicated the existence of marginal zinc deficiency in some children, particularly in grade 2, though it was not severe enough to retard growth. Their iron intake levels (8.2, 10.2, and 10.2 mg for grades 2, 4, and 6, respectively) in combination with the proportion of iron intake from animal foods (37%) were judged to be adequate because no children showed serum ferritin, serum iron, or transferrin saturation levels lower than the criteria levels recommended for iron deficiency. Moreover, no definitely anemic children were found. Daily lipid intakes were 65.7, 74.5, and 78.3 g in grades 2, 4, and 6, respectively, and the mean percentage of energy intake from lipid to total energy intake, 32%, exceeded the level recommended. Mean serum total cholesterol concentrations and the percentage of subjects with elevated cholesterol levels (greater than or equal to 200 mg/dl) were high compared with the reported values. Means of the body mass index (BMI) and Rohrer Index (RI) for the subjects were slightly higher than Japanese standards. With these parameters for obesity, triglycerides and atherogenic index were positively correlated and HDL cholesterol and HDL cholesterol percentage to total cholesterol were negatively correlated.