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1.  Identification of the need for home visiting nurse: development of a new assessment tool 
To develop a Home Visiting Nursing Service Need Assessment Form (HVNS-NAF) to standardize the decision about the need for home visiting nursing service.
The sample consisted of older adults who had received coordinated services by care managers. We defined the need for home visiting nursing service by elderly individuals as the decision of the need by a care manager so that the elderly can continue to live independently. Explanatory variables included demographic factors, medical procedure, severity of illness, and caregiver variables. Multiple logistic regression was carried out after univariate analyses to decide the variables to include and the weight of each variable in the HVNS-NAF. We then calculated the sensitivity and specificity of each cutoff value, and defined the score with the highest sensitivity and specificity as the cutoff value.
Nineteen items were included in the final HVNS-NAF. When the cutoff value was 2 points, the sensitivity was 77.0%, specificity 68.5%, and positive predictive value 56.8%.
HVNS-NAF is the first validated standard based on characteristics of elderly clients who required home visiting nursing service. Using the HVNS-NAF may result in reducing the unmet need for home visiting nursing service and preventing hospitalization.
PMCID: PMC3962667  PMID: 24665229
home visiting nursing service; need assessment; assessment tool
2.  A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Short-Acting β1-Adrenergic Receptor Blocker Landiolol Hydrochloride for Coronary Computed Tomography Angiography in Japanese Patients with Suspected Ischemic Cardiac Disease 
Objectives and Background
The objective of this study was to investigate the image quality-improving and heart rate-lowering effects of landiolol hydrochloride (a short-acting β1-adrenergic receptor blocker) on coronary computed tomography angiography (CCTA). During CCTA, β-adrenergic receptor blockers have been commonly used to lower heart rate and improve image quality.
A total of 258 subjects suspected of having ischemic cardiac disease and requiring CCTA were randomized to either a landiolol hydrochloride 0.125 mg/kg group or placebo group to study the efficacy and safety of landiolol hydrochloride in a multicenter, double-blind, randomized parallel study. The primary endpoint was the diagnosable proportion (proportion of subjects whose coronary stenosis was diagnosable).
The diagnosable proportions about the reconstruction images at mid-diastole were 68.2 and 38.2 % in the landiolol hydrochloride and placebo group, respectively, indicating significant superiority of landiolol hydrochloride over placebo (p < 0.0001). The diagnosable proportions about the optimal reconstruction images were 81.4 and 54.2 % in the landiolol hydrochloride and placebo group, respectively, indicating significant superiority of landiolol hydrochloride over placebo (p < 0.0001). The mean heart rate-lowering effect was first observed soon after administration of landiolol hydrochloride, was most marked at 3–5 min, and disappeared 30 min after completion of administration. The mean heart rate-lowering proportion at that time was −19.1 ± 8.1 % and −5.9 ± 9.7 % in the landiolol hydrochloride and placebo groups, respectively, showing a significantly higher proportion in the landiolol hydrochloride group.
Landiolol hydrochloride was confirmed to significantly and rapidly lower heart rate after intravenous injection, suggesting that it is a safe and useful agent for improving the image quality of CCTA.
PMCID: PMC3889825  PMID: 24174275
3.  A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease 
The purpose of this study was to compare the safety and efficacy of the short-acting β1-receptor blocker, landiolol hydrochloride (0.06 and 0.125-mg/kg), to placebo during coronary computed tomography angiography (CTA) in a phase 2 dose-finding study. A total of 183 patients suspected of having ischemic cardiac disease and scheduled to undergo an invasive coronary angiography were randomized to groups treated with landiolol hydrochloride (0.06 or 0.125-mg/kg) or placebo. The heart rate, safety, and the performance of coronary diagnosis using landiolol hydrochloride were evaluated in a multicenter, double-blind, randomized, parallel study. The patients’ heart rates during the coronary CTA were 67.6 ± 8.7 and 62.6 ± 7.8 beats/min in the 0.06 and 0.125-mg/kg landiolol hydrochloride groups, respectively, both of which were significantly lower than the heat rate of 73.7 ± 11.8 beats/min in the placebo group (P = 0.003 and P < 0.001, respectively). No adverse events or reactions occurred at an incidence of 5 % or greater, confirming the safety of landiolol hydrochloride. The proportion of correctly classified patients was significantly higher in the 0.125-mg/kg landiolol hydrochloride group than in the placebo group (73.6 vs. 50.0 %). Landiolol hydrochloride at doses of 0.06 and 0.125-mg/kg significantly decreased the heart rate compared with a placebo. The present findings suggest that landiolol hydrochloride is safe and useful at a dose of 0.125-mg/kg to improve coronary diagnostic performance during coronary CTA.
PMCID: PMC3722440  PMID: 23784548
Computed tomography; Beta-blocker; Safety; Heart rate; Coronary artery
4.  Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications 
PLoS ONE  2013;8(5):e66116.
For the pending National Claims Database in Japan, researchers will not have access to death information in the enrollment files. We developed and evaluated a claims-based definition of death.
Methodology/Principal Findings
We used healthcare claims and enrollment data between January 2005 and August 2009 for 195,193 beneficiaries aged 20 to 74 in 3 private health insurance unions. We developed claims-based definitions of death using discharge or disease status and Charlson comorbidity index (CCI). We calculated sensitivity, specificity and positive predictive values (PPVs) using the enrollment data as a gold standard in the overall population and subgroups divided by demographic and other factors. We also assessed bias and precision in two example studies where an outcome was death. The definition based on the combination of discharge/disease status and CCI provided moderate sensitivity (around 60%) and high specificity (99.99%) and high PPVs (94.8%). In most subgroups, sensitivity of the preferred definition was also around 60% but varied from 28 to 91%. In an example study comparing death rates between two anticancer drug classes, the claims-based definition provided valid and precise hazard ratios (HRs). In another example study comparing two classes of anti-depressants, the HR with the claims-based definition was biased and had lower precision than that with the gold standard definition.
The claims-based definitions of death developed in this study had high specificity and PPVs while sensitivity was around 60%. The definitions will be useful in future studies when used with attention to the possible fluctuation of sensitivity in some subpopulations.
PMCID: PMC3669209  PMID: 23741526
5.  Effectiveness of a Breastfeeding Self-efficacy Intervention: Do Hospital Practices Make a Difference? 
Breastfeeding self-efficacy interventions are important for improving breastfeeding outcomes. However, the circumstances that may influence the effectiveness of the interventions are unclear, especially in the context of hospitals with suboptimal infant feeding practices. Thus, we aimed to evaluate the effect of a self-efficacy intervention on breastfeeding self-efficacy and exclusive breastfeeding, and further assessed the difference in its effect by hospital-routine type. In this intervention study with a control group, 781 pregnant women were recruited from 2 “Baby-Friendly”-certified hospitals (BFH) and 2 non-Baby-Friendly Hospitals (nBFH) in Japan, and were allocated to an intervention or control group. Participants in the intervention group were provided with a breastfeeding self-efficacy workbook in their third trimester. The primary outcome was breastfeeding self-efficacy and the secondary outcome was infant feeding status. All analyses were stratified by the type of hospital, BFH or nBFH. In BFHs, the intervention improved both breastfeeding self-efficacy through 4 weeks postpartum (p = 0.037) and the exclusive breastfeeding rate at 4 weeks postpartum (AOR 2.32, 95 % CI 1.01–5.33). In nBFHs, however, no positive effect was observed on breastfeeding self-efficacy (p =  0.982) or on the exclusive breastfeeding rate at 4 weeks postpartum (AOR 0.97, 95 % CI 0.52–1.81); in nBFHs, supplementation was provided for breastfed infants and the mother and infant were separated in the vast majority of cases. Infant feeding status at 12 weeks was not improved in either hospital type. The intervention improved breastfeeding self-efficacy and exclusive breastfeeding at 4 weeks postpartum only in BFHs. When breastfeeding self-efficacy interventions are implemented, hospital infant feeding practices may need to be optimized beforehand.
PMCID: PMC3880483  PMID: 23592322
Baby-Friendly Hospitals; Breastfeeding self-efficacy; Exclusive breastfeeding; Intervention; Japan
6.  The clinical use of Kampo medicines (traditional Japanese herbal treatments) for controlling cancer patients’ symptoms in Japan: a national cross-sectional survey 
Kampo medicines are traditional Japanese medicines produced from medicinal plants and herbs. Even though the efficacy of Kampo medicines for controlling cancer-related symptoms is being reported, their actual nationwide clinical use has not been comprehensively investigated. We aimed to investigate physicians’ recognition of Kampo medicines and their clinical use for cancer patients in the field of palliative care.
A cross-sectional self-administered anonymous questionnaire was distributed to 549 physicians working in palliative care teams at 388 core cancer treatment hospitals and 161 certified medical institutions that have palliative care units (PCUs).
Valid responses were obtained from 311 physicians (response rate, 56.7%) who were evenly distributed throughout the country without significant geographical biases. Kampo medicines were prescribed for controlling cancer-related symptoms by 64.3% of the physicians. The symptoms treated with Kampo medicines were numbness/hypoesthesia (n = 99, 49.5%), constipation (n = 76, 38.0%), anorexia/weight loss (n = 72, 36%), muscle cramps (n = 71, 35.5%) and languor/fatigue (n = 64, 32.0%). Regarding open issues about prescription, 60.7% (n = 173) of the physicians raised the issue that the dosage forms need to be better devised.
To increase the clinical use of Kampo medicines, more evidence from clinical studies is necessary. In addition, their mechanisms of action should be clarified through laboratory studies.
PMCID: PMC3537749  PMID: 23167528
Kampo; Kampo medicine; Palliative care; Symptom management; Survey
8.  The effects of an intervention program for promoting interorganizational network building between multidisciplinary agencies and community-based organizations: a cluster trial in Japan 
BMC Public Health  2012;12:178.
Strengthening interorganizational relationships in the community has become an increasingly valued strategy for improving public health in recent years. However, no intervention strategy to foster an interorganizational network in the community has yet been devised. The purpose of this study was to examine the effects on members of an organization of an intervention program designed to promote interorganizational network building between multidisciplinary agencies and community-based organizations (CBOs).
The program was conducted in Setagaya and Suginami wards, Tokyo, Japan, for staff of community comprehensive support centers (CCSCs), which are multidisciplinary organizations responsible for the support of the elderly. A cluster non-randomized design with a CCSC as a cluster unit (N = 47) was used. The intervention group comprised 20 centers and the control group 27 centers. Those 27 centers declined to participate in program sessions, but did participate through completing pre- and post-intervention surveys. In total, 158 staff members were eligible to participate in this study, 73 from the intervention group and 85 from the control group. Of the 73 members in the intervention group, 19 participated in the monthly program sessions, over a period of 10 months. Attendees participated in group discussions during the sessions. The effects of the intervention were examined by comparing three groups (attendees and non-attendees of the program from the intervention group, and the control group) and between two groups (intervention group and control group).
We found no significant difference in any outcome between the intervention group and the control group. However, among the three groups, a significant effect was found in the recognition of knowledge and skills for building networks with CBOs. Recognition of knowledge and skills increased significantly among the attendees compared to non-attendees in the intervention group and the control group. In addition, there was a significant effect, particularly on those with relatively low baseline scores, for the recognition of knowledge and skills.
The tested intervention proved effective for attendees regarding their recognition of knowledge and skills for promoting interorganizational network building with CBOs.
PMCID: PMC3373367  PMID: 22404971
Interorganizational network; Multidisciplinary agency; Community-based organization; Intervention program
9.  Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study 
Critical Care  2012;16(1):R33.
Fever is frequently observed in critically ill patients. An independent association of fever with increased mortality has been observed in non-neurological critically ill patients with mixed febrile etiology. The association of fever and antipyretics with mortality, however, may be different between infective and non-infective illness.
We designed a prospective observational study to investigate the independent association of fever and the use of antipyretic treatments with mortality in critically ill patients with and without sepsis. We included 1,425 consecutive adult critically ill patients (without neurological injury) requiring > 48 hours intensive care admitted in 25 ICUs. We recorded four-hourly body temperature and all antipyretic treatments until ICU discharge or 28 days after ICU admission, whichever occurred first. For septic and non-septic patients, we separately assessed the association of maximum body temperature during ICU stay (MAXICU) and the use of antipyretic treatments with 28-day mortality.
We recorded body temperature 63,441 times. Antipyretic treatment was given 4,863 times to 737 patients (51.7%). We found that treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen independently increased 28-day mortality for septic patients (adjusted odds ratio: NSAIDs: 2.61, P = 0.028, acetaminophen: 2.05, P = 0.01), but not for non-septic patients (adjusted odds ratio: NSAIDs: 0.22, P = 0.15, acetaminophen: 0.58, P = 0.63). Application of physical cooling did not associate with mortality in either group. Relative to the reference range (MAXICU 36.5°C to 37.4°C), MAXICU ≥ 39.5°C increased risk of 28-day mortality in septic patients (adjusted odds ratio 8.14, P = 0.01), but not in non-septic patients (adjusted odds ratio 0.47, P = 0.11).
In non-septic patients, high fever (≥ 39.5°C) independently associated with mortality, without association of administration of NSAIDs or acetaminophen with mortality. In contrast, in septic patients, administration of NSAIDs or acetaminophen independently associated with 28-day mortality, without association of fever with mortality. These findings suggest that fever and antipyretics may have different biological or clinical or both implications for patients with and without sepsis.
Trial registration NCT00940654
PMCID: PMC3396278  PMID: 22373120
body temperature; antipyretic; fever; critical illness; mortality
10.  A region-based palliative care intervention trial using the mixed-method approach: Japan OPTIM study 
BMC Palliative Care  2012;11:2.
Disseminating palliative care is a critical task throughout the world. Several outcome studies explored the effects of regional palliative care programs on a variety of end-points, and some qualitative studies investigated the process of developing community palliative care networks. These studies provide important insights into the potential benefits of regional palliative care programs, but the clinical implications are still limited, because: 1) many interventions included fundamental changes in the structure of the health care system, and, thus, the results would not be applicable for many regions where structural changes are difficult or unfeasible; 2) patient-oriented outcomes were not measured or explored only in a small number of populations, and interpretation of the results from a patient's view is difficult; and 3) no studies adopted a mixed-method approach using both quantitative and qualitative methodologies to interpret the complex phenomenon from multidimensional perspectives.
This is a mixed-method regional intervention trial, consisting of a pre-post outcome study and qualitative process studies. The primary aim of the pre-post outcome study is to evaluate the change in the number of home deaths, use of specialized palliative care services, patient-reported quality of palliative care, and family-reported quality of palliative care after regional palliative care intervention. The secondary aim is to explore the changes in a variety of outcomes, including patients' quality of life, pain intensity, family care burden, and physicians' and nurses' knowledge, difficulties, and self-perceived practice. Outcome measurements used in this study include the Care Evaluation Scale, Good Death Inventory, Brief pain Inventory, Caregiving Consequence Inventory, Sense of Security Scale, Palliative Care Knowledge test, Palliative Care Difficulties Scale, and Palliative Care Self-reported Practice Scale. Study populations are a nearly representative sample of advanced cancer patients, bereaved family members, physicians, and nurses in the region.
Qualitative process studies consist of 3 studies with each aim: 1) to describe the process in developing regional palliative care in each local context, 2) to understand how and why the regional palliative care program led to changes in the region and to propose a model for shaping regional palliative care, and 3) to systemically collect the barriers of palliative care at a regional level and potential resolutions. The study methodology is a case descriptive study, a grounded theory approach based on interviews, and a content analysis based on systemically collected data, respectively.
This study is, to our knowledge, one of the most comprehensive evaluations of a region-based palliative care intervention program. This study has 3 unique aspects: 1) it measures a wide range of outcomes, including quality of care and quality of life measures specifically designed for palliative care populations, whether patients died where they actually preferred, the changes in physicians and nurses at a regional level; 2) adopts qualitative studies along with quantitative evaluations; and 3) the intervention is without a fundamental change in health care systems. A comprehensive understanding of the findings in this study will contribute to a deeper insight into how to develop community palliative care.
Trial Registration
UMIN Clinical Trials Registry (UMIN-CTR), Japan, UMIN000001274.
PMCID: PMC3349547  PMID: 22233691
11.  Age, gender, will, and use of home-visit nursing care are critical factors in home care for malignant diseases; a retrospective study involving 346 patients in Japan 
BMC Palliative Care  2011;10:17.
We aimed to clarify the factors affecting outcomes of home care for patients with malignant diseases.
Of 607 patients who were treated in 10 clinics specialized in home care between January and December 2007 at Chiba, Fukuoka, Iwate, Kagoshima, Tochigi and Tokyo prefectures across Japan, 346 (57%; 145 men and 201 women) had malignant diseases. We collected information on medical and social backgrounds, details of home care, and its outcomes based on their medical records.
Median age of the patients was 77 years (range, 11-102), and 335 patients were economically self-sufficient. Their general condition was poor; advanced cancer (n = 308), performance status of 3-4 (n = 261), and dementia (n = 121). At the beginning of home care, 143 patients and 174 family members expressed their wish to die at home. All the patients received supportive treatments including fluid replacement and oxygenation. Median duration of home care was 47 days (range, 0-2,712). 224 patients died at home. For the remaining 122, home care was terminated due to complications (n = 109), change of attending physicians (n = 8), and others (n = 5). The factors which inhibited the continuity of home care were the non-use of home-visit nursing care (hazard ratio [HR] = 1.78, 95% confidence interval [CI]: 1.05-3.00, p = 0.03), the fact that the patients themselves do not wish to die at home (HR = 1.83, CI: 1.09-3.07, p = 0.02), women (HR = 1.81, CI: 1.11-2.94, p = 0.02), and age (HR = 0.98, CI: 0.97-1.00, p = 0.02).
Continuation of home care is influenced by patients' age, gender, will, and use of home-visit nursing.
PMCID: PMC3227568  PMID: 22044683
palliative medicine; cancer; dementia; complication; performance status
12.  Alternative statistical methods for estimating efficacy of interferon beta-1b for multiple sclerosis clinical trials 
In the randomized study of interferon beta-1b (IFN beta-1b) for multiple sclerosis (MS), it has usually been evaluated the simple annual relapse rate as the study endpoint. This study aimed to investigate the performance of various regression models using information regarding the time to each recurrent event and considering the MS specific data generation process, and to estimate the treatment effect of a MS clinical trial data.
We conducted a simulation study with consideration of the pathological characteristics of MS, and applied alternative efficacy estimation methods to real clinical trial data, including 5 extended Cox regression models for time-to-event analysis, a Poisson regression model and a Poisson regression model with Generalized Estimating Equations (GEE). We adjusted for other important covariates that may have affected the outcome.
We compared the simulation results for each model. The hazard ratios of real data were estimated for each model including the effects of other covariates. The results (hazard ratios of high-dose to low-dose) of all models were approximately 0.7 (range, 0.613 - 0.769), whereas the annual relapse rate ratio was 0.714.
The precision of the treatment estimation was increased by application of the alternative models. This suggests that the use of alternative models that include recurrence event data may provide better analyses.
PMCID: PMC3118202  PMID: 21612661

Results 1-12 (12)