Takahiro Kiuchi

Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis

Objectives To evaluate the ability of tacrolimus to reduce the corticosteroid dose in patients with myasthenia gravis (MG) and the drugs safety in a double-blind, placebo-controlled, parallel group study. Methods Patients being treated with oral prednisolone at doses equivalent to 10–20 mg/day, and with stable symptoms, were randomised to tacrolimus or placebo in a 28-week double-blind study. The dose of corticosteroid was tapered with the procedures specified in the protocol. The primary efficacy endpoint was the mean daily prednisolone dose given in the last 12 weeks of the study. Results Eighty patients received the study drug (40 patients in each group) and were included in the full analysis set. In the full analysis set, there was no significant difference in the primary efficacy endpoint between the two groups (p=0.078). However, some secondary analyses suggested the steroid-sparing effect of tacrolimus. Tacrolimus was well tolerated, and no safety concerns were noted. Conclusions This study suggests that tacrolimus has a potential advantage as a steroid-sparing agent in the treatment of MG patients. Clinical trial registration number NCT00309088. Name of the trial registry: FK506 Phase 3 Study: A Study for Steroid Non-Resistant MG Patients.

Health literacy and health communication

Health communication consists of interpersonal or mass communication activities focused on improving the health of individuals and populations. Skills in understanding and applying information about health issues are critical to this process and may have a substantial impact on health behaviors and health outcomes. These skills have recently been conceptualized in terms of health literacy (HL). This article introduces current concepts and measurements of HL, and discusses the role of HL in health communication, as well as future research directions in this domain. Studies of HL have increased dramatically during the past few years, but a gap between the conceptual definition of HL and its application remains. None of the existing instruments appears to completely measure the concept of HL. In particular, studies on communication/interaction and HL remain limited. Furthermore, HL should be considered not only in terms of the characteristics of individuals, but also in terms of the interactional processes between individuals and their health and social environments. Improved HL may enhance the ability and motivation of individuals to find solutions to both personal and public health problems, and these skills could be used to address various health problems throughout life. The process underpinning HL involves empowerment, one of the major goals of health communication.

Increase in Memory (CD4+CD29+ and CD4+CD45RO+) T and Naive (CD4+CD45RA+)T-Cell Subpopulations in Smokers

To examine the effects of smoking on lymphocyte subpopulations, we measured the following cell subpopulations: CD4+ T-cell subpopulations (i.e., CD4+CD29+, CD4+ CD45RO+, and CD4+CD45RA+ cells); CD8+ T-cell subpopulations (i.e., CD8+CD11a+ and CD8+CD11b+ cells); and natural killer cell subpopulations (i.e., CD16+CD57-, CD16+CD57+, and CD16-CD57+ cells). We measured these subpopulations, together with total CD4+ T, total CD8+ T, total CD3+ T, B (CD19+), and total lymphocytes, in 10 male heavy smokers, 38 male light-to-moderate smokers, and 33 male nonsmokers. The mean ages were 30 y, 31 y, and 32 y, respectively, and ages did not vary significantly among the smokers. CD4+CD29+ and CD4+CD45RO+ (memory T) cells in heavy smokers were significantly more numerous than those in light-to-moderate smokers and nonsmokers. Also, these memory T-cell subpopulations were significantly more numerous in light-to-moderate smokers than in nonsmokers. The number of CD4+CD45RA+ (naive T) cells was significantly larger in heavy smokers than nonsmokers; numbers of CD4+CD45RO+ T and CD4+CD29+ T cells (memory T cells) were significantly correlated with daily cigarette consumption. Numbers of CD3+ T, CD4+ T, CD19+ B, and total lymphocytes in heavy smokers were significantly larger than in nonsmokers. There were significantly more CD3+ T, CD4+ T, and total lymphocytes in light-to-moderate smokers than in nonsmokers. The numbers of CD4+ T lymphocytes in heavy smokers were significantly larger than in light-to-moderate smokers. Perhaps CD4+ T cell subpopulations, especially memory T cells, are most susceptible to the effects of smoking on lymphocyte subpopulations.

Influence of sex and age on serum nitrite/nitrate concentration in healthy subjects.

Measurement of serum nitrite/nitrate (NOx) concentrations has been considered useful to estimate nitric oxide production in humans. However little is known about the physiologic range and the factors affecting serum NOx levels. The aim of this study was, thus, to investigate the influence of sex and age on serum NOx levels in healthy subjects. We selected 263 healthy subjects (118 women and 145 men, 20-69 y) from 505 consecutive subjects who received annual medical checkups at our hospital. Serum NOx levels were determined using an analyzer employing the Griess method. The linear regression analysis showed that NOx increased significantly according to age in women (r=0.22, P<0.05), but did not in men (P=NS). Women of the younger age group (<40 y) showed significantly lower NOx levels than men of the same age group (P<0.05), whereas there was no significant difference between men and women of the older age (> or =40 y). Then, to investigate whether menopause affects serum NOx levels, middle aged women (46-55 y) were selected. Multiple logistic regression analysis showed that menopause was an independent factor for increased serum NOx levels in middle aged women (r=0.4, P<0.05). These results suggest that the serum NOx concentration is affected by age in healthy women, possibly depending on menopausal state.

Communicative and critical health literacy, and self-management behaviors in end-stage renal disease patients with diabetes on hemodialysis

OBJECTIVE Health literacy (HL) has been linked to disease self-management and various health outcomes, and can be separated into components of functional, communicative and critical skills. The high comorbidity between diabetes and end-stage renal disease (ESRD) poses concerns for compromised disease self-management. This study aimed to identify the relationships between HL and self-management behaviors in end-stage renal disease patients with diabetes. METHODS Self-report questionnaires measuring HL and self-management with the functional, communicative and critical HL scale and Summary of Diabetes Self-Care Activities, respectively, were implemented with a sample of 63 patients. Socio-demographic and clinical characteristics were obtained from medical records. RESULTS Self-management in diabetes was associated with communicative and critical HL, but not functional HL. Educational attainment was associated only with functional HL. No relationship between HL and glycated hemoglobin (HbA1c) was identified. CONCLUSION Communicative and critical HL skills are associated with self-management in ESRD patients with diabetes. Education levels are not related to self-management. PRACTICE IMPLICATIONS Healthcare professionals and health information aiming to improve self-management in ESRD patients with diabetes should consider their capacities of communicative and critical HL instead of solely assessing functional HL.

A world wide web-based user interface for a data management system for use in multi-institutional clinical trials—Development and experimental operation of an automated patient registration and random allocation system

We have employed the Hypertext Transfer Protocol (HTTP) and Hypertext Markup Language (HTML) to develop an automated patient registration and random allocation system for use in a multi-institutional clinical trial. We made it available on-line to World Wide Web clients in each hospital through a user friendly graphical user interface. During experimental operation, the physicians found it satisfactory from the viewpoint of both ease of operation and response time. For the development of a graphical user interface in network-based information system for use in multi-institutional clinical trials, HTTP/HTML has several advantages over an ordinary client-server model. Therefore, we concluded that we would adopt HTP/HTML for the construction of user interfaces for physicians in each spital and for data managers in our coordinating center.

Polymorphism of the apolipoprotein E and angiotensin I converting enzyme genes in Japanese patients with myocardial infarction.

ObjectiveTo investigate the genetic contribution for myocardial infarction. MethodsWe investigated common polymorphisms of apolipoprotein E gene and angiotensin converting enzyme (ACE) gene in Japanese population. Subjects were 422 healthy people and 254 patients with myocardial infarction. We evaluated the 287 base pair (bp) insertion (I)/deletion (D) polymorphism in intron 16 of the ACE gene and a polymorphism in the apolipoprotein E gene by using the polymerase chain reaction. ResultsThe ACE genotype prevalences for II, ID, and DD were 36.2, 46.1, and 17.7%, respectively, among the myocardial infarction patients. The prevalence of the D allele of the ACE gene among the myocardial infarction patients (0.593) exceeded that among the healthy controls (0.407). The prevalences of the ϵ2, ϵ3, and ϵ4 alleles of the apolipoprotein E genotype among healthy controls were 0.024, 0.882, and 0.094, and those among survivors of myocardial infarction were 0.024, 0.834, and 0.142, respectively. Myocardial infarction patients had an excessive prevalence of the apolipoprotein E ϵ4 allele (P < 0.05). Multiple regression analysis demonstrated that the independent risk factors for developing myocardial infarction were age, DD genotype of ACE gene, and apolipoprotein E ϵ4 allele. Stenotic coronary vessels in myocardial infarction patients did not differ significantly among the patients with various ACE and apolipoprotein E genotypes in the present study. ConclusionsAmong the Japanese, apolipoprotein E ϵ4 carriers and subjects with ACE DD genotype are at an increased risk of myocardial infarction.

Online machine translation use with nursing literature: evaluation method and usability.

Japanese nurses are now being required to use research in clinical practice. As a result, they increasingly need to read nursing research literature written in English. Online machine translation is a convenient tool that may address any existing language barrier. The quality of machine translation has been evaluated using various methods; however, its reliability for nursing literature is unknown. In this study, existing methods for evaluating online machine translation quality were examined for structural accuracy and intelligibility of translations of nursing literature, and the usability of machine translations is discussed. In total, 297 English sentences from nursing study abstracts were evaluated for accuracy and intelligibility; 75 word items were identified as specific terms. Interrater reliability of the evaluation method was measured using two raters. The results showed the strong reliability of the existing evaluation method. Also, a possibly usable online machine translation system being offered in Japan was identified. Specific terms seemed to influence the extent of the intelligibility of the translations. Future studies need to include more samples of the nursing population to examine general perceptions of the usability of online machine translation systems for reading English nursing literature among the Japanese nursing population.

Development and trial operation of a World Wide Web-based data entry system for the collection of statistical data on the management of the national university hospitals in Japan

A WWW-based, on-line, data-entry system for the collection of statistical data on the management of Japanese national university hospitals has been developed. Trial operation of the system showed that it can reduce the labour and budgetary costs of data collection and also demonstrated that an on-line, data-entry system is feasible in Japan. In April 1997, we began production use of the system, and we are to develop another WWW-based data-entry system that can deal with all other statistics on hospital management.

Predicting complete loss to follow-up after a health-education program: number of absences and face-to-face contact with a researcher

BackgroundResearch on health-education programs requires longitudinal data. Loss to follow-up can lead to imprecision and bias, and complete loss to follow-up is particularly damaging. If that loss is predictable, then efforts to prevent it can be focused on those program participants who are at the highest risk. We identified predictors of complete loss to follow-up in a longitudinal cohort study.MethodsData were collected over 1 year in a study of adults with chronic illnesses who were in a program to learn self-management skills. Following baseline measurements, the program had one group-discussion session each week for six weeks. Follow-up questionnaires were sent 3, 6, and 12 months after the baseline measurement. A person was classified as completely lost to follow-up if none of those three follow-up questionnaires had been returned by two months after the last one was sent.We tested two hypotheses: that complete loss to follow-up was directly associated with the number of absences from the program sessions, and that it was less common among people who had had face-to-face contact with one of the researchers. We also tested predictors of data loss identified previously and examined associations with specific diagnoses.Using the unpaired t-test, the U test, Fishers exact test, and logistic regression, we identified good predictors of complete loss to follow-up.ResultsThe prevalence of complete loss to follow-up was 12.2% (50/409). Complete loss to follow-up was directly related to the number of absences (odds ratio; 95% confidence interval: 1.78; 1.49-2.12), and it was inversely related to age (0.97; 0.95-0.99). Complete loss to follow-up was less common among people who had met one of the researchers (0.51; 0.28-0.95) and among those with connective tissue disease (0.29; 0.09-0.98). For the multivariate logistic model the area under the ROC curve was 0.77.ConclusionsComplete loss to follow-up after this health-education program can be predicted to some extent from data that are easy to collect (age, number of absences, and diagnosis). Also, face-to-face contact with a researcher deserves further study as a way of increasing participation in follow-up, and health-education programs should include it.