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1.  Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials 
Trials  2013;14:333.
Established on 1 June 2005, the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is the largest clinical trial registry in Japan, and joined the World Health Organization (WHO) registry network in October 2008. Our aim was to understand the registration trend and overall characteristics of Japan domestic, academic (non-industry-funded) clinical trials, which constitute the main body of registrations in UMIN-CTR. In addition, we aimed to investigate the accessibility of clinical trials in UMIN-CTR to people worldwide, as well as the accessibility of clinical trials conducted in Japan but registered abroad to Japanese people in the Japanese language.
We obtained the data for registrations in UMIN-CTR from the UMIN Center, and extracted Japan domestic, academic clinical trials to analyze their registration trend and overall characteristics. We also investigated how many of the trials registered in UMIN-CTR could be accessed from the International Clinical Trials Registry Platform (ICTRP). Finally, we searched for all clinical trials conducted in Japan and investigated how many of them were also registered in Japanese registries. All of the above analyses included clinical trials registered from 2 June 2005 to 1 June 2010.
During the period examined, the registration trend showed an obvious peak around September 2005 and rapid growth from April 2009. Of the registered trials, 46.4% adopted a single-arm design, 34.5% used an active control, only 10.9% were disclosed before trial commencement, and 90.0% did not publish any results. Overall, 3,063 of 3,064 clinical trials registered in UMIN-CTR could be accessed from ICTRP. Only 8.7% of all clinical trials conducted in Japan and registered in were also registered in Japanese registries.
The International Committee of Medical Journal Editors (ICMJE) announcements about clinical trial registration and the Ethical Guidelines for Clinical Research published by the Japanese government are considered to have promoted clinical trial registration in UMIN-CTR. However, problems associated with trial design, retrospective registration, and publication of trial results need to be addressed in future. Almost all clinical trials registered in UMIN-CTR are accessible to people worldwide through ICTRP. However, many trials conducted in Japan but registered abroad cannot be accessed from Japanese registries in Japanese.
PMCID: PMC4015268  PMID: 24124926
UMIN-CTR; Clinical trial registration; Non-industry-funded trial; Accessibility; Comparative effectiveness research; Results publication
2.  Decay of Impact after Self-Management Education for People with Chronic Illnesses: Changes in Anxiety and Depression over One Year 
PLoS ONE  2013;8(6):e65316.
In people with chronic illnesses, self-management education can reduce anxiety and depression. Those benefits, however, decay over time. Efforts have been made to prevent or minimize that “decay of impact”, but they have not been based on information about the decay’s characteristics, and they have failed. Here we show how the decay’s basic characteristics (prevalence, timing, and magnitude) can be quantified. Regarding anxiety and depression, we also report the prevalence, timing, and magnitude of the decay.
Adults with various chronic conditions participated in a self-management educational program (n = 369). Data were collected with the Hospital Anxiety and Depression Scale four times over one year. Using within-person effect sizes, we defined decay of impact as a decline of ≥0.5 standard deviations after improvement by at least the same amount. We also interpret the results using previously-set criteria for non-cases, possible cases, and probable cases.
Prevalence: On anxiety, decay occurred in 19% of the participants (70/369), and on depression it occurred in 24% (90/369). Timing: In about one third of those with decay, it began 3 months after the baseline measurement (6 weeks after the educational program ended). Magnitude: The median magnitudes of decay on anxiety and on depression were both 4 points, which was about 1 standard deviation. Early in the follow-up year, many participants with decay moved into less severe clinical categories (e.g., becoming non-cases). Later, many of them moved into more severe categories (e.g., becoming probable cases).
Decay of impact can be identified and quantified from within-person effect sizes. This decay occurs in about one fifth or more of this program’s participants. It can start soon after the program ends, and it is large enough to be clinically important. These findings can be used to plan interventions aimed at preventing or minimizing the decay of impact.
PMCID: PMC3681854  PMID: 23785418
3.  Preliminary study of online machine translation use of nursing literature: quality evaluation and perceived usability 
BMC Research Notes  2012;5:635.
Japanese nurses are increasingly required to read published international research in clinical, educational, and research settings. Language barriers are a significant obstacle, and online machine translation (MT) is a tool that can be used to address this issue. We examined the quality of Google Translate® (English to Japanese and Korean to Japanese), which is a representative online MT, using a previously verified evaluation method. We also examined the perceived usability and current use of online MT among Japanese nurses.
Randomly selected nursing abstracts were translated and then evaluated for intelligibility and usability by 28 participants, including assistants and research associates from nursing universities throughout Japan. They answered a questionnaire about their online MT use. From simple comparison of mean scores between two language pairs, translation quality was significantly better, with respect to both intelligibility and usability, for Korean-Japanese than for English-Japanese. Most respondents perceived a language barrier. Online MT had been used by 61% of the respondents and was perceived as not useful enough.
Nursing articles translated from Korean into Japanese by an online MT system could be read at an acceptable level of comprehension, but the same could not be said for English-Japanese translations. Respondents with experience using online MT used it largely to grasp the overall meanings of the original text. Enrichment in technical terms appeared to be the key to better usability. Users will be better able to use MT outputs if they improve their foreign language proficiency as much as possible. Further research is being conducted with a larger sample size and detailed analysis.
PMCID: PMC3576310  PMID: 23151362
Online machine translation; Evaluation; Usability; Nursing literature; Japanese nurses
4.  Predicting complete loss to follow-up after a health-education program: number of absences and face-to-face contact with a researcher 
Research 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.
Data 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, Fisher's exact test, and logistic regression, we identified good predictors of complete loss to follow-up.
The 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.
Complete 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.
PMCID: PMC3215183  PMID: 22032732
5.  Birefringence measurement of cornea and anterior segment by office-based polarization-sensitive optical coherence tomography 
Biomedical Optics Express  2011;2(8):2392-2402.
We present a case series of cornea and anterior segment disorders investigated by an office-based polarization-sensitive optical coherence tomography (PS-OCT). Blebs of glaucoma patients treated by trabeculectomy, and corneas of keratoconus and keratoplasty patients were measured by PS-OCT. Birefringence formations in trabeculectomy bleb were measured in 1 control eye and 3 eyes of trabeculectomy model rabbits. Polarization insensitive scattering OCT and the depth-resolved birefringence were measured simultaneously by PS-OCT. Abnormal birefringence was observed in keratoconus cases with advanced thinning and with a rupture of Descemet’s membrane. The graft-host interface of the keratoplasty case showed abnormal birefringence. The appearance of abnormal birefringence in the cornea was likely to be an indication of cross-linking of collagen fibrils. The measurement of rabbit showed abnormal birefringence in the scarring eyes. Wide regions of strong birefringence were observed in the eyes of trabeculectomy patients who had high intraocular pressure. Visualization of scarring in bleb by PS-OCT may be useful for the planning of secondary surgery. PS-OCT showed promising for the study and diagnosis diseases related to abnormal fibrous tissues of the cornea and anterior eye segment.
PMCID: PMC3149537  PMID: 21833376
(170.1610) Clinical application; (170.2655) Functional monitoring and imaging; (170.3880) Medical and biological imaging; (170.4500) Optical coherence tomography; (170.4460) Ophthalmic optics and devices; (170.4470) Ophthalmology
6.  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.
PMCID: PMC2990724  PMID: 21054840
7.  Carteolol Hydrochloride Suppresses the Generation of Reactive Oxygen Species and Rescues Cell Death After Ultraviolet Irradiation of Cultured Lens Epithelial Cells 
Anti-oxidant activities of adrenergic β-blockers are proposed in various organs. The aim of the present study was to investigate the effect of carteolol hydrochloride, an adrenergic β-blocker, on the production of reactive oxygen species (ROS) and the viable cell number after ultraviolet irradiation of cultured lens epithelial cells (LECs).
Materials and Methodology:
Cultured LECs were exposed to 0, 10–5, 10–4, and 10–3 M carteolol hydrochloride for 30 min followed by ultraviolet B (UVB) irradiation at intensity of 100, 200, or 400 mJ/cm2. The amount of ROS in the LECs was measured using dichlorodihydrofluorescein at 30 min after exposure to UVB. In addition, the number of living LECs was counted at 15 h after exposure to UVB.
Exposure to 10–3 M carteolol hydrochloride significantly decreased the amount of ROS after exposure to UVB at intensities of 100, 200, and 400 mJ/cm2. In addition, 10–3 M carteolol hydrochloride significantly increased the viable cell number after exposure to UVB at 400 mJ/cm2. However, 10–4 and 10–5M carteolol hydrochloride had no significant effect on ROS or the viable cell number in LECs.
Carteolol hydrochloride protects LECs against UVB irradiation by inhibiting the intracellular production of ROS.
PMCID: PMC3031156  PMID: 21283534
Reactive oxygen species; carteolol hydrochloride; ultraviolet; antioxidant; lens epithelial cells.
8.  Hidden decay of impact after education for self-management of chronic illnesses: hypotheses 
Chronic Illness  2013;9(1):73-80.
People with chronic illnesses can benefit from self-management education. However, those benefits are said to decay over time (there is some evidence that this ‘decay of impact’ does occur), and the reinforcements used to prevent that decay appear to be ineffective. We hypothesize that the reinforcements appear to be ineffective because decay of impact occurs only in a subgroup of these programs' participants, so any benefits of reinforcements in that subgroup are concealed by whole-group summary statistics. We also hypothesize that reinforcements can benefit those who need them – those who would otherwise have decay. One approach to testing these hypotheses requires analysis of individual-level data, which is uncommon in this field. Some useful data could come from studies that have already been completed, but the strongest evidence will require prospectively designed tests in future trials. If the hypotheses are false, then time and resources spent on reinforcements can be saved or redirected. If the hypotheses are true, then reinforcements can be implemented with less waste and they can be made more effective. These programs can also be improved to better fit their users’ needs, and there can be a new basis for evaluating the programs’ effectiveness.
PMCID: PMC3697900  PMID: 22777566
Chronic illness; self-management; backsliding; decay of impact; reinforcement

Results 1-8 (8)