Quality of life assessment and reporting in randomized controlled trials: a study of literature published from Japan

BACKGROUND: Standardization of quality of life (QOL) assessment and reporting in clinical trials is an imperative issue. While English-speaking countries have led this movement in standardization, there persists to be a limited amount of information from non-English-speaking including Japan. In this study, we bibliographically analyze the reporting of randomized controlled trials (RCT) conducted in Japan that used a QOL instrument. METHODS: A PubMed search of reports published between 1970–2003 followed by an examination of QOL reporting and its frequency of use in RCTs published from Japan. RESULTS: Percentages of QOL reporting in RCTs have increased between 1970–2003 both worldwide (0% for 1970–1974 to 4.4% for 2000–2003) and in Japan (0% to 1.8% for the identical periods). We found and evaluated 46 RCT reports published from Japan (32 in English, 14 in Japanese). The most commonly studied clinical condition was cancer (26, 56.5%) and the most common intervention was drug therapy (29, 63.0%). QOL was used as the primary endpoint in 10 studies (21.7%). Authors used established QOL instruments in 12 studies (26.1%), developed original instruments in 8 studies (17.5%) and assessed the symptoms or performance status in 10 studies (21.7%). Authors conceptually defined QOL in only 6 studies (13.0%). Neither response rate nor number of respondents for questionnaire surveys was specified in 16 studies (34.8%); furthermore, 11 studies (23.9%) did not describe respondents' attributes. CONCLUSIONS: Findings on relative frequency suggested that Japanese authors of RCT reports have less interest in QOL instruments than other international researchers in Western Europe and North America. Examination of RCT reports published from Japan revealed that there were several points to be improved in reporting QOL instruments. This study highlights the need to define QOL measures specific to clinical specialty and to examine methodology for assessing and reporting QOL

Parental Smoking and Smoking Status of Japanese Dental Hygiene Students: A Pilot Survey at a Dental Hygiene School in Japan

This study aimed to determine the frequency of smoking and to explore factors associated with the smoking habits of female students at a dental hygiene school in Japan. Questionnaires regarding cigarette smoking were given to 168 female students. The response rate was 97.6%. The prevalence of smoking, including current and occasional smokers, was 20.3%. Among family members, only the smoking status of their mother significantly influenced the smoking status of the students. The odds ratio for smoking among dental hygiene students whose mothers were smokers in comparison to students whose mothers were not smokers was 5.1 (95% confidence interval 2.1–12.2, p=0.000). Decision tree analysis showed that the smoking habit of dental hygiene students was correlated with their mothers’ smoking history, as well as the smoking status of junior high school teachers, the smoking habits of close friends and a history of participating in a smoking prevention program when in elementary school. The increased smoking rate of young females, including dental hygienists, is a growing problem in Japan. The smoking statuses of dental hygiene students might be closely influenced by their mothers’ smoking status

Improvement of the target sensitivity in DECIGO by optimizing its parameters for quantum noise including the effect of diffraction loss

DECIGO is the future Japanese gravitational wave detector in outer space. We previously set the default design parameters to provide a good target sensitivity to detect the primordial gravitational waves (GWs). However, the updated upper limit of the primordial GWs by the Planck observations motivated us for further optimization of the target sensitivity. Previously, we had not considered optical diffraction loss due to the very long cavity length. In this paper, we optimize various DECIGO parameters by maximizing the signal-to-noise ratio (SNR), for the primordial GWs to quantum noise including the effects of diffraction loss. We evaluated the power spectrum density for one cluster in DECIGO utilizing the quantum noise of one differential Fabry-Perot interferometer. Then we calculated the SNR by correlating two clusters in the same position. We performed the optimization for two cases: the constant mirror-thickness case and the constant mirror-mass case. As a result, we obtained the SNR dependence on the mirror radius, which also determines various DECIGO parameters. This result is the first step toward optimizing the DECIGO design by considering the practical constraints on the mirror dimension and implementing other noise sources.Comment: 13 pages, 12 figure

One-Year Period Prevalence of Oral Aphthous Ulcers and Oral Health-Related Quality of Life in Patients with Behçet's Disease

The aim of this study was to investigate the 1-year period prevalence of oral aphthous ulcers (OAUs) and their association with oral health-related quality of life (OHQOL) in patients with Behçet's disease (BD) and in the general population. In this cross-sectional study, 675 patients with Behçet's disease (BD group) and 1,097 males and females in the Japanese general population (control group) completed both questionnaires on their OAU status during the prior year and the General Oral Health Assessment Index (GOHAI). In the BD group, 84% of patients reported experiencing an OAU during the previous year, and the mean number of OAUs/year was 13. In the control group, 31% of individuals experienced an OAU during the previous year, and the mean number of OAUs/year was one. Multivariate analysis indicated that both BD patients (OR, 6.2; 95% CI, 4.8-8.0) and controls (OR, 2.6; 95% CI, 2.0-3.5) who had OAUs at least twice per year were more likely to have GOHAI scores below the norm than were controls who had fewer than two OAUs per year. The association between HLA-B * 51 and OAUs remains unknown. The presence of OAUs has a negative effect on the OHQOL of patients with BD

Live-attenuated vaccination in patients with inflammatory bowel disease while continuing or after elective switch to vedolizumab

Background/Aims Vedolizumab (VDZ) is a gut-selective agent with a favorable safety profile. We aimed to assess the feasibility of elective switch from other advanced therapies to VDZ and subsequent live-attenuated vaccination while continuing VDZ in patients with inflammatory bowel diseases (IBD). Methods We measured antibody titers specific for measles, rubella, mumps, and varicella viruses in IBD patients under immunosuppressive therapy. Those with negative titers and without vaccination history were judged unimmunized. Patients were administered vaccines while continuing VDZ or switched to VDZ if receiving other advanced therapies and then administered vaccines. Co-primary outcomes were the rate of maintaining disease severity after vaccination and the rate without vaccine-induced infection. Results Among 107 unimmunized patients, 37 agreed to receive live-attenuated vaccines while continuing VDZ (17 patients) or after switching to VDZ (20 patients). In the 20 patients who electively switched to VDZ, disease severity was maintained except for 1 patient who developed intestinal infection. After 54 weeks, 18 patients (90%) continued to receive VDZ, excluding 2 patients who reverted to their originally administered biologics. In all 37 patients administered live-attenuated vaccines under VDZ treatment, disease severity was maintained after vaccination. Antibody titers became positive or equivocal in 34 patients (91.9%). There were no cases of vaccine-induced infection during a median observation period of 121 weeks. Conclusions While live-attenuated vaccines are contraindicated under immunosuppressive therapy, they may be safely administered while receiving VDZ immunotherapy. Switching from other advanced therapies to VDZ and subsequently receiving live-attenuated vaccines may be a safe alternative in unimmunized patients