Quality of life with docetaxel plus cisplatin versus paclitaxel plus carboplatin in patients with completely resected non-small cell lung cancer: quality of life analysis of TORG 0503.

PURPOSE: The TORG0503 study was undertaken to select a preferred platinum-based third-generation regimen for patients with completely resected non-small cell lung cancer (NSCLC). This study aimed to describe the quality of life (QOL) analysis of that study. METHODS: Patients with completely resected NSCLC were randomized to receive three cycles of docetaxel plus cisplatin (DC) or paclitaxel plus carboplatin (PC) on day 1 every 3 weeks. QOL was assessed at three time points (baseline, after two cycles, and after three cycles) using the Functional Assessment of Cancer Therapy-taxane (FACT-Taxane). The adjusted odds ratio (OR) and 95% confidence interval (CI) were calculated by logistic regression analysis that was adjusted for the baseline score in the FACT-Taxane total score and each subscale to evaluate treatment (PC vs. DC) effectiveness. RESULTS: QOL data from 104 patients (DC, n = 56 patients; PC, n = 48) were analyzed. In the FACT-Taxane total score, the baseline-adjusted OR (95% CI) of not worse QOL for the DC group was 3.3 (1.4-8.3) compared with the PC group. In the taxane subscale, the baseline-adjusted OR (95% CI) was 6.2 (2.6-16.0). CONCLUSION: Total QOL was maintained better in the DC group than in the PC group, especially the taxane subscale that consists of neurotoxicity and taxane components in spite of no treatment-related death in both arms between DC and PC. We might recommend DC as the control regimen for the next clinical trial from the viewpoint of QOL, similar to the primary outcomes in TORG0503.

Behavioral changes of preventive activities of influenza among children in satellite cities of a metropolitan area of Tokyo, Japan, by the COVID-19 pandemic.

OBJECTIVE: In children in a metropolitan area of Tokyo, Japan, behavioral change and influenza infection associated with the frequency of nonpharmaceutical interventions (NPI) was assessed from the 2018-2019 season (Preseason) and the 2020-2021 season (coronavirus disease 2019 [COVID-19] season). METHODS: We conducted an exclusive survey among children attending preschool, elementary school, and junior high school in the Toda and Warabi regions, Japan, during the 2018-2019 (Preseason, distributed via mail) and 2020-2021 seasons (COVID-19 season, conducted online). The proportion of preventive activities (hand washing, face mask-wearing, and vaccination) was compared in the Preseason with that of the COVID-19 season. The multivariate logistic regression model was further applied to calculate the adjusted odds ratio (AOR) with 95% confidence intervals (CIs) for influenza infection associated with NPI frequency (hand washing and face mask wearing) in each Preseason and COVID-19 season. RESULTS: The proportion of vaccinated children who carried out hand washing and face mask wearing was remarkably higher during the COVID-19 season (48.8%) than in the Preseason (18.2%). A significant influenza infection reduction was observed among children who washed hands and wore face masks simultaneously (AOR, 0.87; 95% CI, 0.76-0.99; P = 0.033). CONCLUSIONS: A strong interest and performance in the intensive measures for the prevention of influenza under the COVID-19 pandemic was demonstrated. Positive association was observed from a combination of NPI, hand washing, and face mask-wearing and influenza infection. This study's findings could help in activities or preventive measures against influenza and other communicable diseases in children.

Impact of a national screening programme on obesity and cardiovascular risk factors.

AIMS: The benefits of nationwide screening and tailored health guidance on improving obesity and cardiovascular risk factors is uncertain. The aim of the present study was to investigate the association of the national health screening and tailored health guidance with population health outcomes. METHODS AND RESULTS: A fuzzy regression discontinuity design analysed data of men and women aged 40-74 years who participated in a nationwide health screening programme in Japan from 1 April 2008 to 31 March 2019 and were recorded in the Japanese National Database. Exposure was assignment to the national health guidance of counselling on healthy lifestyle and clinical follow-up for individuals found to have waist circumference ≥85 cm for men ≥90 cm for women with one or more cardiovascular risk factors during annual national health screening. The primary outcomes were changes in obesity status and cardiovascular risk factors 1 year after screening. Of 3 490 112 men and 2 328 929 women, the assignment to the health guidance resulted in small reductions in obesity parameters: waist circumference; men, -0.27 cm [95% confidence interval (CI) -0.29 to -0.26]; women -0.34 (-0.41 to -0.27); body mass index, -0.07 kg/m2 (-0.075 to -0.066); -0.11 kg/m2 (-0.13 to -0.10); weight, -0.21 kg (-0.22 to -0.19); -0.28 kg (-0.32 to -0.24) that attenuated over time. Short-term improvements were also observed in blood pressure, haemoglobin A1c, fasting glucose and triglycerides across both sexes. CONCLUSION: A nationwide health screening programme was associated with only small, and transient improvements in obesity and cardiovascular risk factors.

In this national cohort of 5 819 041 men and women in Japan, we provide robust evidence that nationwide assignment to the health guidance resulted in only a small reduction in obesity parameters in men and women which was lost within only a few years. Exposure to the health guidance also failed to lead to long-term changes in cardiovascular risk factors and lifestyle behaviours. Japan is the only country with large populace across the globe that provides the annual prevention programme, and thus this study renders unique results of international importance.

Epidemiological survey to establish thresholds for influenza among children in satellite cities of Tokyo, Japan, 2014-2018.

Objective: We described the characteristics of children reported as having influenza across five consecutive influenza seasons and investigated the usefulness of setting influenza thresholds in two satellite cities of Tokyo, Japan. Methods: An annual survey was conducted among parents of children at preschools (kindergartens and nursery schools), elementary schools and junior high schools in Toda and Warabi cities, Saitama prefecture, at the end of the 2014-2018 influenza seasons. Using the World Health Organization method, we established seasonal, high and alert thresholds. Results: There were 64 586 children included in the analysis. Over the five seasons, between 19.1% and 22% of children annually were reported as having tested positive for influenza. Influenza type A was reported as the dominant type, although type B was also reported in more than 40% of cases in the 2015 and 2017 seasons. The median period of the seasonal peak was 3 weeks in mid-January, regardless of school level. Of the five surveyed seasons, the high threshold was reached in 2014 and 2018, with no season exceeding the alert threshold. Discussion: This study provides insights into the circulation of influenza in children in the study areas of Toda and Warabi, Japan, from 2014 to 2018. Although we were able to utilize these annual surveys to calculate influenza thresholds from five consecutive seasons, the prospective usefulness of these thresholds is limited as the survey is conducted at the end of the influenza season.

Effectiveness of Influenza Vaccination among Children in Satellite Cities of a Metropolitan Area in Tokyo, Japan during the 2014/2015-2018/2019 Season.

Influenza vaccination is recommended for children. In particular, those aged 6 months to 12 years were recommended two vaccinations in Japan, whereas the recommended year range for the twice vaccination is 6 months to 8 years by the World Health Organization (WHO). This study assessed the effectiveness of influenza vaccination and whether the twice vaccinations enhanced preventive effects against influenza infection among children living in two satellite cities of a metropolitan area in Tokyo, Japan. During the influenza season of 2014-2018, parents of all preschool, elementary school, and junior high school children participated in an annual survey. Adjusted odds ratios (AOR) with 95% confidence intervals (CIs) were calculated via multivariate logistic regression analysis to evaluate influenza vaccination effectiveness and trends in the number of vaccinations. Among the 108,362 children who received the research questionnaire, 76,753 (70.8%) responded. After excluding responses without basic information, 64,586 children were included in the analysis. Vaccination was more effective in preschool and lower grade elementary school children given the increase in the number of vaccinations (test for trend: P < 0.001). The AOR of influenza for pre, grade 1 elementary, and grade 2 schoolchildren who received two vaccinations was 0.63 (95% CI, 0.59-0.69), 0.75 (0.67-0.83), and 0.81 (0.71-0.92), respectively, when compared to those without vaccination. However, no trend in vaccinations and their effectiveness was observed in the third and higher-grade school children. Our findings support the recommendation by the WHO, and could help guide influenza vaccination policies for children in Japan.

Effects of a Self-Monitoring Quality of Life Intervention in Outpatients with Breast Cancer: A Preliminary Report of A Randomized Controlled Trial.

OBJECTIVE: This preliminary report used data from a randomized controlled clinical trial to investigate the beneficial effects of a self-monitoring quality of life (SMQOL) intervention on communication, medical care and patient outcomes in Japanese women with breast cancer. METHODS: This study compared a SMQOL intervention group with a control group that received usual care after 4 months on self-efficacy aspects of patient-physician communication among outpatients with breast cancer in Japan using the Perceived Efficacy in Patient-Physician Interactions (PEPPI) questionnaire. Patients were randomly assigned to the intervention and control groups using permuted-block randomization. The intervention groups were asked to complete a paper-based quality-of-life (QOL) questionnaire in addition to the usual care provided in the control group. Analysis of covariance was used to assess the difference in PEPPI scores between the intervention and control groups. Additionally, subgroup analyses were performed for outpatients with breast cancer accompanied by depression or anxiety. RESULTS: In total, 232 patients were eligible for this study and randomized. Seven patients did not answer the PEPPI questionnaire at baseline after group allocation, leaving 225 patients for inclusion in the analyses. The modified intention-to-treat ITT analysis showed the SMQOL intervention had no significant effect on PEPPI total score (P = 0.226). We found a significant between-group difference in PEPPI total score in the anxiety group (P = 0.045), namely, the self-efficacy aspects of patient-physician communication of those with anxiety in the intervention group were better than for those in the control group after 4 months. CONCLUSION: Use of the SMQOL had beneficial effects on communication self-efficacy between patients and physicians for outpatients with breast cancer, those with anxiety.

Perceptions of Japanese and Dutch women with early breast cancer about monitoring their quality of life.

OBJECTIVE: Monitoring quality of life (QoL) in patients with cancer can provide insight into functional, psychological and social consequences associated with illness and its treatment. The primary objective of this study is to examine the influence of cultural factors on the communication between the patient and the health care provider and the perceived QoL in women with breast cancer in Japan and the Netherlands. METHODS: In Japanese and Dutch women with early breast cancer, the number, content and frequency of QoL-related issues discussed at the medical encounter were studied. Patients completed questionnaires regarding QoL and evaluation of communication with the CareNoteBook. RESULTS: The total number, frequency and content of QoL-related issues discussed differed between the two countries. Japanese women (n = 134) were significantly more reticent in discussing QoL-issues than the Dutch women (n = 70) (p < .001). Furthermore, Dutch patients perceived the CareNoteBook methodology significantly more positively than the Japanese patients (p < .001). Both groups supported the regular assessment via a CareNoteBook methodology. CONCLUSIONS: Japanese women are more reluctant in expressing their problems with the illness, its treatment and patient-physician communication than Dutch women.

Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial.

BACKGROUND: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. METHODS: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). RESULTS: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. CONCLUSIONS: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, a post-hoc subset analysis suggested that the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000012842 . Registered 14 January 2014.

Psychosocial determinants of adherence with oral anticancer treatment: 'we don't need no education'.

INTRODUCTION: Given the potentially fatal consequences of inadequate adherence with oral anticancer treatment in persons with cancer, understanding the determinants of adherence is vital. This paper aims at identifying psychosocial determinants of adherence to oral anticancer treatment. METHODS: We reviewed the literature on psychosocial determinants of adherence with oral anticancer treatment, based on published literature in English, from 2015 to present. Literature searches were performed in PubMed, Embase, Web of Science, Cochrane library, Emcare, and PsychINFO, with 'cancer', 'medication adherence', 'psychology', and 'oral anticancer treatment' as search terms. The obtained 608 papers were screened by two independent reviewers. RESULTS: In the 25 studies identified, illness perceptions, medication beliefs, health beliefs, and depression were found to be the major psychosocial determinants of adherence to oral anticancer treatment; sociodemographic and clinical characteristics were found to be of no major importance. The quality of the identified studies as assessed by two independent reviewers was found to be acceptable overall. The majority of papers were from North America and focused on patients with breast cancer; sample size varied from 13 to 1371; adherence was assessed with questionnaires derived from various theoretical models, pill counts and electronic pharmacy records; illness perceptions reflecting adaptive coping, and medication beliefs reflecting high necessity and low concerns were found to be associated with adherence. CONCLUSION: Psychosocial concepts are major determinants of adherence with oral anticancer treatment. 'Beliefs about medicines' and 'illness perceptions' in particular determine adherence with this treatment. Studies aiming at impacting adherence would benefit from interventions with a solid basis in behavioral theory in order to help health care providers explore and address illness perceptions and medication beliefs. Pre-consultation screening of adherence behavior may be a helpful supportive approach to improve adherence. Blaming the victim ('patients should be educated about the importance of adherence') is better replaced by encouraging health professionals to identify and address maladaptive psychosocial determinants of adherence.

Analysis of GPI-anchored proteins involved in germline stem cell proliferation in the Caenorhabditis elegans germline stem cell niche.

Stem cells divide and undergo self-renewal depending on the signals received from the stem cell niche. This phenomenon is indispensable to maintain tissues and organs in individuals. However, not all the molecular factors and mechanisms of self-renewal are known. In our previous study, we reported that glycosylphosphatidylinositol (GPI)-anchored proteins (GPI-APs) synthesized in the distal tip cells (DTCs; the stem cell niche) are essential for germline stem cell proliferation in Caenorhabditis elegans. Here, we characterized the GPI-APs required for proliferation. We selected and verified the candidate GPI-APs synthesized in DTCs by RNA interference screening and found that F57F4.3 (GFI-1), F57F4.4 and F54E2.1 are necessary for germline proliferation. These proteins are likely involved in the same pathway for proliferation and activated by the transcription factor PQM-1. We further provided evidence suggesting that these GPI-APs act through fatty acid remodelling of the GPI anchor, which is essential for association with lipid rafts. These findings demonstrated that GPI-APs, particularly F57F4.3/4 and F54E2.1, synthesized in the germline stem cell niche are located in lipid rafts and involved in promoting germline stem cell proliferation in C. elegans. The findings may thus shed light on the mechanisms by which GPI-APs regulate stem cell self-renewal.

Illness Perceptions and Quality of Life in Patients with Non-Small-Cell Lung Cancer: A 3-Month Follow-Up Pilot Study.

PURPOSE: Examine illness perceptions, functional health and quality of life of lung cancer patients throughout chemotherapy treatment. PATIENTS AND METHODS: Longitudinal design with baseline measure 12 days after the first chemotherapy and follow-up measure 3 months later, where illness perceptions (BIPQ), functional health, and quality of life (EORTC QLQ-C-30) were measured. A total of 21 patients with non-small-cell lung cancer took part. Non-parametric testing was performed given the pilot nature of the study and the associated relatively small sample size. RESULTS: Small to medium changes in illness perceptions and functional health between the two measurement points were detected, with both becoming more positive. More negative illness perceptions at the beginning of the treatment were associated with less functioning and lower quality of life at both beginning and end of treatment. CONCLUSION: Addressing illness perceptions seems a clinically relevant approach in improving functioning and quality of life of patients with non-small-cell lung cancer.

Validity and Reliability of the Japanese Version of the 10-Item Perceived Efficacy in Patient-Physician Interactions (PEPPI-10) Scale in Breast Cancer Outpatients.

The 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-10) questionnaire was used as an indirect measure of the patients' perception of the strength of their therapeutic connection with their physician. The English version of the PEPPI-10 could serve as a valuable research tool for analyzing the relationship between patient and physician. The incidence of breast cancer is amongst the highest in Japan, and Patient Reported Outcome is often used as an outcome measure for breast cancer. It is particularly important to establish a strong patient-physician interaction for patients with breast cancer, since these patients require long-term treatment. We designed the present study to assess the reliability and validity of the Japanese version of the PEPPI-10 in female Japanese breast cancer outpatients. A cross-sectional study was performed at the Saitama Cancer Center, Japan. From August 2014 to August 2015, the Japanese versions of the PEPPI-10 that measure patient-perceived self-efficacy and the Brief Illness Perception Questionnaire (BIPQ) that measure illness perception were used for 92 breast cancer patients who received outpatient chemotherapy (mean age: 52.9 years, Cancer Stage I or Stage II : 82.6%, receiving adjuvant chemotherapy: 69.6%). We found that the Japanese version of the PEPPI-10 scale had a high coefficient of internal consistency (Cronbach's α coefficient, 0.83) for reliability, and concurrent validity analysis indicated that the utility of PEPPI-10 was moderately correlated with that of the BIPQ. In conclusion, the Japanese version of the PEPPI-10 is a useful tool that can empower breast cancer outpatients during the course of their treatment.

Effectiveness of a Self-Monitoring Quality of Life Intervention For Patients with Cancer Receiving Palliative Care: A Randomized Controlled Clinical Trial.

Background: Use of patient-reported outcome measures in routine clinical practice has important benefits for patients with cancer. To examine the effect of a self-monitoring quality of life (QOL) intervention on global QOL and physical and emotional function in patients with cancer receiving palliative care. Methods: Prospective randomized study had been undertaken at Toshima Hospital, Japan. This study compared an intervention group that completed the shortened Care Notebook booklet versus a control group that received usual care. The primary outcome was global QOL and secondary outcomes were physical and emotional function. Participants completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative at baseline, and at 1 and 3 weeks. The effects of the intervention were evaluated with a linear mixed-effects model. Results: Forty-three patients were randomized. One patient in each group could not receive the allocated intervention, leaving 41 patients for inclusion in the modified intention-to-treat (ITT) analysis for the primary outcome. Twenty-seven patients were analyzed for the secondary outcomes using per protocol set (PPS). The ITT analysis showed no significant overall effect on global QOL (P=0.285), but the PPS analysis showed a significant overall effect on global QOL (P=0.034) and physical function (P=0.047) for group difference over time in the linear mixed-effects model. Conclusions: Use of the Care Notebook might have beneficial effects. The results could be interpreted as the effectiveness of the intervention of the Care Notebook for with cancer receiving palliative care.

Age-Related Trends in Home Blood Pressure, Home Pulse Rate, and Day-to-Day Blood Pressure and Pulse Rate Variability Based on Longitudinal Cohort Data: The Ohasama Study.

Background Home blood pressure is a more accurate prognosticator than office blood pressure and allows the observation of day-to-day blood pressure variability. Information on blood pressure change during the life course links the prediction of blood pressure elevation with age. We prospectively assessed age-related trends in home blood pressure, home pulse rate, and their day-to-day variability evaluated as a coefficient of variation. Methods and Results We examined 1665 participants (men, 36.0%; mean age, 56.2 years) from the general population of Ohasama, Japan. A repeated-measures mixed linear model was used to estimate the age-related trends. In a mean of 15.9 years, we observed 5438 points of measurements including those at baseline. The home systolic blood pressure linearly increased with age and was higher in men than in women aged <70 years. There was an inverse-U-shaped age-related trend in home diastolic blood pressure. The day-to-day home systolic blood pressure linearly increased with age in individuals aged >40 years. However, an U-shaped age-related trend in day-to-day diastolic blood pressure variability with the nadir point at 65 to 69 years of age was observed. No significant sex differences in the day-to-day blood pressure variability were observed (P≥0.22). The average and day-to-day variability of home pulse rate decreased with age but were lower and higher, respectively, in men than in women. Conclusions The current descriptive data are needed to predict future home blood pressure and pulse rate. The data also provide information on the mechanism of day-to-day blood pressure and pulse rate variability.

UDP-N-acetylglucosamine-dolichyl-phosphate N-acetylglucosaminephosphotransferase is indispensable for oogenesis, oocyte-to-embryo transition, and larval development of the nematode Caenorhabditis elegans.

N-linked glycosylation of proteins is the most common post-translational modification of proteins. The enzyme UDP-N-acetylglucosamine-dolichyl-phosphate N-acetylglucosaminephosphotransferase (DPAGT1) catalyses the first step of N-glycosylation, and DPAGT1 knockout is embryonic lethal in mice. In this study, we identified the sole orthologue (algn-7) of the human DPAGT1 in the nematode C. elegans. The gene activity was disrupted by RNAi and deletion mutagenesis, which resulted in larval lethality, defects in oogenesis and oocyte-to-embryo transition. Endomitotic oocytes, abnormal fusion of pronuclei, abnormal AB cell rotation, disruption of permeation barriers of eggs, and abnormal expression of chitin and chitin synthase in oocytes and eggs were the typical phenotypes observed. The results indicate that N-glycosylation is indispensable for these processes. We further screened an N-glycosylated protein database of C. elegans, and identified 456 germline-expressed genes coding N-glycosylated proteins. By examining RNAi phenotypes, we identified five germline-expressed genes showing similar phenotypes to the algn-7 (RNAi) animals. They were ribo-1, stt-3, ptc-1, ptc-2, and vha-19. We identified known congenital disorders of glycosylation (CDG) genes (ribo-1 and stt-3) and a recently found CDG gene (vha-19). The results show that phenotype analyses using the nematode could be a powerful tool to detect new CDG candidate genes and their associated gene networks.

Simulation Models in Gastric Cancer Screening: A Systematic Review

Background: Together with such high-quality approaches as randomized controlled trials and large-scale cohort studies, simulation models are often employed to evaluate the effect of cancer screening methods and decide on their appropriateness. This study aimed to evaluate all effects of gastric cancer screening that have been assessed using simulation models, including cost-effectiveness, mortality reduction, and early-stage detection. Methods: We performed a systematic review using PubMed and Web of Science. We evaluated the effect of screening related to cost, such as incremental cost-effectiveness and incremental cost-effectiveness ratios; we also separately assessed effects other than cost, such as quality-adjusted life-years, number of deaths prevented, life-years saved, relative risk of mortality from gastric cancer, life expectancy, and incidence reduction. The methods targeted for evaluation were Helicobacter pylori testing or endoscopy. Results: We identified 19 studies dealing with simulation models in gastric cancer screenings: 14 examined H. pylori screening and 7 focused on endoscopy. Among those studies, two assessed both H. pylori and endoscopy screening. Most of the studies adopted a Markov model, and all the studies evaluated cost-effectiveness. Of the 14 H. pylori screening studies, 13 demonstrated cost-effectiveness and 11 also showed good results other than cost-effectiveness, such as extension of life-years and increase in early-stage detection. In three of the five endoscopy studies, the target population was patients; all five studies obtained good results for cost-effectiveness and four observed good results other than for cost-effectiveness. Conclusions: In this study, we showed that the H. pylori screening test was cost-effective in terms of simulation model investigations. However, the H. pylori screening test should not ordinarily be recommended since there is insufficient evidence that it reduces gastric cancer mortality. In Japan, simulation modeling should be employed to plan for cancer control, and the appropriate use of simulation models should be examined for future use.

Effects of a Self-Monitoring Quality of Life Intervention for Patients with Cancer Receiving Palliative Care in Japan: Study Protocol for a Randomized Controlled Trial

Background: Previous studies suggest the use of patient-reported outcome measures in routine clinical practice has important benefits for patients with cancer, particularly as feedback regarding patients' quality of life (QOL) improves doctor-patient communication and clinical decision making. This study aimed to examine the effect of using the Care Notebook as a routine self-monitoring QOL intervention in clinical practice for patients with cancer receiving palliative care. The results are expected to clarify the practical use of the Care Notebook in this population. Methods: This prospective randomized study is being undertaken at Toshima Hospital, Japan. Participating patients who are randomly assigned to the intervention group will be asked to complete the shortened Care Notebook booklet for patients with cancer in palliative care once each day. A control group will receive usual care. The primary outcome is global health status/QOL (Global QOL), as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative. Data will be collected at baseline (after allocation), and at 1 week and 3 weeks in both the control and intervention groups. The effects of the intervention will be evaluated with a mixed random effects model. The required sample size is 200 patients. We obtained approval from Toshima Hospital (No 26-11) and the Tokyo Medical and Dental University Ethics Committee (No 1756). The findings will be disseminated through publications in peer-reviewed journals and attendance at domestic and international conferences. The trial was registered with the UMIN clinical trials registry (Trial registration number: UMIN000025322). Conclusions: This study will provide evidence on whether medical staff can use the Care Notebook as a routine self-monitoring QOL intervention in clinical practice for patients with cancer receiving palliative care. We expect that a routine Care Notebook intervention for patients with cancer will be recommended in healthcare facilities.

N-Terminal Pro-B-Type Natriuretic Peptide Is Not a Significant Predictor of Stroke Incidence After 5 Years　- The Ohasama Study.

BACKGROUND: N-terminal pro-B-type natriuretic peptide (NT-proBNP) has been used for risk stratification in heart failure or acute coronary syndrome, but the beyond 5-year predictive value of NT-proBNP for stroke remains an unsettled issue in Asian patients. The aim of the present study was to clarify this point.Methods and Results:We followed 1,198 participants (33.4% men; mean age, 60.5±11.1 years old) in the Japanese general population for a median of 13.0 years. A first stroke occurred in 93 participants. Referencing previous reports, we stratified participants according to NT-proBNP 30.0, 55.0, and 125.0 pg/mL. Using the NT-proBNP <30.0 pg/mL group as a reference, adjusted HR for stroke (95% CI) in the NT-proBNP 30.0-54.9-pg/mL, 55.0-124.9-pg/mL, and ≥125.0-pg/mL groups were 1.92 (0.94-3.94), 1.77 (0.85-3.66), and 1.99 (0.86-4.61), respectively. With the maximum follow-up period set at 5 years, the hazard ratio of the NT-proBNP≥125.0-pg/mL group compared with the <30.0-pg/mL group increased significantly (HR, 4.51; 95% CI: 1.03-19.85). On extension of the maximum follow-up period, however, the association between NT-proBNP and stroke risk weakened. CONCLUSIONS: NT-proBNP was significantly associated with an elevated stroke risk. Given, however, that the predictive power decreased with the number of years after NT-proBNP measurement, NT-proBNP should be re-evaluated periodically in Asian patients.

Nocturnal blood pressure decline based on different time intervals and long-term cardiovascular risk: the Ohasama Study.

A diminished nocturnal decline in blood pressure (BP) represents a risk factor for cardiovascular disease. To define daytime and nighttime ambulatory BP, clock time-dependent methods are used when information on diary-based sleeping time is unavailable. We aimed to compare fixed-clock intervals with diary records to identify nocturnal BP declines as a predictor of long-term cardiovascular risk among the general population. Data were obtained from 1714 participants with no history of cardiovascular disease in Ohasama, Japan (mean age, 60.6 years; 64.9% women). We defined extreme dippers, dippers, non-dippers, and risers as nocturnal systolic BP decline ≥20%, 10-19%. 0-9%, and <0%, respectively. Over a mean follow-up period of 17.0 years, 206 cardiovascular deaths occurred. Based on diary records, multivariable-adjusted hazard ratios (HRs) for cardiovascular death compared with dippers were 1.24 (95% confidence interval [CI], 0.82-1.87) in extreme dippers, 1.21 (0.87-1.69) in non-dippers, and the highest HR of 2.31 (1.47-3.62) was observed in risers. Using a standard fixed-clock interval (daytime 09:00-21:00; nighttime 01:00-06:00), a nighttime 2 h-early shifted fixed-clock (daytime 09:00-21:00; nighttime 23:00-04:00), or a nighttime 2 h-late shifted fixed-clock (daytime 09:00-21:00; nighttime 03:00-08:00), the HR (95%CI) in risers compared with dippers was 1.57 (1.08-2.27), 2.02 (1.33-3.05), or 1.29 (0.86-1.92), respectively. Although use of diary records remains preferable, the standard and nighttime 2 h-early shifted fixed-clock intervals appear feasible for population-based studies.

Home blood pressure predicts stroke incidence among older adults with impaired physical function: the Ohasama study.

OBJECTIVE: Several observational studies have found modifying effects of functional status on the association between conventional office blood pressure (BP) and adverse outcomes. We aimed to examine whether the association between higher BP and stroke was attenuated or inverted among older adults with impaired function using self-measured home BP measurements. METHODS: We followed 501 Japanese community-dwelling adults aged at least 60 years (mean age, 68.6 years) with no history of stroke. Multivariate-adjusted hazard ratios for 1-SD increase in home BP and office BP measurements were calculated by the Cox proportional hazards model. Functional status was assessed by self-reported physical function. RESULTS: During a median follow-up of 11.5 years, first strokes were observed in 47 participants. Higher home SBP, but not office SBP, was significantly associated with increased risk of stroke among both 349 participants with normal physical function and 152 participants with impaired physical function [hazard ratio (95% confidence interval) per 14.4-mmHg increase: 1.74 (1.12-2.69) and 1.77 (1.06-2.94), respectively], with no significant interaction for physical function (P = 0.56). Higher home DBP, but not office DBP, was also significantly associated with increased risk of stroke (P ≤ 0.029) irrespective of physical function (all P > 0.05 for interaction). Neither home BP nor office BP was significantly associated with all-cause mortality irrespective of physical function. CONCLUSION: Higher home BP was associated with increased risk of stroke even among those with impaired physical function. Measurements of home BP would be useful for stroke prevention, even after physical function decline.