Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005-2017.

BACKGROUND: Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals. METHODS: We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment. RESULTS: The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs. CONCLUSIONS: The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of "successful" clinical trials, making the net effect not zero but negative.

Lack of a bridge between screening and medical management for hypertension: health screening cohort in Japan.

BACKGROUND: Patient journeys for hypertensive individuals after detection at screening have not been well examined in a general population. Thus, we aimed to assess the medical treatment status and subsequent longitudinal changes in blood pressure in a middle-aged Japanese population. METHODS: We conducted a cohort study using a nationwide Japanese health screening cohort, from April 2014 to March 2019. Among health screening participants aged 40-74 years who had not previously received treatment for hypertension, hypertensive patients were newly identified based on screening results, and their medical treatment status for hypertension during the year following their initial screening was assessed. The main outcomes were longitudinal changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 4 years after initial screening. RESULTS: Of the 153,523 screening participants (mean age = 49.7 years), 16,720 (10.9%) and 4150 (2.7%) were newly detected as having hypertension, with baseline SBP of 140-159 mmHg (grade 1) and ≥ 160 mmHg (grade 2-3), respectively. Among them, 15.9% of the grade 1 hypertensive participants and 36.3% of the grade 2-3 hypertensive participants started receiving medical treatment during the year following initial screening. A linear generalised estimating equation with propensity score matching showed that receiving medical treatment was associated with 5.77 mmHg lower SBP (95% CI - 6.64 to - 4.90) and 3.82 mmHg lower DBP (95% CI - 4.47 to - 3.16) in the grade 1 hypertensive group, and 14.69 mmHg lower SBP (95% CI - 16.35 to - 13.04) and 8.42 mmHg lower DBP (95% CI - 9.49 to - 7.34) in the grade 2-3 hypertensive group. CONCLUSIONS: Health screenings detected hypertension in a substantial percentage of the middle-aged population in this study. However, detection was often followed by insufficient medical treatment and inappropriate blood pressure management. These findings indicate an inadequate link between health screenings and medical treatments in patients with hypertension.

Impact of trajectories of abdominal aortic calcification over 2 years on subsequent mortality: a 10-year longitudinal study.

Background: Although both the presence and progression over time of vascular calcification have been shown to independently predict cardiovascular disease and mortality in chronic dialysis patients, the impact of the pattern of accumulation of abdominal aortic calcification on mortality has not yet been investigated. Methods: We conducted a longitudinal study at a dialysis hospital in Hokkaido, Japan from 2005 to 2014. An abdominal calcification index (ACI) was generated for 396 patients from their annual abdominal computed tomography (CT) scans. The trajectories of ACIs during the first 2 years were classified using group-based trajectory modeling into four groups; stable (29.0%), slow increase (29.2%), rapid nonlinear increase (24.4%) and advanced with slow increase (17.4%). Incidence rates by group of all-cause mortality during the follow-up period (mean of 4.5 years) were investigated using the Cox proportional hazard model. Results: Compared with the stable trajectory, both the rapid nonlinear increase and the advanced with slow increase trajectories were associated with an increased risk of death [adjusted hazard ratios (HR) 1.91; 95% confidence interval (CI) 1.02-3.58 and adjusted HR 2.79; 95% CI: 1.44-5.11, respectively]. Sensitivity analyses indicated that ACI trajectories were associated with subsequent mortality, while ACI at individual time points was not. Conclusions: Chronic hemodialysis patients with a trajectory of longitudinal high or rapid accumulation of vascular calcification over time were at a higher risk of death. Individual trajectories of vascular calcification may be suggested to allow for more accurate mortality risk calculations than one-time assessment.

Psychometric Validation of the Czech Version of the Quality of Life - Alzheimer's Disease Scale in Patients with Early-Stage Dementia.

BACKGROUND/AIMS: The aim of this study was to perform a psychometric validation of the Czech version of the Quality of Life - Alzheimer's Disease scale (QoL-AD) for patients with early-stage dementia. METHODS: The sample included 212 patient-proxy pairs. For convergent validity, the Czech version of the Bristol Activities of Daily Living Scale (BADLS-CZ), the Short Physical Performance Battery (SPPB), and the Geriatric Depression Scale (GDS) were used. RESULTS: The reliability of the QoL-AD for patients and caregivers was good (Cronbach's α = 0.85, ICC = 0.25-0.54). A positive correlation existed between the QoL-AD and the SPPB, and negative correlations existed between the QoL-AD and the BADLS-CZ as well as between the QoL-AD and the GDS. Factor analysis resulted in a three-factor solution (physical and mental health, family life, and social security). CONCLUSION: The Czech version of the QoL-AD has good psychometric properties in compliance with international recommendations.

Influence of family dynamics on burden among family caregivers in aging Japan.

BACKGROUND: Long-term care for the elderly is largely shouldered by their family, representing a serious burden in a hyper-aging society. However, although family dynamics are known to play an important role in such care, the influence of caring for the elderly on burden among caregiving family members is poorly understood. OBJECTIVE: To examine the influence of family dynamics on burden experienced by family caregivers. METHODS: We conducted a cross-sectional study at six primary care clinics, involving 199 caregivers of adult care receivers who need long-term care. Participants were divided into three groups based on tertile of Index of Family Dynamics for Long-term Care (IF-Long score), where higher scores imply poorer relationships between care receivers and caregiving family: best, <2; intermediate, 2 to <5; worst, ≥5. The mean differences in burden index of caregivers (BIC-11) between the three groups were estimated by linear regression model with adjustment for care receiver's activity of daily living and cognitive function. RESULTS: Mean age of caregivers was 63.2 years (with 40.7% aged ≥ 65 years). BIC-11 scores were higher in the worst IF-Long group (adjusted mean difference: 4.4, 95% confidence interval: 1.2 to 7.5) than in the best IF-Long group. We also detected a positive trend between IF-Long score and BIC-11 score (P-value for trend <0.01). CONCLUSION: Our findings indicate that family dynamics strongly influences burden experienced by caregiving family members, regardless of the care receiver's degree of cognitive impairment. These results underscore the importance of evaluating relationships between care receivers and their caregivers when discussing a care regimen for care receivers.

Quality of life and comorbidity among older home care clients: role of positive attitudes toward aging.

PURPOSE: Comorbidity has a negative impact on quality of life (QoL). This study aimed to investigate whether the impact of comorbidity on QoL is lower in older home care clients with positive attitudes toward aging. METHODS: Totally, 361 older adults aged 50-91 years who were clients of 14 home care agencies in two regions in the Czech Republic gave an in-person interview to research nurses and completed the WHOQOL-BREF, the WHOQOL-OLD, and the Attitudes to Aging Questionnaire. The Charlson comorbidity index was calculated using ICD-10 codes. To address possible interaction between comorbidity and attitudes toward aging for QoL, the presence of additive interaction between comorbidity and attitudes toward aging on QoL was examined by synergy index. All analyses were adjusted by age, gender, education, and living arrangement. RESULTS: A higher comorbidity index was significantly associated with lower scores of both QoL measures; one index increase was associated with 3.7 [95 % confidence interval (CI) 1.5: 5.9] decreases in generic QoL and 3.6 (95 % CI 1.3: 5.9) decreases in older-specific QoL. In stratified analyses by attitudes toward aging, comorbidity showed no association with QoL among those with positive attitudes, while it was significantly associated with low QoL in those without positive attitudes. The presence of additive interactions between comorbidity and less than positive attitudes on falling in low QoL was clearly suggested. CONCLUSIONS: The negative impact of comorbidity on QoL might be mitigated by promoting a positive self-perception of aging in older people.

Psychological distress and academic self-perception among international medical students: the role of peer social support.

BACKGROUND: Psychological distress among medical students is commonly observed during medical education and is generally related to poor academic self-perception. We evaluated the role of peer social support at medical schools in the association between psychological distress and academic self-perception. METHODS: An online survey was conducted in a medical degree program for 138 international students educated in English in the Czech Republic. The Medical Student Well-Being Index was used to define the students' psychological distress. Perceived peer social support was investigated with the Multidimensional Scale of Perceived Social Support. Poor academic self-perception was defined as the lowest 30% of a subscale score of the Dundee Ready Education Environment Measure. Analyses evaluated the presence of additive interactions between psychological distress and peer social support on poor academic self-perception, adjusted for possible confounders. RESULTS: Both psychological distress and low peer social support were negatively associated with poor academic self-perception, adjusted for local language proficiency and social support from family. Students with psychological distress and low peer social support had an odds ratio of 11.0 (95% confidence interval (CI): 2.1-56.6) for poor academic self-perception as compared with those without distress who had high peer social support. The presence of an additive interaction was confirmed in that the joint association was four times as large as what would have been expected to be on summing the individual risks of psychological distress and low peer social support (synergy index = 4.5, 95% CI: 1.3-14.9). CONCLUSIONS: Psychological distress and low peer social support may synergistically increase the probability of poor academic self-perception among international medical students. Promoting peer social relationships at medical school may interrupt the vicious cycle of psychological distress and poor academic performance.

[A case of malignant hyperthermia with evident symptoms in the postoperative period].

A 36-year-old man (185 cm tall, weighing 85 kg) was scheduled for fixation of a right carpal bone fracture. He had no operative history, and his preoperative laboratory data were normal. A laryngeal mask was inserted after intravenous propofol and fentanyl administration without a muscle relaxant. Anesthesia was maintained by sevoflurane in a mixture of air and oxygen. A tourniquet was placed on the right upper arm. One hour after the operation, his heart rate increased to 90-100 beats x min(-1) from 70-80 beats x min(-1) at the start of the operation, and tachycardic continued, even after release of the tourniquet. Although end-tidal CO2 was 50-60 mmHg, his body temperature remained 37.6 degrees C, and neither muscle stiffness nor brown urine was observed. The duration of the operation and the duration of anesthesia were 2 hours 40 min and 4 hours, respectively. The patient went back to the ward without myalgia after removal of the laryngeal mask. On the postoperative day one, the patient had brown urine. On the postoperative day 2, he experienced myalgia of the upper and lower extremities and masseter muscle. On the postoperative day 3, myoglobinuria was detected. As in this case, although evident symptoms of malignant hyperthermia are not always observed during operations, some cases show obvious symptoms during the postoperative period. Thus, it is important to be aware of the symptoms of malignant hyperthermia postoperatively for early diagnosis and treatment.

Nudge-Based Interventions on Health Promotion Activity Among Very Old People: A Pragmatic, 2-Arm, Participant-Blinded Randomized Controlled Trial.

OBJECTIVES: Social distancing due to the coronavirus disease 2019 crisis can exacerbate inactivity in older adults. Novel approaches for older adults must be designed to improve their activity and maintain their health. This study examined the effect of nudge-based behavioral interventions on health-promoting activities in older adults in Japan. DESIGN: Two-arm, participant-blinded randomized controlled trial. SETTING AND PARTICIPANTS: Japanese continuing care retirement community residents (n = 99, median age 82 years, 73% women) INTERVENTION: Two-step nudge-based behavioral intervention promoting tablet usage. METHODS: We enrolled participants from an ongoing Internet of Things project in a retirement community in Japan. For the health promotion program, tablet computers were installed in a common area for participants to receive information about their health. The intervention group received a 1-time loss-emphasized nudge (first step), followed by asking questions about when they planned to use it again (second step). The control group used the tablet computers without being asked those questions. The main outcome was the participants' mean daily tablet activity every 4 weeks for the next 16 weeks. RESULTS: Ninety-nine individuals were randomly assigned to the intervention or control group. The rate ratios for tablet use were significantly higher in the intervention group in the second and third periods. The subgroup analysis showed that these effects were largely attributable to men. CONCLUSIONS AND IMPLICATIONS: Nudge-based interventions can be effective in promoting activities for older adults, especially older men. The finding of this study indicates a possible intervention to engage people who are socially isolated.

A thematic analysis of students' discussions on death and body donation in international online focus groups.

Historically, Anatomy education is an in-person discipline involving exposure to human body donors that facilitates personal and professional growth through, in part, the initiation of reflection on the topic of death. However, during the COVID-19 pandemic the decreased exposure to cadaveric anatomy for many health professions students may have influenced the depth of their individual reflections on this topic. Accordingly, this study aimed to investigate the effect of an alternate approach-focus group discussions between peers with varying degrees of exposure to cadaveric material-that may offer one strategy to stimulate deep reflection on the topic of death. A programmatic intervention was introduced, wherein students (n = 221) from 13 international universities discussed differences in their anatomy courses during small focus group sessions as part of an online exchange program. An inductive semantic thematic analysis was conducted on responses to an open-ended text-response question on how the activity influenced students' reflections about death. Resulting themes were organized into categories that described the content and topics of the students' discussions as they grappled with this sensitive topic. The students reportedly engaged in deep reflection and expressed an increased sense of connectedness with their peers, despite their disparate exposure levels to cadaveric anatomy and being physically distanced. This demonstrates that focus groups with students experiencing different laboratory contexts can be used to help all students reflect on the topic of death and that interchanges between dissecting and non-dissecting students can initiate thoughts about death and body donation among non-dissecting students.

Health profession students' outlooks on the medical profession during the COVID-19 pandemic: a global perspective.

BACKGROUND: This article summarizes a global study of the effect of the COVID-19 pandemic on junior health professions students' outlook on medicine. The pandemic has significantly affected health professions education. There is limited understanding of how students' pandemic experiences will affect them, and what impact these events may have on their career paths or the future of the professions. This information is important as it impacts the future of medicine. METHODS: In the Fall 2020 semester, 219 health professions students at 14 medical universities worldwide responded to the question: 'Has this experience (with COVID-19) changed your outlook on medicine as a profession?'. Short essay responses were semantically coded and organized into themes and subthemes using an inductive approach to thematic analysis. RESULTS: 145 responses were submitted. Themes were identified: (1) students reflected on the interaction between politics and healthcare; (2) reported becoming more aware of the societal expectations placed on healthcare professionals, including undertaking high risks and the sacrifices that healthcare professionals must make; (3) found reassurance from the recognized importance of healthcare professionals and expressed pride to be entering the profession; and (4) reflected on the current state of healthcare, including its limitations and future. CONCLUSION: Most students, independent of the extent of the pandemic in their respective countries, noted a change in their outlook regarding medicine. An overall positive outlook was noted in most junior students. Educators need to work on nurturing these sentiments and attitudes to help young students maintain a healthy relationship towards their chosen profession.

Vepafestinib is a pharmacologically advanced RET-selective inhibitor with high CNS penetration and inhibitory activity against RET solvent front mutations.

RET receptor tyrosine kinase is activated in various cancers (lung, thyroid, colon and pancreatic, among others) through oncogenic fusions or gain-of-function single-nucleotide variants. Small-molecule RET kinase inhibitors became standard-of-care therapy for advanced malignancies driven by RET. The therapeutic benefit of RET inhibitors is limited, however, by acquired mutations in the drug target as well as brain metastasis, presumably due to inadequate brain penetration. Here, we perform preclinical characterization of vepafestinib (TAS0953/HM06), a next-generation RET inhibitor with a unique binding mode. We demonstrate that vepafestinib has best-in-class selectivity against RET, while exerting activity against commonly reported on-target resistance mutations (variants in RETL730, RETV804 and RETG810), and shows superior pharmacokinetic properties in the brain when compared to currently approved RET drugs. We further show that these properties translate into improved tumor control in an intracranial model of RET-driven cancer. Our results underscore the clinical potential of vepafestinib in treating RET-driven cancers.

Are acceptance rates of a national preventive home visit programme for older people socially imbalanced?: a cross sectional study in Denmark.

BACKGROUND: Preventive home visits are offered to community dwelling older people in Denmark aimed at maintaining their functional ability for as long as possible, but only two thirds of older people accept the offer from the municipalities. The purpose of this study is to investigate 1) whether socioeconomic status was associated with acceptance of preventive home visits among older people and 2) whether municipality invitational procedures for the preventive home visits modified the association. METHODS: The study population included 1,023 community dwelling 80-year-old individuals from the Danish intervention study on preventive home visits. Information on preventive home visit acceptance rates was obtained from questionnaires. Socioeconomic status was measured by financial assets obtained from national registry data, and invitational procedures were identified through the municipalities. Logistic regression analyses were used, adjusted by gender. RESULTS: Older persons with high financial assets accepted preventive home visits more frequently than persons with low assets (adjusted OR = 1.5 (CI95%: 1.1-2.0)). However, the association was attenuated when adjusted by the invitational procedures. The odds ratio for accepting preventive home visits was larger among persons with low financial assets invited by a letter with a proposed date than among persons with high financial assets invited by other procedures, though these estimates had wide confidence intervals. CONCLUSION: High socioeconomic status was associated with a higher acceptance rate of preventive home visits, but the association was attenuated by invitational procedures. The results indicate that the social inequality in acceptance of publicly offered preventive services might decrease if municipalities adopt more proactive invitational procedures.

The Anatomy Course During COVID-19: The Impact of Cadaver-Based Learning on the Initiation of Reflection on Death.

Background: During the COVID-19 pandemic, in-person cadaveric dissection laboratories for teaching anatomy were omitted by many schools around the world. While knowledge domains can be easily evaluated via remote exams, non-traditional discipline-independent skills such as those encouraged through reflection on the topic of death are often overlooked. This study investigated how different anatomy course formats played a role in initiating students' reflections on death during the COVID-19 pandemic. Method: In fall 2020, 217 medical, dental, premedical, and health sciences students from 13 international universities discussed differences in their anatomy courses online. Formats of anatomy courses ranged from dissection-based, prosection-based, hybrid (combination of dissection and prosection) to no laboratory exposure at all. Students' responses to the question, "Did/does your anatomy course initiate your thinking about life's passing?" were collected, and they self-reported themes that were present in their reflections on death using a multiple-choice prompt. Statistical analyses to detect differences between students with and without exposure to cadavers were performed using the chi-squared test. Results: When comparing students who had exposure to human anatomical specimens to those who had no exposure, the majority of students with exposure thought that the course did initiate thoughts about life's passing, compared to students without exposure (P < 0.05). Reflection themes were consistent across groups. Discussion: These findings indicate that anatomy dissection courses are important for the initiation of students' feelings about the topic of death. Omission of cadaveric dissection- or prosection-based laboratories will decrease the likelihood that students initiate reflection on this topic and gain important transferable skills.

Body mass index change and estimated glomerular filtration rate decline in a middle-aged population: health check-based cohort in Japan.

BACKGROUND: Obesity is a growing public health problem worldwide. We evaluated the mediators and association between changes in obesity metrics and renal outcomes in the general population. METHODS: Using the Japanese nationwide health check-based cohort from April 2011 to March 2019, we selected individuals aged 40-74 years, with a baseline estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2, whose body mass index (BMI) change was assessed. The primary outcome was combined 30% decline in eGFR, eGFR <15 mL/min/1.73 m2 and end-stage renal disease. RESULTS: During 245 147 person-years' follow-up among 50 604 participants (mean eGFR, 83.7 mL/min/1.73 m2; mean BMI, 24.1 kg/m2), 645 demonstrated eGFR decline (incidence rate 2.6/1000 person-years, 95% CI: 2.4 to 2.8). We observed continued initial changes in BMI for over 6 years and a U-shaped association between BMI change and eGFR decline. Compared with 0% change in BMI, adjusted HRs for changes of -10%, -4%, 4% and 10% were 1.53 (95% CI: 1.15 to 2.04), 1.14 (95% CI: 1.01 to 1.30), 1.16 (95% CI: 1.02 to 1.32) and 1.87 (95% CI: 1.25 to 2.80), respectively. The percentage of excess risk of BMI increase (>4%) mediated by three risk factors (blood pressure, haemoglobin A1c and total cholesterol), was 13.3%. CONCLUSION: In the middle-aged Japanese population, both, increase and decrease in BMI were associated with subsequent eGFR decline. Changes in risk factors mediated a small proportion of the association between BMI increase and eGFR decline. Our findings support the clinical significance of monitoring BMI as a renal risk factor.

[A consideration of the support for terminal care at the private skilled nursing home].

The increase in the number of residents in elderly care facilities has developed into a growing demand for home-based terminal care rather than treatments at medical institutions. Like many others, the Active Life Toyonaka (private skilled nursing home) has received more requests from its residents for adequate terminal care. It is unfortunate, however, that quite a few residents are obliged to be hospitalized for medical reasons that result in death. The purpose of our study is to determine what a terminal care should be like in a private skilled nursing home. The study has been conducted with the focuse on the successful case of a 90-year-old male resident diagnosed as having prostate cancer with bone metastasis. Our study has concluded that the crucial factors for a better terminal care should go as follows: (1) Having good coordination with medical institutions, (2) Reporting every change in residents' condition and administering an immediate treatment for alleviating pains of the residents, (3) Providing the residents with comfortable life of less restraint on activities in home-based care, (4) Sharing the same information among the staff of all divisions who is in charge of residents (doctors, nurses, caregivers, etc.) and (5) Establishing relationships of mutual trust with residents and their families. Nurses, especially, need to play important roles as coordinators among all the personnel concerned.

Undiagnosed and untreated chronic kidney disease and its impact on renal outcomes in the Japanese middle-aged general population.

BACKGROUND: The effectiveness of identifying and monitoring early-stage chronic kidney disease (CKD) is not fully recognised. This study quantified people with undiagnosed CKD among the middle-aged Japanese population and clarified potential risks of untreated CKD. METHODS: We included 71 233 individuals who underwent annual health check-ups (AHC) in 2014 for both baseline and follow-up proteinuria and serum creatine measurements. CKD was identified by AHC data as proteinuria or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. We differentiated undiagnosed from diagnosed CKD using the medical claims database. In undiagnosed CKD, we assessed risk differences for disease progression, defined as an eGFR decline slope >3 mL/min/1.73 m2/year or proteinuria incidence over 3 years, between those who visited a physician for CKD treatment within 6 months after AHC and those who did not. RESULTS: CKD prevalence was 5.7% (5.2% undiagnosed and 0.5% diagnosed). Only 2.1% of the patients with undiagnosed CKD visited a physician for CKD treatment within 6 months after AHC. Between-group risk differences in instrumental variable adjustment models showed that those left untreated progressed to kidney diseases 16.3% more often than those who visited physicians for CKD treatment. CONCLUSION: CKD was undiagnosed in 5.2% of the middle-aged general population. Only a few people visited physicians for CKD treatment. Visiting physicians for CKD treatment during the first 6 months after screening may be associated with a lower risk of kidney disease progression.

Psychometric Properties of the Czech Version of the Falls Efficacy Scale-International in Patients with Early-Stage Dementia.

INTRODUCTION: A fear of falling marks an important psychological factor connected with a reduction in the life space of people with dementia. The Czech version of the Falls Efficacy Scale-International (FES-I) has not been validated in patients with early-stage dementia. METHODS: The tests were administered to 282 patients with early-stage dementia. The test battery included the following: the FES-I, the Short Physical Performance Battery, the Geriatric Depression Scale, the Bristol Activity Daily Living Scale, and the Quality of Life-Alzheimer's Disease Scale. Internal reliability (Cronbach's α and intraclass correlation [ICC]), Pearson's and Spearman's correlations, exploratory factor analysis, and a t test for independent samples were used for statistical analyses. RESULTS: The Czech version of the FES-I had excellent internal and test-retest reliability (Cronbach's α = 0.98, ICC = 0.90; 95' CI 0.82-0.94). Factor analysis suggested 2 relevant factors. A significantly higher FES-I score was associated with patients with early-stage dementia who were older (p = 0.003) or female (p = 0.001), lived alone (p = 0.0001), spent >8 h a day alone (p = 0.032), used mobility aids (p < 0.0001), or had severe hearing (p = 0.004) or vision impairment (p < 0.0001) or a lower education (r = -0.16, p = 0.007). CONCLUSION: The Czech version of the FES-I had very good reliability and validity and may be useful in future cross-cultural comparisons in research among patients with early-stage dementia.

Gender differences in improvement of older-person-specific quality of life after hearing-aid fitting.

BACKGROUND: Age-related hearing loss is the third most common reason for disability in the world and has a significant impact on quality of life (QoL) amongst older adults. OBJECTIVE: To determine how the QoL assessment in older-person-specific domains differs between older men and women with age-related hearing loss before and after hearing-aid fittings. METHODS: The present study was carried out with 105 hearing-impaired outpatients (aged ≥ 60 years) before and after hearing-aid fittings at the University Hospital Olomouc, Czech Republic. The instrument used was the World Health Organization Quality of Life-Older Adults module (WHOQOL-Old). It was completed before hearing-aid fittings and after the first check-up hearing-aid adjustment. The Wilcoxon paired test multiple logistic regression was used to evaluate changes in the QoL after hearing-aid fittings. The distributions of men a women into three subgroups, improved, unchanged, and worsened in each domain, were compared using Fisher's exact test. RESULTS: A significant QoL improvement when fitting a hearing-aid in the area of Sensory abilities was confirmed in both men and women (p < 0.001). In Autonomy, a significant improvement was recorded only amongst men (p = 0.010). In Past, present and future activities and Social participation, a significant improvement was only recorded amongst women (p = 0.029; p = 0.001). Significant differences were revealed between men and women in changes for Sensory Abilities (p = 0.019), Social Participation (p = 0.036) and Intimacy (p = 0.002). CONCLUSIONS: The findings of this study suggest that there are gender differences in QoL improvement amongst people with age-related hearing loss after hearing-aid fitting.

Nudging patients with chronic kidney disease at screening to visit physicians: A protocol of a pragmatic randomized controlled trial.

BACKGROUND/AIMS: Strategies for an effective intervention after chronic kidney disease (CKD) screening have not been well examined. We describe the rationale and design of a protocol of a pragmatic randomized controlled trial (RCT) to test the effect of a behavioral intervention using the nudge approach in behavioral economics on CKD patients' visiting behaviors to physicians and change in their kidney function after CKD screening. METHODS: The RCT will include CKD patients (N = 4500) detected at screening (estimated glomerular filtration rate [eGFR] <60 mL/min/1.74 m2 or urine protein ≥1+), aged 40-63 years. The two intervention groups will receive a "usual letter" and "nudge-based letter," while the control group will only receive a conventional follow-up. Our primary outcome is proportion of patients' visiting physicians for 6 months after the intervention; the secondary outcome is change in the eGFR at 2 years after the intervention. RESULTS: We developed an efficient intervention program after CKD screening and designed the pragmatic RCT to assess its effectiveness in the real world. Our trial is unique in that it investigates the effect of the nudge approach in behavioral economics. By the end of 2018, we have enrolled 1,692 participants, and randomized 677 participants into the usual letter group, 677 participants into the nudge-based letter group, and 338 participants into the control group. We have confirmed that health checkup data could identify a large number of eligible participants. CONCLUSION: The trial's results will contribute to filling in the gap between screening and subsequent medical interventions for preventing CKD progression.