Clinics In Japan Research Articles

Improved responsiveness for JKOOS+ compared to KOOS in Japanese patients undergoing total knee arthroplasty

BackgroundExisting knee related patient reported outcome measurements (PROMs) have overwhelmingly been developed and validated in western chair-based societies, suggesting a potential for a western bias in PROMs evaluation of patients with knee conditions. We, therefore, endeavor to evaluate the responsiveness of the previously developed culturally relevant Japanese version of the knee injury and osteoarthritis outcome score (JKOOS+). MethodsWe enrolled 114 patients scheduled for total knee arthroplasty (TKA) across 8 knee clinics in Japan. Patients completed the Oxford Knee Score (OKS) and JKOOS + both at the time of enrollment and again 1-year post-TKA. Responsiveness was evaluated using effect size and standardized response mean (SRM). An effect size or SRM >0.8 is considered adequately responsive. We further tested the difference in responsiveness between the original Japanese language KOOS activities of daily living (ADL) domain and the novel Japanese ADL (JADL) domain using the modified Jacknife test. ResultsAll domains were adequately responsive with the exception of the KOOS sports and recreation domain, which has previously been ignored by TKA researchers due to its lack of applicability to elderly patients undergoing TKA. The JADL domain outperformed the ADL domain in both effect size (1.51 v. 1.45) and SRM (1.67 v. 1.57) (p < 0.001). The novel Knee Flexion (KF) domain was adequately responsive, though less responsive than other domains except sports and recreation (p < 0.01 v. all other PROMs domains). ConclusionsThe JKOOS+ JADL domain is significantly more responsive than the Europe-developed ADL domain to TKA in Japanese knee patients suffering from knee osteoarthritis (OA). The KF domain, unique to the JKOOS+ and intended to assess difficulty with knee flexion, is adequately responsive to TKA in Japanese patients suffering from OA.

Analysis of patch testing with cocamidopropyl betaine and its impurities in patients with intractable scalp dermatitis in a single clinic in Japan.

The allergen responsible for cocamidopropyl betaine (CAPB) allergies has been debated. To investigate the sensitizing agents of CAPB, the patch test positivity rates of impurities were examined in Japanese patients with CAPB-related allergic contact dermatitis. Thirty patients with scalp dermatitis and positive patch tests for CAPB and/or lauramidopropyl betaine (LAPB) were enrolled in this study. They were patch tested with the detergents that they had been using at the time of their first visit and with the impurities dimethylaminopropylamine (DMAPA) and lauramidopropyl dimethylamine (LAPDMA). The positivity rate in patch tests of the 37 detergents that the patients had been using was 78.4% (29/37). The positivity rates of DMAPA 1% pet., 1% aq. and 0.2% aq. were 32.1% (9/28), 14.3% (4/28) and 13.3% (4/30), respectively, whereas those of LAPDMA 0.1% and 0.05% were 30.0% (9/30) and 16.7% (5/30), respectively. Among the 30 patients, 6 exhibited positive results for both DMAPA and LAPDMA, 3 showed positive results for DMAPA alone and 6 produced positive results for LAPDMA alone. Patch tests produced an overall positivity rate for DMAPA, LAPDMA or both of 50.0% (15/30) in patients with scalp dermatitis and positive patch test results for CAPB and/or LAPB.

Care provided by midwives and the unmet needs of pregnant and postpartum women: A qualitative study of Japanese mothers

ObjectivesWe aimed to clarify the content of care provided by midwives working in hospitals and clinics in Japan and the unmet needs in midwifery care from mothers’ perspectives. DesignThis study employed a qualitative approach through semi-structured interviews. SettingFifteen Japanese women, whose youngest singleton children were aged 12–18 months, were asked to recall their experiences with midwives, from pregnancy through the first postpartum year. Verbatim records were analyzed using thematic analysis. ResultsSeven themes regarding the care provided by midwives were generated: confirmation of physical condition, maintenance and promotion of perinatal physiological process, support for better preparation for childbirth, assistance in labour and childbirth, support for a new life with a baby at home, support for the family, and care for comfort and confidence as a mother. Unmet needs were identified in all themes, except for ‘confirmation of physical condition’ and ‘support for the family’. Ten subthemes, under the five themes of unmet needs, were integrated into three categories: midwives’ responses to potential concerns, lack of continuity of care, and lack of personalised care. Key conclusions and implications for practiceMidwives in hospitals and clinics in Japan mainly provided care from pregnancy to one-month postpartum, in line with global core competencies. However, they could respond more effectively to the potential concerns of women, and provide continuous, personalised care more sufficiently. Improving working environments for midwives and collaborating with postpartum public health services are key to addressing these unmet needs of women, leading to women-centred care.

Dental Utilization Stratified by the Purpose of Visit: A Population-Based Study in Japan

BackgroundThis study aimed to provide a stratified description of dental visit utilisation by Japanese residents based on patient age, sex, prefecture, and the purpose of the visits. MethodsThis cross-sectional study used the National Database of Health Insurance Claims of Japan to identify participants visiting dental clinics in Japan (April 2018–March 2019). Dental care utilisation by populations stratified by age, sex, and prefecture was assessed. We estimated the slope index of inequality (SII) and relative index of inequality (RII) to evaluate regional differences based on regional income and education. ResultsAmongst the Japanese population, 18.6% utilised preventive dental care visits; 59,709,084 participants visited dental clinics, with children aged 5 to 9 years having the highest proportion. SII and RII were higher for preventive dental visits than those for treatments in all settings. The largest regional differences for preventive care were observed in SII of children aged 5 to 9 years and in RII of men in their 30s and women aged 80 years and older. ConclusionsThis nationwide population-based study revealed that the proportion of people utilising preventive dental care in Japan was low, with regional differences. Preventive care needs to be more easily accessible and available to improve the oral health of residents. The above findings may provide an important basis for improving policies related to dental care for residents.

Freeze-dried noncoagulating platelet-derived factor concentrate is a safe and effective treatment for early knee osteoarthritis.

While a wide variety of platelet-rich plasma (PRP) solutions has been developed, innovation continues. In this case, the freeze-dried platelet factor concentrate (PFC-FD) represents another step in PRP refinement. The preparation of PFC-FD at a central laboratory with freeze drying for shelf stabilization should provide additional quality improvements if clinical effectiveness can be demonstrated. Therefore, this study was undertaken to assess the safety and effectiveness of PFC-FD in a prospective open-label trial of patients suffering from knee osteoarthritis (OA). 312 consecutive knee OA patients (67% female, mean age 63 ± 10years), were prospectively recruited in an outpatient knee clinic in Japan. Of these, 10 (3.2%) were lost to follow-up at < 12months and 17 (5.5%) sought additional knee therapy during the follow-up period. The primary outcome of interest was achievement of the OMERACT-OARSI responder criteria with secondary outcomes of adverse events and PROMs scores 1, 3, 6, 12months following a single PFC-FD injection. 285 patients (91%) completed 12month PROMs. The 17 who sought additional therapy were considered failures leaving an effective sample size of 302 for our primary outcome in which 62% of patients achieved OMERACT-OARSI responder status by 12months. This varied by OA class with Kellgren-Lawrence grade 4 patients 3.6 times less likely to be responders than grade 1-2 patients. 6% of patients experienced a non-serious adverse event, primarily pain or swelling at the injection site. PFC-FD provides an observable clinical improvement in 62% of knee OA patients at 12months post-injection with very little risk of any clinically relevant adverse event. Of course, nearly 40% of patients did not experience an observable clinical improvement, primarily among those with worse KL grades. Therapeutic, Level II.

The user experience of a mobile medication support application and its impact on medication compliance for people living with HIV: Results of a 12-week pilot study.

Continuity of care between hospital visits through mobile application (app) creates new opportunities for people living with HIV (PLWH) in situations where face-to-face interventions are difficult. This study investigated the user experience of a mobile medication support app and its impact on improving anti-retroviral therapy (ART) compliance and facilitating teleconsultation between PLWH and medical staff. Two clinics in Japan were invited to participate in a 12-week trial of the medication support app between July 27, 2018, and March 31, 2021. Medication compliance was assessed based on responses to scheduled medication reminders; Users, including PLWH and medical staff, were asked to complete an in-app satisfaction survey to rate their level of satisfaction with the app and its specific features on a 5-point Likert scale. A total of 10 PLWH and 11 medical staff were included in this study. During the trial, the medication compliance rate was 90%, and the mean response rates to symptom and medication alerts were 73% and 76%, respectively. Overall, 81% of PLWH users and 65% of medical staff were satisfied with the medication support app. Over 80% of medical staff and PLWH users were satisfied with the ability to record medication taken, record symptoms of concern, and enquire about drug combinations. Further, 90% of PLWH users were satisfied with the communication function with medical staff. Our preliminary results demonstrate the feasibility of this medication support app in improving medication compliance and enhancing communication between PLWH and medical staff.

P-201 Developmental analysis of blastocysts with blastomere exclusion during compaction and its relationship to pregnancy outcomes and preimplantation genetic testing for aneuploidy results

Abstract Study question What effects do blastocysts with blastomere exclusion during compaction have on embryo morphokinetics, morphology grade, genetic testing for aneuploidy (PGT-A) results, and pregnancy outcomes? Summary answer Blastocysts with blastomere exclusion leads to delay blastulation and poor morphology grade, but does not affect pregnancy outcomes and euploidy in PGT-A. What is known already It has been reported that aneuploid blastomeres are excluded during compaction, which is a mechanism for chromosome repair in blastocysts through the exclusion of aneuploid cells.Furthermore, in this phenomenon, it is known that the first cleavage of embryos is often abnormal, in which three or more cells originate from a single cell division event.However, this phenomenon has not been reported in the evaluation of embryo morphokinetics, artificial intelligence (AI) scores, or PGT-A results. Study design, size, duration In this retrospective study, we analyzed clinical medical reports at the Takahashi Women’s Clinic in Japan. We included 934 blastocysts cultured in a time-lapse incubator (EmbryoScope) after intracytoplasmic sperm injection (ICSI) from January 2018 to June 2021. Participants/materials, setting, methods Blastocysts cultured using a time-lapse incubator (EmbryoScope) after ICSI were classified into a control group (N = 515) with blastomere compaction or a BE group (N = 419) with blastomere exclusion during compaction. The first type of cleavage, AI score (IDAScore), embryo morphokinetics, and single frozen-thawed blastocyst transfer outcome were evaluated.Logistic regression analysis was performed to compare the two groups, considering patient age, blastocyst grade (Gardner classification), culture days, body mass index, and basal anti-Müllerian hormone level. Main results and the role of chance Comparing the control and BE groups, the first cleavage abnormality rate was 16.9% vs. 67.3% (P &amp;lt; 0.001), the percentage with good embryo grade (Gardner criteria ≧BB) was 93.4% vs. 61.0% (P &amp;lt; 0.001), and the mean score by AI analysis was 8.3 ± 1.3 vs. 6.4 ± 1.9 (P &amp;lt; 0.001), respectively. The BE group had a higher rate of abnormal cleavage and a significantly worse embryo grade and AI score than the control group.In the evaluation of embryo morphokinetics, the time to morula was 84.2 ± 7.0 h vs. 89.0 ± 8.5 h (P &amp;lt; 0.05) and time to blastocyst was 105.9 ± 9.4 h vs. 114.7 ± 11.4 h (P &amp;lt; 0.05). The BE group significantly delayed blastulation compared to the control group.The euploidy, mosaicism, and aneuploidy rates of PGT-A were 13.6% (9/66), 9.1% (6/66), and 77.3% (51/66) in the control group vs. 13.2% (5/38), 13.2% (5/38), and 73.7% (28/38) in the BE group, respectively. There was no significant difference in the PGT-A results between the two groups. Furthermore, the single-blastocyst transfer pregnancy rates (gestational sac with heart activity) in the control and BE groups were 47.1% (147/312) and 32.6% (60/184), respectively. Pregnancy rate was lower in the BE group, but was not significantly different from that of the control group. Limitations, reasons for caution The study was conducted at a single in vitro fertilization center. Embryo transfer results were based on ongoing pregnancies, while live birth data for all pregnancies are not yet available. Wider implications of the findings Although the BE group was graded worse, statistical analysis considering the grade showed no significant difference in PGT-A and pregnancy rates between the two groups.These results suggest that blastocysts with blastomere exclusion can be useful as transferable embryos if they grow to a transferable grade. Trial registration number not applicable

Determining Optimal Intervals for In-Person Visits during Video-based Telemedicine in Patients with Hypertension: A Cluster Randomized Controlled Trial.

Introducing telemedicine in outpatient treatment may improve patient satisfaction and convenience. However, the optimal in-person visit interval for video-based telemedicine in patients with hypertension remains unreported in Japan. We determined the optimal in-person visit interval for video-based telemedicine in patients with hypertension. Design: This was a cluster randomized controlled noninferiority trial. Participants: The target sites were eight clinics in Japan that had a telemedicine system, and the target patients were individuals with essential hypertension. Among patients receiving video-based telemedicine, those who underwent in-person visits at 6-month intervals were included in the intervention group, and those who underwent in-person visits at 3-month intervals were included in the control group. Main Measures: The follow-up period of the participants was 6 months. The primary endpoint of the study was the change in systolic blood pressure, and the secondary endpoints were the rate of treatment continuation after 6 months, patient satisfaction, health economic evaluation, and safety evaluation. Overall, 64 patients were enrolled. Their mean age was 54.5 ± 10.3 years, and 39 (60.9%) patients were males. For the primary endpoint, the estimated difference in the change in systolic blood pressure between the two groups was 1.18 (90% confidence interval: -3.68 to 6.04). Notably, the criteria for noninferiority were met. Patient satisfaction was higher in the intervention group than in the control group. Furthermore, the indirect costs indicated that lost productivity was significantly less in the intervention group than in the control group. Moreover, the treatment continuation rate did not differ between the intervention and control groups, and there were no adverse events in either group. Blood pressure control status and safety did not differ between the intervention and control groups. In-person visits at 6-month intervals may cause a societal cost reduction and improve patient satisfaction during video-based telemedicine. UMIN000040953.

Current Fertility Knowledge of Senior High School Students, Infertile Patients, and Medical Staff at an Infertility Clinic in Japan

Background: In a survey on fertility knowledge published in 2013 (Cardiff Fertility Knowledge Scale [CFKS]), Japan ranked 78th among 79 countries. This finding encouraged the Japanese government to revise the curriculum for sex education in 2015. The present study was conducted to assess the current fertility knowledge of senior high school students, infertile patients, and medical staff at an infertility clinic in Japan. Methods: A cross-sectional study of 899 senior high school students (average age 16.8 years), 461 infertile female patients (36.9 years), and 127 medical staff at our infertility clinic (33.1 years) was performed between July 2020 and January 2021. The questionnaire included 13 items from CFKS and our 12 original items on fertility and infertility treatments. Results: The positive response rates of senior high school students, infertile female patients, and medical staff were 69.4, 86.9, and 86.5% for CFKS, respectively, and were similar for all 25 items. The positive response rate was higher in all three groups than in the surveys conducted in 2013 (36.0%) and 2015 (44.4%) in Japan. Conclusions: Although sex education may have improved these scores, other resources (media and social media) may also be responsible for this increase.

Content of Telephone Consultations of Patients With Inflammatory Bowel Disease: A Single-Center Descriptive Study.

This study aimed to analyze the specific contents of telephone consultations of patients with inflammatory bowel disease. A medical record survey was conducted at a clinic in Japan for 1 year. Telephone consultation sheets recorded by nurses for calls with the patients or their relatives were reviewed. Content analysis was used to summarize the telephone consultation content. Consultations were categorized into 8 categories. Coding was conducted by 2 independent researchers. Concordance rates were evaluated using kappa coefficients. We analyzed 476 sheets. A total of 229 participants consulted the clinic at least once. The mean number of consultations per person was 2.1. Of these patients, 96 (40.9%) had ulcerative colitis. The kappa coefficient was 0.89. The most frequent consultation was "Consultation on worsening health: Inflammatory bowel disease is likely to have worsened" (42.0%). The second most frequent response was "Consultation or progress report on a worsening health condition: The disease is unlikely to have worsened" (19.8%). For consultations related to worsening the disease, it would be useful to assess symptoms over the phone using a disease activity index to ascertain the degree of worsening and to develop a screening tool for determining whether patients can continue remote support or require face-to-face consultation.

A Comparative Study of Acute Gastroenteritis Symptoms in Single- versus Multiple-Virus Infections.

Many different enteric viruses can cause acute gastroenteritis in humans worldwide. While a single virus can indeed cause disease, multiple-virus infections are commonly reported. However, data regarding a comparison between single- and multiple-virus infections upon clinical manifestations of acute gastroenteritis are relatively limited. In this study, a total of 2383 fecal specimens were collected from children with acute gastroenteritis during June 2014-July 2017 in a pediatric clinic in Japan and tested for 11 viruses by multiplex RT-PCR. At least 1 virus was found in 1706 (71.6%) specimens and norovirus GII was the most frequent agent, followed by rotavirus A and other viruses. Multiple-virus infections were identified in 565 cases (33.1%). While major clinical symptoms were found to be significantly different in some single- vs. multiple-virus infections, the disease severity was statistically non-significant. Our study highlights the burden of multiple-virus infections for acute gastroenteritis and the clinical features of patients with multiple-virus infections.

The Insomnia Severity Index: Factor Structure and Measurement and Structural Invariance across Perinatal Time Points.

Insomnia is associated with adverse outcomes in women in the perinatal period; thus, the assessment of insomnia is important for pregnant women. The Insomnia Severity Index (ISI) is an instrument used globally to assess the severity of insomnia. However, its factor structure and structural invariance for pregnant women have not been studied. Therefore, we aimed to conduct factor analyses to search for the best model to fit its structural invariance. A cross-sectional study with the ISI was conducted at one hospital and five clinics in Japan from January 2017 to May 2019. A set of questionnaires was administered on two occasions with a one-week interval. The study included 382 pregnant women ranging in gestational age from 10 to 13 weeks. One week later, 129 participants answered the retest. After exploratory and confirmatory factor analyses, the measurement and structural invariance between parity and two time points was tested. The two-factor structure model showed an acceptable fit for the ISI in pregnant women (χ2 (12) = 28.516, CFI = 0.971, RMSEA = 0.089). The model also showed satisfactory measurement and structure invariance between parity and time points. The findings indicate that the ISI's use would be appropriate for pregnant women as a two-factor subscale of "severity" and "impact", regardless of the parity or time point. The ISI's factor structure may vary by subject; hence, it is necessary to confirm the measurement and structural invariance of the subject for whom the ISI will be used. Furthermore, interventions that focus not only on total scores and cutoff points but also on the phenomenon of subscales should be considered.

Fatigue on Waking, Insomnia, and Workplace Relationship Problems May Help to Detect Suicidal Ideation among New Middle-Aged Primary Care Patients: A 6-Month Prospective Study in Japan.

Signs of suicidal depression often go undetected in primary care settings. This study explored predictive factors for depression with suicidal ideation (DSI) among middle-aged primary care patients at 6 months after an initial clinic visit. New patients aged 35-64 years were recruited from internal medicine clinics in Japan. Baseline characteristics were elicited using self-administered and physician questionnaires. DSI was evaluated using the Zung Self-Rating Depression Scale and the Profile of Mood States at enrollment and 6 months later. Multiple logistic regression analysis was conducted to calculate adjusted odds ratios for DSI. Sensitivity, specificity, and likelihood ratios for associated factors were calculated. Among 387 patients, 13 (3.4%) were assessed as having DSI at 6 months. Adjusted for sex, age, and related factors, significant odds ratios for DSI were observed for "fatigue on waking ≥1/month" (7.90, 95% confidence intervals: 1.06-58.7), "fatigue on waking ≥1/week" (6.79, 1.02-45.1), "poor sleep status" (8.19, 1.05-63.8), and "relationship problems in the workplace" (4.24, 1.00-17.9). Fatigue on waking, sleep status, and workplace relationship problems may help predict DSI in primary care. Because the sample size in this investigation was small, further studies with larger samples are needed to confirm our findings.

Blunted humoral immune response to the fourth dose of BNT162b2 COVID-19 vaccine in patients undergoing hemodialysis.

We aimed to investigate the impact of a fourth dose of BNT162b2 vaccine (Comirnaty®, Pfizer-BioNTech) on anti-SARS-CoV-2 (anti-S IgG) antibody titers in patients receiving hemodialysis (HD) and healthcare workers (HCWs). A multi-institutional retrospective study at five dialysis clinics in Japan was conducted using 238 HD patients and 58 HCW controls who received four doses of the BNT162b2 mRNA vaccine. Anti-S IgG titers were measured at 1, 3, and 6months after the second dose, at 1 and 5/6months after the third dose, and at 1month after the fourth dose of vaccine. The log anti-S IgG titers of the HD patients after the second vaccination were significantly lower than those of the control group, but equalized 1month after the third vaccination: 9.94 (95% CI 9.82-10.10) vs. 9.81 (95% CI 9.66-9.96), (P = 0.32). In both groups, the fold-increase in anti-S IgG titers was significantly lower after the fourth dose than after the third dose of vaccine. In addition, there was a strong negative correlation between antibody titers 1month after the fourth vaccination and antibody titers immediately before the vaccination. In both groups, the waning rate of anti-S IgG titers from the post-vaccination peak level after the third vaccine dose was significantly slower than that after the second dose. These findings suggest that the humoral immune response was blunted after the fourth dose of the conventional BNT162b2 vaccine. However, multiple vaccinations could extend the window of humoral immune protection.

Simple Symptom-Based Prediction of COVID-19: A Single-Center Study of Outpatient Fever Clinic in Japan.

Coronavirus disease 2019 (COVID-19) symptoms are not fully understood in non-hospitalized individuals in Japan, and COVID-19 differentiation by symptoms alone remained challenging. Therefore, this study aimed to examine COVID-19 prediction from symptoms using real-world data in an outpatient fever clinic. We compared the symptoms of COVID-19-positive and negative patients who visited the outpatient fever clinic at Imabari City Medical Association General Hospital and tested for COVID-19 from April 2021 to May 2022. This retrospective single-center study enrolled 2,693 consecutive patients. COVID-19-positive patients had a higher frequency of close contact with COVID-19-infected patients compared with COVID-19-negative patients. Moreover, patients with COVID-19 had high-grade fever at the clinic compared with patients without COVID-19. Additionally, the most common symptom in patients with COVID-19 was sore throat (67.3%), followed by cough (62.0%), which was approximately twice as common in patients without COVID-19. COVID-19 was more frequently identified in patients having a fever (≥37.5℃) with a sore throat, a cough, or both. The positive COVID-19 rate reached approximately half (45%) when three symptoms were present. These results suggested that COVID-19 prediction by combinations of simple symptoms and close contact with COVID-19-infected patients might be useful and lead to recommendations for testing of COVID-19 in symptomatic individuals.

Mortality Risks and Causes of Death by Dementia Types in a Japanese Cohort with Dementia: NCGG-STORIES.

Prognosis-related information regarding dementia needs to be updated, as changes in medical and long-term care environments for patients with dementia in recent decades may be improving the prognosis of the disease. We aimed to investigate the mortality, cause of death, and prognostic factors by types of dementia in a Japanese clinic-based cohort. The National Center for Geriatrics and Gerontology-Life Stories of People with Dementia consists of clinical records and prognostic data of patients who visited the Memory Clinic in Japan. Patients who attended the clinic between July 2010 and September 2018, or their close relatives, were asked about death information via a postal survey. A cohort of 3,229 patients (mean age, 76.9; female, 1,953) was classified into six groups: normal cognition (NC), mild cognitive impairment (MCI), Alzheimer's disease (AD), vascular dementia, dementia with Lewy bodies (DLB), and frontotemporal lobar degeneration. A Cox proportional hazards model was employed to compare the mortality of each type of dementia, MCI, and NC. Patients with all types of dementia and MCI had higher mortality rates than those with NC (hazard risks: 2.61-5.20). The most common cause of death was pneumonia, followed by cancer. In the MCI, AD, and DLB groups, older age, male sex, and low cognitive function were common prognostic factors but not presence of apolipoprotein E ɛ4 allele. Our findings suggest important differences in the mortality risk and cause of death among patients with dementia, which will be useful in advanced care planning and policymaking.

Transformation of the Cardiovascular Clinics in Japan - How to Overcome Crisis Due to Changes in the External Environment.

The first percutaneous coronary intervention (PCI) was performed in September 1977, and after 1980 this minimally invasive treatment was established in Japan. To deliver this treatment to a larger population, a number of cardiovascular clinics emerged across the country in the 2000s, and the number of PCI cases performed has been steadily increasing, to >250,000 cases per year. In the early 2000s, a single catheterization unit was profitable, if it performed a certain number of treatments and was adequately staffed without excessive capital investment. In the late 1990s, the price of a balloon catheter medical device used for PCI was approximately JPY300,000, although the price was reduced to JPY32,000, almost one-tenth in price, in the April 2022 revision of the National Health Insurance. The reimbursement of the mainstream drug-eluting stent has also decreased from JPY421,000, when it was first introduced, to JPY136,000 currently. In addition, the consumption tax and reforms in working hours will have a major impact on clinic management. We present a history of cardiovascular clinics in Japan and their present and future positions under the variable external environment.

Validation of a new instrument for measuring disease-specific quality of life: A pilot study among patients with chronic kidney disease and hyperkalemia.

To prepare for a longitudinal study of the effects of potassium-lowering treatment on quality of life (QOL), we quantified the validity of a new disease-specific instrument for measuring QOL, using data from patients who had hyperkalemia (HK) due to chronic kidney disease (CKD) or chronic heart failure, and were also being treated with potassium binders (PBs). In this cross-sectional study, the participants were 98 patients at five outpatient clinics in Japan. The outcome measures were the Medical Outcomes Study 36-item short-form (SF-36), a widely used generic measure of QOL, and the Quality of Life Disease-specific Impact Scale (QDIS-7), a recently-developed disease-specific measure of QOL. Internal-consistency reliability was quantified, and factor analysis was done to confirm hypothesized QOL dimensions. Validation tests used two external criteria: CKD stage, and PB formulation. PB formulation was used because different formulations are associated with different degrees of patients' burden. Using a previously-described method, we computed the relative validity (RV) of the two measures. Two factor scoring of the SF-36 and one factor scoring of the QDIS-7, as standardized from previous studies, were confirmed. The RVs showed that the QDIS-7 was much more valid than the SF-36, for discriminating between groups defined clinically (by CKD stage), and also between groups defined by PB formulation. Reliability was satisfactory: 0.73-0.95 for the SF-36 and 0.86 for the QDIS-7. The QDIS-7 with CKD or PB attributions was more valid than the SF-36 for measuring the effects of CKD and of PB formulation on QOL.

Clinical outcomes of personalized blastocyst embryo transfer after endometrial receptivity analysis: A multicenter, retrospective cohort study.

To evaluate clinical outcomes after endometrial receptivity analysis (ERA). This was a multicenter, retrospective cohort study involving 861 women who underwent ERA testing at certified fertility clinics in Japan, and who received subsequent personalized blastocyst embryo transfers (ET) between 2018 and 2020. Clinical outcomes, including pregnancies, miscarriages, and live births, were evaluated according to receptivity status for ERA. Mean patient age was 37.7 years (SD = 4.0), and the median number of previous ETs was 2 (interquartile range, 2-3). 41.0% (353/861) of patients were non-receptive for ERA testing. Clinical pregnancy, miscarriage, and live birth rates for personalized blastocyst ET were 44.5% (226/508), 26.1% (59/226), and 26.8% (136/508) for receptive patients, and 43.1% (152/353), 28.3% (43/152), and 28.9% (102/353) for non-receptive patients, all statistically nonsignificant. Multiple logistic regression demonstrated similar nonsignificant associations between receptivity and clinical outcomes. Greater patient age, smoking, and longer duration of infertility were significantly and negatively associated with receptivity, whereas a history of delivery was positively associated and statistically significant. Clinical outcomes after ERA testing were similar between receptive and non-receptive patients. Further prospective study including an appropriate comparison group are warranted to evaluate the efficacy of ERA testing.

Construction of an Explanatory Model for Quality of Life in Outpatients with Ulcerative Colitis

Introduction: To date, no studies have reported explanatory models of health-related quality of life (HRQoL) in patients with ulcerative colitis. Therefore, this study aimed to examine HRQoL and its related factors in outpatients with ulcerative colitis to construct an explanatory model. Methods: We conducted a cross-sectional survey at a clinic in Japan. The HRQoL was evaluated using the 32-item Inflammatory Bowel Disease Questionnaire. We extracted explanatory variables of HRQoL from demographic, physical, psychological, and social factors reported in previous studies and created a predictive explanatory model. The relationship between explanatory variables and the questionnaire total score was examined using Spearman’s rank correlation coefficient, the Mann-Whitney test, or the Kruskal-Wallis test. We conducted multiple regression and path analyses to examine the effect of explanatory variables on the total score. Results: We included 203 patients. Variables that were associated with the total score were the partial Mayo score (r = −0.451), treatment side effects (p = 0.004), the Hospital Anxiety and Depression Scale-Anxiety score (r = −0.678), the Hospital Anxiety and Depression Scale-Depression score (r = −0.528), and the availability of an advisor during difficult times (p = 0.001). The model included the partial Mayo score, treatment side effects, the Hospital Anxiety and Depression Scale-Anxiety score, and the availability of an advisor during difficult times as explanatory variables of the total score that showed the best goodness-of-fit (adjusted R² = 0.597). The anxiety score exerted the greatest negative effect on the questionnaire total score (β = −0.586), followed by the partial Mayo score (β = −0.373), treatment side effects (β = 0.121), and availability of an advisor during difficult times (β = −0.101). Conclusion: Psychological symptoms exerted the strongest direct effect on HRQoL in outpatients with ulcerative colitis and mediated the relationship between social support and HRQoL. Nurses should listen carefully to the concerns and anxieties of patients to ensure that a social support system is provided by leveraging multidisciplinary collaborations.