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Abstract Background Light absorption by melanin is greater in the ultraviolet spectrum than in the visible light spectrum. Purple light in the near‐ultraviolet–visible region (380–430 nm) also corresponds to a highly absorptive wavelength of melanin. Therefore, images captured under purple light are remarkably suited to detect subtle alterations in skin pigment contents. Objectives We compared two prototype dermoscopy cameras (DZ‐D100; Casio Computer Co., Ltd.): one with a 385 nm light (P385) and the other with a 405 nm light (P405), to clarify which wavelength could more clearly show dermoscopic structures. Methods Sixteen Japanese patients with 19 lesions, who visited our department were photographed with the P385 and P405 cameras under the same conditions. We evaluated the visual perception of lines, dots/clods, lesion borders and background around the lesion, as well as exposure, including appropriate brightness and underexposure, using the scores. Results Underexposure was significantly less in the P385 image than in the P405 image (p

Abstract Background In clinical practice, the quality of images may vary depending on the imaging device, and the focus of the dermoscope is on the superficial layer of the lesion. Therefore, it is desirable to have a dermoscopy device that can easily focus on any lesion and clearly show the findings. Objectives We conducted a clinical study to compare dermoscopic images of the same skin tumours obtained using a prototype dermoscopy camera, DZ‐D100 (DD, Casio Computer Co., Ltd.), and three existing dermoscopy imaging devices (Derma9500S®‐GR or DG, Derma Medical Inc.; DELTA 20® T or DT, HEINE Optotechnik; and DermLite Foto II Pro® or DF, DermLite LLC). Methods Dermoscopic images of 117 skin tumours from 94 patients who visited Chiba University Hospital were evaluated by two experts in terms of the focus, and the clarity and presence or absence (the primary endpoint) of seven findings (pigmented lines, shiny white lines, dots/globules, blue‐grey structures, vascular structures, milia‐like cysts and comedo‐like openings). Results No significant differences in the number of cases with each of the seven findings (pigmented lines, shiny white lines, dots/globules, blue‐grey structures, vascular structures, milia‐like cysts and comedo‐like openings) among the four groups were observed. The clarity of focus was significantly better with the DD than with the other three devices (all, p

Abstract Background This retrospective cohort study aimed to evaluate the impact of the COVID‐19 pandemic on colorectal cancer care and mortality using a large cancer registry in Hiroshima Prefecture, Japan. The study aimed to estimate the all‐cause mortality rates within 1 year of diagnosis among colorectal cancer patients diagnosed during the pandemic period (2020 and 2021) compared to those diagnosed during the pre‐pandemic period (2018 and 2019). Methods The day of diagnosis was set as Day 0 and Cox regression models were utilized to estimate crude hazard ratios (HRs) and adjusted HRs, accounting for age, sex, cancer stage, and treatment status. Two sensitivity analyses of overall survival were performed with different cutoffs of the pre‐pandemic/pandemic periods and year‐to‐year comparisons. Subgroup analyses were performed using likelihood ratio tests. Results A total of 15,085 colorectal cancer patients were included, with 6499 eligible for follow‐up. A median age of included patients was 72 years old, of which 59% were male. The distribution of cancer stages showed little variation between the pre‐pandemic and pandemic periods. With a median follow‐up of 177 days, the number of events was 316/3111 (173 events per 1000 person‐years [E/1000PY], 95% confidence interval [CI]: 154–192 E/1000PY) in the pre‐pandemic period, and 326/2746 (245 E/1000PY, 95% CI: 220–274 E/1000PY) in the pandemic period (crude HR: 1.42, 95% CI: 1.22–1.66; adjusted HR: 1.25, 95% CI: 1.07–1.46). The two sensitivity analyses and subgroup analyses consistently supported these findings. Conclusions The study revealed an increased colorectal cancer mortality during the pandemic period, suggesting a continuous impact of the COVID‐19 pandemic on the known and unknown risk factors for colorectal cancer for several years. Further studies are necessary to mitigate the adverse effects on patient outcomes.

This document provides a design description of a data acquisition device that allows an alert to be issued to suggest to the driver to take a break after having subjected his body to a certain amount of acceleration and pressure changes after driving on a road with too many curves. The tests were carried out using sensors based on microelectromechanical systems. The system was strategically installed at specific points on the body of the driver and car. Several electronic arrays were carried out, like the design of a printed circuit board. The establishment of an inter-integrated circuit communication and its multiplexing to work with several devices with the same address simultaneously. Finally, in this context, the document also presents the critical velocity for each curve in the Hakone roadway, which was obtained by using a mathematical model and contrasted with data acquisition values for acceleration. The risk of skidding on a curve increases when the driver does not reduce driving velocity; only a slight variance in acceleration or environmental conditions is enough. The value of acceleration was acquired for the analysis of each curve; there is a greater possibility of skidding in curves 2 and 4 because their radius is smaller and the critical speed is approximately 60 km/h, which is very close to the driving speed. On the other hand, the deceleration value of −0.65 G read on the head accelerometer can increase fatigue symptoms such as blurry vision or dizziness.

Abstract Background Anti‐PD‐1‐based immunotherapy is considered a preferred first‐line treatment for advanced BRAF V600‐mutant melanoma. However, a recent international multi‐center study suggested that the efficacy of immunotherapy is poorer in Asian patients in the non‐acral cutaneous subtype. We hypothesized that the optimal first‐line treatment for Asian patients may be different. Methods We retrospectively collected data of Asian patients with advanced BRAF V600‐mutant melanoma treated with first‐line BRAF/MEK inhibitors (BRAF/MEKi), anti‐PD‐1 monotherapy (Anti‐PD‐1), and nivolumab plus ipilimumab (PD‐1/CTLA‐4) between 2016 and 2021 from 28 institutions in Japan. Results We identified 336 patients treated with BRAF/MEKi (n = 236), Anti‐PD‐1 (n = 64) and PD‐1/CTLA‐4 (n = 36). The median follow‐up duration was 19.9 months for all patients and 28.6 months for the 184 pa tients who were alive at their last follow‐up. For patients treated with BRAF/MEKi, anti‐PD‐1, PD‐1/CTLA‐4, the median ages at baseline were 62, 62, and 53 years (p = 0.03); objective response rates were 69%, 27%, and 28% (p

Introduction Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin–angiotensin–aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients’ quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient’s QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient’s QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient’s QOL, in patients with HK.Methods and analysis This is a prospective cohort study with 6 months of follow-up in 30–40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients’ characteristics. To assess the impact of treatment on a patient’s QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient’s QOL.Ethics and dissemination Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals.Trial registration number NCT05297409.

Aim: We examined the association between the location of cardiac arrest and outcomes of patients with out-of-hospital cardiac arrest (OHCA) who underwent extracorporeal cardiopulmonary resuscitation (ECPR). Methods: This was a secondary analysis of SAVE-J II, a multicentre retrospective registry with 36 participating institutions across Japan, which enrolled adult patients with OHCA who underwent ECPR. The outcomes of interest were favourable neurologic outcome at discharge. We compared the outcome between OHCA cases that occurred at residential and public locations, using a multilevel logistic regression model allowing for the random effect of each hospital. Results: Among 1,744 enrolled OHCAs, 809 and 935 occurred at residential (house: 603; apartment: 206) and public (street: 260; workplace: 210; others: 465) locations, respectively. The proportion of favourable neurologic outcomes was lower in OHCAs at residential locations than those at public locations (88/781 (11.3%) vs.131/891 (14.7%); adjusted odds ratio, 0.72 [95% confidence interval, 0.53–0.99]). However, subgroup analyses for patients with EMS aged

Abstract Background Although corticosteroid therapy with dose tapering is the most commonly used treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF), there is no consensus on the tapering regimen. This study aimed to investigate the association between early corticosteroid dose tapering and in-hospital mortality in patients with AE-IPF. Methods In this retrospective cohort study, we analyzed the data of a cohort from eight Japanese tertiary care hospitals and routinely collected administrative data from a cohort from 185 Japanese hospitals. Patients with AE-IPF were classified into the early and non-early tapering groups depending on whether the maintenance dose of corticosteroids was reduced within two weeks of admission. Propensity score analysis with inverse probability weighting (IPW) was performed to estimate the effect of early corticosteroid dose tapering. Results The multi-center cohort included 153 eligible patients, of whom 47 (31%) died, whereas the administrative cohort included 229 patients, of whom 51 (22%) died. Patients with early tapering tended to have a better prognosis than those without it (unadjusted hazard ratio [95% confidence interval] 0.41 [0.22–0.76] and 0.65 [0.36–1.18] in the multi-center and administrative cohorts, respectively). After IPW, the early tapering group had a better prognosis than the non-early tapering group (IPW-adjusted hazard ratio [95% confidence interval] 0.37 [0.14–0.99] and 0.27 [0.094–0.83] in the multi-center and administrative cohorts, respectively). Conclusion Early corticosteroid dose tapering was associated with a favorable prognosis in patients with AE-IPF. Further studies are warranted to confirm the effects of early corticosteroid dose tapering in patients with AE-IPF.

Abstract Background The effect of ICU admission time on patient outcomes has been shown to be controversial in several studies from a number of countries. The imbalance between ICU staffing and medical resources during off-hours possibly influences the outcome for critically ill or injured patients. Here, we aimed to evaluate the association between ICU admission during off-hours and in-hospital mortality in Japan. Methods This study was an observational study using a multicenter registry (Japanese Intensive care PAtient Database). From the registry, we enrolled adult patients admitted to ICUs from April 2015 to March 2019. Patients with elective surgery, readmission to ICUs, or ICU admissions only for medical procedures were excluded. We compared in-hospital mortalities between ICU patients admitted during off-hours and office-hours, using a multilevel logistic regression model which allows for the random effect of each hospital. Results A total of 28,200 patients were enrolled with a median age of 71 years (interquartile range [IQR], 59 to 80). The median APACHE II score was 18 (IQR, 13 to 24) with no significant difference between patients admitted during off-hours and those admitted during office-hours. The in-hospital mortality was 3399/20,403 (16.7%) when admitted during off-hours and 1604/7797 (20.6%) when admitted during office-hours. Thus, off-hours ICU admission was associated with lower in-hospital mortality (adjusted odds ratio 0.91, [95% confidence interval, 0.84–0.99]). Conclusions ICU admissions during off-hours were associated with lower in-hospital mortality in Japan. These results were against our expectations and raised some concerns for a possible imbalance between ICU staffing and workload during office-hours. Further studies with a sufficient dataset required for comparing with other countries are warranted in the future.

Objectives: The clinical evidence for the effect of narrow-spectrum antimicrobial shortages on bacterial susceptibility is limited. Our purposes were to determine the affects of the disruption of most of the cefazolin (CEZ) supply in Japan on the susceptibility of pathogens and to analyze how long these changes persisted after the shortage of CEZ. Methods: We performed an interrupted time series analysis using the Japanese Infectious Disease Nationwide database. We analyzed each pathogen before and after CEZ shortage in 52 university hospitals from 2018 to 2020. May to November 2019 was designated as the implementation term for CEZ shortage. The primary outcome was the susceptibility to CEZ and other antimicrobial agents. Amongst all pathogens isolated from facilities, we identified pathogens that were tested for susceptibility to CEZ. Results: Of the 26 pathogens identified, analysis was performed on a total of 36,346 isolates of five pathogens (Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, and Staphylococcus aureus). Amongst four Gram-negative pathogens with low susceptibility, there were no significant immediate changes after the CEZ shortage; however, the slope change significantly increased by 1.29 to 2.69% per month and continued to improve one year after the shortage. Regarding S. aureus, which was highly susceptible at the baseline, neither immediate change nor slope was significant. Conclusion: This quasi-experimental analysis using a nationwide-large database revealed that restriction of use because of narrow-spectrum antimicrobial shortages may lead to improved susceptibility over the subsequent year. The results suggest that temporary switching of antimicrobial agents on a national scale could be effective.

Abstract Metabolic syndrome and lumbar spinal stenosis (LSS) are common age-related diseases. However, the causal relationship between them remains unclear. This study aimed to identify the effects of LSS on metabolic syndrome incidence in community-dwelling adults. This prospective cohort study included participants of the Aizu cohort study (LOHAS) aged

Abstract The impact of prehospital notification by emergency medical services (EMS) on outcomes of endovascular therapy (EVT) for large vessel occlusion (LVO) remains unclear. We therefore explored the association between prehospital notification and clinical outcomes after EVT. In this single-center retrospective study from 2016 through 2020, we identified all LVO patients who received EVT. Based on the EMS’s usage of a prehospital stroke notification system, we categorized patients into two groups, Hotline and Non-hotline. The primary outcome was good neurological outcome at 90 days; other time metrics were also evaluated. Of all 312 LVO patients, the proportion of good neurological outcomes was 94/218 (43.1%) in the Hotline group and 8/34 (23.5%) in the Non-hotline group (adjusted odds ratio 2.86; 95% confidence interval 1.12 to 7.33). Time from hospital arrival to both tissue plasminogen activator and to groin puncture were shorter in the Hotline group (30 (24 to 38) min vs 48(37 to 65) min, p

Abstract Gynecologic laparoscopic surgery has a high incidence of postoperative nausea and vomiting (PONV). Studies suggest that low intraoperative end-tidal carbon dioxide (EtCO2) is associated with an increased incidence of PONV, but the results have not been consistent among studies. This study investigated the association between intraoperative EtCO2 and PONV in patients undergoing gynecologic laparoscopic surgeries under general anesthesia. This retrospective cohort study involved patients who underwent gynecologic laparoscopic surgeries under general anesthesia at Kyoto University Hospital. We defined low EtCO2 as a mean EtCO2 of

Abstract Background Solitary death is an emerging public health problem in developed countries. Alcohol abuse is associated with social isolation and excess mortality. However, data on the association between alcohol abuse and solitary death are limited. Our purposes were to assess whether alcohol abuse is associated with a long interval from death to discovery among people living alone. Methods This is a cross-sectional study using the data on subjects from the largest forensic database in Kyoto, Japan, from February 2012 to December 2015. Solitary death was defined as a phenomenon of dying alone at home and remaining undiscovered for more than 1 week. All the subjects who lived alone and aged over 18 at the time of death were included in the study. The presence of alcohol abuse was identified via an investigation during home visits. Proportional ratios were calculated using a fitted logit model to evaluate the association of alcohol abuse on solitary death after adjusting for possible confounders. Results A total of 235 subjects were included in the analysis. The mean age (standard deviation) of subjects at the time of death was 63.4 (15.1) years, and approximately 61.8% and 38.9% of subjects in the alcohol and non-alcohol abuse groups, respectively, experienced solitary death. Multivariable analyses revealed that alcohol abuse was associated with solitary death (adjusted proportion ratio: 1.50; 95% confidence interval: 1.12–2.00). Conclusions The findings of this study could help identify individuals at higher risk of solitary death. Moreover, calling the attention of people with alcohol abuse may be beneficial to prevent solitary death.

BackgroundData on the effects of intraoperative end-tidal carbon dioxide (EtCO2) levels on postoperative organ dysfunction are limited. Thus, this study was designed to investigate the relationship between the intraoperative EtCO2 level and postoperative organ dysfunction in patients who underwent major abdominal surgery under general anesthesia.MethodsWe conducted a cohort study involving patients who underwent major abdominal surgery under general anesthesia at Kyoto University Hospital. We classified those with a mean EtCO2 of less than 35 mmHg as low EtCO2. The time effect was determined as the minutes when the EtCO2 value was below 35 mmHg, whereas the cumulative effect was evaluated by measuring the area below the 35-mmHg threshold. The outcome was postoperative organ dysfunction, defined as a composite of at least one organ dysfunction among acute renal injury, circulatory dysfunction, respiratory dysfunction, coagulation dysfunction, and liver dysfunction within 7 days after surgery.ResultsOf the 4,171 patients, 1,195 (28%) had low EtCO2, and 1,428 (34%) had postoperative organ dysfunction. An association was found between low EtCO2 and increased postoperative organ dysfunction (adjusted risk ratio, 1.11; 95% confidence interval [CI], 1.03-1.20; p = 0.006). Additionally, long-term exposure to EtCO2 values of less than 35 mmHg (≥224 min) was associated with postoperative organ dysfunction (adjusted risk ratio, 1.18; 95% CI, 1.06-1.32; p = 0.003) and low EtCO2 severity (area under the threshold) (adjusted risk ratio, 1.13; 95% CI, 1.02-1.26; p = 0.018).ConclusionsIntraoperative low EtCO2 of below 35 mmHg was associated with increased postoperative organ dysfunction.

BackgroundPrevious studies have shown that diarrhea, defined as a dichotomized cutoff, is associated with increased mortality of patients in intensive care units (ICUs). This study aimed to examine the dose-response relationship between the quantity of diarrhea and mortality in ICU patients with newly developed diarrhea.MethodsWe conducted this single-center retrospective cohort study. We consecutively included all adult patients with newly developed diarrhea in the ICU between January 2017 and December 2018. Newly developed diarrhea was defined according to the World Health Organization definition. The consistency of diarrhea was evaluated by the Bristol stool chart scale, and the quantity of diarrhea was assessed on the day when patients newly developed diarrhea. The primary outcome was in-hospital mortality. The risk ratio (RR) and 95% confidence interval (CI) for the association between diarrhea quantity and mortality were estimated using multivariable modified Poisson regression models.ResultsAmong the 231 participants, 68.4% were men; the median age was 72 years. The median diarrhea quantity was 401g (interquartile range [IQR] 230‒645g), and in-hospital mortality was 22.9%. More diarrhea at baseline was associated with higher in-hospital mortality; the adjusted RR (95% CI) per 200-g increase was 1.10 (1.01‒1.20), p = 0.029. In sensitivity analyses with near quartile categories of diarrhea quantity (ConclusionsA greater quantity of diarrhea was an independent risk factor for in-hospital mortality. The diarrhea quantity may be an indicator of disease severity in ICU patients.

Objective: This study aimed to evaluate the influence of advanced glycation end-product (AGE) accumulation on the prevalence and severity of overactive bladder (OAB) in community-dwelling elderly adults. Methods: We conducted a cross-sectional study involving 269 Japanese community dwellers aged ≥75 years in 2015. AGE accumulation was non-invasively measured via skin autofluorescence (SAF) values using AGE Reader. The primary and secondary outcomes were the presence and severity of OAB evaluated using the Overactive Bladder Symptom Score (OABSS). Individuals with an urgency score of ≥2 and sum score of ≥3 were considered to have OAB. The associations of SAF with the prevalence and severity of OAB were assessed using logistic and linear regression models, respectively, adjusted for clinically important confounders. Results: The median age of participants was 78 years. Of 269 participants, 110 (40.9%) were men and 75 (27.9%) had OAB. The median SAF was 2.2 arbitrary units (AUs). Increasing median SAF was observed with increasing age. Multivariable analysis revealed that SAF was not associated with either the likelihood of having OAB (odds ratio per AU=0.77, 95% confidence interval: 0.37–1.62) or the natural log-transformed OABSS (β per AU=−0.07, 95% confidence interval: −0.26–0.12). Conclusions: In this study, AGE accumulation, as assessed by SAF, was not associated with the prevalence and severity of OAB in Japanese community-dwelling elderly people aged ≥75 years.

Abstract Background While survival of systemic lupus erythematosus (SLE) patients has improved substantially, problems remain in the management of their emotional health. Medium to high-dose glucocorticoid doses are known to worsen emotional health; the effect is unclear among patients receiving relatively low-dose glucocorticoids. This study aims to investigate the association between low glucocorticoid doses and emotional health in lupus low disease activity state (LLDAS). Methods This cross-sectional study drew on data from SLE patients in 10 Japanese institutions. The participants were adult patients with SLE duration of ≥ 1 year who met LLDAS criteria at the study visit from April 2018 through September 2019. The exposure was the daily glucocorticoid dose (mg oral prednisolone). The outcome was the emotional health score of the lupus patient-reported outcome scale (range: 0 to 100). Multiple linear regression analysis was performed with adjustment for confounders including disease-related damage, activity, and psychotropic drug use. Results Of 192 patients enrolled, 175 were included in the analysis. Their characteristics were as follows: female, 89.7%; median age, 47 years (interquartile range (IQR): 37.0, 61.0). Median glucocorticoid dose was 4.0 mg (IQR 2.0, 5.0), and median emotional health score 79.2 (IQR 58.3, 91.7). Multiple linear regression analysis showed daily glucocorticoid doses to be associated with worse emotional health (β coefficient = − 2.54 [95% confidence interval − 4.48 to − 0.60], P = 0.01). Conclusions Daily glucocorticoid doses were inversely associated with emotional health among SLE patients in LLDAS. Further studies are needed to determine whether glucocorticoid tapering leads to clinically significant improvements in emotional health.

Abstract Malignant melanoma (MM) is the most life‐threatening disease among all skin malignancies, and recent genome‐wide studies reported BRAF, RAS, and NF1 as the most frequently mutated driver genes. While epigenetic aberrations are known to contribute to the oncogenic activity seen in various cancers, their role in MM has not been fully investigated. To investigate the role of epigenetic aberrations in MM, we performed genome‐wide DNA methylation analysis of 51 clinical MM samples using Infinium 450k beadarray. Hierarchical clustering analysis stratified MM into two DNA methylation epigenotypes: high‐ and low‐methylation subgroups. Tumor thickness was significantly greater in case of high‐methylation tumors than low‐methylation tumors (8.3 ± 5.3 mm vs 4.5 ± 2.9 mm, P = .003). Moreover, prognosis was significantly worse in high‐methylation cases (P = .03). Twenty‐seven genes were found to undergo significant and frequent hypermethylation in high‐methylation subgroup, where TFPI2 was identified as the most frequently hypermethylated gene. MM cases with lower expression levels of TFPI2 showed significantly worse prognosis (P = .001). Knockdown of TFPI2 in two MM cell lines, CHL‐1 and G361, resulted in significant increases of cell proliferation and invasion. These indicate that MM can be stratified into at least two different epigenetic subgroups, that the MM subgroup with higher DNA methylation shows a more progressive phenotype, and that methylation of TFPI2 may contribute to the tumor progression of MM.

Introduction: Although predialysis hemoglobin concentration is affected by interdialytic weight gain (IDWG), the interaction between these parameters is not well understood. Methods: Using data from the Japanese Dialysis Outcomes and Practice Pattern Study phases 1–5, we analyzed patients who underwent maintenance hemodialysis. The exposure variable was hemoglobin concentration, and the effect modifier was IDWG at baseline. These 2 categorical variables were then combined and analyzed. The primary outcome was major adverse cardiovascular events (MACEs). Hazard ratios were estimated using a Cox model for the association between exposure and MACEs after adjusting for potential confounders. We examined additive interactions between hemoglobin concentration and IDWG by calculating the relative excess risk due to interaction, which is defined as a departure from the additivity of effects. Results: A total of 8234 patients were enrolled. During a median follow-up of 2.1 years, 1062 (12.9%) patients developed MACEs. In IDWG categories of

Abstract Background Nivolumab has changed the treatment of advanced gastric cancer (AGC). Nivolumab shows better outcomes compared to best supportive care among AGC patients who received at least two prior regimens. However, there are no reliable data regarding AGC patients with poor performance status (PS) who received nivolumab. We investigated the efficacy and safety of nivolumab among AGC patients with poor PS. Methods We retrospectively collected clinicopathologic data from patients with AGC who underwent nivolumab monotherapy at our institution from October 2017 to June 2019. Results Forty-nine AGC patients who received nivolumab were assessed. Twenty-seven patients had PS 0 or 1 (Good group) and 22 had PS 2 or 3 (Poor group). The median progression-free survival and overall survival durations were 2.0 and 6.0 months in the Good group, respectively, and 1.2 and 2.8 months in the Poor group, respectively. The overall survival was significantly shorter in the Poor group (6.0 vs 2.8 months, p = 0.0255). The disease control rates were 23 and 9% in the Good and Poor groups, respectively. Thirty-three percent of patients experienced immune-related adverse events in the Good group, and 18% in the Poor group. Conclusion Nivolumab is feasible but insufficient as third- or later-line treatment for AGC patients with poor PS.

Objectives This study aimed to investigate the association between kyphotic posture and future loss of independence (LOI) and mortality in community-dwelling older adults.Design Prospective cohort study.Setting Two Japanese municipalities.Participants We enrolled 2193 independent community-dwelling older adults aged≥65 years at the time of their baseline health check-up in 2008. Kyphotic posture was evaluated using the wall-occiput test (WOT) and classified into three categories: non-kyphotic, mild (>0 and ≤4 cm) and severe (>4 cm).Primary and secondary outcome measures The primary outcome was mortality and the secondary outcomes were LOI (new long-term care insurance certification levels 1–5) and a composite of LOI and mortality. A Cox proportional hazards model was used to estimate the adjusted HRs (aHRs).Results Of the 2193 subjects enrolled, 1621 were included in the primary analysis. Among these, 272 (17%) and 202 (12%) were diagnosed with mild and severe kyphotic postures, respectively. The median follow-up time was 5.8 years. Compared with the non-kyphotic group, the aHRs for mortality were 1.17 (95% CI 0.70 to 1.96) and 1.99 (95% CI 1.20 to 3.30) in the mild and severe kyphotic posture groups, respectively. In the secondary analysis, a consistent association was observed for LOI (mild: aHR 1.70, 95% CI 1.13 to 2.55; severe: aHR 2.08, 95% CI 1.39 to 3.10) and the LOI-mortality composite (mild: aHR 1.27, 95% CI 0.90 to 1.79; severe: aHR 1.83, 95% CI 1.31 to 2.56).Conclusion Kyphotic posture was associated with LOI and mortality in community-dwelling older adults. Identifying the population with kyphotic posture using the WOT might help improve community health.

Abstract Objectives The association between frailty and short‐term prognosis has not been established in critically ill older adults presenting to the emergency department. We sought to examine the association between premorbid frailty and 30‐day mortality in this patient population. Methods This is a retrospective observational study on older adults aged over 75 who were triaged as Level 1 resuscitation with subsequent admissions to intermediate units or intensive care units (ICUs) in a single critical care center, from January to December 2019. We excluded patients with out‐of‐hospital cardiac arrest or those transferred from other hospitals. Frailty was evaluated by the Clinical Frailty Scale (CFS) from the patients’ chart reviews. The primary outcome was 30‐day mortality, and we examined the association between frailty scored on the CFS and 30‐day mortality using a multivariable logistic regression model with CFS 1–4 as a reference. Results A total of 544 patients, median age: 82 years (interquartile rang 78 to 87), were included in the study. Of these, 29% were in shock and 33% were in respiratory failure. The overall 30‐day mortality was 15.1%. The adjusted risk difference (95% confidence interval [CI]) in mortality for CFS 5, CFS 6, and CFS 7–9 was 6.3% (‐3.4 to 15.9), 11.2% (0.4 to 22.0), and 17.7% (5.3 to 30.1), respectively; and the adjusted risk ratio (95% CI) was 1.45 (0.87 to 2.41), 1.85 (1.13 to 3.03), and 2.44 (1.50 to 3.96), respectively. Conclusion The risk of 30‐day mortality increased as frailty advanced in critically ill older adults. Given this high risk of short‐term outcomes, ED clinicians should consider goals of care conversations carefully to avoid unwanted medical care for these patients.

Objectives To examine the association between facility-level adherence to phosphorus management guidelines and mortality among patients with haemodialysis, and to explore the facility-related factors associated with facility-level guideline adherence.Design Prospective cohort study.Setting The Dialysis Outcomes and Practice Pattern Study, which included 57 representative dialysis facilities in Japan between 2012 and 2015.Participants A total of 2054 adult patients who received maintenance haemodialysis were included. We defined exposure according to the following four categories, depending on whether facility-level target ranges of serum phosphorus concentration adhered to the Japanese clinical practice guidelines: adherence group (lower limit ≥3.5 mg/dL and upper limit ≤6.0 mg/dL), low-target group (lower limit 6.0) and high-target group (lower limit ≥3.5 and upper limit >6.0).Primary outcome measure The primary outcome was the patient all-cause mortality rate.Results The mortality rate among the patients was 7.3 per 100 person-years; 27 facilities (47%) set targets according to the guidelines. HRs for mortality with reference to the adherence group were 1.04 (95% CI 0.76 to 1.43) in the low-target group, 1.11 (95% CI 0.68 to 1.81) in the wide-target group and 1.95 (95% CI 1.12 to 3.38) in the high-target group. Involvement of dieticians in dialysis treatment was associated with facility-level guideline adherence (OR 4.51; 95% CI 1.15 to 17.7).Conclusions A higher facility-level target range for phosphorus was associated with increased patient mortality. Among facilities that set the target according to the guidelines, dieticians tended to be involved in dialysis care. These findings suggest the importance of reviewing facilities’ treatment policies in relation to updated guidelines and the need to work with relevant professionals.

Abstract Background The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials supporting recent anticancer drugs approved by the FDA, with a focus on immune checkpoint inhibitors (ICPis). Methods We identified all ICPis approved between 2011 and 2014, thereby obtaining 3 years of follow-up data. We assessed the clinical trials performed for each drug indication and matched each trial with publications in the literature. The primary benchmark was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model that was adjusted for clustering within drug indications and individual covariates. Results Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in the time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8–1.7; P = 0.55). However, findings related to non-ICPis investigated specifically in randomized phase 2 or phase 3 trials were significantly more likely to be published earlier than those related to ICPis (adjusted HR, 7.4; 95% CI, 1.8–29.5; P = 0.005). Conclusion One in 3 sponsor-submitted trials of the most recently approved anticancer drugs remained unpublished 2 years post-FDA approval. We found no evidence that the drug type was associated with the time to overall trial publication.

Objectives Longitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL.Design Nationwide prospective cohort study.Setting Japanese adult residents.Participants Residents aged ≥50 years selected by the quota sampling method.Primary outcome measure Clinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year.Results In total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42).Conclusions Our study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation.

ObjectivesTo investigate the longitudinal association of urgency urinary incontinence (UUI) with loss of independence (LOI) or death among independent community-dwelling older adults.DesignPopulation-based cohort study.SettingThe Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS), Minami-Aizu Town and Tadami Town, Fukushima, Japan.ParticipantsA total of 1,580 participants aged ≥65 years who underwent a health check-up conducted by LOHAS in 2010.MeasurementsExposure was defined as the presence of UUI, which was measured by a questionnaire based on the definition of UUI from the International Continence Society. The primary outcome was defined as incidence of LOI or death. After the check-up in 2010, the outcome was monitored until March 2014. A multivariable Cox proportional hazard analysis was performed to estimate the hazard ratio for the outcome. Ten potential confounders were adjusted in the analysis. Furthermore, we defined the secondary outcomes as two separate outcomes, LOI and death, and performed the same analysis.ResultsAmong all participants, 328 reported UUI. The incidence rates of the outcome were 20.4 and 11.4 (per 1,000 person-years) among participants with and without UUI, respectively. After multivariable adjustment, those who experienced UUI showed a substantial association with LOI or death (HR, 1.65; 95% CI, 1.01-2.68). However, they did not show such an association with LOI alone (HR, 1.07; 95% CI, 0.49-2.33). On the other hand, those with UUI exhibited a substantial association with death (HR, 2.23; 95% CI, 1.22-4.31).ConclusionsIn this study, UUI was associated with the occurrence of LOI or death; however, UUI is not associated with the occurrence of LOI alone among independent community-dwelling older adults. Our results suggest that there may be a difference between UUI-associated diseases that cause LOI and those that cause death.

AimTo clarify the association of poor oral function with loss of independence (LOI) or death in functionally independent older adults in the community.MethodsWe conducted a secondary analysis of data from a prospective cohort study in two municipalities in Japan. We included participants who were older than 65 years of age and had no certification in long-term care at baseline. Poor oral function was evaluated by the Kihon Checklist. Among participants with poor oral function, they were further classified by the degree of quality of life (QOL) impairment due to dysphagia. Main outcome is LOI or death from all cause. The hazard ratio (HR) and 95% confidence of intervals (CIs) were estimated by Cox proportional hazard models adjusted for potential confounders.ResultsOf 1,272 participants, 150 participants (11.8%) had poor oral function. The overall incidence of LOI or death was 10.0% in the participants with poor oral function, while 3.3% in the participants without. Participants with poor oral function were more likely to develop LOI or death than those without (crude HR = 3.17 [95% CIs 1.74-5.78], adjusted HR = 2.30 [95% CIs 1.22-4.36]). 10 participants (0.79%) were classified as poor oral function with QOL impairment, and were more likely to develop LOI or death than those without poor oral function (crude HR = 7.45 [95% CIs 1.80-30.91], adjusted HR = 8.49 [95% CIs 1.88-38.34]).ConclusionsPoor oral function was associated with higher risk of LOI or death in functionally independent older adults in the community.

Objectives The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a well-established and internationally recognised scale for measuring patients’ experience with hospital inpatient care. This study aimed to develop a Japanese version of the HCAHPS and to examine its structural validity, criterion-related validity and internal consistency reliability.Design Multicentere cross-sectional study.Setting A total of 48 hospitals in Japan.Participants 6522 patients aged ≥16 years who were discharged from the participating hospitals.Results Confirmatory factor analysis showed excellent goodness of fit of the same factor structure as that of the original HCAHPS, with the following composites: communication with nurses, communication with doctors, responsiveness of hospital staff, hospital environment, communication about medicines and discharge information. All hospital-level Pearson correlation coefficients between the Japanese HCAHPS composites and overall hospital rating exceeded the criteria. Results of inter-item correlations indicated adequate internal consistency reliability.Conclusions The Japanese HCAHPS has acceptable psychometric properties for assessing patients’ experience with hospital inpatient care. This scale could be used for quality improvement based on the assessment of patients’ experience with hospital care and for health services research in Japan.

Objective To investigate the association between work schedules and motivation for behavioural change of lifestyle, based on the transtheoretical model (TTM) in workers with overweight or obesity.Design A cross-sectional observational study.Setting A healthcare examination centre in Japan.Participants Between April 2014 and March 2016, we recruited 9243 participants who underwent healthcare examination and met the inclusion criteria, namely, age 20–65 years, body mass index (BMI) ≥25 kg/m2 and full-time workers.Exposure Night and shift (night/shift) workers were compared with daytime workers in terms of motivation for behavioural change.Primary and secondary outcome measures The primary outcome was action and maintenance stages of change (SOC) for lifestyle in TTM. In a subgroup analysis, we investigated interactions between characteristics, including age, sex, BMI, current smoking, alcohol habits, hours of sleep and working hours.Results Overall, 1390 participants (15.0%) were night/shift workers; night/shift workers were younger (median age (IQR): 46 (40–54) vs 43 (37–52) years) and the proportion of men was lesser (75.4 vs 60.9%) compared with daytime workers. The numbers of daytime and night/shift workers in the action and maintenance SOC were 2113 (26.9%) and 309 (22.2%), respectively. Compared with daytime workers, night/shift workers were less likely to demonstrate action and maintenance SOC (adjusted OR (AOR): 0.85, 95% CI: 0.74 to 0.98). In a subgroup analysis that included only those with long working hours (≥10 hours/day), results revealed a strong inverse association between night/shift work and action and maintenance SOC (AOR: 0.65, 95% CI: 0.48 to 0.86). A significant interaction was observed between long working hours and night/shift work (P for interaction=0.04).Conclusions In workers with overweight or obesity, a night/shift work schedule was associated with a lower motivation for behavioural change in lifestyle, and the association was strengthened in those with long working hours.

ObjectivesTo investigate the association of mental health and subjective physical functioning with future antibiotic prescriptions.DesignProspective cohort study.SettingA rural town in Japan.ParticipantsParticipants who completed the baseline survey (2008-2010) of the Locomotive Syndrome and Health Outcomes in the Aizu Cohort Study (LOHAS) were recruited. Participants were limited to those without comorbidities according to the Charlson comorbidity index. Participants using antibiotics at baseline were excluded. Mental health and physical functioning were assessed using the Mental Health and Physical Functioning domains of the Short-Form 12 Health Survey, and depressive symptoms were assessed using the Mental Health Inventories at baseline.Main outcome measuresThe main outcome was antibiotic prescriptions found in claims data during 1 year after the baseline survey.ResultsA total of 967 participants were included in the analysis, and 151 (15.6%) participants with at least one missing variable for the confounding factors were excluded, leaving 816 participants for the primary analysis. Among the 816 participants, 65 (8.0%) were newly prescribed at least one antibiotic during the 1-year follow-up period. The most frequently prescribed antibiotics were third-generation cephalosporins (44 prescriptions; 35.5%), macrolides (28 prescriptions; 22.6%), and quinolones (23 prescriptions; 18.6%). A multivariable logistic regression analysis showed an association between higher mental health scores and future antibiotic prescriptions (adjusted odds ratio [AOR], 1.40 per 1 standard deviation [SD] increase; 95% confidence interval [CI], 1.03-1.90), whereas no significant relationship was observed between Physical Functioning scores and future antibiotic prescriptions (AOR, 0.95 per 1 SD increase; 95% CI, 0.75-1.22). During the secondary analysis, adults with depressive symptoms were less likely to be prescribed antibiotics (AOR, 0.27; 95% CI, 0.11-0.70).ConclusionsBetter mental health was associated with increased future antibiotic prescriptions for healthy community-dwelling Japanese adults, suggesting that mentally healthier adults could be a target population for reducing antimicrobial use.

Objective The associations of physical multimorbidity with depressive symptoms have been investigated in a number of studies. However, whether patterns of chronic physical conditions have comparatively different associations with depressive symptoms remains unclear. This study aimed to investigate the associations of physical multimorbidity patterns with depressive symptoms.Design This study was designed as a nationwide cross-sectional survey in Japan.Setting General sample of the Japanese population.Participants Adult Japanese residents were selected by a quota sampling method. Data were analysed from 1788 residents who reported one or more chronic health conditions.Results Among four physical multimorbidity patterns: cardiovascular-renal-metabolic (CRM), skeletal-articular-digestive (SAD), respiratory-dermal (RDE) and malignant-digestive-urologic (MDU), multivariable logistic regression analyses revealed that the RDE pattern showed the strongest association with depressive symptoms (aOR=1.68, 95% CI: 1.21 to 2.31 for the pattern score highest quartile, compared with the lowest quartile), followed by SAD and MDU patterns (aOR=1.41, 95% CI: 1.01 to 1.98 for the SAD pattern score highest quartile; 1.41, 95% CI: 1.01 to 1.96 for the MDU pattern score highest quartile, compared with the lowest quartile). In contrast, the CRM pattern score was not significantly associated with depressive symptoms (aOR=1.31, 95% CI: 0.90 to 1.89 for the pattern score highest quartile, compared with the lowest quartile).Conclusions Physical multimorbidity patterns have different associations with depressive symptoms. Among these patterns, patients with the RDE pattern may be at a higher risk for developing depressive symptoms. This study reinforces the evidence that cluster pattern of chronic health conditions is a useful measure for clinical management of multimorbidity as it is differently associated with mental health status, which is one of the crucial outcomes for multimorbid patients.

Abstract Background Although many hemodynamically unstable trauma patients undergo computed tomography (CT) to identify a source of bleeding, this practice is currently only recommended by a few guidelines. To clarify whether CT has harmful effects among these patients, we examined the association between CT during initial management and mortality among unstable blunt trauma patients. Methods This was a retrospective cohort study based on Japan Trauma Data Bank 2004–2014 registry data. Study population was adult blunt trauma patients with hypotension on arrival. The primary outcome was the in-hospital mortality. Two types of analyses were performed to adjust for confounding factors including propensity score inverse probability of treatment weighted (IPTW) and instrumental variable (IV) analysis. Results Among 5,809 patients who met inclusion criteria, 5,352 (92.1%) underwent CT. The No CT group was more likely to have severe physiological conditions and lower probability of survival than those of the CT group. In IPTW analysis adjusting for measured confounders, we found a significant protective effect of undergoing CT on in-hospital mortality (excess deaths: −20.6 per 100 patients, 95% CI −26.2 to −14.9). In IV analysis adjusting both for measured and unmeasured confounders, the association between CT and mortality was not statistically significant (excess deaths: −4.1 per 100 patients, 95% CI −23.1 to 14.8). Discussion We did not find clinically meaningful harmful effect of CT on survival for unstable blunt trauma patients even after adjusting both for measured and unmeasured confounders. Conclusions Our results did not support the recommendation of current guideline. We suggest physicians should consider CT as one of the diagnostic options even when patients are unstable.

Abstract As Japan becomes a super-aging society, presentation of the best ways to provide medical care for the elderly, and the direction of that care, are important national issues. Elderly people have multi-morbidity with numerous medical conditions and use many medical resources for complex treatment patterns. This increases the likelihood of inappropriate medical practices and an evidence-practice gap. The present study aimed to: derive findings that are applicable to policy from an elucidation of the actual state of medical care for the elderly; establish a foundation for the utilization of National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), and present measures for the utilization of existing databases in parallel with NDB validation. Cross-sectional and retrospective cohort studies were conducted using the NDB built by the Ministry of Health, Labor and Welfare of Japan, private health insurance claims databases, and the Kyoto University Hospital database (including related hospitals). Medical practices (drug prescription, interventional procedures, testing) related to four issues—potential inappropriate medication, cancer therapy, chronic kidney disease treatment, and end-of-life care—will be described. The relationships between these issues and clinical outcomes (death, initiation of dialysis and other adverse events) will be evaluated, if possible.

Objectives Our study aimed to examine the longitudinal association between social participation and both mortality and the need for long-term care (LTC) simultaneously.Design A prospective cohort study with 9.4 years of follow-up.Setting Six Japanese municipalities.Participants The participants were 15 313 people who did not qualify to receive LTC insurance at a baseline based on the data from the Aichi Gerontological Evaluation Study (AGES, 2003–2013). They received a questionnaire to measure social participation and other potential confounders. Social participation was defined as participating in at least one organisation from eight categories.Primary and secondary outcome measures The primary outcomes were classified into three categories at the end of the 9.4 years observational period: living without the need for LTC, living with the need for LTC and death. We estimated the adjusted OR (AOR) using multinomial logistic regression analyses with adjustment for possible confounders.Results The primary analysis included 9741 participants. Multinomial logistic regression analysis revealed that social participation was associated with a significantly lower risk of the need for LTC (AOR 0.82, 95% CI 0.69 to 0.97) or death (AOR 0.78, 95% CI 0.70 to 0.88).Conclusions Social participation may be associated with a decreased risk of the need for LTC and mortality among elderly patients.

BACKGROUND:Older adults' discussions with family, or with physicians, or with both, about advance care planning (ACP) are increasingly regarded as important for the management of end-of-life care, and yet the factors that induce older adults to engage in ACP discussions are poorly understood. For example, in older adults, is stronger connectedness with family and friends (stronger "networks") associated with ACP discussions? By facilitating, or by impeding ACP discussions? We sought to evaluate the associations between ACP discussions and social networks in Japanese older adults. METHODS:In July 2016 we conducted a cross-sectional survey on 355 community-dwelling patients aged ≥65 years visiting community hospital clinics in Fukushima, Japan. We used the Lubben Social Network Scale (LSNS-6, the shortest available LSNS scale) to assess social networks and recorded two components of social network structure, marital status (dichotomized as "married" vs. "single / other") and living status ("living with others" vs. "living alone"). One item asked if patients had had ACP discussions. We analyzed the LSNS-6 social network and marital and living status data in relation to the occurrence of ACP discussions using multiple logistic regression models with adjustments for possible confounding factors. RESULTS:Respondents' social network was "limited" in 16% of cases; 61% had had ACP discussions. Respondents with a limited social network had a significantly lower tendency to have had ACP discussions than respondents with an "adequate" social network (adjusted odds ratio [AOR]: 0.35; 95% confidence interval [CI]: 0.18-0.66; P < 0.001). Marital status and living status were not significantly associated with ACP discussion. CONCLUSIONS:Among Japanese older adults, weaker social networks may be associated with a lower tendency to discuss ACP. Our findings may help practitioners to quickly screen populations at risk for inadequate ACP discussion by using the LSNS-6.

Cancer immunotherapy has highlighted the clinical relevance of enhancing anti-tumor response of CD8+ T cells in several cancer types. Little is known, however, about the involvement of the immune system in extramammary Paget's disease (EMPD). We examined the cytotoxicity and the effector functions of CD8+ T cells using paired samples of peripheral blood and tumors by flow cytometry. Expression levels of perforin, granzyme B, IFN-g, TNF-a, and IL-2 in CD8+ tumor-infiltrating lymphocytes (TILs) were significantly lower than those in CD8+ T cells of peripheral blood. Significantly higher expression of PD-1 was found in CD8+TILs than in CD8+ T cells of peripheral blood. A high number of CD8+ cells was significantly associated with poor overall survival (OS) adjusted with age, sex, and clinical stage (hazard ratio [HR] = 5.03, P = 0.045, 95% confidence interval [CI] 1.03-24.4). On the other hand, the number of PD-1+ cells was not associated with OS or disease-free survival (DFS). Moreover, we found that tumor cells produced immunosuppressive molecule indoleamine 2,3-dyoxygenae (IDO). In conclusion, CD8+ TILs displayed an exhausted phenotype in EMPD. IDO expression seemed more relevant in inducing CD8 exhaustion than PD-1 upregulation or PD-L1 expression by immune cells. Restoring the effector functions of CD8+ TILs could be an effective treatment strategy for advanced EMPD.

OBJECTIVES:Little is known about the physician characteristics associated with appraisal skills of research evidence, especially the assessment of the validity of study methodology. This study aims to explore physician characteristics associated with proper assessment of overstated conclusions in research abstracts. DESIGN:A secondary analysis of a randomized controlled trial. SETTING AND PARTICIPANTS:We recruited 567 volunteers from the Japan Primary Care Association. METHODS:Participants were randomly assigned to read the abstract of a research paper, with or without an overstatement, and to rate its validity. Our primary outcome was proper assessment of the validity of its conclusions. We investigated the association of physician characteristics and proper assessment using logistic regression models and evaluated the interaction between the associated characteristics and overstatement. RESULTS:We found significant associations between proper assessment and post-graduate year (odds ratio [OR] = 0.67, 95% confidence interval [CI] 0.49 to 0.91, for every 10-year increase) and research experience as a primary investigator (PI; OR = 2.97, 95% CI 1.65 to 5.34). Post-graduate year and PI had significant interaction with overstatement (P = 0.015 and < 0.001, respectively). Among participants who read abstracts without an overstatement, post-graduate year was not associated with proper assessment (OR = 1.04, 95% CI 0.82 to 1.33), and PI experience was associated with lower scores of the validity (OR = 0.58, 95% CI 0.35 to 0.96). CONCLUSION:Physicians who have been in practice longer should be trained in distinguishing overstatements in abstract conclusions. Physicians with research experience might be informed that they tend to rate the validity of research lower regardless of the presence or absence of overstatements. TRIAL REGISTRATION:UMIN000026269.