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Aims: Small common bile duct stones are known to occasionally clear spontaneously. This study aimed to prospectively assess the role of biliary stent placement in promoting the spontaneous clearance of small common bile duct stones. Methods and Results: We analyzed patients presenting with common bile duct stones of ≤5 mm diameter between June 2020 and May 2022. The exclusion criteria included asymptomatic patients, biliary pancreatitis, altered gastrointestinal anatomy, bile duct strictures (malignant or benign), and a history of EST. The biliary stents were inserted without stone removal. Stone clearance was assessed using endoscopic ultrasonography or endoscopic retrograde cholangiopancreatography after 3 months. Our primary endpoint was the clearance rate of common bile duct stones over 6 months, targeting a lower limit for the 95% confidence interval (CI) exceeding 25%. Of the 32 enrolled patients, 18 (56.3%; 95% CI: 37.7–73.6%) exhibited stone clearance. Early complications occurred in 11 patients (34.4%), totaling 12 incidents: acute cholecystitis in four, acute pancreatitis in three, biliary pain in three, and cholangitis in two patients. No severe complications occurred. Six (18.8%) patients experienced asymptomatic stent migration. Following stone clearance, four (12.5%) patients experienced stone recurrence, with an average duration of 256 ± 164 days. Conclusion: Biliary stenting appeared to effectively promote the clearance of small common bile duct stones in approximately half of the patients. However, the potential complications and risks of stone recurrence warrant close monitoring. This trial was registered in the Japan Registry of Clinical Trials (jRCT1042200020). [ABSTRACT FROM AUTHOR]

Aim: Bedriddenness Rank (BR) and Cognitive Function Score (CFS), issued by the Ministry of Health, Labour and Welfare, Japan, are easy-to-use and widely used in the medical and long-term care insurance systems in Japan. This study aims to clarify the criterion-related validity of the CFS with the Mini-Mental State Examination (MMSE) and ABC Dementia Scale (ABC-DS), and to re-evaluate the criterion-related validity of BR with the Barthel Index (BI) or Katz Index (KI) in more appropriate settings and a larger population compared with the previous study. Methods: A single-center prospective observational study was conducted in an acute care hospital in a suburban city in Japan. All inpatients aged 20 years or older admitted from October 1, 2018 to September 30, 2019. The relationship between BR and the BI and KI, and the relationship between CFS and the MMSE and ABC-DS were analyzed using Spearman's correlation coefficients. Results: We enrolled 3,003 patients. Of these, 1,664 (56%) patients exhibited normal BR. The median (interquartile range) values of the BI and KI were 100 (65–100) and 6 (2–6), respectively. Spearman's rank correlation coefficients between BR and the BI and KI were −0.891 (p < 0.001) and −0.877 (p < 0.001), respectively. Of the patients, 1,967 (65.5%) showed normal CFS. The median (interquartile range) MMSE of 951 patients with abnormal CFS and ABC-DS of all patients were 15 (2–21) and 117 (102–117), respectively. Spearman's rank correlation coefficients between CFS and MMSE and ABC-DS were −0.546 (p < 0.001) and −0.862 (p < 0.001), respectively. Conclusions: BR and CFS showed significant criterion-related validity with well-established but complicated objective scales for assessing activities of daily living and cognitive functions, respectively. These two scales, which are easy to assess, are reliable and useful in busy clinical practice or large-scale screening settings. [ABSTRACT FROM AUTHOR]

Background: Several reliable predictive models for falls have been reported, but are too complicated and time-consuming to evaluate. We recently developed a new predictive model using just eight easily-available parameters including the official Japanese activities of daily living scale, Bedriddenness ranks, from the Ministry of Health, Labour and Welfare. This model has not yet been prospectively validated. This study aims to prospectively validate our new predictive model for falls among inpatients admitted to two different hospitals. Methods: A double-centered prospective cohort study was performed from October 1, 2018, to September 30, 2019 in an acute care hospital and a chronic care hospital. We analyzed data from all adult inpatients, for whom all data required by the predictive model were evaluated and recorded. The eight items required by the predictive model were age, gender, emergency admission, department of admission, use of hypnotic medications, previous falls, independence of eating, and Bedriddenness ranks. The main outcome is in-hospital falls among adult inpatients, and the model was assessed by area under the curve. Results: A total of 3,551 adult participants were available, who experienced 125 falls (3.5%). The median age (interquartile range) was 78 (66–87) years, 1,701 (47.9%) were men, and the incidence of falls was 2.25 per 1,000 patient-days and 2.06 per 1,000 occupied bed days. The area under the curve of the model was 0.793 (95% confidence interval: 0.761–0.825). The cutoff value was set as − 2.18, making the specificity 90% with the positive predictive value and negative predictive value at 11.4% and 97%. Conclusions: This double-centered prospective cohort external validation study showed that the new predictive model had excellent validity for falls among inpatients. This reliable and easy-to-use model is therefore recommended for prediction of falls among inpatients, to improve preventive interventions. Trial registration: UMIN000040103 (2020/04/08) [ABSTRACT FROM AUTHOR]

Objectives To assess the applicability of Electronic Frailty Index (eFI) and Hospital Frailty Risk Score (HFRS) algorithms to Japanese administrative claims data and to evaluate their association with long-term outcomes. Study Design and Setting A cohort study using a regional government administrative healthcare and long-term care (LTC) claims database in Japan 2014–18. Participants Plan enrollees aged ≥50 years. Methods We applied the two algorithms to the cohort and assessed the scores' distributions alongside enrollees' 4-year mortality and initiation of government-supported LTC. Using Cox regression and Fine–Gray models, we evaluated the association between frailty scores and outcomes as well as the models' discriminatory ability. Results Among 827,744 enrollees, 42.8% were categorised by eFI as fit, 31.2% mild, 17.5% moderate and 8.5% severe. For HFRS, 73.0% were low, 24.3% intermediate and 2.7% high risk; 35 of 36 predictors for eFI, and 92 of 109 codes originally used for HFRS were available in the Japanese system. Relative to the lowest frailty group, the highest frailty group had hazard ratios [95% confidence interval (CI)] of 2.09 (1.98–2.21) for mortality and 2.45 (2.28–2.63) for LTC for eFI; those for HFRS were 3.79 (3.56–4.03) and 3.31 (2.87–3.82), respectively. The area under the receiver operating characteristics curves for the unadjusted model at 48 months was 0.68 for death and 0.68 for LTC for eFI, and 0.73 and 0.70, respectively, for HFRS. Conclusions The frailty algorithms were applicable to the Japanese system and could contribute to the identifications of enrollees at risk of long-term mortality or LTC use. [ABSTRACT FROM AUTHOR]

Background: The characterisation of desmoplastic reaction (DR) has emerged as a new, independent prognostic determinant in colorectal cancer. Herein, we report the validation of its prognostic value in a randomised controlled study (SACURA trial).Methods: The study included 991 stage II colon cancer patients. DR was classified by the central review as Mature, Intermediate or Immature based on the presence of hyalinised collagen bundles and myxoid stroma at the desmoplastic front. All clinical and pathological data, including DR characterisations, were prospectively recorded and analysed 5 years after the completion of the registration.Results: The five-year relapse-free survival (RFS) rate was the highest in the Mature group (N = 638), followed by the Intermediate (N = 294) and Immature groups (N = 59). Multivariate analysis revealed that DR classification was an independent prognostic factor, and based on Harrell's C-index, the Cox model for predicting RFS was significantly improved by including DR. In the conditional inference tree analysis, DR categorisation was the first split factor for predicting RFS, followed by T-stage, microsatellite instability status and budding.Conclusions: Histological categorisation of DR provides important prognostic information that could contribute to the efficient selection of stage II colon cancer patients who would benefit from postoperative adjuvant therapy. [ABSTRACT FROM AUTHOR]

Background: The statistical validities of the official Japanese classifications of activities of daily living (ADLs), including bedriddenness ranks (BR) and cognitive function scores (CFS), have yet to be assessed. To this aim, we evaluated the ability of BR and CFS to assess ADLs using inter-rater reliability and criterion-related validity.Methods: New inpatients aged ≥75 years were enrolled in this hospital-based prospective observational study. BR and CFS were assessed once by an attending nurse, and then by a social worker/medical clerk. We evaluated inter-rater reliability between different professions by calculating the concordance rate, kappa coefficient, Cronbach's α, and intraclass correlation coefficient. We also estimated the relationship of the Barthel Index and Katz Index with the BR and CFS using Spearman's correlation coefficients.Results: For the 271 patients enrolled, BR at the first assessment revealed 66 normal, 10 of J1, 15 of J2, 18 of A1, 31 of A2, 37 of B1, 35 of B2, 22 of C1, and 32 of C2. The concordance rate between the two BR assessments was 68.6%, with a kappa coefficient of 0.61, Cronbach's α of 0.91, and an intraclass correlation coefficient of 0.83, thus showing good inter-rater reliability. BR was negatively correlated with the Barthel Index (r = - 0.848, p < 0.001) and Katz Index (r = - 0.820, p < 0.001), showing justifiable criterion-related validity. Meanwhile, CFS at the first assessment revealed 92 normal, 47 of 1, 19 of 2a, 30 of 2b, 60 of 3a, 8 of 3b, 8 of 4, and 0 of M. The concordance rate between the two CFS assessments was 70.1%, with a kappa coefficient of 0.62, Cronbach's α of 0.87, and an intraclass correlation coefficient 0.78, thus also showing good inter-rater reliability. CFS was negatively correlated with the Barthel Index (r = - 0.667, p < 0.001) and Katz Index (r = - 0.661, p < 0.001), showing justifiable criterion-related validity.Conclusions: BR and CFS could be reliable and easy-to-use grading scales of ADLs in acute clinical practice or large-scale screening, with high inter-rater reliabilities among different professions and significant correlations with well-established, though complicated to use, instruments to assess ADLs.Trial Registration: UMIN000041051 (2020/7/10). [ABSTRACT FROM AUTHOR]