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Masaki Tago,1 Risa Hirata,1 Naoko E Katsuki,1 Eiji Nakatani,2 Midori Tokushima,1 Tomoyo Nishi,1 Hitomi Shimada,3 Shizuka Yaita,1 Chihiro Saito,4 Kaori Amari,5 Kazuya Kurogi,6 Yoshimasa Oda,7 Kiyoshi Shikino,8,9 Maiko Ono,10 Mariko Yoshimura,11 Shun Yamashita,1 Yoshinori Tokushima,1 Hidetoshi Aihara,1 Motoshi Fujiwara,1 Shu-ichi Yamashita1 1Department of General Medicine, Saga University Hospital, Saga, Japan; 2Graduate School of Public Health, Shizuoka Graduate University of Public Health, Shizuoka, Japan; 3Shimada Hospital of Medical Corporation Chouseikai, Saga, Japan; 4Shizuoka General Hospital, Shizuoka, Japan; 5Department of Emergency Medicine, Saga-Ken Medical Centre Koseikan, Saga, Japan; 6Department of General Medicine, National Hospital Organization Ureshino Medical Center, Saga, Japan; 7Department of General Medicine, Yuai-Kai Foundation and Oda Hospital, Saga, Japan; 8Department of General Medicine, Chiba University Hospital, Chiba, Japan; 9Department of Community-Oriented Medical Education, Chiba University Graduate School of Medicine, Chiba, Japan; 10Department of General Medicine, Karatsu Municipal Hospital, Saga, Japan; 11Safety Management Section, Saga University Hospital, Saga, JapanCorrespondence: Masaki Tago, Department of General Medicine, Saga University Hospital, 5-1-1 Nabeshima, Saga, 849-8501, Japan, Tel +81 952 34 3238, Fax +81 952 34 2029, Email tagomas@cc.saga-u.ac.jpPurpose: We conducted a pilot study in an acute care hospital and developed the Saga Fall Risk Model 2 (SFRM2), a fall prediction model comprising eight items: Bedriddenness rank, age, sex, emergency admission, admission to the neurosurgery department, history of falls, independence of eating, and use of hypnotics. The external validation results from the two hospitals showed that the area under the curve (AUC) of SFRM2 may be lower in other facilities. This study aimed to validate the accuracy of SFRM2 using data from eight hospitals, including chronic care hospitals, and adjust the coefficients to improve the accuracy of SFRM2 and validate it.Patients and Methods: This study included all patients aged ≥ 20 years admitted to eight hospitals, including chronic care, acute care, and tertiary hospitals, from April 1, 2018, to March 31, 2021. In-hospital falls were used as the outcome, and the AUC and shrinkage coefficient of SFRM2 were calculated. Additionally, SFRM2.1, which was modified from the coefficients of SFRM2 using logistic regression with the eight items comprising SFRM2, was developed using two-thirds of the data randomly selected from the entire population, and its accuracy was validated using the remaining one-third portion of the data.Results: Of the 124,521 inpatients analyzed, 2,986 (2.4%) experienced falls during hospitalization. The median age of all inpatients was 71 years, and 53.2% were men. The AUC of SFRM2 was 0.687 (95% confidence interval [CI]:0.678– 0.697), and the shrinkage coefficient was 0.996. SFRM2.1 was created using 81,790 patients, and its accuracy was validated using the remaining 42,731 patients. The AUC of SFRM2.1 was 0.745 (95% CI: 0.731– 0.758).Conclusion: SFRM2 showed good accuracy in predicting falls even on validating in diverse populations with significantly different backgrounds. Furthermore, the accuracy can be improved by adjusting the coefficients while keeping the model’s parameters fixed.Keywords: accidental falls, inpatients, validation study, accident prevention

Masahiro Shinoda,1 Osamu Hataji,2 Motohiko Miura,3 Masaharu Kinoshita,4 Akira Mizoo,5 Kazunori Tobino,6 Toru Soutome,7 Takanobu Nishi,7 Takeo Ishii,7 Bruce E Miller,8 Ruth Tal-Singer,8 Ryan Tomlinson,8 Taizo Matsuki,7 Paul W Jones,9 Yoko Shibata10 1Department of Respiratory Medicine, Tokyo Shinagawa Hospital, Shinagawa, Tokyo, Japan; 2Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Mie, Japan; 3Department of Respiratory Medicine, Tohoku Rosai Hospital, Sendai, Miyagi, Japan; 4Department of Respiratory Medicine, Nagata Hospital, Yanagawa, Fukuoka, Japan; 5Department of Pulmonary Medicine Japan, Japan Community Healthcare Organization Tokyo Shinjuku Medical Center, Shinjuku, Tokyo, Japan; 6Department of Respiratory Medicine, Iizuka Hospital, Iizuka, Fukuoka, Japan; 7Japan Medical & Development, GSK K.K, Minato-Ku, Tokyo, Japan; 8GSK Pharma R&D, Collegeville, PA, USA; 9General Medicine, GSK, Brentford, Middlesex, UK; 10Department of Pulmonary Medicine, Fukushima Medical University, Fukushima, JapanCorrespondence: Taizo Matsuki, Value Evidence Outcomes, Japan Medical & Development, GSK K.K, Akasaka Intercity AIR 1-8-1 Akasaka, Minato-Ku, Tokyo, 107-0052, Japan, Tel +81-8036928935, Email taizo.2.matsuki@gsk.comBackground: Telemedicine may help the detection of symptom worsening in patients with chronic obstructive pulmonary disease (COPD), potentially resulting in improved outcomes. This study aimed to determine the feasibility and acceptability of telemedicine among patients with COPD and physicians and facility staff in Japan.Methods: This was a 52-week multicenter, prospective, single-arm, feasibility and acceptability cohort study of Japanese patients ≥ 40 years of age with COPD or asthma-COPD overlap. Participants underwent training to use YaDoc, a telemedicine smartphone App, which included seven daily symptom questions and weekly COPD Assessment Test (CAT) questions. The primary endpoint was participant compliance for required question completion. The secondary endpoint was participant and physician/facility staff acceptability of YaDoc based on questionnaires completed at Week 52. The impact of the Japanese COVID-19 pandemic state of emergency on results was also assessed.Results: Of the 84 participants enrolled (mean age: 68.7 years, 88% male), 72 participants completed the study. Completion was high in the first six months but fell after that. Median (interquartile range [IQR]) compliance for daily questionnaire entry was 66.6% (31.0– 91.8) and 81.0% (45.3– 94.3) for weekly CAT entry. Positive participant responses to the exit questionnaire were highest regarding YaDoc ease of use (83.8%), positive impact on managing health (58.8%), and overall satisfaction (53.8%). Of the 26 physicians and facility staff enrolled, 24 completed the study. Of these, the majority (66.7%) responded positively regarding app facilitation of communication between physicians and participants to manage disease. Compliance was similar before and after the first COVID-19 state of emergency in Japan.Conclusion: Daily telemedicine monitoring is potentially feasible and acceptable to both patients and physicians in the management of COPD. These results may inform potential use of telemedicine in clinical practice and design of future studies.Clinical Trial Registration: JapicCTI-194916.Keywords: Japan, patient-reported outcome measure, feasibility, acceptability, telemonitoring, smartphone

Soichiro Hozawa,1 Hiroyuki Ohbayashi,2 Michiko Tsuchiya,3 Yu Hara,4 Laurie A Lee,5 Takashi Nakayama,6 Jun Tamaoki,6 Andrew Fowler,7 Takanobu Nishi6 1Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan; 2Tohno Chuo Clinic, Gifu, Japan; 3Department of Respiratory Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan; 4Department of Pulmonology, Yokohama City University Graduate School of Medicine, Kanagawa, Japan; 5GSK, Collegeville, PA, USA; 6GSK, Tokyo, Japan; 7GSK, Brentford, Middlesex, UKCorrespondence: Takanobu NishiGlaxoSmithKline K.K., 1-8-1 Akasaka, Minato-ku, Tokyo, 107-0052, JapanTel +81-70-4135-5303Fax +81-3-4231-5974Email takanobu.2.nishi@gsk.comPurpose: The pivotal CAPTAIN study reported a favorable safety profile with once-daily inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with inadequately controlled asthma, some of whom were Japanese. Here, we evaluate the long-term (52 weeks) safety of FF/UMEC/VI in Japanese patients with asthma.Patients and Methods: This was a Phase III, 52-week, multicenter, non-comparator, non-randomized, open-label study (NCT03184987) in Japanese adults receiving maintenance therapy with ICS/LABA, with or without LAMA. At enrollment, patients were allocated to either FF/UMEC/VI 100/62.5/25mcg (Group 1) or 200/62.5/25mcg (Group 2). Patients in Group 1 could have their treatment stepped up to 200/62.5/25mcg at Week 24 if their Asthma Control Questionnaire (ACQ)-7 score was > 0.75. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Secondary endpoints included vital signs, electrocardiogram measurements, and clinical laboratory tests (biochemistry, hematology, urinalysis). Efficacy was assessed as “other” endpoints.Results: A total of 111 Japanese patients were included in the intention-to-treat (ITT) population. Overall, 77 (69%) patients reported ≥ 1 AE (Group 1: n=30 [64%]; step-up group: n=7 [78%]; Group 2: n=40 [73%]). SAEs were reported for 1 (2.1%) and 2 (3.6%) patients in Groups 1 and 2, respectively. All SAEs were considered unrelated to study treatment. One AE and one SAE led to study withdrawal: oropharyngeal discomfort (Group 1); eosinophilic granulomatosis with polyangiitis (Group 2). No new safety concerns were identified throughout the 52-week treatment period.Conclusion: In this uncontrolled open-label study, no new safety concerns were observed with long-term (52 weeks) treatment with once-daily FF/UMEC/VI among 111 Japanese patients with asthma.Keywords: asthma, inhalers, Japan, safety, treatment outcome

Naonori Masuda, Masashi Kojima, Mariko Yamashita, Tomo Nishi, Nahoko Ogata Department of Ophthalmology, Nara Medical University, Nara, Japan Purpose: To compare the choroidal structure beneath the macular area in eyes with reticular pseudodrusen (RPD) and age-matched controls.Methods: This study was performed at Nara Medical University Hospital, Japan. Twenty eyes of 14 patients (82.3±4.2 years, mean ± standard deviation) with RPD and 35 eyes of 20 age-matched controls (81.5±6.0 years) were studied. The choroidal structure was determined by binarizing the images obtained by enhanced depth imaging optical coherence tomography in all patients and controls. The total, luminal, and stromal choroidal areas were quantified by the binarization method.Results: The total choroidal area of the eyes with RPD was significantly smaller than that of control eyes (P=0.001, unpaired t-test). Both the luminal and stromal areas in eyes with RPD were significantly smaller than that of control eyes (P=0.001, paired t-test), but there was no significant difference in the luminal/stromal ratio between eyes with RPD and control eyes.Conclusion: The total, luminal, and stromal choroidal areas in eyes with RPD were smaller than those of the control eyes. The reduction of the choroidal luminal and stromal areas may be due to a loss of the oxygen demand of the choroid due to RPE dysfunction. Keywords: reticular pseudodrusen, age-related macular degeneration, choroidal structure, binarization method

Mariko Yamashita, Tomo Nishi, Taiji Hasegawa, Nahoko Ogata Department of Ophthalmology, Nara Medical University, Kashihara, Nara, Japan Purpose: To report the effects of aflibercept on eyes with large retinal pigment epithelial detachment (PED) associted with polypoidal choroidal vasculopathy (PCV). Methods: We reviewed the medical records of patients with PEDs associated with PCV that were treated with aflibercept after intravitreal ranibizumab had failed. Results: Three eyes of patients aged 72, 79, and 80 years were studied. Reflective material was seen in the PED along the outer surface of the retinal pigment epithelium (RPE) by spectral-domain optical coherence tomography (SD-OCT). A complete resolution of the serous PEDs was found after two aflibercept injections; however, all eyes had a fibrovascular PED. In addition, one eye developed a retinal hemorrhage and a recurrent PED just after the third injection of aflibercept. The visual acuity in this eye decreased from 10/20 to 2/20. Conclusion: The reflective material below the outer surface of the RPE in serous PED suggests the presence of neovascularization. Intravitreal aflibercept could be considered for large PEDs in eyes with PCV but should be carefully applied. Keywords: age-related macular degeneration, retinal pigment epithelial detachment, polypoidal choroidal vasculopathy, aflibercept

Tomo Nishi, Futoshi Taketani, Tetsuo Ueda, Nahoko Ogata Department of Ophthalmology, Nara Medical University, Kashihara City, Nara, Japan Purpose: To determine the amplitude of pseudoaccommodation and higher-order aberrations with three types of implanted monofocal intraocular lenses (IOLs): aspheric yellow (IQ); spheric yellow (NT); and spheric clear (AT). Setting: Department of Ophthalmology, Nara Medical University, Nara, Japan. Methods: We studied 60 patients who underwent small incision phacoemulsification with the implantation of a monofocal IQ, NT, or AT IOL. The pseudoaccommodation was measured by the lens-loading method, and the postoperative ocular higher-order aberrations were measured with a Hartmann–Shack wavefront analyzer through natural and 4 mm pupils. Results: Sixty eyes of 60 patients were studied. The average amplitude of the pseudoaccommodation was 0.45±0.24 D with the IQ IOL, which was significantly lower than that with the AT IOL at 0.81±0.37 D (Tukey's test; P0.05). The degree of spherical aberration was significantly different for the IQ, NT, and AT lenses (analysis of variance, P=0.016). The spherical aberration through the IQ IOL was significantly lower than that through the NT and the AT IOLs (Tukey's test; P

We studied Nd3-XBiXFe4GaO12 films to obtain perpendicular magnetic anisotropy as well as large Faraday effect. NdBi2Fe4GaO12 (Bi2:NIGG) and Nd0.5Bi2.5Fe4GaO12 (Bi2.5:NIGG) films were obtained on Nd2BiFe4GaO12 (Bi1:NIGG) layer prepared on glass substrates by metal-organic decomposition (MOD) method. Bi2:NIGG and Bi2.5:NIGG films showed large Faraday rotation angles of 7.5 and 10.5 degree/µm, at a wavelength of 520 nm, respectively. Those films have perpendicular magnetic anisotropy with a coercivity of 350 Oe and a saturation magnetic field of 730 Oe.

Bi-substituted rare-earth iron garnets, R3−xBixFe5O12 (Bi:RIG), where R represents one of the rare-earth elements, exhibit the excellent magneto-optical (MO) properties that increase with Bi content x. In addition, magnetic properties of Bi:RIGs, such as the magnetization, the magnetic anisotropy, and the magnetostriction, could be controlled by choosing rare-earth elements. In this paper, we report on R0.5Bi2.5Fe5O12 (Bi2.5:RIG, R = Pr, Sm, and Eu) thin films on Gd3Ga5O12 (GGG) (100) single crystal substrates prepared by the metal–organic decomposition method. XRD analysis reveals that Bi2.5:RIG thin films are grown along the same orientation with GGG substrates, and their lattice constants are dependent on the ionic radii of the rare-earth ions. MO measurements show that Faraday spectra of the Bi2.5:RIG thin films have a typical spectral structure observed for Bi:RIGs. The magnetic anisotropy constants, the uniaxial magnetic anisotropy energy Ku, and the magnetocrystalline anisotropy energy K1 of Bi2.5:RIG (R = Y, Pr, Nd, Sm, and Eu) thin films are investigated by using the ferromagnetic resonance measurement. [ABSTRACT FROM AUTHOR]