BMJ Publishing Group Acta Medica Okayama 2044-6055 14 10 2024 Decline in and recovery of fertility rates after COVID-19-related state of emergency in Japan e087657 EN Tomohiro Mitoma Department of Obstetric and Gynecology, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Jota Maki Department of Obstetric and Gynecology, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Hikaru Ooba Department of Obstetric and Gynecology, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Hisashi Masuyama Department of Obstetric and Gynecology, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Introduction The COVID-19 pandemic led to a decline in fertility rates worldwide. Although many regions have experienced a temporary drop in fertility rates with the spread of the infection, subsequent recovery has varied across countries. This study aimed to evaluate the impact of COVID-19 infection rates and regional sociodemographic factors on the recovery of fertility rates in Japan following the state of emergency. Methods This study examined prefectural fertility data from before the COVID-19 pandemic to forecast fertility rates up to 2022 using a seasonal autoregressive integrated moving average model. A regression analysis was conducted on fertility rates during the first state of emergency and the subsequent recovery rate with respect to the number of new COVID-19 cases and sociodemographic factors specific to each prefecture. Results During the first state of emergency, the monthly fertility rate decreased by an average of -13.8% (SD: 6.26, min: -28.78, max: 0.15) compared with the previous year. Over the following 22 months, the average fertility recovery rate was +2.31% (SD: 3.57; min: -8.55, max: 19.54). Multivariate analysis of the impact of the pandemic on fertility changes during the first emergency indicated a negative correlation between new COVID-19 cases per capita and the proportion of nuclear households. No significant correlation was found between fertility recovery rate and new COVID-19 cases or emergency duration. When classifying fertility rate fluctuation patterns before and after the emergency into four clusters, variations were noted in the proportion of the elderly population, marriage divorce rate and the number of internet searches related to pregnancy intentions across the clusters. Conclusions No association was found between pregnancy intentions related to the spread of infection, such as the number of new cases and the fertility recovery rate following the first state of emergency. Differences in the patterns of decline and recovery during the pandemic were observed based on population composition and internet searches for infection and pregnancy across different prefectures. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2755-9734 27 1 2024 Potential dopaminergic deficit in patients with geriatric psychiatric disorders as revealed by DAT-SPECT: a cross-sectional study 1 9 EN Shintaro Takenoshita Department of Neuropsychiatry, Okayama University Hospital Seishi Terada Department of Neuropsychiatry, Okayama University Faculty of Medicine Dentistry and Pharmaceutical Sciences Katsuhide Kojima Department of Radiology, Okayama University Hospital Naoto Nishikawa Department of Neuropsychiatry, Okayama University Hospital Tomoko Miki Department of Neuropsychiatry, Okayama University Hospital Osamu Yokota Department of Neuropsychiatry, Okayama University Faculty of Medicine Dentistry and Pharmaceutical Sciences Masaki Fujiwara Department of Neuropsychiatry, Okayama University Hospital Manabu Takaki Department of Neuropsychiatry, Okayama University Faculty of Medicine Dentistry and Pharmaceutical Sciences Background It has been reported that patients with geriatric psychiatric disorders include many cases of the prodromal stages of neurodegenerative diseases. Abnormal I-123-2 beta-carbomethoxy-3 beta-(4-iodophenyl)-N-(3-fluoropropyl) nortropane dopamine transporter single-photon emission computed tomography (DAT-SPECT) reveals a nigrostriatal dopaminergic deficit and is considered useful to detect dementia with Lewy bodies and Parkinson's disease as well as progressive supranuclear palsy and corticobasal degeneration. We aimed to determine the proportion of cases that are abnormal on DAT-SPECT in patients with geriatric psychiatric disorders and to identify their clinical profile. Methods The design is a cross-sectional study. Clinical findings of 61 inpatients aged 60 years or older who underwent DAT-SPECT and had been diagnosed with psychiatric disorders, but not neurodegenerative disease or dementia were analysed. Results 36 of 61 (59%) had abnormal results on DAT-SPECT. 54 of 61 patients who had DAT-SPECT (89%) had undergone I-123-metaiodobenzylguanidine myocardial scintigraphy (I-123-MIBG scintigraphy); 12 of the 54 patients (22.2%) had abnormal findings on I-123-MIBG scintigraphy. There were no cases that were normal on DAT-SPECT and abnormal on I-123-MIBG scintigraphy. DAT-SPECT abnormalities were more frequent in patients with late-onset (55 years and older) psychiatric disorders (69.0%) and depressive disorder (75.7%), especially late-onset depressive disorder (79.3%). Conclusion Patients with geriatric psychiatric disorders include many cases showing abnormalities on DAT-SPECT. It is suggested that these cases are at high risk of developing neurodegenerative diseases characterised by a dopaminergic deficit. It is possible that patients with geriatric psychiatric disorders with abnormal findings on DAT-SPECT tend to show abnormalities on DAT-SPECT first rather than on I-123-MIBG scintigraphy. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2052-4897 12 3 2024 Plasma angiotensin-converting enzyme 2 (ACE2) is a marker for renal outcome of diabetic kidney disease (DKD) (U-CARE study 3) e004237 EN Asami Ueno Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Yasuhiro Onishi Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Koki Mise Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Satoshi Yamaguchi Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Ayaka Kanno Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Ichiro Nojima Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Chigusa Higuchi Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Haruhito A. Uchida Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Kenichi Shikata Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Satoshi Miyamoto Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Atsuko Nakatsuka Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Jun Eguchi Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Kazuyuki Hida Department of Diabetology and Metabolism, National Hospital Organization Okayama Medical Center Akihiro Katayama Department of Diabetology and Metabolism, National Hospital Organization Okayama Medical Center Mayu Watanabe Department of Diabetology and Metabolism, National Hospital Organization Okayama Medical Center Tatsuaki Nakato Department of Internal Medicine, Okayama Saiseikai General Hospital Atsuhito Tone Department of Internal Medicine, Okayama Saiseikai General Hospital Sanae Teshigawara Okayama Saiseikai General Hospital Takashi Matsuoka Department of Diabetic Medicine, Kurashiki Central Hospital Shinji Kamei Department of Diabetic Medicine, Kurashiki Central Hospital Kazutoshi Murakami Department of Diabetic Medicine, Kurashiki Central Hospital Ikki Shimizu Sakakibara Heart Institute of Okayama Katsuhito Miyashita Japanese Red Cross Okayama Hospital Shinichiro Ando Okayama City General Medical Center Tomokazu Nunoue Nunoue Clinic Jun Wada Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Introduction ACE cleaves angiotensin I (Ang I) to angiotensin II (Ang II) inducing vasoconstriction via Ang II type 1 (AT1) receptor, while ACE2 cleaves Ang II to Ang (1-7) causing vasodilatation by acting on the Mas receptor. In diabetic kidney disease (DKD), it is still unclear whether plasma or urine ACE2 levels predict renal outcomes or not. Research design and methods Among 777 participants with diabetes enrolled in the Urinary biomarker for Continuous And Rapid progression of diabetic nEphropathy study, the 296 patients followed up for 9 years were investigated. Plasma and urinary ACE2 levels were measured by the ELISA. The primary end point was a composite of a decrease of estimated glomerular filtration rate (eGFR) by at least 30% from baseline or initiation of hemodialysis or peritoneal dialysis. The secondary end points were a 30% increase or a 30% decrease in albumin-to-creatinine ratio from baseline to 1 year. Results The cumulative incidence of the renal composite outcome was significantly higher in group 1 with lowest tertile of plasma ACE2 (p=0.040). Group 2 with middle and highest tertile was associated with better renal outcomes in the crude Cox regression model adjusted by age and sex (HR 0.56, 95% CI 0.31 to 0.99, p=0.047). Plasma ACE2 levels demonstrated a significant association with 30% decrease in ACR (OR 1.46, 95% CI 1.044 to 2.035, p=0.027) after adjusting for age, sex, systolic blood pressure, hemoglobin A1c, and eGFR. Conclusions Higher baseline plasma ACE2 levels in DKD were protective for development and progression of albuminuria and associated with fewer renal end points, suggesting plasma ACE2 may be used as a prognosis marker of DKD.Trial registration number UMIN000011525. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2044-6055 12 7 2022 Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial e060040 EN Tomonori Yokoyama Department of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Takao Mukai Division of Oral Surgery, Kawasaki Medical School Hospital Naoki Kodama Department of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Kana Takao Division of Oral Surgery, Kawasaki Medical School Hospital Takashi Hiraoka Department of Rehabilitation Medicine, Kawasaki Medical School Nobuyuki Arai Department of Rehabilitation Medicine, Kawasaki Medical School Jitsuro Yano Department of Speech-Language Pathology and Audiology, Faculty of Rehabilitation, Kawasaki University of Medical Welfare Hiroaki Nagatsuka Department of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Yousuke Manda Department of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Kozo Hanayama Department of Rehabilitation Medicine, Kawasaki Medical School Shogo Minagi Department of Occlusal & Oral Functional Rehabilitation, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Introduction Palatal augmentation prosthesis (PAP) is used in patients with articulation and swallowing disorders caused by postoperative loss of tongue tissue due to tongue cancer, cerebrovascular disease sequelae and age-related hypofunction. We have previously reported a newly designed soft PAP fabricated using an thermoplastic material that is particularly appropriate for early intervention. However, the effect of soft PAP on oral function improvement remains to be elucidated. The aim of this study is to investigate whether soft PAP can improve dysarthria and dysphagia occurring as cerebrovascular disease sequelae. Methods and analysis This prospective, randomised, controlled trial will compare the immediate and training effects of rehabilitation using soft PAP with those of rehabilitation without using it. Primary outcomes are the single-word intelligibility test score and pharyngeal transit time (PTT). Secondary outcomes are tongue function (evaluated based on maximum tongue pressure, repetitions of tongue pressure and endurance of tongue pressure), articulation function (evaluated based on speech intelligibility, oral diadochokinesis, Voice-Related Quality of Life (V-RQOL)) and swallowing function (evaluated using Eating Assessment Tool-10). The study results will help determine the efficacy of Soft PAP in improving functional outcomes of word intelligibility and PTT. We hypothesised that early rehabilitation using Soft PAP would more effectively improve articulation and swallowing function compared with conventional rehabilitation without using soft PAP. Ethics and dissemination Ethical approval was obtained from the Okayama University Certified Review Board. The study findings will be published in an open access, peer-reviewed journal and presented at relevant conferences and research meetings. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2044-6055 12 6 2022 Patients' acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial e060621 EN Yuto Yamada Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Masaki Fujiwara Department of Neuropsychiatry, Okayama University Hospital Taichi Shimazu Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control Tsuyoshi Etoh Department of Nursing, Shimane University Hospital Masafumi Kodama Okayama Psychiatric Medical Center Ryuhei So Okayama Psychiatric Medical Center Takanori Matsushita Zikei Hospital Yusaku Yoshimura Zikei Hospital Shigeo Horii Zikei Hospital Maiko Fujimori Division of Supportive Care, Survivorship and Translational Research, National Cancer Center Institute for Cancer Control Hirokazu Takahashi Division of Screening Assessment and Management, National Cancer Center Institute for Cancer Control Naoki Nakaya Tohoku Medical Megabank Organization, Tohoku University Tempei Miyaji Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo Shiro Hinotsu Department of Biostatistics and Data Management, Sapporo Medical University Keita Harada Department of Gastroenterology, Okayama University Hospital Hiroyuki Okada Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Yosuke Uchitomi Group for Supportive Care and Survivorship Research, National Cancer Center Institute for Cancer Control Norihito Yamada Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Masatoshi Inagaki Department of Psychiatry, Faculty of Medicine, Shimane University Objectives We examined the efficacy of case management (CM) interventions to encourage participation in colorectal cancer screening for patients with schizophrenia. This study aimed to clarify patients' acceptability of the intervention and the helpful components of the intervention. Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers. Study design and setting This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. The intervention comprised education and patient navigation for colorectal cancer screening. Interviews were conducted with patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention. Participants Of the 172 patients with schizophrenia who participated in the trial, 153 were included. In addition, three out of six providers were included. Data collection and analysis Using a structured interview, the case manager asked participants about patient acceptability and the helpful components of the intervention. Content analysis was conducted for the responses obtained, and the number of responses was tabulated by two researchers. For the interviews with the providers, opinions obtained from verbatim transcripts were extracted and summarised. Results Forty-three of the 56 patients perceived that the intervention was acceptable. For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents). Psychiatric care providers evaluated the intervention as acceptable, appropriate and easy to understand and administer. However, providing the intervention to all patients simultaneously was considered difficult with the current human resources. Conclusions This study showed that the CM intervention was perceived as acceptable by patients and acceptable and appropriate by psychiatric care providers. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2397-5776 7 1 2022 Geriatric trauma prognosis trends over 10 years: analysis of a nationwide trauma registry e000735 EN Takeshi Nishimura Department of Emergency and Critical Care Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Hiromichi Naito Department of Emergency and Critical Care Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Atsunori Nakao Department of Emergency and Critical Care Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Shinichi Nakayama Department of Emergency and Critical Care Medicine, Hyogo Emergency Medical Center Purpose With Japan's population rapidly skewing toward aging, the number of geriatric trauma patients is expected to increase. Since we need to continue to improve the quality of geriatric trauma patient care, this study aimed to evaluate in-hospital mortality trends among geriatric trauma patients in Japan over a recent 10-year period. Methods This was a retrospective cohort study of data from a Japanese nationwide trauma registry (the Japan National Trauma Data Bank) on patients admitted between January 1, 2008 and December 31, 2017. Geriatric patients were defined as those 65 years old and older. The primary outcome was to clarify in-hospital mortality trends and changes over these 10 years. Results We identified 265 268 eligible trauma patients. Excluding those under 65 years old and those with inadequate or unknown age data, missing prognosis, out-of-hospital cardiac arrest, and burns, 107 766 patients were enrolled in this study. The total trauma patient in-hospital mortality trend was evaluated using the Cochran-Armitage test and showed a significant decrease (p<0.001). Although severe trauma patients (Injury Severity Score (ISS) >= 16) showed a significant decreasing trend (p<0.001) over time (from 26.1% to 14.5%), less-severe trauma patients (ISS <16) did not (p=0.41) (from 2.7% to 2.1%). Mixed logistic regression analysis showed that the number of year patients stayed in the hospital was significantly associated with mortality. Conclusions While recognizing the limitations of the current analysis, our data demonstrated that prognoses for severe trauma patients over 65 years old improved dramatically over these 10 years, especially in those with severe trauma. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2044-6055 11 7 2021 Study protocol for endoscopic ultrasonography-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm: a multicentre prospective study e046505 EN Kazuyuki Matsumoto Department of Gastroenterology and Hepatology, Okayama University Hospital Hironari Kato Department of Gastroenterology and Hepatology, Okayama University Hospital Masayuki Kitano Second Department of Internal Medicine, Wakayama Medical University Kazuo Hara Gastroenterology, Aichi Cancer Center Masaki Kuwatani Gastroenterology and Hepatology, Hokkaido University Hospital Reiko Ashida Second Department of Internal Medicine, Wakayama Medical University Mamoru Takenaka Department of Gastroenterology and Hepatology, Kindai University Tatsuhiro Yamazaki Department of Gastroenterology and Hepatology, Okayama University Hospital Jun Sakurai Center for Innovative Clinical Medicine, Okayama University Hospital Michihiro Yoshida Center for Innovative Clinical Medicine, Okayama University Hospital Hiroyuki Okada Department of Gastroenterology and Hepatology, Okayama University Hospital Introduction The management of small pancreatic neuroendocrine neoplasms (PNENs) remains controversial. The standard treatment for PNENs is surgical resection; however, invasiveness of surgical procedure remains higher and the incidence of postoperative adverse events is still high. Recently, the efficacy and safety of endoscopic ultrasonography (EUS)-guided ethanol injection for small PNENs has been preliminarily demonstrated. Thus, a multicentre prospective study is being conducted to evaluate the efficacy and safety of EUS-guided ethanol injection therapy for small PNENs. Methods and analysis The major eligibility criteria are the presence of pathologically diagnosed grade (G) 1 tumour, a tumour size of <= 15 mm and non-functional PNEN or insulinoma. For treatment, we will use a 25-gauge needle and pure ethanol. Contrast-enhanced CT (CE-CT) will be performed on postoperative day 3-5, and if enhanced areas of the tumour are still apparent, an additional session is scheduled during the same hospitalisation period. We set the total amount of ethanol per session to 2 mL. To evaluate the efficacy and safety, CE-CT will be performed at 1 and 6 months after treatment. The primary endpoint is the percentage of subjects who achieved all of the following evaluated points. Efficacy will be evaluated based on the achievement of complete ablation (defined as no enhanced area within the tumour on CE-CT) at 1 and 6 months. Safety will be evaluated based on the avoidance of severe adverse events within 1 month after treatment, continuing severe pancreatic fistula at 1 month after treatment and the incidence and/or exacerbation of diabetes mellitus at 6 months after treatment. Ethics and dissemination This protocol has been approved by Okayama University Certified Review Board (approval number. CRB19-007). The results will be submitted to peer-reviewed journals and will be presented at international conferences. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2044-6055 11 2 2021 Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study e042099 EN Miho Saiga Department of Plastic and Reconstructive Surgery, Okayama University Hospital Yuko Hosoya Department of Plastic and Reconstructive Surgery, Iwate Medical University Hiroki Utsunomiya Department of Surgery and Plastic Surgery, Showa University Koto Toyosu Hospital Yukiko Kuramoto Department of Plastic and Reconstructive Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research Satoko Watanabe Department of Plastic and Reconstructive Surgery, Okayama University Hospital Koichi Tomita Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Osaka University Yukiko Aihara Department of Plastic and Reconstructive Surgery, Faculty of Medicine, University of Tsukuba Mayu Muto Department of Plastic and Reconstructive Surgery, Yokohama City University Medical Center Makoto Hikosaka Department of Plastic and Reconstructive Surgery, National Center for Child Health and Development Takashi Kawaguchi Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences Tempei Miyaji Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo Takuhiro Yamaguchi Division of Biostatistics, Tohoku University Graduate School of Medicine Sadamoto Zenda Division of Radiation Oncology, National Cancer Center Hospital East Aya Goto Department of Plastic and Reconstructive Surgery, Iwate Medical University Minoru Sakuraba Department of Plastic and Reconstructive Surgery, Iwate Medical University Taro Kusano Kusano Taro Clinic Kenta Miyabe Department of Plastic and Reconstructive Surgery, Showa University Hospital Tomoaki Kuroki Department of Plastic and Reconstructive Surgery, Showa University Hospital Tomoyuki Yano Department of Plastic and Reconstructive Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research Mifue Taminato Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Osaka University Mitsuru Sekido Department of Plastic and Reconstructive Surgery, Faculty of Medicine, University of Tsukuba Yui Tsunoda Department of Plastic and Reconstructive Surgery, Yokohama City University Medical Center Toshihiko Satake Department of Plastic and Reconstructive Surgery, Toyama University Hospital Hiroyoshi Doihara Department of Breast and Endocrine Surgery, Okayama University Hospital Yoshihiro Kimata Department of Plastic and Reconstructive Surgery, Okayama University Hospital Introduction The aim of breast reconstruction (BR) is to improve patients' health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient's life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate breast reconstruction (IBR). Methods and analysis This ongoing prospective, observational multicentre study will assess 406 patients who had unilateral breast cancer and underwent mastectomy and IBR, and were recruited from April 2018 to July 2019. All participants were recruited from seven hospitals: Okayama University Hospital, Iwate Medical University Hospital, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Showa University Hospital, University of Tsukuba Hospital, Osaka University Hospital and Yokohama City University Medical Center. The patients will be followed up for 36 months postoperatively. The primary endpoint of this study will be the time-dependent changes in BREAST-Q satisfaction with breast subscale scores for 12 months after reconstructive surgery, which will be collected via an electronic PRO system. Ethics and dissemination This study will be performed in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare, the modified Act on the Protection of Personal Information and the Declaration of Helsinki. This study protocol was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, on 2 February 2018 (1801-039) and all other participating sites. The findings of this trial will be submitted to an international peer-reviewed journal. No potential conflict of interest relevant to this article was reported.

BMJ Publishing Group Acta Medica Okayama 2044-6055 9 12 2019 Fall-related mortality trends in older Japanese adults aged >= 65 years: a nationwide observational study e033462 EN Hideharu Hagiya Department of General Internal Medicine, Osaka University Hospital Toshihiro Koyama Department of Pharmaceutical Biomedicine, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University Yoshito Zamami Department of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School Yasuhisa Tatebe Department of Pharmacy, Okayama University Hospital Tomoko Funahashi Department of Pharmaceutical Biomedicine, Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University Kazuaki Shinomiya Department of Pharmaceutical Care and Clinical Pharmacy, Faculty of Pharmaceutical Sciences Tokushima Bunri University Yoshihisa Kitamura Department of Pharmacy, Okayama University Hospital Shiro Hinotsu Department of Biostatistics, Sapporo Medical University Toshiaki Sendo Department of Pharmacy, Okayama University Hospital Hiromi Rakugi Department of General Internal Medicine, Osaka University Hospital Mitsunobu R. Kano Department of Pharmaceutical Biomedicine, Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University OBJECTIVES: Fall-related mortality among older adults is a major public health issue, especially for ageing societies. This study aimed to investigate current trends in fall-related mortality in Japan using nationwide population-based data covering 1997-2016. DESIGN: We analysed fall-related deaths among older persons aged ≥65 years using the data provided by the Japanese Ministry of Health, Labour and Welfare. RESULTS: The crude and age-standardised mortality rates were calculated per 100 000 persons by stratifying by age (65-74, 75-84 and ≥85 years) and sex. To identify trend changes, a joinpoint regression model was applied by estimating change points and annual percentage change (APC). The total number of fall-related deaths in Japan increased from 5872 in 1997 to 8030 in 2016, of which 78.8% involved persons aged ≥65 years. The younger population (65-74 years) showed continuous and faster-decreasing trends for both men and women. Average APC among men aged ≥75 years did not decrease. Among middle-aged and older women (75-84 and ≥85 years) decreasing trends were observed. Furthermore, the age-adjusted mortality rate of men was approximately twice that of women, and it showed a faster decrease for women. CONCLUSIONS: Although Japanese healthcare has shown improvement in preventing fall-related deaths over the last two decades, the crude mortality for those aged over 85 years remains high, indicating difficulty in reducing fall-related deaths in the super-aged population. Further investigations to uncover causal factors for falls in older populations are required. No potential conflict of interest relevant to this article was reported.