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Background: Respiratory syncytial virus (RSV) is a leading cause of acute respiratory illness, with severe outcomes in older adults. Information on the prevalence, hospitalization rate, and impact on the health-related quality of life (HRQoL) of RSV in older adults with acute respiratory infections (ARI) in outpatient settings in Japan is limited., Methods: This multi-center epidemiological study included outpatients aged ≥60 years presenting with ARI between August 2021 and February 2023. Nasal and throat swabs were collected and tested by reverse transcription polymerase chain reaction (RT-PCR). The prevalence of RT-PCR-confirmed RSV (cRSV)-ARI, cRSV-lower respiratory tract disease (LRTD), and other respiratory viruses was calculated by season, region, age group, and RSV subtype. HRQoL was assessed via patient-reported outcomes., Results: The study included 923 ARI episodes (cRSV-ARI: N = 24; non-cRSV-ARI: N = 899). In years 1 and 2 (August 2021-July 2022 and August 2022-February 2023), the prevalence of cRSV-ARI was 2.5% and 2.8%, respectively. There was a predominance of RSV-B and RSV-A subtypes in years 1 and 2, respectively. In years 1 and 2 combined, 37.5% of cRSV-ARI cases had lower respiratory tract infection; all cRSV-LRTD cases occurred in those aged 60-74 years. RSV-ARI cases reported throat, chest, and respiratory symptoms, leading to impaired functioning and HRQoL., Conclusions: During the observed study period, RSV was circulating among older adults in Japan. RSV was a leading cause of ARI and LRTD. More data are needed to fully clarify the burden of RSV among older adults in Japan., Competing Interests: Declaration of Competing interest Eliazar Sabater Cabrera has been employed by and has held financial equities in GSK; Daniel Molnar was employed by and held financial equities in GSK during the conduct of the study and preparation of the manuscript; Silvia Damaso has been employed by and has held financial equities in GSK; Jean-Yves Pirçon has been employed by and has held financial equities in GSK; Maria Moitinho de Almeida has been employed by and has held financial equities in GSK; Victor Preckler Moreno was employed by and held financial equities in GSK when the study was conducted; Taizo Matsuki was employed by and held financial equities in GSK when the study was conducted, and is currently employed by MSD; Hiroshi Takahashi received funding from GSK to conduct this study; Daisuke Himeji received funding from GSK to conduct this study. Yasushi Fukushima received funding from GSK to conduct this study. These authors declare no other financial or non-financial relationships and activities. Hiroyuki Ohbayashi declares no financial or non-financial relationships and activities and no conflicts of interest; Takayuki Sakurai declares no financial or non-financial relationships and activities and no conflicts of interest; Arihiro Kiyosue declares no financial or non-financial relationships and activities and no conflicts of interest., (Copyright © 2024 [Author/Employing Institution]. Published by Elsevier B.V. All rights reserved.)

Introduction: Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms., Methods and Analysis: We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients' hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions., Ethics and Dissemination: The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings., Trial Registration Number: NCT05913700., Competing Interests: Competing interests: TMorimoto reports lecturer's fees from Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Pfizer, Tsumura and UCB; manuscript fee from Pfizer; advisory board for GlaxoSmithKline, Novartis and Teijin. AC, MMdA, YH and LH are employees of, and hold stocks or stock options of GlaxoSmithKline. VPM and TMatsuki were employees of and held stocks or stock options in GlaxoSmithKline at the time of manuscript development., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)