BMJ Open Respiratory Research (Jan 2021)

Comprehensive and long-term surveys of COVID-19 sequelae in Japan, an ambidirectional multicentre cohort study: study protocol

  • Takanori Kanai,
  • Yasunori Sato,
  • Keigo Kobayashi,
  • Katsunori Masaki,
  • Fumitake Saito,
  • Atsushi Kumanogoh,
  • Toru Takebayashi,
  • Yuko Kitagawa,
  • Kazuo Tsubota,
  • Kazuno Negishi,
  • Koichi Fukunaga,
  • Hajime Tabuchi,
  • Masaru Mimura,
  • Naoto Minematsu,
  • Yoshito Takeda,
  • Hirofumi Kamata,
  • Makoto Ishii,
  • Naoki Hasegawa,
  • Keita Masuzawa,
  • Shinnosuke Ikemura,
  • Ichiro Kawada,
  • Tadashi Manabe,
  • Hiroyuki Yasuda,
  • Hiroki Kabata,
  • Eisuke Shimizu,
  • Daisuke Ito,
  • Saeko Takahashi,
  • Shigeto Shimmura,
  • Ho Lee,
  • Takashi Ishiguro,
  • Ryuya Edahiro,
  • Akira Umeda,
  • Toshiro Sato,
  • Rei Goto,
  • Shotaro Chubachi,
  • Naoki Miyazaki,
  • Jin Nakahara,
  • Masaki Okamoto,
  • Yoshitaka Oyamada,
  • Kensuke Nakagawara,
  • Ho Namkoong,
  • Hideki Terai,
  • Takae Tanosaki,
  • Kyoko Shimamoto,
  • Hiromu Tanaka,
  • Satoshi Okamori,
  • Yoshiki Ishibashi,
  • Sei Harada,
  • Takanori Fujita,
  • Shogyoku Bun,
  • Sho Kanzaki,
  • Keitaro Fukuda,
  • Jun Yamagami,
  • Toshiyuki Hirano,
  • Takashi Inoue,
  • Junko Kagyo,
  • Tetsuya Shiomi,
  • Keiko Ohgino,
  • Koichi Sayama,
  • Kengo Otsuka,
  • Naoki Miyao,
  • Toshio Odani,
  • Sohei Nakayama,
  • Yusuke Suzuki,
  • Rie Baba,
  • Ichiro Nakachi,
  • Naota Kuwahara,
  • Shuko Mashimo,
  • Soichiro Ueda,
  • Yohei Funatsu,
  • Hidefumi Koh,
  • Takashi Yoshiyama,
  • Kota Ishioka,
  • Morio Nakamura,
  • Ai Goto,
  • Norihiro Harada,
  • Yu Kusaka,
  • Yasushi Nakano,
  • Kazumi Nishio,
  • Hiroki Tateno,
  • Nobuhiro Kodama,
  • Kazuto Hagimura,
  • Ryo Takemura,
  • Kaoru Ogawa,
  • Masayuki Amagai,
  • Yoko Ibuka

DOI
https://doi.org/10.1136/bmjresp-2021-001015
Journal volume & issue
Vol. 8, no. 1

Abstract

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Introduction The rapid spread of COVID-19 posed a global burden. Substantial number of people died of the disease in the acute phase of infection. In addition, a significant proportion of patients have been reported to suffer from post-acute phase symptoms, sequelae of COVID-19, which may negatively influence the quality of daily living and/or socioeconomic circumstances of the patients. However, no previous study has comprehensively and objectively assessed the quality of life of patients by using existing international scales. Further, evidence of socioeconomic consequences among patients with COVID-19 is scarce. To address the multidimensional issues from sequelae of COVID-19, evidence from comprehensive surveys beyond clinical perspectives is critical that investigates health, and social determinants of disease progression as well as socioeconomic consequences at a large scale.Methods and analysis In this study, we plan to conduct a nationwide and comprehensive survey for the sequelae of COVID-19 in a total of 1000 patients diagnosed at 27 hospitals throughout Japan. This study will evaluate not only the health-related status of patients from clinical perspectives but also the Health-related Quality of Life (HRQoL) scores, socioeconomic status and consequences to discuss the sequelae of the disease and the related risk factors. The primary endpoint is the frequency of long-term complications of COVID-19 infection. The secondary endpoints are risk factors for progression to sequelae of COVID-19 infection. The study will provide robust and important evidence as a resource to tackle the issues from the sequelae of COVID-19 from the multi-dimensional perspectives.Ethics and dissemination This trial was approved by the Keio University School of Medicine Ethics Committee (20200243, UMIN000042299). The results of this study will be reported at a society meeting or published in a peer-reviewed journal.