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

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

doi:10.1136/bmjresp-2021-001015

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

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

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English
Article number	e001015
Journal	BMJ Open Respiratory Research
Volume	8
Issue number	1
DOIs	https://doi.org/10.1136/bmjresp-2021-001015
Publication status	Published - 2021 Nov 26

Keywords

COVID-19
clinical epidemiology
respiratory infection

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

Access to Document

10.1136/bmjresp-2021-001015

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Nakagawara, K., Namkoong, H., Terai, H., Masaki, K., Tanosaki, T., Shimamoto, K., Lee, H., Tanaka, H., Okamori, S., Kabata, H., Chubachi, S., Ikemura, S., Kamata, H., Yasuda, H., Kawada, I., Ishii, M., Ishibashi, Y., Harada, S., Fujita, T., ... Fukunaga, K. (2021). Comprehensive and long-term surveys of COVID-19 sequelae in Japan, an ambidirectional multicentre cohort study: Study protocol. BMJ Open Respiratory Research, 8(1), Article e001015. https://doi.org/10.1136/bmjresp-2021-001015

Nakagawara, K, Namkoong, H, Terai, H , Masaki, K, Tanosaki, T, Shimamoto, K, Lee, H, Tanaka, H, Okamori, S, Kabata, H , Chubachi, S, Ikemura, S, Kamata, H, Yasuda, H, Kawada, I, Ishii, M, Ishibashi, Y, Harada, S, Fujita, T, Ito, D, Bun, S, Tabuchi, H, Kanzaki, S, Shimizu, E, Fukuda, K, Yamagami, J, Kobayashi, K, Hirano, T, Inoue, T, Kagyo, J, Shiomi, T, Ohgino, K, Sayama, K, Otsuka, K, Miyao, N, Odani, T, Oyamada, Y, Masuzawa, K, Nakayama, S, Suzuki, Y, Baba, R, Nakachi, I, Kuwahara, N, Ishiguro, T, Mashimo, S, Minematsu, N, Ueda, S, Manabe, T, Funatsu, Y, Koh, H, Yoshiyama, T, Saito, F, Ishioka, K, Takahashi, S, Nakamura, M, Goto, A, Harada, N, Kusaka, Y, Nakano, Y, Nishio, K, Tateno, H, Edahiro, R, Takeda, Y, Kumanogoh, A, Kodama, N, Okamoto, M, Umeda, A, Hagimura, K, Sato, T, Miyazaki, N, Takemura, R, Sato, Y , Takebayashi, T , Nakahara, J, Mimura, M, Ogawa, K, Shimmura, S, Negishi, K, Tsubota, K, Amagai, M , Goto, R , Ibuka, Y , Hasegawa, N , Kitagawa, Y , Kanai, T & Fukunaga, K 2021, 'Comprehensive and long-term surveys of COVID-19 sequelae in Japan, an ambidirectional multicentre cohort study: Study protocol', BMJ Open Respiratory Research, vol. 8, no. 1, e001015. https://doi.org/10.1136/bmjresp-2021-001015

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abstract = "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.",

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

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T1 - Comprehensive and long-term surveys of COVID-19 sequelae in Japan, an ambidirectional multicentre cohort study

T2 - Study protocol

AU - Nakagawara, Kensuke

AU - Namkoong, Ho

AU - Terai, Hideki

AU - Masaki, Katsunori

AU - Tanosaki, Takae

AU - Shimamoto, Kyoko

AU - Lee, Ho

AU - Tanaka, Hiromu

AU - Okamori, Satoshi

AU - Kabata, Hiroki

AU - Chubachi, Shotaro

AU - Ikemura, Shinnosuke

AU - Kamata, Hirofumi

AU - Yasuda, Hiroyuki

AU - Kawada, Ichiro

AU - Ishii, Makoto

AU - Ishibashi, Yoshiki

AU - Harada, Sei

AU - Fujita, Takanori

AU - Ito, Daisuke

AU - Bun, Shogyoku

AU - Tabuchi, Hajime

AU - Kanzaki, Sho

AU - Shimizu, Eisuke

AU - Fukuda, Keitaro

AU - Yamagami, Jun

AU - Kobayashi, Keigo

AU - Hirano, Toshiyuki

AU - Inoue, Takashi

AU - Kagyo, Junko

AU - Shiomi, Tetsuya

AU - Ohgino, Keiko

AU - Sayama, Koichi

AU - Otsuka, Kengo

AU - Miyao, Naoki

AU - Odani, Toshio

AU - Oyamada, Yoshitaka

AU - Masuzawa, Keita

AU - Nakayama, Sohei

AU - Suzuki, Yusuke

AU - Baba, Rie

AU - Nakachi, Ichiro

AU - Kuwahara, Naota

AU - Ishiguro, Takashi

AU - Mashimo, Shuko

AU - Minematsu, Naoto

AU - Ueda, Soichiro

AU - Manabe, Tadashi

AU - Funatsu, Yohei

AU - Koh, Hidefumi

AU - Yoshiyama, Takashi

AU - Saito, Fumitake

AU - Ishioka, Kota

AU - Takahashi, Saeko

AU - Nakamura, Morio

AU - Goto, Ai

AU - Harada, Norihiro

AU - Kusaka, Yu

AU - Nakano, Yasushi

AU - Nishio, Kazumi

AU - Tateno, Hiroki

AU - Edahiro, Ryuya

AU - Takeda, Yoshito

AU - Kumanogoh, Atsushi

AU - Kodama, Nobuhiro

AU - Okamoto, Masaki

AU - Umeda, Akira

AU - Hagimura, Kazuto

AU - Sato, Toshiro

AU - Miyazaki, Naoki

AU - Takemura, Ryo

AU - Sato, Yasunori

AU - Takebayashi, Toru

AU - Nakahara, Jin

AU - Mimura, Masaru

AU - Ogawa, Kaoru

AU - Shimmura, Shigeto

AU - Negishi, Kazuno

AU - Tsubota, Kazuo

AU - Amagai, Masayuki

AU - Goto, Rei

AU - Ibuka, Yoko

AU - Hasegawa, Naoki

AU - Kitagawa, Yuko

AU - Kanai, Takanori

AU - Fukunaga, Koichi

PY - 2021/11/26

Y1 - 2021/11/26

N2 - 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.

AB - 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.

KW - COVID-19

KW - clinical epidemiology

KW - respiratory infection

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DO - 10.1136/bmjresp-2021-001015

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ER -

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

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