TY - JOUR
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
N1 - Publisher Copyright:
©
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.
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U2 - 10.1136/bmjresp-2021-001015
DO - 10.1136/bmjresp-2021-001015
M3 - Article
C2 - 34836924
AN - SCOPUS:85121033263
SN - 2052-4439
VL - 8
JO - BMJ Open Respiratory Research
JF - BMJ Open Respiratory Research
IS - 1
M1 - e001015
ER -