Cargando…
KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea
INTRODUCTION: Despite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectas...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044940/ https://www.ncbi.nlm.nih.gov/pubmed/31959610 http://dx.doi.org/10.1136/bmjopen-2019-034090 |
_version_ | 1783501674967465984 |
---|---|
author | Lee, Hyun Choi, Hayoung Sim, Yun Su Park, Shinhee Kim, Woo Jin Yoo, Kwang Ha Lee, Seung Jun Kim, Tae-Hyung Yang, Bumhee Jeong, Ina Um, Soo-Jung Kim, Deog Kyeom Lee, Ji-Hyun Kwon, Byoung Soo Cho, Young-Jae Park, Hye Yun Lee, Chang-Hoon Rhee, Chin Kook Lee, Sang Haak Na, Ju Ock Jang, An-Soo Jung, Ji Ye Ra, Seung Won Lee, Ji-Ho Kim, Sang-Ha Kim, Changhwan Kim, Youlim Lee, Chang Youl Kim, Hyun Kuk Lee, Jae Seung Lee, Sei Won Oh, Yeon-Mok |
author_facet | Lee, Hyun Choi, Hayoung Sim, Yun Su Park, Shinhee Kim, Woo Jin Yoo, Kwang Ha Lee, Seung Jun Kim, Tae-Hyung Yang, Bumhee Jeong, Ina Um, Soo-Jung Kim, Deog Kyeom Lee, Ji-Hyun Kwon, Byoung Soo Cho, Young-Jae Park, Hye Yun Lee, Chang-Hoon Rhee, Chin Kook Lee, Sang Haak Na, Ju Ock Jang, An-Soo Jung, Ji Ye Ra, Seung Won Lee, Ji-Ho Kim, Sang-Ha Kim, Changhwan Kim, Youlim Lee, Chang Youl Kim, Hyun Kuk Lee, Jae Seung Lee, Sei Won Oh, Yeon-Mok |
author_sort | Lee, Hyun |
collection | PubMed |
description | INTRODUCTION: Despite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectasis. METHODS AND ANALYSIS: The Korean Multicenter Bronchiectasis Audit and Research Collaboration (KMBARC) is a prospective, non-interventional observational cohort study on bronchiectasis in Korea. The inclusion criteria of this registry are as follows: (1) adult patients (aged ≥18 years) with or without respiratory symptoms (cough, chronic sputum and/or recurrent respiratory infection) and chest computed tomography revealing bronchiectasis affecting one or more lobes and (2) stable status at the time of registration: patients with bronchiectasis who were admitted for a respiratory aetiology can be enrolled at least 4 weeks after hospital discharge. The exclusion criteria are as follows: (1) bronchiectasis due to cystic fibrosis; (2) traction bronchiectasis associated with interstitial lung disease; (3) patients actively being treated for pneumonia, pulmonary tuberculosis or non-tuberculous mycobacterial infection; (4) patients who are unable or unwilling to provide informed consent; and (5) pregnant patients. Although the KMBARC questionnaires for baseline and annual follow-up data are similar to the European Multicentre Bronchiectasis Audit and Research Collaboration questionnaires, KMBARC has distinctive features such as use of Bronchiectasis Health Questionnaires, measurement with fatigue and depression scales, blood tests, use of consensus definition of exacerbations and information on emergency room or hospitalisation. We aim to recruit at least 1200 patients over the study period from more than 26 hospitals in South Korea. Patients will undergo a detailed baseline and yearly assessment for up to 5 years. The study objectives of the KMBARC registry are as follows: (1) uncovering the natural course of bronchiectasis; (2) aiding in establishing evidence-based bronchiectasis guidelines in Korea; and (3) encouraging and facilitating studies on bronchiectasis in Korea. ETHICS AND DISSEMINATION: This study received necessary approval from the Institutional Review Boards of all participating institutions. The Asan Medical Center Institutional Review Board gave overall approval for the study. Results will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: KCT0003088. |
format | Online Article Text |
id | pubmed-7044940 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-70449402020-03-09 KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea Lee, Hyun Choi, Hayoung Sim, Yun Su Park, Shinhee Kim, Woo Jin Yoo, Kwang Ha Lee, Seung Jun Kim, Tae-Hyung Yang, Bumhee Jeong, Ina Um, Soo-Jung Kim, Deog Kyeom Lee, Ji-Hyun Kwon, Byoung Soo Cho, Young-Jae Park, Hye Yun Lee, Chang-Hoon Rhee, Chin Kook Lee, Sang Haak Na, Ju Ock Jang, An-Soo Jung, Ji Ye Ra, Seung Won Lee, Ji-Ho Kim, Sang-Ha Kim, Changhwan Kim, Youlim Lee, Chang Youl Kim, Hyun Kuk Lee, Jae Seung Lee, Sei Won Oh, Yeon-Mok BMJ Open Respiratory Medicine INTRODUCTION: Despite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectasis. METHODS AND ANALYSIS: The Korean Multicenter Bronchiectasis Audit and Research Collaboration (KMBARC) is a prospective, non-interventional observational cohort study on bronchiectasis in Korea. The inclusion criteria of this registry are as follows: (1) adult patients (aged ≥18 years) with or without respiratory symptoms (cough, chronic sputum and/or recurrent respiratory infection) and chest computed tomography revealing bronchiectasis affecting one or more lobes and (2) stable status at the time of registration: patients with bronchiectasis who were admitted for a respiratory aetiology can be enrolled at least 4 weeks after hospital discharge. The exclusion criteria are as follows: (1) bronchiectasis due to cystic fibrosis; (2) traction bronchiectasis associated with interstitial lung disease; (3) patients actively being treated for pneumonia, pulmonary tuberculosis or non-tuberculous mycobacterial infection; (4) patients who are unable or unwilling to provide informed consent; and (5) pregnant patients. Although the KMBARC questionnaires for baseline and annual follow-up data are similar to the European Multicentre Bronchiectasis Audit and Research Collaboration questionnaires, KMBARC has distinctive features such as use of Bronchiectasis Health Questionnaires, measurement with fatigue and depression scales, blood tests, use of consensus definition of exacerbations and information on emergency room or hospitalisation. We aim to recruit at least 1200 patients over the study period from more than 26 hospitals in South Korea. Patients will undergo a detailed baseline and yearly assessment for up to 5 years. The study objectives of the KMBARC registry are as follows: (1) uncovering the natural course of bronchiectasis; (2) aiding in establishing evidence-based bronchiectasis guidelines in Korea; and (3) encouraging and facilitating studies on bronchiectasis in Korea. ETHICS AND DISSEMINATION: This study received necessary approval from the Institutional Review Boards of all participating institutions. The Asan Medical Center Institutional Review Board gave overall approval for the study. Results will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: KCT0003088. BMJ Publishing Group 2020-01-19 /pmc/articles/PMC7044940/ /pubmed/31959610 http://dx.doi.org/10.1136/bmjopen-2019-034090 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Respiratory Medicine Lee, Hyun Choi, Hayoung Sim, Yun Su Park, Shinhee Kim, Woo Jin Yoo, Kwang Ha Lee, Seung Jun Kim, Tae-Hyung Yang, Bumhee Jeong, Ina Um, Soo-Jung Kim, Deog Kyeom Lee, Ji-Hyun Kwon, Byoung Soo Cho, Young-Jae Park, Hye Yun Lee, Chang-Hoon Rhee, Chin Kook Lee, Sang Haak Na, Ju Ock Jang, An-Soo Jung, Ji Ye Ra, Seung Won Lee, Ji-Ho Kim, Sang-Ha Kim, Changhwan Kim, Youlim Lee, Chang Youl Kim, Hyun Kuk Lee, Jae Seung Lee, Sei Won Oh, Yeon-Mok KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea |
title | KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea |
title_full | KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea |
title_fullStr | KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea |
title_full_unstemmed | KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea |
title_short | KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea |
title_sort | kmbarc registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in korea |
topic | Respiratory Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044940/ https://www.ncbi.nlm.nih.gov/pubmed/31959610 http://dx.doi.org/10.1136/bmjopen-2019-034090 |
work_keys_str_mv | AT leehyun kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT choihayoung kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT simyunsu kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT parkshinhee kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimwoojin kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT yookwangha kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leeseungjun kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimtaehyung kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT yangbumhee kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT jeongina kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT umsoojung kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimdeogkyeom kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leejihyun kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kwonbyoungsoo kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT choyoungjae kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT parkhyeyun kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leechanghoon kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT rheechinkook kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leesanghaak kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT najuock kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT jangansoo kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT jungjiye kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT raseungwon kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leejiho kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimsangha kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimchanghwan kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimyoulim kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leechangyoul kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT kimhyunkuk kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leejaeseung kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT leeseiwon kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea AT ohyeonmok kmbarcregistryprotocolforamulticentreobservationalcohortstudyonnoncysticfibrosisbronchiectasisinkorea |