{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:46Z","timestamp":1792787266995,"version":"4.5.0"},"reference-count":45,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2022,3,27]],"date-time":"2022-03-27T00:00:00Z","timestamp":1648339200000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Japanese Association for Acute Medicine","award":["No grant number"],"award-info":[{"award-number":["No grant number"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,3,9]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Sepsis is not only the leading cause of death in the intensive care unit (ICU) but also a major risk factor for physical and cognitive impairment and mental disorders, known as postintensive care syndrome (PICS), reduced health-related quality of life (HRQoL) and even mental health disorders in patient families (PICS-family; PICS-F). The ABCDEF bundle is strongly recommended to overcome them, while the association between implementing the bundle and the long-term outcomes is also unknown.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a multicentre prospective observational study at 26 ICUs. All consecutive patients between 1 November 2020 and 30 April 2022, who are 18 years old or older and expected to stay in an ICU for more than 48 hours due to sepsis or septic shock, are enrolled. Follow-up to evaluate survival and PICS\/ PICS-F will be performed at 3, 6 and 12 months and additionally every 6 months up to 5 years after hospital discharge. Primary outcomes include survival at 12\u2009months, which is the primary outcome, and the incidence of PICS defined as the presence of any physical impairment, cognitive impairment or mental disorders. PICS assessment scores, HRQoL and employment status are evaluated. The association between the implementation rate for the ABCDEF bundle and for each of the individual elements and long-term outcomes will be evaluated. The PICS-F, defined as the presence of mental disorders, and HRQoL of the family is also assessed. Additional analyses with data up to 5 years follow-up are planned.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study received ethics approvals from Saiseikai Utsunomiya Hospital (2020-42) and all other participating institutions and was registered in the University Hospital Medical Information Network Clinical Trials Registry. Informed consent will be obtained from all patients. The findings will be published in peer-reviewed journals and presented at scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>UMIN000041433.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-054478","type":"journal-article","created":{"date-parts":[[2022,3,28]],"date-time":"2022-03-28T23:15:48Z","timestamp":1648509348000},"page":"e054478","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Effects of evidence-based ICU care on long-term outcomes of patients with sepsis or septic shock (ILOSS): protocol for a multicentre prospective observational cohort study in Japan"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6867-1420","authenticated-orcid":false,"given":"Keibun","family":"Liu","sequence":"first","affiliation":[{"name":"Critical Care Research Group, The Prince Charles Hospital, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Kotani","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Medicine, Showa University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensuke","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takai","family":"Chihiro","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasunari","family":"Morita","sequence":"additional","affiliation":[{"name":"Department of Emergency and Intensive Care Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenzo","family":"Ishii","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Intensive Care Unit, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Fujizuka","sequence":"additional","affiliation":[{"name":"Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Maebashi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisetsu","family":"Yasumura","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation, Naha City Hospital, Naha, Okinawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Taniguchi","sequence":"additional","affiliation":[{"name":"Tajima Emergency & Critical Care Medical Center, Toyooka Public Hospital, Toyooka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Hamagami","sequence":"additional","affiliation":[{"name":"Tajima Emergency & Critical Care Medical Center, Toyooka Public Hospital, Toyooka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobutake","family":"Shimojo","sequence":"additional","affiliation":[{"name":"Emergency and Critical Care Medicine, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Nitta","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Unit, Niigata University Medical and Dental Hospital, Niigata, Niigata, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Hongo","sequence":"additional","affiliation":[{"name":"Emergency Department, Okayama Saiseikai General Hospital, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Akieda","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, SUBARU Health Insurance Society Ota Memorial Hospital, Ota, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maeda","family":"Atsuo","sequence":"additional","affiliation":[{"name":"Department of Emergency and Disaster Medicine, Showa University Fujigaoka Hospital, Yokohama, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Kaneko","sequence":"additional","affiliation":[{"name":"Emergency and Critical Care Center, Mie University Hospital, Tsu, Mie, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Sakuda","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Medicine, Okinawa Kyodo Hospital, Naha, Okinawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohkichi","family":"Andoh","sequence":"additional","affiliation":[{"name":"Division of Anesthesiology, Sendai City Hospital, Sendai, Miyagi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiyoshi","family":"Nagatomi","sequence":"additional","affiliation":[{"name":"Department of Emergency medicine and Critical Care, St. Marianna University School of Medicine, Yokohama-City Seibu Hospital, Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukiko","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of emergency, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuhei","family":"Irie","sequence":"additional","affiliation":[{"name":"Department of Emergency and Critical care medicine, Fukuoka University Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Kamijo","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Shinshu University Hospital, Matsumoto, Nagano, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Hanazawa","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation, Japan Red Cross Narita Hospital, Narita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Kasugai","sequence":"additional","affiliation":[{"name":"Department of Emergency and Critical Care Medicine, Nagoya University Graduate School of Medicine Faculty of Medicine, Nagoya, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matsuoka","family":"Ayaka","sequence":"additional","affiliation":[{"name":"Department of Emergency and Critical Care Medicine Faculty, Saga University Hospital, Saga, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Oike","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan Kawarai","family":"Lefor","sequence":"additional","affiliation":[{"name":"Department of Surgery, Jichi Medical University, Shimotsuke, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunihiko","family":"Takahashi","sequence":"additional","affiliation":[{"name":"M & D Data Science Center, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajime","family":"Katsukawa","sequence":"additional","affiliation":[{"name":"Japanese Society for Early Mobilization, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Ogura","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,3,28]]},"reference":[{"key":"2025121515023838000_12.3.e054478.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)30696-2"},{"key":"2025121515023838000_12.3.e054478.2","doi-asserted-by":"crossref","first-page":"380","DOI":"10.1016\/S2213-2600(14)70061-X","article-title":"Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit","volume":"2","author":"Vincent","year":"2014","journal-title":"Lancet Respir Med"},{"key":"2025121515023838000_12.3.e054478.3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2010.1553"},{"key":"2025121515023838000_12.3.e054478.4","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e3181d8cc1d"},{"key":"2025121515023838000_12.3.e054478.5","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-013-2815-1"},{"key":"2025121515023838000_12.3.e054478.6","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0116304","article-title":"Long term health-related quality of life in survivors of sepsis in South West Wales: an epidemiological study","volume":"9","author":"Battle","year":"2014","journal-title":"PLoS One"},{"key":"2025121515023838000_12.3.e054478.7","doi-asserted-by":"publisher","DOI":"10.1002\/jhm.2197"},{"key":"2025121515023838000_12.3.e054478.8","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2010.761"},{"key":"2025121515023838000_12.3.e054478.9","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.201411-504OC"},{"key":"2025121515023838000_12.3.e054478.10","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1097\/CCM.0000000000002208","article-title":"Muscle weakness and 5-year survival in acute respiratory distress syndrome survivors","volume":"45","author":"Dinglas","year":"2017","journal-title":"Crit Care Med"},{"key":"2025121515023838000_12.3.e054478.11","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200409-1295OC"},{"key":"2025121515023838000_12.3.e054478.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccc.2016.12.005"},{"key":"2025121515023838000_12.3.e054478.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2018.08.037"},{"key":"2025121515023838000_12.3.e054478.14","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1016\/j.cnc.2020.10.007","article-title":"Use of diaries in intensive care unit delirium patients: German nursing perspectives","volume":"33","author":"Nydahl","year":"2021","journal-title":"Crit Care Nurs Clin North Am"},{"key":"2025121515023838000_12.3.e054478.15","doi-asserted-by":"publisher","DOI":"10.4037\/ajcc2015348"},{"key":"2025121515023838000_12.3.e054478.16","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000003765"},{"key":"2025121515023838000_12.3.e054478.17","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000002149"},{"key":"2025121515023838000_12.3.e054478.18","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000002175"},{"key":"2025121515023838000_12.3.e054478.19","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000003299"},{"key":"2025121515023838000_12.3.e054478.20","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1186\/s40560-017-0222-3","article-title":"The clinical practice guideline for the management of ARDS in Japan","volume":"5","author":"Hashimoto","year":"2017","journal-title":"J Intensive Care"},{"key":"2025121515023838000_12.3.e054478.21","unstructured":"et al Egi M , Ogura H , Yatabe T . The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J-SSCG 2020) [online]. Available: https:\/\/www.jsicm.org\/pdf\/guidelineEN\/J-SSCG2020_JICstyle_re.pdf [Accessed 1 Jun 2021]."},{"key":"2025121515023838000_12.3.e054478.22","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.0287"},{"key":"2025121515023838000_12.3.e054478.23","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1007\/s11136-015-1108-2","article-title":"Japanese population norms for preference-based measures: EQ-5D-3L, EQ-5D-5L, and SF-6D","volume":"25","author":"Shiroiwa","year":"2016","journal-title":"Qual Life Res"},{"key":"2025121515023838000_12.3.e054478.24","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201702-0372OC"},{"key":"2025121515023838000_12.3.e054478.25","first-page":"56","article-title":"Functional evaluation: the BARTHEL index","volume":"14","author":"Mahoney","year":"1965","journal-title":"Md State Med J"},{"key":"2025121515023838000_12.3.e054478.26","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.1993.00540010086023"},{"key":"2025121515023838000_12.3.e054478.27","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0447.1983.tb09716.x"},{"key":"2025121515023838000_12.3.e054478.28","doi-asserted-by":"publisher","DOI":"10.1097\/00005053-200203000-00006"},{"key":"2025121515023838000_12.3.e054478.29","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1097\/CCM.0000000000003482","article-title":"Caring for critically ill patients with the ABCDEF bundle: results of the ICU liberation collaborative in over 15,000 adults","volume":"47","author":"Pun","year":"2019","journal-title":"Crit Care Med"},{"key":"2025121515023838000_12.3.e054478.30","doi-asserted-by":"publisher","DOI":"10.1097\/CCE.0000000000000353"},{"key":"2025121515023838000_12.3.e054478.31","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrtlng.2013.11.003"},{"key":"2025121515023838000_12.3.e054478.32","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.2107138"},{"key":"2025121515023838000_12.3.e054478.33","doi-asserted-by":"publisher","DOI":"10.1007\/s11908-016-0544-7"},{"key":"2025121515023838000_12.3.e054478.34","first-page":"775","article-title":"Long-term survival following sepsis","volume":"117","author":"Schmidt","year":"2020","journal-title":"Dtsch Arztebl Int"},{"key":"2025121515023838000_12.3.e054478.35","doi-asserted-by":"crossref","DOI":"10.1186\/s13054-020-02842-5","article-title":"Urine TITIN N-fragment as a novel biomarker for critical illness myopathy: a pilot study","volume":"24","author":"Nakano","year":"2020","journal-title":"Crit Care"},{"key":"2025121515023838000_12.3.e054478.36","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1007\/s00134-019-05851-3","article-title":"C-reactive protein clustering to clarify persistent inflammation, immunosuppression and catabolism syndrome","volume":"46","author":"Nakamura","year":"2020","journal-title":"Intensive Care Med"},{"key":"2025121515023838000_12.3.e054478.37","doi-asserted-by":"crossref","DOI":"10.2196\/20324","article-title":"Institution-specific machine learning models for prehospital assessment to predict hospital admission: prediction model development study","volume":"8","author":"Shirakawa","year":"2020","journal-title":"JMIR Med Inform"},{"key":"2025121515023838000_12.3.e054478.38","unstructured":"Ministry of Health, Labour and Welfare, Japan . Ethical Guidelines for Medical and Health Research Involving Human Subjects [online]. Available: https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka\/0000080278.pdf [Accessed 20 Jan 2021]."},{"key":"2025121515023838000_12.3.e054478.39","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e3181cb0cdc"},{"key":"2025121515023838000_12.3.e054478.40","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-014-3496-0"},{"key":"2025121515023838000_12.3.e054478.41","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.17687"},{"key":"2025121515023838000_12.3.e054478.42","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1097\/CCM.0000000000004197","article-title":"Best practices for conducting interprofessional team rounds to facilitate performance of the ICU liberation (ABCDEF) bundle","volume":"48","author":"Stollings","year":"2020","journal-title":"Crit Care Med"},{"key":"2025121515023838000_12.3.e054478.43","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1016\/j.chest.2017.03.054","article-title":"Identifying barriers to delivering the awakening and breathing coordination, delirium, and early Exercise\/Mobility bundle to minimize adverse outcomes for mechanically ventilated patients: a systematic review","volume":"152","author":"Costa","year":"2017","journal-title":"Chest"},{"key":"2025121515023838000_12.3.e054478.44","doi-asserted-by":"publisher","DOI":"10.1186\/cc12745"},{"key":"2025121515023838000_12.3.e054478.45","doi-asserted-by":"publisher","DOI":"10.1055\/s-0032-1321984"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-054478","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T23:02:47Z","timestamp":1765839767000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-054478"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3]]},"references-count":45,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2022,3,28]]},"published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1136\/bmjopen-2021-054478"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-054478","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3]]}}}