Palliative  sedation rate for noncancer terminally ill patients at home in Japan

Palliative sedation rate for noncancer terminally ill patients at home in Japan | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Palliative sedation rate for noncancer terminally ill patients at home in Japan Moyuru Shionozaki, Ryo Yamamoto, Jun Hamano This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6149686/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 04 Jun, 2025 Read the published version in BMC Palliative Care → Version 1 posted 10 You are reading this latest preprint version Abstract Background Previous studies have investigated the frequency and target symptoms of palliative sedation in patients with home-based cancer. However, the status of home-based non-cancer patients remains unclear. This study aimed to determine the frequency and target symptoms of palliative sedation in home-based non-cancer patients in Japan. Methods We conducted a post hoc analysis of a multicenter prospective cohort study of elderly non-cancer patients at home in Japan between January 2020 and December 2020. The physicians routinely assessed and recorded symptoms and treatment every 3 months until home care was discontinued or until the patient died at home. This multicenter prospective cohort study targeted non-cancer patients aged 65 years and over receiving care at home or in nursing homes. Results Of the 829 patients, 195 died at home or in nursing homes. Seven patients (3.6%) received palliative sedation before death. The target symptoms for sedation were delirium and dyspnea. Conclusions The sedation rate for noncancer patients at home is relatively low, and the major target symptoms of sedation are delirium and dyspnea. palliative sedation noncancer patients home care Background Dissemination and awareness of palliative care for noncancer patients is important [ 1 ]. Noncancer older people with multiple comorbidities suffer more frequently and significantly [ 2 ]. If the refractory symptoms cannot be resolved with medication or other alternatives, sedation is necessary. There are reports of patients with cancer on the frequency of palliative sedation or details of sedation in palliative care wards or home care settings[ 3 – 5 ]. However, there is a lack of data on palliative sedation for non-cancer patients in the home setting, and international discussions on this topic remain inadequate. Hence, we aimed to explore the details of palliative sedation in home care. Method This was a prospective cross-sectional observational study. This study was a secondary data analysis of a survey conducted as part of the Epochal-J study. The details of this study have been previously published [ 6 ]. The research plan states that data from the primary study may be used in a secondary manner that is not linked to personally identifiable information. Exploring the trajectory of end-of-life symptoms in elderly non-cancer patients at home and in nursing homes in Japan (Epochal-J study), by 59 hospitals and clinics, All non-cancer patients aged 65 years or older for whom home or nursing home visits were initiated between 1 January 2020 and 31 December 2020 were enrolled. The follow-up period was from 1 January 2020 to 31 December 2021. Patients received usual care, including assessment and treatment, at each healthcare facility. The doctor or nurse in charge at each medical institution registers new patients on the day the home visit starts and records the survey items on the day the home visit starts (data at start), 3, 6, 9 and 12 months after the start, when home care is discontinued or when the patient dies.Participants:Eligibility criteria were: 1) patients aged 65 years and over; 2) patients receiving care at home or in a nursing home. Exclusion criteria were: 1) patients with advanced cancer and 2) patients/families who refused to participate in the study. Age, sex, place of death, major diseases, reason for death, target symptoms for sedation, medications for symptoms, medications used for sedation, sedation methods, duration of sedation, and duration of home care were also measured. We defined sedation based on previous studies[ 7 ] to standardise participants' understanding. Intermittent and continuous deep sedations were considered palliative sedation. Intermittent sedation was defined as the intermittent administration of sedatives (benzodiazepines, propofol, and barbiturates) to relieve treatment-resistant symptoms. Continuous deep sedation, framed as sedatives (benzodiazepines, propofol, and barbiturates), was administered continuously or regularly to relieve treatment-resistant symptoms and keep the patient in a coma until death. Patients receiving a midazolam dose < 10 mg/day and those taking insomnia medications were excluded in order to focus solely on sedation for symptom relief. The decision to administer sedation was left to the discretion of the treating physician. Fisher's exact test was used to compare whether there was a difference in symptoms before death between the group that required sedation and the group that did not.All statistical analyses were performed with EZR ver1.61 (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria). More precisely, it is a modified version of R commander designed to add statistical functions frequently used in biostatistics.[ 8 ] Results A total of 785 patients were included in the Epochal-J study. During the one-year follow-up, 195 patients died, with seven patients (3.6%) receiving palliative sedation before death and three of these patients received continuous deep sedation (CDS). The characteristics of the patients who died are shown in Table 1 .Palliative sedation was required in 3.8% and 2.7% of patients who died at home and nursing homes, respectively. A summary of patients who required sedation is shown in Table 2 . Table 1 Background Characteristics of Patients With and Without Palliative Sedation with palliative sedation wituout palliative sedation total n % n % (n) number of patient 7 3.6 188 96.4 195 Age (years ± SD) 84.3 ± 9.5 86.9 ± 8.7 Sex Male 4 57.1 78 41.5 82 Female 3 42.9 110 58.5 113 Place of death Home 6 85.7 152 80.9 158 Nursing Home 1 14.3 36 19.1 37 Others 2 1.1 2 Diseases and conditions requiring home visits Dementia 3 56 29.8 59 Heart disease 1 33 17.6 34 Cerebrovascular accident 21 11.2 21 Respiratory disease 2 19 10.1 21 Neurological disease 17 9 17 Kidney disease 11 5.9 11 Musculoskeletal disease 6 3.2 6 Liver disease 1 2 1.1 3 Others 23 12.2 23 Among the target symptoms that required sedation, delirium was present in five patients and dyspnea in three patients (with overlap). Regarding the type of sedation, continuous deep sedation was used for dyspnea, and intermittent sedation was used for delirium. Among the seven patients who required sedation, five (71.4%) experienced delirium within 1 week of death. In contrast, of 177 patients who did not require sedation, 21 (11.2%) experienced delirium. When patients who required sedation were compared with those who did not, there was a significant difference in the presence or absence of delirium within 1 week of death. (p = 0.0071) Among the five patients who received sedation due to delirium, two did not receive sedation and medications for delirium. Symptoms rated as overwhelming on the IPOS three days before death were as follows (multiple symptoms per patient possible): restlessness (14), poor appetite (9), fatigue (5), dyspnea (2), pain (1), vomiting (1), constipation (1), mouth pain or dryness (1), drowsiness (1), and emotional distress (1). Discussion The most important finding of this study was that palliative sedation was administered to only seven noncancer terminally ill patients (3.6%) in home-based settings and residential care facilities in Japan. Compared with those for cancer patients, sedation rates for home-based noncancer patients in this study were lower. Sedation rates ranging from 14%-35% have been reported [ 4 , 5 ]. There are three possible reasons for the low sedation rates observed in this study. First, there are differences in the quality and intensity of pain. Previous studies comparing symptoms between cancer and non-cancer patients have reported that while the frequency of pain is similar in both groups, the intensity of pain tends to be lower in non-cancer patients. [ 9 ] This may partly explain the findings in our study, where pain was not a primary indication for palliative sedation and the overall sedation rate was lower in non-cancer patients. Second, differences in care settings may explain the results. Previous studies in cancer patients have shown that the rate of palliative sedation tends to be lower at home than in hospital. In cancer patients, factors contributing to this difference include limited resources and difficulty in monitoring at home, and the likelihood that hospitalised patients will have more severe symptoms requiring sedation. [ 10 , 11 ] Although data on palliative sedation rates for non-cancer patients in hospitals remain scarce, it is possible that the same reasons may have contributed to the lower sedation rate in home care observed in this study. For example, the use of subcutaneous midazolam - the most common method of sedation - requires several steps in the home setting: prescription by a doctor, securing the medication, preparing the syringe or infusion pump, and monitoring the patient. Compared with hospitals, where all processes are managed internally, the more complex and resource-limited environment of home care may raise the threshold for administering sedation. Third, refractory symptoms requiring sedation may not have been adequately assessed by physicians. In this study, patients who did not receive palliative sedation reported symptoms that could potentially warrant sedation - such as dyspnea, pain and psychological distress - within three days of death.It has been reported that specialists in elderly care have lower rates of sedation [ 10 ], which might be reflected in these findings. In this study, primary care physicians provided the necessary care. However, in Japan, there is currently no formal training for primary care physicians to provide palliative care at home, and it is left to individual skill. Therefore, training in palliative care, including sedation, is needed. Guidelines from the European Association for Palliative Care concerning palliative sedation are also available for noncancer patients [ 12 ]. However, in Japan, there are only guidelines for palliative sedation of patients with cancer [ 13 ]. For both palliative care medicine practitioners and general practitioners, there is a need for consensus regarding palliative sedation for noncancer patients. The second important finding is that, among these cases, three required continuous deep sedation, which was administered to patients presenting with delirium and dyspnea, similar to that of cancer patients [ 14 ]. Previous studies on patients with cancer have often administered sedation for symptoms such as delirium, pain, and dyspnea [ 15 ]. In home-based care for noncancer patients, pain, delirium, and dyspnea can occur [ 16 ]. The strength of this study lies in its focus on noncancer patients receiving home care in Japan. However, this study had several limitations. First, it is unclear whether all physicians understood the differences in palliative sedation. Assessing whether refractory symptoms were appropriately evaluated was difficult in this study. Second, we assessed pain from a doctor's perspective in this study and could not assess whether the pain was refractory from a patient’s perspective; thus, it was difficult to determine whether palliative sedation was appropriate. Third, this result does not represent the average outcome, as the participants in this study were actively engaged in in-home care. Fourth, the number of study participants was limited, and only a small number of them required palliative sedation, which may reduce the generalizability of the findings. Future studies with larger sample sizes are needed to validate these findings. Fifth, since the method of sedation was left to the discretion of each participant, some methods that are not commonly used were included. Sixth, with regard to physician bias, factors such as individual experience and beliefs, as well as differences in sedation rates according to medical specialty, can be considered. However, as this study used secondary data, it was difficult to account for these biases. Given these limitations, future research should be designed with greater methodological rigor and attention to contextual factors, to provide more comprehensive insights and improve the applicability of the findings. Conclusion In this study, palliative sedation was administered to non-cancer patients receiving home-based care, primarily for symptoms such as delirium and dyspnea. However, the overall incidence of sedation remained low at 3.6%. Declarations Ethics approval and consent to participate This study was conducted in accordance with the ethical standards of the Declaration of Helsinki and the Ethical Guidelines for Epidemiological Research issued by the Ministry of Health, Labor, and Welfare of Japan. This study was approved by the Institutional Review Board of the University of Tsukuba (No. 1651). Consent for publication Not applicable Availability of data and materials The datasets generated and analyzed during the present study are not publicly available because they contain information that could compromise research participants’ privacy/consent but are available from the corresponding author upon reasonable request. Competing interests The authors declare that they have no competing interests. Funding This work was supported by JSPS KAKENHI (Grant Number 19K10551) and a research grant from the Mitsubishi Foundation (201930027). The funder had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of data; the preparation, review, and approval of the manuscript; or the decision to submit the manuscript for publication. Authors' contributions All the authors contributed substantially to the conception and design of this study. JH facilitated the acquisition of data; MS, RY, and JH interpreted and drafted the manuscript; all authors revised the manuscript critically; and all authors read and approved the final version. Acknowledgements The participating investigators and study sites of this study were as follows: Keijiro Miyake, M.D., Ph.D. (Keijiro Clinic), Yoshihiro Kataoka, M.D., Ph.D. (Oomori Clinic/ Hitachi Oota Family Clinic), Masanori Kawahara, M.D., Ph.D. (Soshukai Okabe Clinic Sendai), Hongja Kim, M.D. (Kaita Hospital), Takashi Inaba, M.D. (Kasama City Hospital), Hiroki Takahashi, M.D. (Kamisu Saiseikai Hospital), Kaoru Okawa, M.D. (Kameda Medical Center), Ryo Osawa, M.D. (Kitaibaraki Family Clinic), Fuminao Kitanishi, M.D. (Total Family Care Kitanishi Clinic), Keiichirou Sakato, M.D. (Kensei Kuroishi Clinic), Takuya Shinjo, M.D. (Shinjo Clinic), Yohei Shinya, M.D. (Chubu Tokushukai Hospital), Yu Yamamoto, M.D. (Tsukuba Central Hospital), Hiroshi Taira, M.D. (Torimachi Clinic), Kazuhiro Hisajima, M.D. (Dr. GON Kamakura Clinic), Tomoyuki Koga, M.D. (Nozominohana Clinic), Asumi Nakamura, M.D. (Himawari Clinic), Kotaro Hashimoto, M.D. (Fukushima Home Palliative Care Clinic), Ryo Takayanagi, M.D. (Maebashi Kyoritsu Clinic), Mariko Shutoh, M.D., Ph.D. (Minato Home Care Clinic), Shouko Nishimizu, M.D. (Miyazaki Clinic), Yuri Morimoto, M.D. (Morimoto Clinic), Jun Sasaki M.D. (Yushoukal Medical Corporation), Junichiro Toya, M.D. (Sakura-shinmachi Urban Clinic), Hiroto Shirayama, M.D. (Osaka Kita Home Care Clinic), Yasuhiro Saitou, M.D. (GP Clinic Jiyugaoka), Nobuyuki Miyata, M.D. (Miyata Clinic), Yurika Kawamura, M.D., Ph.D. (Miyata Clinic), Masakatsu Shimizu, M.D., Ph.D. (Shimizu Medical Clinic), Ryo Yamamoto, M.D. (Saku Central Hospital Advanced Care Center), Yousuke Kimura, M.D. (Yamato Clinic), Yasuyuki Arai, M.D., Ph.D. (Iki-iki Clinic), Hideki Shishido, M.D. (Shishido Internal Medicine Clinic), Kazushi Nakano, M.D., Ph.D. (Nakano Zaitakuiryou Clinic), Maiko Haruki, M.D. (Orange Home-Care Clinic), and Sen Otomo, M.D. (Seimeikan Clinic). References Hall S, Petkova H, Tsouros AD, Costantini M, Higginson IJ. Palliative Care for Older People: Better Practices. World Health Organization. Regional Office for Europe; 2011. Nicholson C, Davies JM, George R, Smith B, Pace V, Harris L, et al. What are the main palliative care symptoms and concerns of older people with multimorbidity?-a comparative cross-sectional study using routinely collected Phase of Illness, Australia-modified Karnofsky Performance Status and Integrated Palliative Care Outcome Scale data. Ann Palliat Med. 2018;7(Suppl 3):S164–75. Heijltjes MT, van Thiel GJMW, Rietjens JAC, van der Heide A, de Graeff A, van Delden JJM. Changing Practices in the Use of Continuous Sedation at the End of Life: A Systematic Review of the Literature. J Pain Symptom Manage. 2020;60:828–e8463. Mercadante S, Porzio G, Valle A, Fusco F, Aielli F, Costanzo V. Palliative Sedation in Patients with Advanced Cancer Followed at Home: A Systematic Review. J Pain Symptom Manage. 2011;41:754–60. Mercadante S, Porzio G, Valle A, Aielli F, Casuccio A, Home Care-Italy Group. Palliative Sedation in Patients with Advanced Cancer Followed at Home: A Prospective Study. J Pain Symptom Manage. 2014;47:860–6. Hamano J, Shinjo T, Fukumoto K, Kodama M, Kim H, Otomo S, et al. Unresolved Palliative Care Needs of Elderly Non-Cancer Patients at Home: A Multicenter Prospective Study. J Prim Care Community Health. 2023;14:21501319231221431. Isseki M. Effect of continuous deep sedation on survival in patients with advanced cancer (J-Proval): a propensity score-weighted analysis of a prospective cohort study. Lancet Oncol. 2016;17:115–22. Kanda Y. Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transpl. 2013;48:452–8. Van Lancker A, Van Hecke A, Verhaeghe S, Mattheeuws M, Beeckman D. A comparison of symptoms in older hospitalised cancer and non-cancer patients in need of palliative care: a secondary analysis of two cross-sectional studies. BMC Geriatr. 2018;18:40. Tan F, Li N, Wu Y, Zhang C. Palliative Sedation Determinants: Systematic Review and meta-analysis in palliative medicine. BMJ Support Palliat Care. 2023;13:e664–675. Calvo-Espinos C, Ruiz de Gaona E, Gonzalez C, Ruiz de Galarreta L, Lopez C. Palliative sedation for cancer patients included in a home care program: a retrospective study. Palliat Support Care. 2015;13:619–24. Surges SM, Brunsch H, Jaspers B, Apostolidis K, Cardone A, Centeno C, et al. Revised European Association for Palliative Care (EAPC) recommended framework on palliative sedation: An international Delphi study. Palliat Med. 2024;38:213–28. Imai K, Morita T, Akechi T, Baba M, Yamaguchi T, Sumi H, et al. The Principles of Revised Clinical Guidelines about Palliative Sedation Therapy of the Japanese Society for Palliative Medicine. J Palliat Med. 2020;23:1184–90. Caraceni A, Speranza R, Spoldi E, Ambroset CS, Canestrari S, Marinari M, et al. Palliative Sedation in Terminal Cancer Patients Admitted to Hospice or Home Care Programs: Does the Setting Matter? Results From a National Multicenter Observational Study. J Pain Symptom Manage. 2018;56:33–43. Arantzamendi M, Belar A, Payne S, Rijpstra M, Preston N, Menten J, et al. Clinical Aspects of Palliative Sedation in Prospective Studies. A Systematic Review. J Pain Symptom Manage. 2021;61:831–e84410. Conen K, Guthrie DM, Stevens T, Winemaker S, Seow H. Symptom trajectories of non-cancer patients in the last six months of life: Identifying needs in a population-based home care cohort. PLoS ONE. 2021;16:e0252814. Tables Table 2 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table2.docx Cite Share Download PDF Status: Published Journal Publication published 04 Jun, 2025 Read the published version in BMC Palliative Care → Version 1 posted Editorial decision: Revision requested 24 Apr, 2025 Reviews received at journal 22 Apr, 2025 Reviews received at journal 16 Apr, 2025 Reviewers agreed at journal 14 Apr, 2025 Reviews received at journal 13 Apr, 2025 Reviewers agreed at journal 12 Apr, 2025 Reviewers agreed at journal 12 Apr, 2025 Reviewers invited by journal 11 Apr, 2025 Submission checks completed at journal 11 Apr, 2025 First submitted to journal 10 Apr, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6149686","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":442761209,"identity":"1e8e44c5-cb65-401c-aace-62f24287b4f0","order_by":0,"name":"Moyuru Shionozaki","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAz0lEQVRIiWNgGAWjYPCC/zz87A1A2sCCaC3MMpI9B0BaJIjXYmNwIwHEIEKLbnuPmXRlGxuP5MznVzf8KJBg4G/vTsCrxezMGTPJs208PPzSOWU3e4AOkzhzdgN+LTdyzCQb2yR4JGfnpN3gAWoxkMglSosBj8HNM2k3/5CgJYHH4Ab7sdvE2XLmWLFlw7kDPJI9OWy3ZQwkeAj75XjzxpsNZQfs+dmPP7v55o+NHH97L34tDAwcBlAGD5jBQ0A5CLA/QGeMglEwCkbBKEAFAM68RcC6sXM8AAAAAElFTkSuQmCC","orcid":"","institution":"Saku Central Hospital","correspondingAuthor":true,"prefix":"","firstName":"Moyuru","middleName":"","lastName":"Shionozaki","suffix":""},{"id":442761211,"identity":"c80bc7a9-0815-4f9f-af4f-be4a44fe7998","order_by":1,"name":"Ryo Yamamoto","email":"","orcid":"","institution":"Saku Central Hospital Advanced Care Center","correspondingAuthor":false,"prefix":"","firstName":"Ryo","middleName":"","lastName":"Yamamoto","suffix":""},{"id":442761213,"identity":"0b251e0c-2b5b-4894-b4b0-0c1f3ebadf24","order_by":2,"name":"Jun Hamano","email":"","orcid":"","institution":"University of Tsukuba","correspondingAuthor":false,"prefix":"","firstName":"Jun","middleName":"","lastName":"Hamano","suffix":""}],"badges":[],"createdAt":"2025-03-04 00:53:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6149686/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6149686/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12904-025-01799-y","type":"published","date":"2025-06-04T15:57:27+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":84242687,"identity":"58c220b6-1994-46e0-9c28-f027598a7760","added_by":"auto","created_at":"2025-06-09 16:11:21","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":436771,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6149686/v1/7a8c62ef-d72e-4e1b-9509-0aa0b69f173f.pdf"},{"id":80656999,"identity":"23b4ee96-cef9-4545-a3a6-f7177964da61","added_by":"auto","created_at":"2025-04-15 15:48:22","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":16256,"visible":true,"origin":"","legend":"","description":"","filename":"Table2.docx","url":"https://assets-eu.researchsquare.com/files/rs-6149686/v1/bb809aee7246b7305283a139.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Palliative sedation rate for noncancer terminally ill patients at home in Japan","fulltext":[{"header":"Background","content":"\u003cp\u003eDissemination and awareness of palliative care for noncancer patients is important [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Noncancer older people with multiple comorbidities suffer more frequently and significantly [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. If the refractory symptoms cannot be resolved with medication or other alternatives, sedation is necessary. There are reports of patients with cancer on the frequency of palliative sedation or details of sedation in palliative care wards or home care settings[\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. However, there is a lack of data on palliative sedation for non-cancer patients in the home setting, and international discussions on this topic remain inadequate. Hence, we aimed to explore the details of palliative sedation in home care.\u003c/p\u003e"},{"header":"Method","content":"\u003cp\u003eThis was a prospective cross-sectional observational study. This study was a secondary data analysis of a survey conducted as part of the Epochal-J study. The details of this study have been previously published [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. The research plan states that data from the primary study may be used in a secondary manner that is not linked to personally identifiable information. Exploring the trajectory of end-of-life symptoms in elderly non-cancer patients at home and in nursing homes in Japan (Epochal-J study), by 59 hospitals and clinics, All non-cancer patients aged 65 years or older for whom home or nursing home visits were initiated between 1 January 2020 and 31 December 2020 were enrolled. The follow-up period was from 1 January 2020 to 31 December 2021. Patients received usual care, including assessment and treatment, at each healthcare facility. The doctor or nurse in charge at each medical institution registers new patients on the day the home visit starts and records the survey items on the day the home visit starts (data at start), 3, 6, 9 and 12 months after the start, when home care is discontinued or when the patient dies.Participants:Eligibility criteria were: 1) patients aged 65 years and over; 2) patients receiving care at home or in a nursing home. Exclusion criteria were: 1) patients with advanced cancer and 2) patients/families who refused to participate in the study. Age, sex, place of death, major diseases, reason for death, target symptoms for sedation, medications for symptoms, medications used for sedation, sedation methods, duration of sedation, and duration of home care were also measured.\u003c/p\u003e \u003cp\u003eWe defined sedation based on previous studies[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] to standardise participants' understanding. Intermittent and continuous deep sedations were considered palliative sedation. Intermittent sedation was defined as the intermittent administration of sedatives (benzodiazepines, propofol, and barbiturates) to relieve treatment-resistant symptoms. Continuous deep sedation, framed as sedatives (benzodiazepines, propofol, and barbiturates), was administered continuously or regularly to relieve treatment-resistant symptoms and keep the patient in a coma until death. Patients receiving a midazolam dose\u0026thinsp;\u0026lt;\u0026thinsp;10 mg/day and those taking insomnia medications were excluded in order to focus solely on sedation for symptom relief. The decision to administer sedation was left to the discretion of the treating physician. Fisher's exact test was used to compare whether there was a difference in symptoms before death between the group that required sedation and the group that did not.All statistical analyses were performed with EZR ver1.61 (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria). More precisely, it is a modified version of R commander designed to add statistical functions frequently used in biostatistics.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 785 patients were included in the Epochal-J study. During the one-year follow-up, 195 patients died, with seven patients (3.6%) receiving palliative sedation before death and three of these patients received continuous deep sedation (CDS). The characteristics of the patients who died are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.Palliative sedation was required in 3.8% and 2.7% of patients who died at home and nursing homes, respectively. A summary of patients who required sedation is shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBackground Characteristics of Patients With and Without Palliative Sedation\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003ewith palliative sedation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003ewituout palliative sedation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003etotal\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e(n)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003enumber of patient\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e188\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e96.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e195\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e84.3\u0026thinsp;\u0026plusmn;\u0026thinsp;9.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e86.9\u0026thinsp;\u0026plusmn;\u0026thinsp;8.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e41.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e82\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e110\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e58.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e113\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlace of death\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e85.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e152\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e80.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e158\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNursing Home\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOthers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eDiseases and conditions requiring home visits\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDementia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e29.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e59\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeart disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCerebrovascular accident\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRespiratory disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeurological disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKidney disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMusculoskeletal disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLiver disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOthers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAmong the target symptoms that required sedation, delirium was present in five patients and dyspnea in three patients (with overlap). Regarding the type of sedation, continuous deep sedation was used for dyspnea, and intermittent sedation was used for delirium. Among the seven patients who required sedation, five (71.4%) experienced delirium within 1 week of death. In contrast, of 177 patients who did not require sedation, 21 (11.2%) experienced delirium. When patients who required sedation were compared with those who did not, there was a significant difference in the presence or absence of delirium within 1 week of death. (p\u0026thinsp;=\u0026thinsp;0.0071)\u003c/p\u003e \u003cp\u003eAmong the five patients who received sedation due to delirium, two did not receive sedation and medications for delirium. Symptoms rated as overwhelming on the IPOS three days before death were as follows (multiple symptoms per patient possible): restlessness (14), poor appetite (9), fatigue (5), dyspnea (2), pain (1), vomiting (1), constipation (1), mouth pain or dryness (1), drowsiness (1), and emotional distress (1).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe most important finding of this study was that palliative sedation was administered to only seven noncancer terminally ill patients (3.6%) in home-based settings and residential care facilities in Japan.\u003c/p\u003e \u003cp\u003eCompared with those for cancer patients, sedation rates for home-based noncancer patients in this study were lower. Sedation rates ranging from 14%-35% have been reported [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. There are three possible reasons for the low sedation rates observed in this study.\u003c/p\u003e \u003cp\u003eFirst, there are differences in the quality and intensity of pain. Previous studies comparing symptoms between cancer and non-cancer patients have reported that while the frequency of pain is similar in both groups, the intensity of pain tends to be lower in non-cancer patients. [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] This may partly explain the findings in our study, where pain was not a primary indication for palliative sedation and the overall sedation rate was lower in non-cancer patients.\u003c/p\u003e \u003cp\u003eSecond, differences in care settings may explain the results. Previous studies in cancer patients have shown that the rate of palliative sedation tends to be lower at home than in hospital. In cancer patients, factors contributing to this difference include limited resources and difficulty in monitoring at home, and the likelihood that hospitalised patients will have more severe symptoms requiring sedation. [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] Although data on palliative sedation rates for non-cancer patients in hospitals remain scarce, it is possible that the same reasons may have contributed to the lower sedation rate in home care observed in this study. For example, the use of subcutaneous midazolam - the most common method of sedation - requires several steps in the home setting: prescription by a doctor, securing the medication, preparing the syringe or infusion pump, and monitoring the patient. Compared with hospitals, where all processes are managed internally, the more complex and resource-limited environment of home care may raise the threshold for administering sedation.\u003c/p\u003e \u003cp\u003eThird, refractory symptoms requiring sedation may not have been adequately assessed by physicians. In this study, patients who did not receive palliative sedation reported symptoms that could potentially warrant sedation - such as dyspnea, pain and psychological distress - within three days of death.It has been reported that specialists in elderly care have lower rates of sedation [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], which might be reflected in these findings. In this study, primary care physicians provided the necessary care. However, in Japan, there is currently no formal training for primary care physicians to provide palliative care at home, and it is left to individual skill. Therefore, training in palliative care, including sedation, is needed. Guidelines from the European Association for Palliative Care concerning palliative sedation are also available for noncancer patients [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. However, in Japan, there are only guidelines for palliative sedation of patients with cancer [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. For both palliative care medicine practitioners and general practitioners, there is a need for consensus regarding palliative sedation for noncancer patients.\u003c/p\u003e \u003cp\u003eThe second important finding is that, among these cases, three required continuous deep sedation, which was administered to patients presenting with delirium and dyspnea, similar to that of cancer patients [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Previous studies on patients with cancer have often administered sedation for symptoms such as delirium, pain, and dyspnea [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. In home-based care for noncancer patients, pain, delirium, and dyspnea can occur [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe strength of this study lies in its focus on noncancer patients receiving home care in Japan. However, this study had several limitations. First, it is unclear whether all physicians understood the differences in palliative sedation. Assessing whether refractory symptoms were appropriately evaluated was difficult in this study. Second, we assessed pain from a doctor's perspective in this study and could not assess whether the pain was refractory from a patient\u0026rsquo;s perspective; thus, it was difficult to determine whether palliative sedation was appropriate. Third, this result does not represent the average outcome, as the participants in this study were actively engaged in in-home care. Fourth, the number of study participants was limited, and only a small number of them required palliative sedation, which may reduce the generalizability of the findings. Future studies with larger sample sizes are needed to validate these findings. Fifth, since the method of sedation was left to the discretion of each participant, some methods that are not commonly used were included. Sixth, with regard to physician bias, factors such as individual experience and beliefs, as well as differences in sedation rates according to medical specialty, can be considered. However, as this study used secondary data, it was difficult to account for these biases. Given these limitations, future research should be designed with greater methodological rigor and attention to contextual factors, to provide more comprehensive insights and improve the applicability of the findings.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn this study, palliative sedation was administered to non-cancer patients receiving home-based care, primarily for symptoms such as delirium and dyspnea. However, the overall incidence of sedation remained low at 3.6%.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the ethical standards of the Declaration of Helsinki and the Ethical Guidelines for Epidemiological Research issued by the Ministry of Health, Labor, and Welfare of Japan. This study was approved by the Institutional Review Board of the University of Tsukuba (No. 1651).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the present study are not publicly available because they contain information that could compromise research participants’ privacy/consent but are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported by JSPS KAKENHI (Grant Number 19K10551) and a research grant from the Mitsubishi Foundation (201930027). The funder had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of data; the preparation, review, and approval of the manuscript; or the decision to submit the manuscript for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the authors contributed substantially to the conception and design of this study. JH facilitated the acquisition of data; MS, RY, and JH interpreted and drafted the manuscript; all authors revised the manuscript critically; and all authors read and approved the final version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe participating investigators and study sites of this study were as follows: Keijiro Miyake, M.D., Ph.D. (Keijiro Clinic), Yoshihiro Kataoka, M.D., Ph.D. (Oomori Clinic/ Hitachi Oota Family Clinic), Masanori Kawahara, M.D., Ph.D. (Soshukai Okabe Clinic Sendai), Hongja Kim, M.D. (Kaita Hospital), Takashi Inaba, M.D. (Kasama City Hospital), Hiroki Takahashi, M.D. (Kamisu Saiseikai Hospital), Kaoru Okawa, M.D. (Kameda Medical Center), Ryo Osawa, M.D. (Kitaibaraki Family Clinic), Fuminao Kitanishi, M.D. (Total Family Care Kitanishi Clinic), Keiichirou Sakato, M.D. (Kensei Kuroishi Clinic),\u0026nbsp;Takuya Shinjo, M.D. (Shinjo Clinic), Yohei Shinya, M.D. (Chubu Tokushukai Hospital), Yu Yamamoto, M.D. (Tsukuba Central Hospital), Hiroshi Taira, M.D. (Torimachi Clinic), Kazuhiro Hisajima, M.D. (Dr. GON Kamakura Clinic), Tomoyuki Koga, M.D. (Nozominohana Clinic), Asumi Nakamura, M.D. (Himawari Clinic), Kotaro Hashimoto, M.D. (Fukushima Home Palliative Care Clinic), Ryo Takayanagi, M.D. (Maebashi Kyoritsu Clinic), Mariko Shutoh, M.D., Ph.D. (Minato Home Care Clinic), Shouko Nishimizu, M.D. (Miyazaki Clinic), Yuri Morimoto, M.D. (Morimoto Clinic), Jun Sasaki M.D. (Yushoukal Medical Corporation), Junichiro Toya, M.D. (Sakura-shinmachi Urban Clinic), Hiroto Shirayama, M.D. (Osaka Kita Home Care Clinic), Yasuhiro Saitou, M.D. (GP Clinic Jiyugaoka), Nobuyuki Miyata, M.D. (Miyata Clinic), Yurika Kawamura, M.D., Ph.D. (Miyata Clinic), Masakatsu Shimizu, M.D., Ph.D. (Shimizu Medical Clinic), Ryo Yamamoto, M.D. (Saku Central Hospital Advanced Care Center), Yousuke Kimura, M.D. (Yamato Clinic), Yasuyuki Arai, M.D., Ph.D. (Iki-iki Clinic), Hideki Shishido, M.D. (Shishido Internal Medicine Clinic), Kazushi Nakano, M.D., Ph.D. (Nakano Zaitakuiryou Clinic), Maiko Haruki, M.D. (Orange Home-Care Clinic), and Sen Otomo, M.D. (Seimeikan Clinic).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHall S, Petkova H, Tsouros AD, Costantini M, Higginson IJ. Palliative Care for Older People: Better Practices. World Health Organization. Regional Office for Europe; 2011.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNicholson C, Davies JM, George R, Smith B, Pace V, Harris L, et al. What are the main palliative care symptoms and concerns of older people with multimorbidity?-a comparative cross-sectional study using routinely collected Phase of Illness, Australia-modified Karnofsky Performance Status and Integrated Palliative Care Outcome Scale data. Ann Palliat Med. 2018;7(Suppl 3):S164\u0026ndash;75.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHeijltjes MT, van Thiel GJMW, Rietjens JAC, van der Heide A, de Graeff A, van Delden JJM. Changing Practices in the Use of Continuous Sedation at the End of Life: A Systematic Review of the Literature. J Pain Symptom Manage. 2020;60:828\u0026ndash;e8463.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMercadante S, Porzio G, Valle A, Fusco F, Aielli F, Costanzo V. Palliative Sedation in Patients with Advanced Cancer Followed at Home: A Systematic Review. J Pain Symptom Manage. 2011;41:754\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMercadante S, Porzio G, Valle A, Aielli F, Casuccio A, Home Care-Italy Group. Palliative Sedation in Patients with Advanced Cancer Followed at Home: A Prospective Study. J Pain Symptom Manage. 2014;47:860\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHamano J, Shinjo T, Fukumoto K, Kodama M, Kim H, Otomo S, et al. Unresolved Palliative Care Needs of Elderly Non-Cancer Patients at Home: A Multicenter Prospective Study. J Prim Care Community Health. 2023;14:21501319231221431.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIsseki M. Effect of continuous deep sedation on survival in patients with advanced cancer (J-Proval): a propensity score-weighted analysis of a prospective cohort study. Lancet Oncol. 2016;17:115\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKanda Y. Investigation of the freely available easy-to-use software \u0026lsquo;EZR\u0026rsquo; for medical statistics. Bone Marrow Transpl. 2013;48:452\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVan Lancker A, Van Hecke A, Verhaeghe S, Mattheeuws M, Beeckman D. A comparison of symptoms in older hospitalised cancer and non-cancer patients in need of palliative care: a secondary analysis of two cross-sectional studies. BMC Geriatr. 2018;18:40.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTan F, Li N, Wu Y, Zhang C. Palliative Sedation Determinants: Systematic Review and meta-analysis in palliative medicine. BMJ Support Palliat Care. 2023;13:e664\u0026ndash;675.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCalvo-Espinos C, Ruiz de Gaona E, Gonzalez C, Ruiz de Galarreta L, Lopez C. Palliative sedation for cancer patients included in a home care program: a retrospective study. Palliat Support Care. 2015;13:619\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSurges SM, Brunsch H, Jaspers B, Apostolidis K, Cardone A, Centeno C, et al. Revised European Association for Palliative Care (EAPC) recommended framework on palliative sedation: An international Delphi study. Palliat Med. 2024;38:213\u0026ndash;28.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eImai K, Morita T, Akechi T, Baba M, Yamaguchi T, Sumi H, et al. The Principles of Revised Clinical Guidelines about Palliative Sedation Therapy of the Japanese Society for Palliative Medicine. J Palliat Med. 2020;23:1184\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCaraceni A, Speranza R, Spoldi E, Ambroset CS, Canestrari S, Marinari M, et al. Palliative Sedation in Terminal Cancer Patients Admitted to Hospice or Home Care Programs: Does the Setting Matter? Results From a National Multicenter Observational Study. J Pain Symptom Manage. 2018;56:33\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArantzamendi M, Belar A, Payne S, Rijpstra M, Preston N, Menten J, et al. Clinical Aspects of Palliative Sedation in Prospective Studies. A Systematic Review. J Pain Symptom Manage. 2021;61:831\u0026ndash;e84410.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eConen K, Guthrie DM, Stevens T, Winemaker S, Seow H. Symptom trajectories of non-cancer patients in the last six months of life: Identifying needs in a population-based home care cohort. PLoS ONE. 2021;16:e0252814.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 2 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-palliative-care","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pcar","sideBox":"Learn more about [BMC Palliative Care](http://bmcpalliatcare.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pcar/default.aspx","title":"BMC Palliative Care","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"palliative sedation, noncancer patients, home care","lastPublishedDoi":"10.21203/rs.3.rs-6149686/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6149686/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePrevious studies have investigated the frequency and target symptoms of palliative sedation in patients with home-based cancer. However, the status of home-based non-cancer patients remains unclear. This study aimed to determine the frequency and target symptoms of palliative sedation in home-based non-cancer patients in Japan.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe conducted a post hoc analysis of a multicenter prospective cohort study of elderly non-cancer patients at home in Japan between January 2020 and December 2020. The physicians routinely assessed and recorded symptoms and treatment every 3 months until home care was discontinued or until the patient died at home. This multicenter prospective cohort study targeted non-cancer patients aged 65 years and over receiving care at home or in nursing homes.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOf the 829 patients, 195 died at home or in nursing homes. Seven patients (3.6%) received palliative sedation before death. The target symptoms for sedation were delirium and dyspnea.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe sedation rate for noncancer patients at home is relatively low, and the major target symptoms of sedation are delirium and dyspnea.\u003c/p\u003e","manuscriptTitle":"Palliative sedation rate for noncancer terminally ill patients at home in Japan","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-15 15:48:18","doi":"10.21203/rs.3.rs-6149686/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-04-24T16:52:07+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-22T18:36:37+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-16T19:12:13+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"197644295034047983295576697356150750752","date":"2025-04-14T14:04:12+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-13T23:26:51+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"89563034454234321208185041777945983676","date":"2025-04-12T08:13:35+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"256851656663235009441534033198228214578","date":"2025-04-12T06:32:53+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-11T14:55:37+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-04-11T12:22:02+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Palliative Care","date":"2025-04-10T05:26:26+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-palliative-care","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pcar","sideBox":"Learn more about [BMC Palliative Care](http://bmcpalliatcare.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pcar/default.aspx","title":"BMC Palliative Care","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5ef76347-cad2-449d-9917-fe469e6e5756","owner":[],"postedDate":"April 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-06-09T16:06:30+00:00","versionOfRecord":{"articleIdentity":"rs-6149686","link":"https://doi.org/10.1186/s12904-025-01799-y","journal":{"identity":"bmc-palliative-care","isVorOnly":false,"title":"BMC Palliative Care"},"publishedOn":"2025-06-04 15:57:27","publishedOnDateReadable":"June 4th, 2025"},"versionCreatedAt":"2025-04-15 15:48:18","video":"","vorDoi":"10.1186/s12904-025-01799-y","vorDoiUrl":"https://doi.org/10.1186/s12904-025-01799-y","workflowStages":[]},"version":"v1","identity":"rs-6149686","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6149686","identity":"rs-6149686","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}