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Objective This study aims to determine the frequency of falls and their serious complications in palliative care units (PCUs), as well as explore the complex interplay between falls, independence and quality of dying.Design A prospective cohort study.Setting and participants The dying process of patients with advanced cancer in 23 PCUs in Japan.Outcome measures Palliative care specialist physicians recorded whether patients experienced falls, serious complications from falls, activities that led to falls, independence (workability in the last days and use of indwelling urinary catheter) and Good Death Scale as an indicator of quality of dying.Results Of the 1633 patients evaluated, 150 patients (9.2%; 95% CI 7.8% to 11%) experienced falls within 30 days prior to death. The patients who fell were mostly men, had Eastern Cooperative Oncology Group performance status 3 on admission, a longer estimated prognosis on admission and delirium during hospitalisation. Serious falls causing fractures or intracranial haemorrhages were rare in five patients (0.3%; 95% CI 0.038% to 0.57%). The most common reason for falls was the need to use the toilet (64.7%). The Good Death Scale and indwelling urinary catheter use were not significantly associated with falls (p=0.34; p=0.34).Conclusion Falls occur in approximately 10% of patients in PCUs, but serious complications are rare. The relationship between falls, independence and quality of dying is complex, that is, a fall may not be necessarily bad, if it is the result of respect for the patient’s independence. Healthcare providers need to consider fall prevention while supporting patients’ desire to move on their own to maintain independence.

Introduction Malignant wounds are lesions caused by metastasis from distant primary cancers or by direct invasion of the cutaneous structures of a primary cancer, and are most common in patients with breast or head and neck cancers. Malignant wounds not only cause physical symptoms, but also affect survival. Recognizing prognosis in terminal-stage cancer patients is necessary for both patients and health care providers. The prognostic impact of malignant wounds in patients with head and neck cancer has been poorly investigated. Methods This is a secondary analysis of the results of a prospective cohort study that investigated the dying process in patients with advanced cancer in 23 palliative care units in Japan. The primary outcome of this study was the prognostic impact of malignant wounds in patients with head and neck cancer. The difference in survival between patients with head and neck cancer who had malignant wounds and those who did not was compared using the log-rank test. Results Of 1896 patients admitted to palliative care units, 68 had head and neck cancer, and 29 of these had malignant wounds. Overall survival was significantly shorter in patients with malignant wounds than that in those without (median: 19.0 days vs 32.0 days, P = 0.046). Conclusion Patients with head and neck cancer who had malignant wounds had worse overall survival than those who did not.

Background: Most people in Japan wish to spend their final days at home, but the majority fail to do so; earlier studies indicated a more pronounced worsening of symptoms if treated at home. Objectives: This study compared the prevalence of symptom worsening and explored associated factors between patients with advanced cancer receiving palliative care in palliative care units (PCUs) and at home. Design: We conducted a secondary analysis of two multicenter, prospective cohort studies involving patients with advanced cancer receiving palliative care in PCUs or at home. Setting/Subjects: One study was conducted at 23 PCUs (January to December 2017) and the other on 45 palliative home care services (July to December 2017) in Japan. Measurements: Symptom changes were categorized as stable, improved, or worse. Results: Of the 2998 registered patients, 2877 were analyzed. Among them, 1890 patients received palliative care in PCUs, and 987 at home. Patients receiving palliative care at home were more likely to have worsening of pain (17.1% vs. 3.8%; p?0.001) and drowsiness (32.6% vs. 22.2%; p?

Objective: To develop the Japanese version of the Patient Satisfaction Questionnaire (PSQ-J) and examine its validity and reliability. Methods: A cross-sectional, web-based survey was conducted among cancer patients in Japan. The PSQ-J was developed following the forward-backward translation method, using a numerical rating scale. Data on patient characteristics and psychometric scales, like the PSQ-J, willingness to recommend an oncologist to others, trust in the healthcare system, uncertainty, and the Physician Compassion Questionnaire were collected. Validity was examined using exploratory and confirmatory factor analyses and by calculating the correlations between the total PSQ-J score and the criterion variables. Reliability was confirmed by Cronbach's alpha and test-retest score correlations at a two-week interval. Results: The first and second surveys were conducted on 309 and 107 patients, respectively. One-dimensionality and model fit were verified using factor analyses. The PSQ-J was significantly associated with other comparable scales. Cronbach's alpha was 0.962; the correlation between the PSQ-J test-retest scores was 0.835 (p

Abstract Background How clinicians treat patients with terminal dyspnea widely varies, which could hamper quality care. We visualized comprehensive pharmacological treatment delivered by palliative care physicians. Aim To examine adherence to a comprehensive pharmacological treatment algorithm for patients with terminal dyspnea, and to explore its outcomes during 48 h. Design A multicenter cohort study at five sites (February 2020 to June 2021). Setting/Participants We prospectively enrolled consecutive patients with advanced cancer, Eastern Cooperative Oncology Group performance status 3–4, and moderate/severe dyspnea. Participating palliative care physicians initiated algorithm‐based treatment. The primary outcome was the proportion of adherence to the treatment algorithm over 24 h (predefined goal, 70%). We evaluated the adherence, goal achievement, and dyspnea level with a numerical rating scale (NRS), as well as adverse events over 48 h. Results All 108 patients received algorithm‐based pharmacological treatment. Among 96 and 87 patients who were alive at 24 and 48 h, respectively, 96 (100%; 95% confidence interval [CI] = 96%–100%) and 82 (94%; 95%CI = 87%–98%) continued to receive the algorithm treatment, respectively, and 66 (69%; 95%CI = 59%–77%) and 64 (74%; 95%CI = 63%–82%) achieved the treatment goals, respectively. Using a complete case analysis with paired t‐tests, mean dyspnea NRS scores significantly reduced from 7.3 (standard error, 0.2) at the baseline to 4.9 (0.3) at 24 h (n = 72; p

Abstract Background Eating‐related distress (ERD) is one type of psychosocial distress among advanced cancer patients and family caregivers. Its alleviation is a key issue in palliative care; however, there is no validated tool for measuring ERD. Methods The purpose of this study was to validate tools for evaluating ERD among patients and family caregivers. The study consisted of a development and validation/retest phase. In the development phase, we made preliminary questionnaires for patients and family caregivers. After face validity and content validity, we performed an exploratory factor analysis and discussed the final adoption of items. In the validation/retest phase, we examined factor validity with an exploratory factor analysis. We calculated Pearson's correlation coefficients between the questionnaire for patients, the Functional Assessment of Anorexia/Cachexia Therapy Anorexia Cachexia Subscale (FAACT ACS) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire‐Cachexia 24 (EORTC QLQ‐CAX24) and Pearson's correlation coefficients between the questionnaire for family caregivers and the Caregiver Quality of Life Index‐Cancer (CQOLC) for concurrent validity. We calculated Cronbach's alpha coefficients (Cronbach's alpha) and intraclass correlation coefficients (ICCs) for internal consistency and test–retest reliability. We performed the Mann–Whitney U test between the questionnaires and cancer cachexia based on criteria from the international consensus for known‐group validity. Results In the development phase, 162 pairs of patients and family caregivers were asked to participate, and 144 patients and 106 family caregivers responded. In the validation/retest phase, 333 pairs of patients and family caregivers were asked to participate, and 234 patients and 152 family caregivers responded. Overall, 183 patients and 112 family caregivers did the retest. Seven conceptual groups were extracted for the ERD among patients and family caregivers, respectively. Patient factors 1–7 correlated with FAACT ACS (r = −0.63, −0.43, −0.55, −0.40, −0.38, −0.54, −0.38, respectively) and EORTC QLQ‐CAX24 (r = 0.58, 0.40, 0.60, 0.49, 0.38, 0.59, 0.42, respectively). Family factors 1–7 correlated with CQOLC (r = −0.34, −0.30, −0.37, −0.37, −0.46, −0.42, −0.40, respectively). The values of Cronbach's alpha and ICC of each factor and all factors of patients ranged from 0.84 to 0.96 and 0.67 to 0.83, respectively. Those of each factor and all factors of family caregivers ranged from 0.84 to 0.96 and 0.63 to 0.84, respectively. The cachexia group of patients had significantly higher scores than the non‐cachexia group for each factor and all factors. Conclusions Newly developed tools for measuring ERD experienced by advanced cancer patients and family caregivers have been validated.

Abstract Background Acute exacerbation (AE) is a major cause of death in patients with idiopathic pulmonary fibrosis (IPF). AE-IPF patients require optimal palliative care; however, the real-world clinical situations are poorly understood. We aimed to survey the palliative care received by AE-IPF patients, especially with respect to opioid use for dyspnea and the end-of-life discussions (EOLd). Methods Self-administered questionnaires were dispatched to 3423 of the certified pulmonary physicians in Japan. They were asked to report a care report form of one patient each with AE-IPF who died very recently about opioid use for dyspnea and EOLd. We further explored the factors associated with the early use of opioids for dyspnea. Results Among the 3423 physicians, 1226 (35.8%) returned the questionnaire with the report forms of 539 AE-IPF patients. Of 539 AE-IPF patients, 361 (67.0%) received opioids for dyspnea. Of the 361 patients, 72 (20.0%) received opioids during the initial treatment with an intention of recovery (early use), while 289 (80.0%) did when the recovery was deemed impossible. EOLd was held before the onset of AE in 124 patients (23.0%); however, the majority of patients had EOLd after the admission for AE-IPF. EOLd before the onset of AE was significantly associated with the early use of opioids. Conclusion In terminally ill AE-IPF patients, opioids are usually administered when the recovery is deemed impossible, and EOLd are rarely held before the onset of AE. Further studies are warranted on the efficacy of opioids for dyspnea and the appropriate timing of EOLd.

Background: The beliefs and perceptions of parenteral nutrition and hydration (PNH) by advanced cancer patients have not been elucidated. Objectives: To clarify their beliefs and perceptions and to explore the relationships between their beliefs and perceptions and cachexia stages. Design/setting/subjects: A questionnaire survey of advanced cancer patients receiving palliative care across Japan. Measurements: We asked patients to answer 15 items regarding their beliefs and perceptions of PNH. Frequencies were calculated for the patient characteristics and survey parameters. Comparisons were performed using the Mann?Whitney U test. We conducted a factor analysis and a multiple logistic regression analysis to identify the independent factors affecting cancer cachexia stages. Results: Among 495 patients, 378 responded. Due to missing data, 357 remained in the frequency distribution analysis, and 344 were classified into the noncachexia group (n?=?174) and cachexia group (n?=?170). Approximately 60% thought that PNH were beneficial. Approximately 70% considered PNH a standard medical practice. Approximately 70% did not feel that they received a sufficient explanation. There were no significant differences in any items between the two groups. We extracted four conceptual groups. The concept of ?Belief that PNH are harmful? was identified as an independent factor [odds ratio 2.57 (95% confidence intervals 1.10?6.01), p?=?0.030]. Conclusion: More than half of the patients thought that PNH were beneficial and standard medical practices with or without cancer cachexia. The negative perception of PNH decreased in patients with cancer cachexia.

Abstract Background The relationships between cachexia stages and the Functional Assessment of Anorexia/Cachexia Therapy Anorexia Cachexia Subscale (FAACT ACS) 12‐item, 5‐item anorexia symptoms, and 4‐item anorexia concerns have not been investigated in Asian patients with advanced cancer. Methods This is a multicentre questionnaire survey conducted in palliative and supportive care settings across Japan. Consecutive patients were enrolled. Patient characteristics and anthropometric measurements were obtained. Dietary intakes and nutrition impact symptoms were also assessed. Patients evaluated their quality of life (QOL) using FAACT ACS. Subjects were divided into two groups, that is, pre‐cachexia (non‐cachexia) and cachexia and refractory cachexia (cachexia), based on cancer cachexia criteria from the international consensus. Comparisons were performed using the Mann–Whitney U test or chi‐squared test. To evaluate the relationship between cachexia stages and FAACT ACS 12‐item, 5‐item anorexia symptoms, and 4‐item anorexia concerns, adjusted odd ratios (ORs) and 95% confidence intervals (CIs) were calculated in the logistic models. Results Among 495 patients, 378 (76.4%) responded. Due to missing data, 344 patients were classified into the non‐cachexia group (n = 174) and cachexia group (n = 170), and 318 remained in the analysis of FAACT ACS. The cachexia group had a more impaired performance status, a lower body mass index, and a higher frequency of weight loss in 1 month (P = 0.021,

Introduction Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers.Methods and analysis This study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist’s communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients’ distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention.Ethics and dissemination The study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings.Trial registration numbers UMIN000045305, NCT05045040.

Background: Palliative sedation is sometimes needed for refractory symptoms, and the Richmond Agitation?Sedation Scale (RASS) is one of the key measures. The primary aim of this study was to explore the association between RASS and degree of distress quantified by other measures: Item ?symptom control? of Support Team Assessment Schedule (STAS, item 2), Discomfort Scale for Dementia of Alzheimer Type (Discomfort Scale), and Noncommunicative Patient's Pain Assessment Instrument (NOPPAIN), as well as a communication capacity measured by the Communication Capacity Scale (CCS), item 4. Methods: This was a prospective observational study on terminally ill cancer patients with palliative sedation in a palliative care unit of a designated cancer hospital. Primarily responsible palliative care physicians rated RASS, Discomfort Scale, NOPPAIN, and CCS just before sedation and 1, 4, 24, and 48 hours after, and ward nurses rated STAS at the same time. Since the ward nurses evaluated STAS during palliative sedation, we regarded STAS as a standard of distress measure. Results: A total of 249 assessments were performed for 55 patients. RASS was moderately to highly associated with symptom intensity measured by STAS, discomfort measured by the Discomfort Scale, and pain measured by NOPPAIN (r?=?0.63 to 0.73). But communication capacity measured by CCS is not parallel with RASS and demonstrated a valley shape. In 82 assessments with an RASS score of ?1 to ?3, 11 patients (13%) had physical symptoms of STAS of 2 or more. Conclusions: RASS can roughly estimate physical distress in patients with palliative sedation, but a measure to more precisely quantify the symptom experience is needed.

Abstract Background The authors recently performed plastic surgeries for a small number of patients with hemophilia, HIV infection, and morphologic evidence of lipodystrophy. Because the pathophysiological mechanism of HIV-associated lipodystrophy remains to be elucidated, we analyzed subcutaneous adipose tissues from the patients. Methods All six patients had previously been treated with older nucleoside analogue reverse-transcriptase inhibitors (NRTIs; stavudine, didanosine or zidovudine). Abdominal and inguinal subcutaneous fat samples were obtained from the HIV+ patients with hemophilia and HIV− healthy volunteers (n = 6 per group), and analyzed via DNA microarray, real-time PCR, flow cytometry and immunohistochemistry. Results The time from initial NRTI treatment to collecting samples were 21.7 years in average. Cytometric analysis revealed infiltration of inflammatory M1 macrophages into HIV-infected adipose tissue and depletion of adipose-derived stem cells, possibly due to exhaustion following sustained adipocyte death. Genetic analysis revealed that adipose tissue from HIV+ group had increased immune activation, mitochondrial toxicity, chronic inflammation, progressive fibrosis and adipocyte dysfunction (e.g. insulin resistance, inhibited adipocyte differentiation and accelerated apoptosis). Of note, both triglyceride synthesis and lipolysis were inhibited in adipose tissue from patients with HIV. Conclusions Our findings provide important insights into the pathogenesis of HIV-associated lipodystrophy, suggesting that fat redistribution may critically depend on adipocytes’ sensitivity to drug-induced mitochondrial toxicity, which may lead either to atrophy or metabolic complications.

Context: Continuous deep sedation (CDS) is regarded as a far-reaching form of sedative use for symptom control, but there are no established uniform definitions. Objectives: To propose types of sedative use related to CDS using treatment protocols with three parameters: documented treatment goals, rapidity of dose titration, and planned duration of treatment. Methods: Opinion article. Results: We propose four types of sedative use potentially related to CDS: (1) proportional sedation (treatment goal is symptom relief with regular monitoring to maximize patient communication, not a decrease in consciousness; with gradual use of sedatives; there is a chance to cease sedatives), (2) rapid proportional sedation (treatment goal is symptom relief with a rapid loading phase, followed by regular monitoring to maximize patient communication; there is a chance to cease sedatives), (3) deep sedation with a chance of cessation (deep sedation intended initially, followed by regular assessments of appropriateness of treatment goal; there is a chance to cease sedatives), and (4) continuous deep sedation until death (deep sedation indicated from initiation and maintained until death). Conclusion: This article proposes an idea that the use of treatment protocols that visualize treatment goals, rapidity of dose titration, and planned duration of treatment may help understand the existing variations in sedative use over the world. The use of treatment protocols in the same way when defining a medical treatment in other specialty fields might clear up the current confusion about the use of sedatives.

Summary: Background: The benefits of artificial nutrition and hydration in patients with head and neck cancer and esophageal cancer in the late stage remain unknown. We performed a secondary analysis of a cohort study to investigate the effects of enteral tube feeding (ETF) and parenteral nutrition and hydration (PNH) on survival in this population. Methods: Patients with head and neck cancer and esophageal cancer admitted to palliative care units were included. Information on primary nutritional administration routes during the first week of admission and data on the averaged calorie sufficiency rate/total calorie intake, e.g., 75%≤/750 kcal/day≤ and

Abstract Human adipose tissue is a rich source of adipose-derived stem cells (ASCs) and vascular endothelial progenitor cells (EPCs). However, no standardized method has been established for the isolation and purification of adipose-derived EPCs (AEPCs). The aim of this study was to establish a method for the isolation and purification of AEPCs. The stromal vascular fraction (SVF) was extracted from human lipoaspirates, and the CD45−CD31+ fraction of the SVF was collected by magnetic-activated cell sorting (MACS). The CD45−CD31+ fraction was cultured for 4.5 days, followed by a second MACS separation to collect the CD31+ fraction. Purified AEPCs were expanded without being overwhelmed by proliferating ASCs, indicating that a high level (> 95%) of AEPC purification is a key factor for their successful isolation and expansion. AEPCs exhibited typical endothelial markers, including CD31, von Willebrand factor, and the isolectin-B4 binding capacity. AEPCs formed colonies, comparable to cultured human umbilical vein endothelial cells (HUVECs). Both AEPCs and HUVECs formed capillary-like networks in the tube formation assay, with no significant difference in network lengths. We are the first to establish a purification and expansion method to isolate these cells. Because adipose tissue is a clinically accessible and abundant tissue, AEPCs may have potential advantages as a therapeutic tool for regenerative medicine.

Abstract Background The appropriate delivery of death pronouncements potentially affects bereaved families’ wellbeing positively. Although younger physicians need to learn the competencies and entrustable professional activities (EPAs) to conduct death pronouncement independently, both of which have not been clarified. Therefore, this study aimed to develop a list of competencies and EPAs necessary for death pronouncement practice, which resident physicians need to acquire by the end of their residency training (postgraduate year 2). Methods An anonymous modified Delphi study was conducted with a panel of 31 experts. The experts were invited online from general wards in hospitals with resident physicians across Japan to participate in the study using the purposive and snowball sampling method. A non-anonymous web conference was held with three additional external evaluators to finalize the item list. The consensus criterion was defined as a mean response of at least 4 points on a 5-point Likert scale for each competency and EPA item and a rating of 4 or 5 points by at least 80% of the participants. Results Consensus was achieved, with consistently high levels of agreement across panel members, on 11 competencies and 9 EPA items. Additionally, a correspondence matrix table between competencies and EPAs was developed. Conclusions This study clarified the standardized educational outcomes as competencies in death pronouncement practice and the unit of professional practice of physicians who can perform this independently (EPAs), serving as a blueprint to aid the development of an educational model and evaluation method for clinical educational institutions and developers of medical school curriculums.

ObjectivesOne primary concern about receiving care at home is that survival might be shortened because the quality and quantity of treatment provided at home will be inferior to that given in the hospital. Although our previous study demonstrated a longer survival of those with home-based palliative care (PC), it lacked adjustment for some potential confounders including symptoms and treatments during the stay. We aimed to compare the survival times among advanced cancer patients receiving home-based and hospital-based PC with adjusting for symptoms and treatments.MethodWe compared survival time of participants who enrolled two multicenter, prospective cohort studies of advanced cancer patients at 45-home-based PC services between July 2017 and December 2017, and at 23-hospital-based PC services between January 2017 and December 2017. We analyzed with stratification by the estimated survival of Days, Weeks, and Months, which were defined by modified Prognosis in Palliative care Study predictor models-A. We conducted a Cox regression analysis with adjusting for potential confounders including symptoms and treatments during the stay.ResultsA total of 2,998 patients were enrolled in both studies and 2,878 patients were analyzed; 988 patients receiving home-based PC and 1,890 receiving hospital-based PC. The survival time of patients receiving home-based PC was significantly longer than that of patients receiving hospital-based PC for the Days Prognosis (estimated median survival time: 10 days [95% CI 8.1-11.8] vs. 9 days [95% CI 8.3-10.4], p = 0.157), the Weeks prognosis (32 days [95% CI 28.9-35.4] vs. 22 days [95% CI 20.3-22.9], p < 0.001), and the Months Prognosis, (65 days [95% CI 58.2-73.2] vs. 32 days [95% CI 28.9-35.4], p < 0.001).ConclusionIn this cohort of advanced cancer patients with a Weeks or Months prognosis, those receiving home-based PC survived longer than those receiving hospital-based PC after adjusting for symptoms and treatments.

Summary: Background & Aims: The prevalence of artificially administered nutrition and hydration (AANH) in different age groups among patients with advanced cancer remains unknown. The present study investigated the current utilization of AANH according to age groups in palliative care units. Methods: This was a secondary analysis of a prospective cohort study. We obtained information on primary nutritional administration routes during the first week of admission and data on the averaged calorie sufficiency rate or total calorie intake on the 7th day of admission. Patients were divided into five age groups (18–39, 40–59, 60–74, 75–89, and 90- years). Among patients receiving AANH, the proportions of higher-calorie AANH were compared between the five age groups. Results: A total of 1453 patients were included. The proportion of patients categorized as receiving nutrition and hydration via the parenteral route was the highest in the 18–39 and 40–59 groups (52.4 and 41.1%, respectively). Among patients receiving AANH (n = 534), the proportions of patients categorized into the

Abstract Background Accurately predicting impending death is essential for clinicians to clarify goals of care. We aimed to develop diagnostic models to predict death ≤3 days in cancer patients. Methods In this multicenter cohort study, we consecutively enrolled advanced cancer patients admitted to 23 inpatient hospices in 2017. Fifteen clinical signs related to impending death were documented daily from the day when the Palliative Performance Scale (PPS) declined to ≤20–14 days later. We conducted recursive partitioning analysis using the entire data set and performed cross‐validation to develop the model (prediction of 3‐day impending death‐decision tree [P3did‐DT]). Then, we summed the number of systems (nervous/cardiovascular/respiratory/musculoskeletal), where any sign was present to underpin P3did score (range = 0–4). Results Data following PPS ≤20 were obtained from 1396 of 1896 inpatients (74%). The mean age was 73 ± 12 years, and 399 (29%) had gastrointestinal tract cancer. The P3did‐DT was based on three variables and had four terminal leaves: urine output (u/o) ≤200 ml/day and decreased response to verbal stimuli, u/o ≤200 ml/day and no decreased response to verbal stimuli, u/o >200 ml/day and Richmond Agitation‐Sedation Scale (RASS) ≤−2, and u/o >200 ml/day and RASS ≥−1. The 3‐day mortality rates were 80.3%, 53.3%, 39.9%, and 20.6%, respectively (accuracy = 68.3%). In addition, 79.6%, 62.9%, 47.2%, 32.8%, and 17.4% of patients with P3did scores of 4, 3, 2, 1, and 0, respectively, died ≤3 days. Conclusion We successfully developed diagnostic models for death ≤3 days. These may further help clinicians predict impending death and help patients/families prepare for their final days.

Abstract Purpose A sudden unexpected death has significant negative impacts on patients, family caregivers, and medical staff in hospice/palliative care. This study aimed to clarify the incidence and associated factors of sudden unexpected death according to four definitions in advanced cancer patients. Methods We performed a prospective cohort study in 23 inpatient hospices/palliative care units in Japan. Advanced cancer patients aged ≥18 years who were admitted to inpatient hospices/palliative care units were included. The incidence and associated factors of sudden unexpected death were evaluated in all enrolled patients according to four definitions: (a) rapid decline death, defined as a sudden death preceded by functional decline over 1–2 days; (b) surprise death, defined if the primary responsible palliative care physician answered “yes” to the question, “Were you surprised by the timing of the death?”; (c) unexpected death, defined as a death that occurred earlier than the physicians had anticipated; and (d) performance status (PS)‐defined sudden death, defined as a death that occurred within 1 week of functional status assessment with an Australia‐modified Karnofsky PS ≥50. Results Among 1896 patients, the incidence of rapid decline death was the highest (30‐day cumulative incidence: 16.8%, 95% CI: 14.8–19.0%), followed by surprise death (9.6%, 8.1–11.4%), unexpected death (9.0%, 7.5–10.8%), and PS‐defined sudden death (6.4%, 5.2–8.0%). Male sex, liver metastasis, dyspnea, malignant skin lesion, and fluid retention were significantly associated with the occurrence of sudden unexpected death. Conclusion Sudden unexpected death is not uncommon even in inpatient hospices/palliative care units, with range of 6.4–16.8% according to the different definitions.

Background: Although many Japanese patients wish to take a bath in their last days, the safety of bathing for patients with a prognosis of a few days is not known. Objective: To examine whether taking a bath affects the survival of advanced cancer patients with prognoses of a few days. Design: A single-center prospective cohort study. Setting/Subject: Advanced cancer patients in their last days of life in a palliative care unit of a Japanese hospital. We compared patients who took baths with those who did not. The primary endpoint was 24-hour survival rate. Result: Among 110 patients eligible for this prospective study, 89 (72%) met the inclusion criteria. Forty-eight patients (43%, 223 person-days) were eligible for analysis. A total of 28 patient-days were classified into the bathing group, and 192 patient-days were classified into the nonbathing group. After propensity score matching, the 24-hour death rate was 10.7% in the bathing group and 8.0% in the nonbathing group, respectively (mean difference 2.8% with 95% confidence interval of ?11.2% to 16.8%, p?=?0.65). Conclusion: Taking a bath does not appear to bear a significant association with shortening of life among advanced cancer patients in their last days of life.

Abstract Background Hyperactive delirium is known to increase family distress and the burden on health care providers. We compared the prevalence and associated factors of agitated delirium in advanced cancer patients between inpatient palliative care and palliative home care on admission and at 3 days before death. Methods This was a post hoc exploratory analysis of two multicenter, prospective cohort studies of advanced cancer patients, which were performed at 23 palliative care units (PCUs) between Jan and Dec 2017, and on 45 palliative home care services between July and Dec 2017. Results In total, 2998 patients were enrolled and 2829 were analyzed in this study: 1883 patients in PCUs and 947 patients in palliative home care. The prevalence of agitated delirium between PCUs and palliative home care was 5.2% (95% CI: 4.2% ‐ 6.3%) vs. 1.4% (0.7% ‐ 2.3%) on admission (p

Abstract Background The study aimed to clarify the efficacy of the “3‐Day Surprise Question (3DSQ)” in predicting the prognosis for advanced cancer patients with impending death. Patients and Methods This study was a part of multicenter prospective observational study which investigated the dying process in advanced cancer patients in Japan. For patients with a Palliative Performance Scale ≤20, the 3DSQ “Would I be surprised if this patient died in the next 3 days?” was answered by their physicians. In addition to the sensitivity and specificity of the 3DSQ, the characteristics of patients who survived longer than expected were examined via multivariate analysis. Results Among the 1896 patients enrolled, 1411 were evaluated. Among 1179 (83.6%) patients who were classified into the “Not surprised” group, 636 patients died within 3 days. Among 232 (16.4%) patients of “Yes surprised” group, 194 patients lived longer than 3 days. The sensitivity, specificity, positive predictive value, and negative predictive value of the 3DSQ were 94.3% (95% confidence interval [CI]: 92.7% to 95.8%), 26.3% (95% CI: 24.8% to 27.6%), 53.9% (95% CI: 53.0% to 54.7%), and 83.6% (95% CI: 78.7% to 87.7%), respectively. Multivariate analysis showed palpable radial artery, absent respiration with mandibular movement, SpO2 ≥ 90%, opioid administration, and no continuous deep sedation as characteristics of patients who lived longer than expected. Conclusions The 3‐Day Surprise Question can be a useful screening tool to identify advanced cancer patients with impending death.

Although Delphi studies in Western countries have provided a consensus for practices pertaining to advance care planning (ACP), their findings may not be applicable to Asian countries with distinct, family-oriented cultures. This systematic review aimed to synthesize the definitions of and evidence for ACP and analyze recommended practices in Japan. We conducted a systematic review using narrative synthesis in December 2018. Key words were searched from Ichushi-Web by NPO Japan Medical Abstracts Society, Citation Information by the National Institute of Informatics, and Japanese Institutional Repositories Online databases. In addition, in August 2019, we conducted hand searching using Google Scholar and Google. We included original Japanese articles that addressed factors regarding ACP (e.g. definitions, elements, roles and tasks, and timing of ACP). Data were synthesized using thematic analysis. The study protocol was registered prospectively (PROSPERO: CRD42020152391). Of the 3512 studies screened, 27 were included: 22 quantitative and 5 qualitative. Five-position statements/guidelines were added by hand searching. Definitions and several distinct practice patterns of ACP and the importance of families' roles were identified. Unique recommendations addressed the importance of properly eliciting patients' preferences that are the best for both patients and families, engaging the public to raise awareness of ACP, and developing policies and guidelines for ACP. We identified the definition of and unique recommendations for ACP based on Japanese cultural values and norms. Further research is needed to evaluate the recommendations provided in this systematic review.

Abstract Background The use of home health care (HHC) is increasing worldwide. This may have an impact not only on patients and their caregivers’ health but on care resource utilization and costs. We lack information on the impact of HHC on the broader dimensions of health status and care resource utilization. More understanding of the longitudinal HHC impact on HHC patients and caregivers is also needed. Moreover, we know little about the synergy between HHC and social care. Therefore, the present study aims to observe longitudinal changes in health, care resource utilization and costs and caregiving burden among HHC recipients and their caregivers in Taiwan. Methods A prospective cohort study “Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care (HOLISTIC)” will be conducted and 600 eligible patient-caregiver dyads will be recruited and followed with comprehensive quantitative assessments during six home investigations over two years. The measurements include physical function, psychological health, cognitive function, wellbeing, shared decision making and advance care planning, palliative care and quality of dying, caregiving burden, continuity and coordination of care, care resource utilization, and costs. Discussion The HOLISTIC study offers the opportunity to comprehensively understand longitudinal changes in health conditions, care resource utilization and costs and caregiving burden among HHC patients and caregivers. It will provide new insights for clinical practitioners and policymakers. Trial registration ClinicalTrials.gov Identifier is NCT04250103 which has been registered on 31st January 2020.

Background: Dyspnea is a common and distressing symptom in patients with advanced cancer. Opioids, benzodiazepines, and corticosteroids are commonly prescribed pharmacological treatments for cancer dyspnea. Objective: The objective of this survey was to investigate physician-perceived predictive factors for the effectiveness of opioids, benzodiazepines, and corticosteroids in treating cancer dyspnea. Design: This study involves a nationwide survey using self-report questionnaires. Setting/Subjects: Random sampling selected 268 Japanese certified palliative care physicians in Japan. Measurements: We inquired about the 12 physician-perceived predictive factors for the effectiveness of drugs (opioids, benzodiazepines, and corticosteroids) in treating cancer dyspnea. Results: The frequently selected physician-perceived predictive factors for the effectiveness of opioids were tachypnea, respiratory effort, opioid naive, Eastern Cooperative Oncology Group Performance Status 0?2, multiple lung tumors, dry cough, pleural effusion, and pleural lesion. Benzodiazepines were predicted to be effective against dyspnea in patients with depression and severe anxiety. Meanwhile, corticosteroids were predicted to be effective against dyspnea in patients with lymphangitis carcinomatosa, superior vena cava syndrome, major airway obstruction, and audible wheezing. Japanese palliative care physicians anticipate that different drug classes will be effective for treating dyspnea in patients with specific factors. Conclusions: Japanese palliative care physicians expect that different drugs will be effective for dyspnea in patients with specific predictive factors. Future prospective studies are required to assess the effectiveness of each drug class against specific dyspnea.

Background: Toward the individualized care of terminally ill patients with dyspnea (?terminal dyspnea?), it is essential to identify individualized goals of care (GOC) to achieve an acceptable balance between dyspnea intensity and communication capacity. Objective: To explore preferences for individualized GOC for terminal dyspnea, and factors associated with the preferences. Design: A nationwide cross-sectional survey. Setting/Subjects: In total, 1055 bereaved families of cancer patients admitted to 167 inpatient hospices in Japan. Measurements: Preferences for individualized GOC for terminal dyspnea to achieve an acceptable balance between dyspnea intensity and communication capacity, should individuals experience continuous moderate or severe/overwhelming dyspnea despite optimal palliative care, and perceptions about a good death. Results: Among 548 participants (response rate?=?52%), we analyzed responses of 477 families whose loved one suffered dyspnea in the last week of life. In total, 167 (45%; 95% confidence interval [CI]?=?40%?50%) and 272 (80%; 95% CI?=?75%?84%) participants would prioritize dyspnea relief over communication capacity, should they continuously suffer moderate or severe/overwhelming dyspnea, respectively. In multivariate analyses, the determinants of the prioritization of dyspnea relief were perceiving physical comfort as important for a good death (odds ratio [OR]?=?1.389; 95% CI?=?1.062?1.818; p?=?0.017) in moderate dyspnea, and perceiving physical comfort (OR?=?2.505; 95% CI?=?1.718?3.651; p?0.001) and not perceiving mental awareness (OR?=?0.695; 95% CI?=?0.529?0.913; p?=?0.009) as important in severe/overwhelming dyspnea. Conclusions: Preferences for individualized GOC for terminal dyspnea can vary among individuals and with different symptom intensity, and may be influenced by perceptions about a good death. Outcome measurements incorporating an acceptable balance between dyspnea intensity and communication capacity should be developed.

Background: Limited information is available on the relationship between C-reactive protein (CRP) levels and pain in advanced cancer. Objectives: To investigate the relationship between serum levels of CRP and subtypes of pain. Design: A secondary cross-sectional analysis of a prospective cohort study. Setting/Subjects: Patients with advanced cancer admitted to 23 palliative care units in Japan. Measurements: Patients rated the severity of pain on the numerical rating scale (NRS) and physicians evaluated pain on the integrated palliative care outcome scale (IPOS). Physicians assessed neuropathic pain and breakthrough pain based on their presence or absence. Patients were divided into four groups according to CRP levels. Comparisons were performed using the Kruskal?Wallis test or chi-squared test. To evaluate the relationship between CRP and subtypes of pain, adjusted odds ratios (ORs) and 95% confidence intervals (CIs) in logistic models were calculated. Results: We divided 1513 patients into four groups: low CRP (n?=?234), moderate CRP (n?=?513), high CRP (n?=?352), and very high CRP (n?=?414). Spearman's correlation coefficient between CRP and pain NRS and that between CRP and pain IPOS were 0.15 (p?0.001) and 0.16 (p?

Introduction It has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysis A total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and dissemination This study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration number UMIN000025491.

Replantation of an amputated lip using microvascular anastomosis is the best option for restoration of the defect. However, the amputated region often lacks veins with appropriate diameters for microvascular anastomoses and typically necessitates both postoperative exsanguination using medicinal leeches and a blood transfusion. We present a case of the successful replantation of an avulsed lip in which postoperative congestion was evaluated objectively by measuring blood glucose levels in the replanted region. The patient presented to our hospital with an upper lip avulsion that was caused by a dog bite. The lip was replanted by the microvascular anastomoses of one artery and two veins using interposed vein grafts. The replanted lip showed signs of congestion on postoperative day one; exsanguination using medicinal leeches was attempted, while blood glucose levels were measured every three hours. Critical congestion, which did not occur in this patient, was defined as a blood glucose level lower than 40 mg/dL. Lip replantation was successful without any complications in this patient.

Therapeutic effects of adult stem-cell transplantations are limited by poor cell-retention in target organs, and a reduced potential for optimal cell differentiation compared to embryonic stem cells. However, contemporary studies have indicated heterogeneity within adult stem-cell pools, and a novel culturing technique may address these limitations by selecting those for cell proliferation which are highly functional. Here, we report the preservation of stemness in human adipose-derived stem cells (hASCs) by using microgravity conditions combined with microspheres in a stirred suspension. The cells were bound to microspheres (100−300 μm) and cultured using a wave-stirring shaker. One-week cultures using polystyrene and collagen microspheres increased the proportions of SSEA-3(+) hASCs 4.4- and 4.3-fold (2.7- and 2.9-fold increases in their numbers), respectively, compared to normal culture conditions. These cultured hASCs expressed higher levels of pluripotent markers (OCT4, SOX2, NANOG, MYC, and KLF), and had improved abilities for proliferation, colony formation, network formation, and multiple-mesenchymal differentiation. We believe that this novel culturing method may further enhance regenerative therapies using hASCs.

Filler injection demand is increasing worldwide, but no ideal filler with safety and longevity currently exists. Sodium alginate (SA) is the sodium salt of alginic acid, which is a polymeric polysaccharide obtained by linear polymerization of two types of uronic acid, d-mannuronic acid (M) and l-guluronic acid (G). This study aimed to evaluate the therapeutic value of SA. Nine SA types with different M/G ratios and viscosities were tested and compared with a commercially available sodium hyaluronate (SH) filler. Three injection modes (onto the periosteum, intradermally, or subcutaneously) were used in six rats for each substance, and the animals were sacrificed at 4 or 24 weeks. Changes in the diameter and volume were measured macroscopically and by computed tomography, and histopathological evaluations were performed. SA with a low M/G ratio generally maintained skin uplift. The bulge gradually decreased over time but slightly increased at 4 weeks in some samples. No capsule formation was observed around SA. However, granulomatous reactions, including macrophage recruitment, were observed 4 weeks after SA implantation, although fewer macrophages and granulomatous reactions were observed at 24 weeks. The long-term volumizing effects and degree of granulomatous reactions differed depending on the M/G ratio and viscosity. By contrast, SH showed capsule formation but with minimal granulomatous reactions. The beneficial and adverse effects of SA as a filler differed according to the viscosity or M/G ratio, suggesting a better long-term volumizing effect than SH with relatively low immunogenicity

Summary:. Tumoral calcinosis is a rare condition in which a calcified mass grows around a large joint, and can occur in patients undergoing renal dialysis. Here, we report the case of a 64-year-old man with a long history of dialysis who presented with a giant, painless mass in his right shoulder joint. A near-complete surgical resection is performed without muscle function loss and with no sign of recurrence after 1 year.

Background:. Multidirectional cranial distraction osteogenesis (MCDO) is a procedure of ours developed earlier for treating craniosynostosis. However, the numerous bone flaps led to prolonged operative time and occasional bone detachment from dura. We have since simplified the osteotomy design. In treating sagittal synostosis, required bone flaps have been reduced to 11 (from ~20). Methods:. In a 2-year period (2014–2015), 5 boys with sagittal synostosis underwent MCDO using our simplified and fixed-form osteotomy. Mean age at surgery was 9.4 months (range, 8–11 months). Pre- and postoperative cranial morphology was assessed by cephalic index and by mid-sagittal vector analysis. Results:. Improved cranial shape was confirmed by 3-dimensional CT scans and by mid-sagittal vector index. Mean preoperative cephalic index (68.7) progressively increased to means of 78.5 immediately after distraction device removal, 75.2 at postoperative month 6, and 75.1 at 1 year postoperatively. There were no major complications, although transient cerebrospinal fluid leakage and loosening of anchor pins occurred in 1 patient. Conclusions:. Simplified MCDO has a number of advantages over conventional distraction procedures such as discretionary reshaping/expansion of cranium and predictable osteogenesis and is a valid treatment option for patients with sagittal synostosis.