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Pharmacists’ roles in cachexia care are unclear. This study aimed to clarify the knowledge and practice of cachexia care and identify factors related to the practice of cachexia care among pharmacists. Information on the knowledge and practice of cachexia care was obtained. Components of practicing multimodal care were evaluated. Participants were categorized into two groups according to practicing multimodal care levels. Comparisons were made between the groups, and multiple regression analysis was employed. Of the 451 pharmacists, 243 responded. They were categorized into the Practicing group (n = 119) and Not practicing group (n = 124). Significant differences were observed for the number of advanced cancer patients/month, frequency of caring for them, and involvement in training programs on cachexia. The Practicing group had significantly better knowledge about cachexia. The Practicing group used guidelines, items, and symptoms more frequently to detect cachexia. The Practicing group tended to detect cachexia and initiate interventions in earlier phases and in patients with a better status. Multivariate logistic regression analysis showed that the most significant factor was the regular provision of care (odds ratio, 2.07; 95% confidence interval, 1.10–3.92). The regular provision of care was associated with the practice of multimodal care.

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: Death pronouncement is an important moment that can impact a family's bereavement process; however, necessary improvements in physicians' behavior during death pronouncement remain unclear. Objectives: To explore whether the lack of certain behaviors by the physician was associated with a perceived need for improving death pronouncement for advanced cancer patients in palliative care units (PCUs). Methods: This study was a secondary analysis of a nationwide multicenter questionnaire survey conducted in 2018 that targeted bereaved family members of cancer patients who died in PCUs. We performed univariate analysis to investigate the need to improve behavior toward death pronouncement. We performed bivariate analysis to investigate the relationship among the need for improvement in behavior toward death pronouncement, physician attribution (primary responsible physician, a member of the same team, and another physician), and nine specific behaviors. Results: Four hundred twenty-two questionnaires (64.2%) were returned. We analyzed 356 responses and found that 32.5% perceived the need to improve death pronouncement. Lack of certain behaviors at death pronouncement, especially not explicitly explaining the cause of death to family members (odds ratio: 11.89, p?0.001), were positively associated with the need for improvement. There were significant differences among the types of physician attribution regarding the need for improvement (primary responsible physician vs. a member of the same team vs. another physician [15.1% vs. 42.6% vs. 45.7%, p?

Abstract Background Staying at home during the dying process is important for many patients; and palliative care units (PCUs) can help facilitate home death. This study compared patient survival between those who were discharged to home from a palliative care unit and those who were not, and aimed to identify the factors associated with home death after the discharge. Methods This retrospective cohort study used a database of patients admitted to a palliative care unit at Kouseiren Takaoka Hospital in Japan. All consecutive patients admitted to the hospital’s PCU between October 2016 and March 2020 were enrolled. Patient survival and factors potentially associated with survival and place of death were obtained. A total of 443 patients with cancer were analyzed, and 167 patients were discharged to home and 276 were not. Results Propensity score matching analyses revealed that median survival time was significantly longer in patients who were discharged to home than those who were not (57 vs. 27 days, P

Background: Physicians' attitudes can be critical in quality end-of-life care. However, the determinants of the attitudes and whether the attitudes can be modified remain unclear. Objectives: To investigate factors correlated with physicians' positive attitudes toward end-of-life care and whether these attitudes are modifiable through acquired factors (e.g., education or mentorship). Design: A nationwide survey was conducted in 300 institutions and selected randomly from 1037 clinical training hospitals in Japan. Participants: From each selected institution, two resident physicians of postgraduate year (PGY) 1 or 2 and two clinical fellows from PGY 3?5 were requested to answer the survey. Measurements: The primary outcome was the Frommelt Attitudes Toward the Care of the Dying (FATCOD) scale score. Factors (e.g., the respondents' age, sex, number of years of clinical experience, training environment, religion, and beliefs around death) were examined for correlation with FATCOD score. Results: In all, 198 physicians and 134 clinical fellows responded to the survey (response rate: 33.0% and 22.3%, respectively). Factors with the strongest correlation with FATCOD scores were mostly unmodifiable factors (e.g., being female and one's beliefs around death). Modifiable factors were also identified?number of patient deaths experienced, level of interest in palliative care, availability of support from senior mentors, and frequency of consultation with nonphysician medical staff. Conclusion: Physicians' attitudes toward end-of-life care correlate more strongly with nonmodifiable factors, but attitudes can be meaningfully improved via mentoring by senior physicians. Future studies are warranted to determine the effective interventions to foster positive attitudes among physicians involved in end-of-life care.

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.

Background: Holistic multimodal interventions have not been established for cancer cachexia. The beliefs and perceptions of health care professionals (HCPs) based on their experiences influence the interventions. Objectives: HCPs' knowledge, perceptions, and practices in cancer cachexia management were evaluated. Design/Setting/Subjects/Measurements: A nationwide questionnaire survey was conducted that focused on the perspectives of HCPs on interventions in 451 designated cancer hospitals across Japan. Descriptive statistics were applied. Results: Among 2255 participants, 1320 responded (58.5%), and 1188 in 258 institutes were included in the analysis. The current international definition of cancer cachexia is not commonly known and recent clinical practice guidelines have not been widely adopted. More than 50% of participants considered ?5% weight loss in six months and ECOG PS (Eastern Cooperative Oncology Group Performance Status) 2?4 to be cancer cachexia, whereas 50% answered that there was no relationship between life expectancy and cancer cachexia. Participants tended to consider it important to initiate nutritional and exercise interventions before cancer cachexia becomes apparent. The majority of participants recognized the importance of holistic multimodal interventions, particularly for the management of physical and psychological symptoms; however, only 20% reported that they educated patients and families. Furthermore, 33% of participants considered themselves to have provided patients and families with sufficient nutritional and exercise interventions and evidence-based information. Conclusion: The results reveal that HCPs are not regularly providing education and emotional support to patients and families suffering from cancer cachexia. The results also show the need for education for HCPs to enhance implementation of holistic multimodal interventions for cancer cachexia.

Background: Junior physicians' perceived difficulty in end-of-life care of patients with cancer has not been structurally investigated; therefore, current challenges and solutions in this area remain unknown. Objectives: To identify some difficulties junior physicians face in delivering end-of-life care for patients with cancer and to clarify the support required to reduce these difficulties. Design: A nationwide survey was conducted in over 300 institutions selected randomly from 1037 clinical training hospitals in Japan. Participants: From each of these institutions, two resident physicians of postgraduate year (PGY) 1 or 2, two clinical fellows of PGY 3?5, and an attending physician were requested to respond to the survey. Measurements: The survey investigated issues regarding end-of-life care using the palliative care difficulties scale with two additional domains (?discussion about end-of-life care? and ?death pronouncement?). Items related to potential solutions for alleviating the difficulties as well were investigated. Results: A total of 198 resident physicians, 134 clinical fellows, and 96 attending physicians responded to the survey (response rate: 33.0%, 22.3%, and 32.0%). The results revealed that junior physicians face difficulties within specific domains of end-of-life care. The most challenging domain comprised communication and end-of-life discussion with patients and family members, symptom alleviation, and death pronouncement. The most favored supportive measure for alleviating these difficulties was mentorship, rather than educational opportunities or resources regarding end-of-life care. Conclusion: The findings of this study reveal the need for further effort to enrich the mentorship and support systems for junior physicians delivering end-of-life care.

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.

Abstract Background Cancer pain may be refractory to standard pharmacological treatment. Interventional procedures are important for quality of analgesia. The aim of the present study was to clarify the availability of four interventional procedures (celiac plexus neurolysis/splanchnic nerve neurolysis, phenol saddle block, epidural analgesia, and intrathecal analgesia), the number of procedures performed by specialists, and their associated factors. In addition, we aimed to establish how familiar home hospice physicians and oncologists are with the different interventional procedures available to manage cancer pain. Methods A cross-sectional survey using a self-administered questionnaire was conducted. Subjects were certified pain specialists, interventional radiologists, home hospice physicians, and clinical oncologists. Results The numbers of valid responses/mails were 545/1,112 for pain specialists, 554/1,087 for interventional radiology specialists, 144/308 for home hospice physicians, and 412/800 for oncologists. Among pain specialists, depending on intervention, 40.9-75.2% indicated that they perform each procedure by themselves, and 47.5-79.8% had not performed any of the procedures in the past 3 years. Pain specialists had performed the four procedures 4,591 times in the past 3 years. Among interventional radiology specialists, 18.1% indicated that they conduct celiac plexus neurolysis/splanchnic nerve neurolysis by themselves. Interventional radiology specialists had performed celiac plexus neurolysis/splanchnic nerve neurolysis 202 times in the past 3 years. Multivariate analysis revealed that the number of patients seen for cancer pain and the perceived difficulty in gaining experience correlated with the implementation of procedures among pain specialists. Among home hospice physicians and oncologists, depending on intervention, 3.5-27.1% responded that they were unfamiliar with each procedure. Conclusions Although pain specialists responded that the implementation of each intervention was possible, the actual number of the interventions used was limited. As interventional procedures are well known, it is important to take measures to ensure that pain specialists and interventional radiology physicians are sufficiently utilized to manage refractory cancer pain.

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,

Background: Bathing in a tub is integral to Japanese culture. It improves palliative care patients' symptoms and may improve quality of life. Objectives: This study aimed to determine the prevalence and impressions of bathing for terminally ill cancer patients and its relations to the evaluations of perceived end-of-life care and achievement of a good death. Design: This was a cross-sectional, anonymous, self-report questionnaire survey. Setting/Subjects: The questionnaire for this study was sent to bereaved family members who had lost loved ones in 14 general hospitals and 187 palliative care wards in Japan. Measurements: The bereaved family members of the patients who had actually bathed were asked about their impression of bathing. The short version of the Good Death Inventory (GDI) and the Care Evaluation Scale were used to evaluate ?achievement of a good death.? In total, 1819 surveys were sent between July and September 2018 to bereaved family members of patients who had died between February 2014 and January 2018 in 14 general hospitals and 187 palliative care wards in Japan. Overall 885 questionnaires (valid response rate 48%) returned by bereaved family members were analyzed. Results: Overall, 85% of bereaved family members of patients who bathed evaluated the experience positively, 86% reported that the patient's face seemed to become calm after the bath, and 28% of bereaved family members whose loved one had not bathed reported regretting it. The total GDI score for the bereaved family's desired death was 82.7???13.0 for the bathing group and 75.4???15.7 for the no bathing group, a significant difference (effect size?=?0.52, p?0.01). Conclusions: Bathing before death was evaluated positively and was associated with the achievement of a good death.

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 Respiratory modalities applied at the end of life may affect the burden of distressing symptoms and quality of dying and death (QODD) among patients with end-stage interstitial lung disease (ILD); however, there have been few studies into respiratory modalities applied to these patients near death. We hypothesized that high-flow nasal cannula (HFNC) might contribute to improved QODD and symptom relief in patients with end-stage ILD. Objectives This multicenter study examined the proportion of end-of-life respiratory modalities in a hospital setting and explored its impact on QODD and symptom relief among patients dying with ILD. Methods Consecutive patients with ILD who died in four participating hospitals in Japan from 2015 to 2019 were identified and divided into four groups according to end-of-life respiratory modality: conventional oxygen therapy (COT), HFNC, non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). In addition, a mail survey was performed to quantify the QODD and symptom relief at their end of life from a bereaved family’s perspective. QODD and symptom relief were quantified using the Good Death Inventory (GDI) for patients with a completed bereavement survey. The impact of end-of-life respiratory modalities on QODD and symptom relief was measured by multivariable linear regression using COT as a reference. Results Among 177 patients analyzed for end-of-life respiratory modalities, 80 had a completed bereavement survey. The most common end-of-life respiratory modality was HFNC (n = 76, 42.9%), followed by COT (n = 62, 35.0%), NIV (n = 27, 15.3%), and IMV (n = 12, 6.8%). Regarding the place of death, 98.7% of patients treated with HFNC died outside the intensive care unit. Multivariable regression analyses revealed patients treated with HFNC had a higher GDI score for QODD [partial regression coefficient (B) = 0.46, 95% CI 0.07–0.86] and domain score related to symptom relief (B = 1.37, 95% CI 0.54–2.20) than those treated with COT. Conclusion HFNC was commonly used in patients with end-stage ILD who died in the hospital and was associated with higher bereaved family ratings of QODD and symptom relief. HFNC might contribute to improved QODD and symptom relief in these patients who die in a hospital setting.

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 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.

Abstract Background Malignant ascites often causes discomfort in advanced cancer patients. Paracentesis is the most common treatment modality, but it requires frequently repeated treatment. Cell-free and concentrated ascites reinfusion therapy (CART) may prolong the paracentesis interval, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites. Methods This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient’s request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want paracentesis if indicated), and adverse events. Results We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3–98.8) completed the study intervention. All patients had an ECOG performance status of 3 or 4. The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm. In the CART arm, the median reinfused albumin volume was 12.6 g. Median paracentesis-free survivals were 5 days (95% CI: 2–6) in the CART arm, and 6 days (3–9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2–5) and 5 days (1–9), respectively. A total of 73% of patients received paracentesis within 2 days from their first request for the next paracentesis. One patient in the CART arm developed Grade 1 fever. Conclusions A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be a complementary outcome measure with paracentesis-free survival in future trials. Trial registration Registered at University Hospital Medical Information Network Clinical Trial Registry as UMIN000031029 . Registered on 28/01/2018.

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.

Background: It is unclear which laxatives are appropriate to prevent opioid-induced constipation (OIC). This study will evaluate whether prophylactic use of naldemedine prevents OIC in patients with cancer who start opioid administration. Methods: This study is a multicenter, double-blinded, randomized, placebo-controlled trial. Patients who meet the eligibility criteria and give consent will be randomly assigned to the naldemedine or placebo group. Both groups will take each drug once a day after breakfast for 14 days. Results: The primary endpoint is the proportion of patients with a Bowel Function Index of less than 28.8 on Day 14. The secondary endpoints include assessment scales of the impact of constipation on comprehensive quality of life. Conclusions: This is the first study proposed to assess the superiority of naldemedine over placebo in the prevention of OIC. If naldemedine is found to be effective in reducing OIC compared with the placebo, it will be regarded as a new standard for OIC prophylaxis at opioid initiation. Trial registration: jRCT identifier: jRCTs031200397. Registered March 5, 2021, https://rctportal.niph.go.jp/en/detail?trial_id=jRCTs031200397.

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

Objective: This study aimed to explore the predictors of morphine efficacy in the alleviation of dyspnea in COPD. Background: Dyspnea is prevalent in patients with chronic obstructive pulmonary disease (COPD) and often persists despite conventional treatment. Methods: A secondary analysis of a multi-institutional prospective before?after study was conducted focusing on morphine use for alleviating dyspnea in COPD patients. Subjects included COPD patients with dyspnea at seven hospitals in Japan. Patients received 12 mg/day of oral morphine (or 8 mg/day if they had low body weight or renal impairment). Univariate and multivariate logistic regression analyses were performed with numerical rating scale (NRS) score of the current dyspnea intensity in the evening of day 0, Eastern Cooperative Oncology Group Performance Status (ECOG PS; ?2 or ?3), age, and partial arterial pressure of carbon dioxide (PaCO2) as independent factors; an improvement of ?1 in the evening NRS score of dyspnea from day 0 to 2 was the dependent factor. Results: Thirty-five patients were enrolled in this study between October 2014 and January 2018. Excluding one patient who did not receive the treatment, data from 34 patients were analyzed. In the multivariate analysis, lower PaCO2 was significantly associated with morphine efficacy for alleviating dyspnea (odds ratio [OR] 0.862, 95% confidence interval [CI] 0.747?0.994), whereas the NRS of dyspnea intensity on day 0 (OR 1.426, 95% CI 0.836?2.433), ECOG PS (OR 4.561, 95% CI 0.477?43.565), and patients' age (OR 0.986, 95% CI 0.874?1.114) were not. Discussion: Morphine can potentially alleviate dyspnea in COPD patients with lower PaCO2. Trial registration: UMIN000015288 (http://www.umin.ac.jp/ctr/index.htm)

Background: During end-of-life care, the place in which the patients spend time influences their quality of life. Objective: To clarify what it means to spend last days at home and in inpatient hospice. Design: This study was a part of a nationwide multicenter questionnaire survey of bereaved family members of cancer patients evaluating the quality of end-of-life care in Japan. Setting/Subjects: A nationwide questionnaire survey was conducted with 779 family members of cancer patients who had died at inpatient hospices. We asked participants about the perceived benefits of spending last days at home and inpatient hospice during the patient's last days. Measurements: A nationwide questionnaire. Results: Of participants, 37.6% (n?=?185 [95% confidence interval, 33%?42%]) felt that the inpatient hospice was like a home. The family members who reported that the inpatient hospice felt like home significantly tended to report high satisfaction with the level of care (p?0.01). Factors that the participants perceived as benefits of the inpatient hospice were: ?If anything changes, as health care professionals are easily available, he/she can handle it? (88.1%), ?he/she is reassured? (78.4%), and ?he/she is safe? (72.7%). On the contrary, factors that they perceived as benefits of home were: ?He/she can do what he/she wants to do without worrying about the eye of other people? (44.1%), ?he/she can relax? (43.5%), and ?he/she is free? (42.0%). Conclusions: Spending the last days of life in either an inpatient hospice or at home has specific benefits. The place a patient spends his/her end-of-life days should be based on patient and family values.

Background Where patients receive end-of-life care influences their quality of life.Objectives To clarify the effects of staying in a private or shared room in inpatient hospices.Design A part of a Japanese multicentre survey to evaluate the quality of end-of-life care.Setting/participants 779 bereaved families whose relatives who died from cancer in inpatient hospices.Measurements The primary outcome was family-perceived need for improvement in environment-related professional care. Secondary end-points included: family satisfaction, environment-related family perception, and quality of death and dying (Good Death Inventory: GDI).Results 574 responded (73.7%). 300 patients were in a private room from admission to discharge, 47 were in a shared room less than 50% of the time, and the remaining 85 were in a shared room 50% or more. There were significant differences in the need for improvement in shared (vs private) rooms, and in favour of private rooms for: ‘privacy was protected’, ‘easy for visitors to visit’, ‘could discuss sensitive issues with medical staff without concern’, and ‘could visit at night.’, as well as ‘living in calm circumstances’ and ‘spending enough time with family’ of the GDI. Contrarily, significant differences were found in favour of shared rooms for: ‘the patient could interact with other patients’. There was no significant difference in family satisfaction and total score of GDI.Conclusion There are the advantages and disadvantages of spending one’s final days in a private or shared room, and adjusting rooms according to patients and their families’ values is necessary.

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.

Abstract Background To improve the quality of advance care planning (ACP) in primary care, it is important to understand the frequency of and topics involved in the ACP discussion between patients and their family physicians (FPs). Methods A secondary analysis of a previous multicenter cross-sectional observational study was performed. The primary outcome of this analysis was the frequency of and topics involved in the ACP discussion between outpatients and FPs. In March 2017, 22 family physicians at 17 clinics scheduled a day to assess outpatients and enrolled patients older than 65 years who were recognized by FPs as having regular visits. We defined three ACP discussion topics: 1) future decline in activities of daily living (ADL), 2) future inability to eat, and 3) surrogate decision makers. FPs assessed whether they had ever discussed any ACP topics with each patient and their family members, and if they had documented the results of these discussions in medical records before patients were enrolled in the present study. We defined patients as being at risk of deteriorating and dying if they had at least 2 positive general indicators or at least 1 positive disease-specific indicator in the Japanese version of the Supportive and Palliative Care Indicators Tool. Results In total, 382 patients with a mean age of 77.4 ± 7.9 years were enrolled, and 63.1% were female. Seventy-nine patients (20.7%) had discussed at least one ACP topic with their FPs. However, only 23 patients (6.0%) had discussed an ACP topic with family members and their FPs, with the results being documented in their medical records. The topic of future ADL decline was discussed and documented more often than the other two topics. Patients at risk of deteriorating and dying discussed ACP topics significantly more often than those not at risk of deteriorating and dying (39.4% vs. 16.8%, p

Abstract Background The objective of this study was to explore the underlying etiologies associated with the resolution and improvement of delirium in ill‐hospitalized cancer patients. Methods We conducted a secondary analysis of a multicenter, prospective, observational study to estimate the effectiveness of pharmacotherapy for delirium. Participants were cancer patients with delirium. We assessed the Delirium Rating Scale, Revised‐98 (DRS‐R98) severity scale score at baseline and three days after pharmacotherapy initiation. Delirium resolution was defined as a DRS‐R98 severity scale score ≤9, and improvement was defined as ≥50% reduction at Day 3. Results We enrolled 566 patients (491 patients had performance status of 3 or 4). The resolution and improvement rates in all patients were 22.6% and 19.3%, respectively. Univariate analysis determined that nonrespiratory infection (OR 2.18, 95% CI 1.38‐3.45) was significantly associated with greater resolution, while dehydration (0.40, 0.19‐0.87), organic damage to the central nervous system (CNS) (0.32, 0.43‐0.72), hypoxia (0.25, 0.12‐0.52), and hyponatremia (0.34, 0.12‐0.97) were significantly associated with no resolution. Potential causes associated with delirium improvement were nonrespiratory infection (1.93, 1.19‐3.13), organic damage to the CNS (0.40, 0.18‐1.90), and hypoxia (0.32, 0.16‐0.65). After multivariate analysis, dehydration (0.34, 0.15‐0.76), organic damage to the CNS (0.25, 0.10‐0.60), and hypoxia (0.29, 0.14‐0.61) were significantly associated with no resolution. Conclusions Delirium caused by nonrespiratory infection may be reversible, while delirium associated with dehydration, organic damage to the CNS, hypoxia, or hyponatremia seems to be irreversible in ill‐hospitalized cancer patients.

Background: The dysbiosis of gut microbiota has been implicated in the pathogenesis of inflammatory bowel diseases; however, the underlying mechanisms have not yet been elucidated. Heavily glycosylated mucin establishes a first-line barrier against pathogens and serves as a niche for microbial growth. Methods: To elucidate relationships among dysbiosis, abnormal mucin utilisation, and microbial metabolic dysfunction, we analysed short-chain fatty acids (SCFAs) and mucin components in stool samples of 40 healthy subjects, 49 ulcerative colitis (UC) patients, and 44 Crohn's disease (CD) patients from Japan. Findings: Levels of n-butyrate were significantly lower in stools of both CD and UC patients than in stools of healthy subjects. Correlation analysis identified seven bacterial species positively correlated with n-butyrate levels; the major n-butyrate producer, Faecalibacterium prausnitzii, was particularly underrepresented in CD patients, but not in UC patients. In UC patients, there were inverse correlations between mucin O-glycan levels and the production of SCFAs, such as n-butyrate, suggesting that mucin O-glycans serve as an endogenous fermentation substrate for n-butyrate production. Indeed, mucin-fed rodents exhibited enhanced n-butyrate production, leading to the expansion of RORgt+Treg cells and IgA-producing cells in colonic lamina propria. Microbial utilisation of mucin-associated O-glycans was significantly reduced in n-butyrate-deficient UC patients. Interpretation: Mucin O-glycans facilitate symbiosynthesis of n-butyrate by gut microbiota. Abnormal mucin utilisation may lead to reduced n-butyrate production in UC patients. Fund: Japan Society for the Promotion of Science, Health Labour Sciences Research Grant, AMED-Crest, AMED, Yakult Foundation, Keio Gijuku Academic Development Funds, The Aashi Grass Foundation, and The Canon Foundation. Keywords: Microbiota, Butyrate, Mucin, Inflammatory bowel disease

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 Dyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD.Methods and analysis We will conduct a multicentre, prospective, randomised, placebo-controlled, single-blinded phase II study of a single subcutaneous morphine injection for dyspnoea in patients with ILD. In patients with ILD who have dyspnoea at rest refractory to conventional treatment will be eligible for participation in this study. The morphine dose will be 2 mg. The primary endpoint is changes in dyspnoea intensity from baseline to 60 min after treatment as measured using an 11-point Numerical Rating Scale and compared between the morphine and placebo groups.Ethics and dissemination Ethical approval has been obtained by the Osaka City University Certified Review Board. The results of this study will be submitted for publication in an international peer-reviewed journal and the findings will be presented at international scientific conferences.Trial registration number jRCTs051190030; pre-results.

Abstract Background Constant evaluation is important for maintaining and improving the quality of end-of-life care. We therefore conduct the fourth Japan Hospice and Palliative Evaluation Study (J-HOPE4) as a continuous evaluation study. In this present paper, we describe the design of J-HOPE4. The main purposes of J-HOPE4 are as follows:1) to evaluate the processes, structures, and outcomes of palliative care acute hospitals, palliative care units, and home hospice services; 2) to examine bereaved family members’ self-reported psychosocial conditions, such as grief and depression as bereavement outcomes;3) to provide data to ensure and improve the quality of care provided by participating institutions via feedback based on the results from each institution; and 4) provide clinical and academic information concerning the implications of various issues in palliative care by conducting additional studies. Methods We will conduct a cross-sectional, anonymous, self-reported questionnaire survey. In total, 190 institutions will participate in this study, meaning that 12,000 bereaved family members will be sent a questionnaire. Discussion This is one of the largest cross-sectional surveys involving hospice and palliative care, both in Japan and worldwide. Because this study will have a large sample size, the findings are expected to be generalizable to other settings.

We aimed to develop an adaptable prognosis prediction model that could be applied at any time point during the treatment course for patients with cancer receiving chemotherapy, by applying time-series real-world big data.Between April 2004 and September 2014, 4,997 patients with cancer who had received systemic chemotherapy were registered in a prospective cohort database at the Kyoto University Hospital. Of these, 2,693 patients with a death record were eligible for inclusion and divided into training (n = 1,341) and test (n = 1,352) cohorts. In total, 3,471,521 laboratory data at 115,738 time points, representing 40 laboratory items [e.g., white blood cell counts and albumin (Alb) levels] that were monitored for 1 year before the death event were applied for constructing prognosis prediction models. All possible prediction models comprising three different items from 40 laboratory items (40C3 = 9,880) were generated in the training cohort, and the model selection was performed in the test cohort. The fitness of the selected models was externally validated in the validation cohort from three independent settings.A prognosis prediction model utilizing Alb, lactate dehydrogenase, and neutrophils was selected based on a strong ability to predict death events within 1-6 months and a set of six prediction models corresponding to 1,2, 3, 4, 5, and 6 months was developed. The area under the curve (AUC) ranged from 0.852 for the 1 month model to 0.713 for the 6 month model. External validation supported the performance of these models.By applying time-series real-world big data, we successfully developed a set of six adaptable prognosis prediction models for patients with cancer receiving chemotherapy.