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Palliative care is provided according to patient needs. Healthcare providers can use the Phase of Illness to assess patient needs and improve palliative care. However, patients' phase changes after the palliative care team's intervention remain unknown. This study clarified the Phase of Illness of patients referred to palliative care teams at hospitals and the changes in their phase after the intervention. Our study was a secondary analysis of a multicenter survey involving patient-reported outcomes. This study was conducted between February and August 2021 at eight facilities with palliative care teams. The participants were patients for whom the palliative care team received a new request for intervention during the patient enrollment period. Out of the 310 patients, 68 (21.9%) were in the stable phase, 141 (45.5%) in the unstable phase, 87 (28.1%) in the deteriorating phase, and 14 (4.5%) in the terminal phase at the time of referral. The total score for symptom distress at the time of referral was the highest in the deteriorating phase (65.7), followed by the unstable (54.1), terminal (47.5), and stable phases (40.5). Furthermore, 20.4% of patients in the unstable phase at the time of referral moved to the stable phase after one week of the intervention. This study identified the distribution and changes in the Phase of Illness of patients referred to palliative care teams. Assessments for the Phase of Illness must be standardized in palliative care teams to set benchmarks. [ABSTRACT FROM AUTHOR]

Background: Discrepancies in symptom assessment between providers and patients are reported in cancer care, and the use of patient-reported outcome measures (PROMs) has been recommended for patients receiving palliative care. However, the status of the routine use of PROMs in palliative care in Japan is presently unclear. Therefore, this study aimed to clarify this complex question. To this end, we administered a questionnaire survey either online or via telephone interviews (questionnaire: sent to 427 designated cancer hospitals, 423 palliative care units [PCUs], and 197 home hospices; interviews: conducted at 13 designated cancer hospitals, nine PCUs, and two home hospices). Results: Questionnaires were returned from 458 institutions (44% response rate). We found that 35 palliative care teams (PCTs, 15%), 66 outpatient palliative care services (29%), 24 PCUs (11%) and one (5%) home hospice routinely used PROMs. The most frequently implemented instrument was the Comprehensive Care Needs Survey questionnaire. Moreover, 99 institutions (92%) that routinely used PROMs responded these instruments as useful in relieving patients' symptoms; and moreover, the response rate in regard to usefulness in symptom management was higher than that of institutions that did not routinely use PROMs (p = 0.002); > 50% of the institutions that routinely used PROMs stated that use of these instruments was influenced by disease progression and patients' cognitive function. Moreover, 24 institutions agreed to be interviewed, and interviews demonstrated the benefits of and the barriers to the implementation of PROMs. Effective methods used in the implementation of PROMs were introduced as efforts to reduce the burden placed on patients and to promote healthcare providers' education in the use of PROMs. Conclusions: This survey quantified the status of the routine use of PROMs within specialized palliative care in Japan, revealed barriers to wider PROM use, and identified needed innovations. Only 108 institutions (24%) routinely used PROMs within specialized palliative care. Based on the results of the study, it is necessary to carefully consider the usefulness of PROs in clinical palliative care, perform careful selection of PROMs according to the patient's condition, and evaluate how specifically to introduce and operate PROMs. [ABSTRACT FROM AUTHOR]

Context: Some patients require continuous deep sedation (CDS) for refractory symptoms despite intensive palliative care. The principle of proportionality is proposed on the basis of clinical decisions, but no validated tools to assist such decision making are available. Aim: To develop a scoring system to determine whether CDS is proportionally appropriate. Subjects and Methods: A secondary analysis of a nationwide questionnaire survey of Japanese palliative care specialists was performed. Physicians were asked to rate the degree that they believed CDS to be appropriate in a total of 27 scenarios based on a combination of 3 factors with 3 levels: (1) the estimated survival (days, weeks, and months), (2) the patient's wish (clear and consistent, somewhat unclear and/or inconsistent, and unclear or inconsistent), and (3) confidence in refractoriness of the symptom (definite, probable, and unsure). Based on logistic regression analyses, a scoring system with two formulas (the proportionality score to determine that continuous deep sedation is appropriate [ProScoreCDS-appropriate] and proportionality score to determine that continuous deep sedation is inappropriate [ProScoreCDS-inappropriate]) to predict specialists' decision that CDS is appropriate or inappropriate was developed. The accuracy of the formulas was investigated. Results: Among 695 palliative care specialists, 469 returned the questionnaire (response rate, 69%) and 440 were analyzed. Logistic regression analyses identified that all three factors were significantly associated with physicians' decisions about the appropriateness of performing CDS. Using weighted value, the total score ranged from 3 to 67 for ProScoreCDS-appropriate, and 3 to 27 for ProScoreCDS-inappropriate. The area under the curve (AUC) values of ProScoreCDS-appropriate and ProScoreCDS-inappropriate were 0.88 (95% confidence interval [CI], 0.87–0.89) and 0.81 (95% CI, 0.81–0.82), respectively. Using cutoff points of 41 and 14, sensitivity and specificity were 68.6% and 88.9% for ProScoreCDS-appropriate and 67.7% and 76.0% for ProScoreCDS-inappropriate, respectively. Conclusion: A scoring system to determine whether CDS is proportionally appropriate can be constructed, and a further study to develop a clinical tool is promising. [ABSTRACT FROM AUTHOR]

Background: When the suffering of a terminally ill patient is intolerable and refractory, sedatives are sometimes used for symptom relief. Objective: To describe the main principles of revised Japanese clinical guidelines about palliative sedation therapy. Design: Consensus methods using the Delphi technique were used. Results: The main principles of the guidelines that were newly defined or developed are as follows: (1) palliative sedation was defined as "administration of sedatives for the purpose of alleviating refractory suffering" (excluding the aim of reducing patient consciousness); (2) palliative sedation was classified according to the method of administration of sedatives: respite sedation versus continuous sedation (including (continuous) proportional sedation and continuous deep sedation); (3) a description of state-of-the-art recommended treatments for difficult symptoms such as delirium, dyspnea, and pain before the symptom was determined as refractory was included; (4) the principle of proportionality was newly defined from an ethical point of view; and (5) families' consent was regarded as being desirable (mandatory in the previous version). Conclusions: We described the main principles of revised Japanese clinical guidelines about palliative sedation therapy. Further consensus building is necessary. [ABSTRACT FROM AUTHOR]

Background: The number of hospital-based palliative care consultation teams (PCCTs) has increased in Japan, and quality improvement (QI) of PCCTs is an issue. The Japanese Society for Palliative Medicine is building a framework for continuous QI of PCCT activities. Objective: The objective of this study was to develop a program to support QI for PCCTs, and to describe the initial experience with the program. Design: The report details the development of a self-check program, followed by a one-year follow-up observational survey. Methods: We developed a self-check program using the concept of the Plan-Do-Check-Act (PDCA) cycle and a multidisciplinary expert panel. A total of 114 PCCTs entered the program in the first year. Results: We developed three forms for the CHECK, ACT–PLAN, and DO phases aligned with the PDCA cycle. The forms consisted of 34 items across 8 domains. A total of 83 PCCTs (729 members) returned the CHECK, ACT–PLAN forms, and 41 PCCTs returned the DO forms after one year. Overall, 213 high priority issues were identified in the ACT phase. The issues of many PCCTs were "Sharing goals of care is inadequate within the PCCT (33%)" and "Sharing goals of care is inadequate between patient/family or primary team and the PCCT (28%)." Improvements in identified issues were: "achieved" 23% and "almost achieved" 48% after one year. Conclusions: We developed a self-check program to support QI efforts for hospital-based PCCTs. The priority issues among PCCTs and improvement goals with examples were identified. These results will support ongoing efforts to develop a continuous improvement model for QI of PCCTs. [ABSTRACT FROM AUTHOR]

Background: Pharmacotherapy is generally recommended to treat patients with delirium. We sought to describe the current practice, effectiveness, and adverse effects of pharmacotherapy for hypoactive delirium in patients with advanced cancer, and to explore predictors of the deterioration of delirium symptoms after starting pharmacotherapy. Subjects, Materials, and Methods: We included data of patients with advanced cancer who were diagnosed with hypoactive delirium and received pharmacotherapy for treatment of delirium. This was a pharmacovigilance study characterized by prospective registries and systematic data‐recording using internet technology, conducted among 38 palliative care teams and/or units. The severity of delirium and other outcomes were assessed using established measures at days 0 (T0), 3 (T1), and 7 (T2). Results: Available data were obtained from 218 patients. The most frequently used agent was haloperidol (37%). A total of 67 and 42 patients (31% and 19%) had died or discontinued pharmacotherapy by T1 and T2, respectively. Delirium symptoms deteriorated between T0 and T1, but this trend did not reach statistical significance. The most prevalent adverse event was sedation (9%). Delirium severity worsened after starting pharmacotherapy in 121 patients (56%) at T1. In patients whose death was expected within a few days and those with delirium caused by organ failure, symptoms of delirium were significantly more likely to deteriorate after starting pharmacotherapy. Conclusion: Current pharmacotherapy for hypoactive delirium in patients with advanced cancer is not recommended, especially in those whose death is expected within a few days and in those with delirium caused by organ failure. Implications for Practice: Delirium is common among patients with advanced cancer, and hypoactive delirium is the dominant motor subtype in the palliative care setting. Pharmacotherapy is recommended and regularly used to treat delirium. This article describes the effectiveness and adverse effects of pharmacotherapy for hypoactive delirium in patients with advanced cancer. The findings of this study do not support the use of pharmacotherapy for treatment of hypoactive delirium in the palliative care setting. Pharmacotherapy should especially be avoided in patients whose death is expected within a few days and in those with delirium caused by organ failure. Many patients with advanced cancer develop hypoactive delirium. This article describes current practice and overall effectiveness and adverse effects of commonly used pharmacotherapy for hypoactive delirium in advanced cancer patients. [ABSTRACT FROM AUTHOR]

Purposes: Despite extensive debate on palliative sedation over the last few decades, no studies have explored longitudinal changes in physicians' opinion. Moreover, little is known about how physicians' opinions affect their practice. This study aimed to clarify (1) changes in palliative care specialists' opinions on palliative sedation and (2) the effects of these opinions on clinical practice.Methods: In 2000 and 2016, nationwide questionnaire surveys involving Japanese palliative care specialists were performed: measurement was based on agreement with opinions on palliative sedation. In 2016, the physicians reported their practice of continuous deep sedation (CDS) and answered their thoughts on what factors lead to a good death as factors potentially affecting their practice.Results: Of the 695 physicians enrolled in the 2016 survey, 469 responded (67%) and 417 were analyzed (60%). Compared with 54 physicians in 2000, the present respondents were more likely to consider palliative sedation is difficult to perform based on appropriate indications (ES = 0.84, P < 0.001), is unnecessary if conventional palliative care is performed sufficiently (ES = 0.30, P = 0.013), and may result in legal action (ES = 0.35, P = 0.003). The physicians' opinions more strongly affected their practice than their characteristics or thoughts on good death components.Conclusions: Recently, palliative care specialists in Japan tend to encounter more difficulties determining what conventional palliative care is and what palliative sedation is. They also fear legal ramifications. It is necessary to standardize methods of alleviating patients' suffering, to make CDS criteria clearer, and to create a legal basis that respects patients' rights at their end of life. [ABSTRACT FROM AUTHOR]

Context: Although there has long been debate about physicians' intentions and what physicians consider to be proportionally appropriate when performing palliative sedation, few large studies have been performed.Objectives: To identify physicians' intentions when starting continuous deep sedation and to clarify what factors determine whether physicians regard sedation as proportionally appropriate in relation to expected survival, the patients' wishes, and refractoriness.Methods: A nationwide questionnaire survey of Japanese palliative care specialists was performed from August to December 2016. We defined continuous deep sedation as the continuous use of sedatives to relieve intolerable and refractory symptoms with the loss of consciousness until death.Results: Of the 695 palliative care specialists enrolled, 440 were analyzed (response rate, 69%). A total of 95% and 87% of the physicians reported that they explicitly intended to perform symptom palliation and decrease consciousness levels, respectively. Moreover, 38% answered that they explicitly intended to maintain unconsciousness until death, and 11% reported that they intended to shorten survival to some extent. The respondents considered that continuous deep sedation is more appropriate when the predicted survival is shorter, the patients' wishes are consistent and clear, and confidence in the refractoriness of symptoms is higher.Conclusions: Japanese palliative care specialists explicitly intend to control symptoms and reduce the level of consciousness when performing continuous deep sedation, but there are differences in their intentions with regard to maintaining unconsciousness until death. Predicted survival, patients' wishes, and confidence in refractoriness are associated with physicians' judgment that sedation is proportionally appropriate. [ABSTRACT FROM AUTHOR]

Abstract: Although palliative sedation therapy is often required in terminally ill cancer patients, its efficacy and safety are not sufficiently understood. The primary aims of this multicenter observational study were to 1) explore the efficacy and safety of palliative sedation therapy, and 2) identify the factors contributing to inadequate symptom relief and complications, using a prospective study design, clearly defined measurement methods, and a consecutive sample from 21 specialized palliative care units in Japan. A sample of 102 consecutive adult cancer patients who received continuous deep sedation were enrolled. Physicians prospectively evaluated the intensity of patient symptoms, communication capacity, respiratory rate, and complications related to sedation. Symptoms were measured on the Agitation Distress Scale, the Memorial Delirium Assessment Scale, and the ad hoc symptom severity scale (0 = no symptoms, 1 = mild and tolerable symptoms, 2 = intolerable symptoms for less than 15 minutes in the previous one hour, and 3 = intolerable symptoms continuing for more than 15 minutes in the previous one hour). Inadequate symptom relief was defined as presence of hyperactive delirium (item 9 of the Memorial Delirium Assessment Scale ≥2) or grade 2 or 3 symptom intensity 4 hours after sedation. The degree of communication capacity was measured on the Communication Capacity Scale. Palliative sedation therapy succeeded in symptom alleviation in 83% of the cases. Median time elapsed before patients initially had one continuous hour of deep sedation was 60 minutes, but 49% of the patients awakened once after falling into a deeply sedated state. The percentage of patients who were capable of explicit communication decreased from 40% before sedation to 7.1% 4 hours after sedation, and the mean Communication Capacity Score significantly decreased to the level of 15 points (P < 0.001). The respiratory rates did not significantly decrease after sedation (18 ± 9.0 to 16 ± 9.4/min, P = 0.62), but respiratory and/or circulatory suppression (respiratory rate ≤ 8/min, systolic blood pressure ≤ 60mHg, or 50% or more reduction) occurred in 20%, with fatal outcomes in 3.9%. There were no statistically significant differences in patient age, sex, performance status, target symptoms, or classes and initial dose of sedative medications between the patients with adequate and inadequate symptom relief. Respiratory and/or circulatory suppression was significantly more likely to occur in patients receiving sedation for delirium and those with higher levels on the Agitation Distress Scale. Higher dose of midazolam was significantly correlated with younger age, absence of icterus, pre-exposure to midazolam, and length of sedation. Palliative sedation therapy is effective and safe in the majority of terminally ill cancer patients with refractory symptoms. However, a small number of patients experience fatal complications related to sedation. Comparison studies of different sedation regimens are needed to determine the most effective and safe sedation protocol. [Copyright &y& Elsevier]

Abstract: Although palliative sedation therapy is often required in terminally ill cancer patients to achieve acceptable symptom relief, empirical data supporting the ethical validity of this approach are lacking. The primary aim of this study was to systematically investigate whether empirical evidence supports the ethical validity of sedation. This was a multicenter, prospective, observational study, which was conducted by 21 specialized palliative care units in Japan. One-hundred two consecutive adult cancer patients who received continuous deep sedation were enrolled. Continuous deep sedation was defined as the continuous use of sedative medications to relieve intolerable and refractory distress by achieving almost or complete unconsciousness until death. Prior to the study, we conceptualized the ethical validity of sedation from the viewpoints of physicians'' intent, proportionality, and autonomy. Sedation was performed mainly with midazolam and phenobarbital. The initial doses of midazolam and phenobarbital were 1.5 mg/hour and 20 mg/hour, respectively. Main administration routes were continuous subcutaneous infusion and continuous intravenous infusion, and no rapid intravenous injection was reported. Of 59 patients who received artificial hydration or could intake adequate fluids/foods orally before sedation, 63% received artificial hydration therapy after sedation, and in the remaining patients, artificial hydration was withheld or withdrawn due to fluid retention symptoms and/or patient wishes. Of 66 patients who were able to verbally express themselves, 95% explicitly stated that symptoms were intolerable. The etiologies of the symptoms requiring sedation were primarily related to the progression of the underlying malignancy, such as cancer cachexia and organ failure, and standard palliative treatments had failed: steroids in 68% of patients with fatigue, opioids in 95% of patients with dyspnea, antisecretion medications in 75% of patients with bronchial secretion, antipsychotic medications in 74% of patients with delirium, and opioids in all patients with pain. On the basis of the Palliative Prognostic Index, 94% of the patients were predicted to die within 3 weeks. Before sedation, 67% of the patients expressed explicit wishes for sedation. In the remaining 34 patients, previous wishes for sedation were noted in 4 patients, and in the other 30 patients, the families were involved in the decision-making process. The chief reason for patient non-involvement in the decision making was cognitive impairment. These data indicate that palliative sedation therapy performed in specialized palliative care units in Japan generally followed the principles of double effect, proportionality, and autonomy. [Copyright &y& Elsevier]