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 >or=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
To clarify the knowledge and beliefs of the Japanese general population related to legal options, pain medications, communication with physicians, and hydration/nutrition in end-of-life care, and to explore the associations between end-of-life care they had experienced and these beliefs, a questionnaire survey was conducted on two target populations: 5000 general population subjects and 866 bereaved family members of cancer patents who died in 12 palliative care units in Japan. The respondents were requested to report the legal knowledge about end-of-life options, pain-related beliefs, communication-related beliefs, and hydration/nutrition-related beliefs, and their experiences with end-of-life care. A total of 3061 responses were analyzed (effective response rate, 54%). The respondents were classified into six groups: no bereavement experience (n = 949), those who had lost family members within the past 10 years from noncancer diseases at institutions (n = 673), those who lost family members from noncancer disease at home (n = 264), those who lost family members from cancer at institutions other than palliative care units (n = 525), those who lost family members from cancer at home (n = 86), and those who lost family members from cancer at palliative care units (n = 548). Across groups, 32-45% and 50-63% of the respondents stated that treatment withdrawal and double effect act were legal, respectively. Between 34% and 44% believed that cancer pain is not sufficiently relieved, 27-38% believed that opioids shorten life, and 24-33% believed that opioids cause addiction. Communication-related beliefs potentially resulting in barriers to satisfactory end-of-life discussion were identified in 31-40% ("physicians are generally poor at communicating bad news") and in 14-25% ("physicians are not comfortable discussing death"). The bereaved family members of the patients who died in palliative care units were significantly more likely than the other groups to believe that cancer pain is sufficiently relieved, and significantly less likely to believe that opioids shorten life, that opioids cause addiction, that physicians are generally poor at communicating bad news, and that physicians are uncomfortable discussing death. Between 33% and 50% of the respondents, including families from palliative care units, believed "artificial hydration should be continued as the minimum standard until death," while 15-31% agreed that "artificial hydration relieves patient symptoms." A significant proportion of the Japanese general population has beliefs about legal options, pain medications, and communication with physicians that potentially result in barriers to quality end-of-life care. As their experiences in specialized palliative care significantly influenced their belief, systematic efforts to spread quality palliative care activity are of value to lessen these barriers and achieve quality end-of-life care.
BackgroundThe association between C‐reactive protein (CRP) level, symptoms, and activities of daily living (ADL) in advanced cancer patients is unclear.MethodsSecondary data analysis of a multicenter prospective cohort study consisted of 2426 advanced cancer patients referred to palliative care settings was conducted to examine the cross‐sectional relationships between CRP level, symptoms, and ADL disabilities. Laboratory data, symptoms, ADL, and manual muscle testing (MMT) results were obtained at baseline. Participants were divided into four groups: low (CRP < 1 mg/dl), moderate (1 = < CRP <5 mg/dl), high (5 = < CRP < 10 mg/dl), and very high CRP (10 mg/dl = < CRP). The proportions of eight symptoms, five ADL disabilities, and three categories of MMT according to the CRP groups were tested by chi‐square tests. Multiple‐adjusted odd ratios (ORs) were calculated by using ordinal logistic regression after adjustment for age, gender, site of primary cancer, metastatic disease, performance status, chemotherapy, and setting of care.ResultsA total of 1702 patients were analysed. Positive rates of symptoms and ADL disabilities increased with increasing CRP level. In the very high‐CRP group, rates of positivity for anorexia, fatigue, and weight loss were 89.8%, 81.0%, and 79.2%, respectively, and over 70% of patients received assistance for bathing, dressing, going to the toilet, and transfer. The grade of MMT also deteriorated with increasing CRP level. Adjusted ORs for the accumulated symptoms significantly increased with increasing CRP level in the moderate‐CRP, high‐CRP, and very high‐CRP groups [1.6 (95% confidence interval 1.2–2.0), P < 0.001; 2.5 (1.9–3.2), P < 0.001; 3.5 (2.7–4.6), P < 0.001, respectively]. Adjusted ORs for the accumulated ADL disabilities significantly increased in the very high‐CRP groups [2.1 (1.5–2.9), P < 0.001].ConclusionsAssociations between CRP level, symptoms, and ADL were observed in advanced cancer patients receiving palliative care.
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.
The simplified PPI showed essentially the same predictive value as the original PPI and is an alternative when clinicians have difficulties in diagnosing delirium.
In predicting the prognosis of patients with advanced cancer, the PS-PPI was as accurate as the PPI. The PS-PPI was useful for short- and long-term survival prediction and for the prediction of survival for patients undergoing chemotherapy. Cancer 2017;123:1442-1452. © 2016 American Cancer Society.
The modified PiPS was successfully validated and can be useful in palliative care units, hospital-based palliative care teams, and home-based palliative care services.
This study indicates that it is important for home care providers to introduce services to reduce care burden. In addition, a thorough explanation of the patient's symptoms and condition is necessary to reduce distress and anxiety for family caregivers.
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