A Randomized Controlled Trial of Betamethasone on Fatigue in Patients With Advanced Cancer.

CONTEXT: Fatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. OBJECTIVES: To assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. METHODS: A randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1-2 months, with an Eastern Cooperative Oncology Group Performance Status of 2-3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/d) or placebo for seven days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day seven). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. RESULTS: Among the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P = 0.178) and in a NRS for fatigue was -1.2 (95% CIs: -2.5, -0.01; P = 0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. CONCLUSION: The impact of betamethasone 4 mg/d on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.

Visualizing How to Use Antipsychotics for Agitated Delirium in the Last Days of Life.

CONTEXT: How physicians use antipsychotics for agitated delirium in the last days of life varies markedly, which could hamper the quality of care. OBJECTIVES: To examine adherence to an algorithm-based treatment for terminal agitated delirium, and explore its effectiveness and safety. METHODS: A single-center, prospective, observational study was conducted in a 27-bed palliative care unit in Japan. All adult cancer patients who developed agitated delirium with a modified Richmond Agitation-Sedation Scale (RASS) of +1 or more were included; the palliative care specialists determined that the etiology was irreversible, the estimated survival was three weeks or less, and the Eastern Cooperative Oncology Group (ECOG) performance status was three or four. Patients were treated with an algorithm to visualize how to use antipsychotics, with the treatment goal defined as no agitation (RASS≤0) or acceptable agitation for patients and families. We provided all patients nonpharmacological management to alleviate the symptoms of delirium and administered antipsychotic medications when the nonpharmacological approach was insufficient. We measured the adherence rate, RASS, Nursing Delirium Screening Scale items 2, 3, 4 (Nu-DESC), and Agitation Distress Scale item 2 (ADS) on days 0, 1, 3, 7, 14, 21, and 24 hours before death. RESULTS: A total of 164 patients were enrolled. Adherence rates were 99, 94, and 89%, and treatment goals were achieved in 66, 83, and 93% on days one, three, and seven, respectively. The mean RASS decreased from +1.41 to -0.84 on day three; Nu-DESC decreased from 4.19 to 1.83, and ADS decreased from 1.54 to 0.38. There were seven severe adverse events (Common Terminology Criteria for Adverse Events (CTCAE) of 3), including aspiration (n = 3), apnea (n = 2), tremor (n = 1), and muscle rigidity (n = 1) on day three. CONCLUSION: The algorithm-based treatment could be feasible, effective, and safe. Visualizing how palliative care specialists provide pharmacological management could be beneficial for nonspecialist clinicians, and clinical, educational, and research implications warrant further empirical testing.

Development of a Scoring System to Determine Proportional Appropriateness of Continuous Deep Sedation: A Concept-of-Proof Study.

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.

The Principles of Revised Clinical Guidelines about Palliative Sedation Therapy of the Japanese Society for Palliative Medicine.

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.

Association Between Heart Rate and Reversibility of the Symptom, Refractoriness to Palliative Treatment, and Survival in Dyspneic Cancer Patients.

CONTEXT: Dyspnea is one of the most distressing symptoms for terminally ill cancer patients and a predictor of poor prognosis. Identification of simple clinical signs, such as heart rate, indicating clinical course of each patient is of value. OBJECTIVES: To explore the potential association between heart rate and reversibility of the symptom, treatment response to palliative intervention, and survival in terminally ill cancer patients with dyspnea at rest. METHODS: This is a secondary analysis of a multicenter prospective cohort study of patients with advanced cancer to validate multiple prognostic tools. In the patients with dyspnea at rest at the baseline, we examined a potential association between heart rate and the reversibility of dyspnea and refractoriness to palliative treatment using logistic regression analysis. Survivals were compared using the Cox proportional hazards model among four groups with different levels of the heart rate (≤74, 75-84, 85-97, and ≥98). RESULTS: A total of 2298 patients were enrolled, and 418 patients (18%) had dyspnea at rest. Reversibility of dyspnea was significantly higher in the patients with lower heart rate (P for trend = 0.008), and the refractoriness to palliative treatment tended to be higher in the patients with higher heart rate (P for trend = 0.101). The median survival for each heart rate quartile groups was significantly higher in the lower heart rate group (24 vs. 21 vs. 14 vs. 9 days; heart rate ≤74, 75-84, 85-97, and ≥98, respectively; log-rank P < 0.001). CONCLUSION: Heart rate may help clinicians to make the prediction of the patient's clinical course more accurate.

Effects of an advance care planning educational programme intervention on the end-of-life care attitudes of multidisciplinary practitioners at an acute hospital: A pre- and post-study.

BACKGROUND: Advance care planning is a crucial end-of-life care practice. However, an advance care planning educational programme for practitioners in an acute care setting has not yet been established. Consequently, we examined the effects of an advance care planning educational programme in an acute hospital in the hope of achieving increased awareness of end-of-life care. DESIGN: A mixed-methods, pre- and post-design was employed to evaluate the change in attitudes of practitioners post-programme. The intervention programme was conducted thrice over 3 months in 90-min sessions. SETTING/PARTICIPANTS: This study included 85 participants in the baseline assessment working at B acute hospital in Osaka. RESULTS: Participants' scores on the 'Positive attitude for end-of-life care' subscale on the short version of the Frommelt Attitude Toward Care of Dying scale significantly increased after the 6-month intervention. A 'Positive attitude for end-of-life-care' implies that participants would not be afraid to practice end-of-life care. Further, participants' scores on the 'Death relief' subscale of the Death Attitude Inventory also significantly increased. The term 'Death relief' means that death helps in ending suffering. It means participants are not afraid of death. Qualitative results implied that participants believed advance care planning implementation and communicating with patients and patients' families were critical. CONCLUSIONS: Six months post-intervention, participants displayed sustained positive attitudes towards end-of-life care. These results suggest that the present programme was effective at improving practitioners' attitudes towards patients' end-of-life care.

Changes in opinions on palliative sedation of palliative care specialists over 16 years and their effects on clinical practice.

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.

Japanese physicians' experiences of terminally ill patients voluntarily stopping eating and drinking: a national survey.

OBJECTIVES: Voluntarily stopping eating and drinking (VSED) could be regarded as a patients' own non-treatment decision that hastens death, which involves patients voluntarily forgoing food and liquid until death. The aims of this study were to investigate the experience of home hospice physicians and palliative care specialists who care for patients during VSED in Japan, and their opinions on continuous deep sedation (CDS) as a means to relieve patient symptoms during VSED. METHODS: 219 home hospice physicians and 695 palliative care specialists across Japan were surveyed by mail questionnaire in 2016. RESULTS: A total of 571 (62%) responses were analysed. A total of 185 (32%) had experience of patients who selected VSED. In response to questions about CDS to provide relief to patients during VSED, the number of physicians who replied that CDS was acceptable was 88 (15%). CONCLUSIONS: In Japan, 32% of physicians surveyed replied that they had experience of caring for patients during VSED in a clinical setting and 15% considered CDS acceptable.

A combination of routine laboratory findings and vital signs can predict survival of advanced cancer patients without physician evaluation: a fractional polynomial model.

INTRODUCTION: There have been no reports about predicting survival of patients with advanced cancer constructed entirely with objective variables. We aimed to develop a prognostic model based on laboratory findings and vital signs using a fractional polynomial (FP) model. METHODS: A multicentre prospective cohort study was conducted at 58 specialist palliative care services in Japan from September 2012 to April 2014. Eligible patients were older than 20 years and had advanced cancer. We developed models for predicting 7-day, 14-day, 30-day, 56-day and 90-day survival by using the FP modelling method. RESULTS: Data from 1039 patients were analysed to develop each prognostic model (Objective Prognostic Index for advanced cancer [OPI-AC]). All models included the heart rate, urea and albumin, while some models included the respiratory rate, creatinine, C-reactive protein, lymphocyte count, neutrophil count, total bilirubin, lactate dehydrogenase and platelet/lymphocyte ratio. The area under the curve was 0.77, 0.81, 0.90, 0.90 and 0.92 for the 7-day, 14-day, 30-day, 56-day and 90-day model, respectively. The accuracy of the OPI-AC predicting 30-day, 56-day and 90-day survival was significantly higher than that of the Palliative Prognostic Score or the Prognosis in Palliative Care Study model, which are based on a combination of symptoms and physician estimation. CONCLUSION: We developed highly accurate prognostic indexes for predicting the survival of patients with advanced cancer from objective variables alone, which may be useful for end-of-life management. The FP modelling method could be promising for developing other prognostic models in future research.

A Nationwide Survey About Palliative Sedation Involving Japanese Palliative Care Specialists: Intentions and Key Factors Used to Determine Sedation as Proportionally Appropriate.

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.

A prospective, multicenter cohort study to validate a simple performance status-based survival prediction system for oncologists.

BACKGROUND: Survival prediction systems such as the Palliative Prognostic Index (PPI), which includes the Palliative Performance Scale (PPS), are used to estimate survival for terminally ill patients. Oncologists are, however, less familiar with the PPS in comparison with the Eastern Cooperative Oncology Group (ECOG) performance status (PS). This study was designed to validate a simple survival prediction system for oncologists, the Performance Status-Based Palliative Prognostic Index (PS-PPI), which is a modified form of the PPI based on the ECOG PS. METHODS: This multicenter, prospective cohort study enrolled all consecutive patients who were referred to 58 palliative care services in Japan. The primary responsible physicians rated the variables required to calculate the PS-PPI and the PPI. Patient survival in these risk groups was compared, and the sensitivity and specificity of the PS-PPI and the PPI were evaluated. Patients were subclassified as patients receiving care from in-hospital palliative care teams, palliative care units, or home-based palliative care services. Subsets of patients receiving chemotherapy were also analyzed. RESULTS: This study included 2346 patients. Survival predictions based on the PPI and the PS-PPI differed significantly among the 3 risk groups (P < .001). The PS-PPI was more sensitive, whereas the PPI was more specific. All areas under the receiver operating characteristic curves of both indices were >0.78 for predicting survival at all times, from 3 weeks to 180 days. CONCLUSIONS: 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.

Clinical Implications of C-Reactive Protein as a Prognostic Marker in Advanced Cancer Patients in Palliative Care Settings.

CONTEXT: Plasma C-reactive protein (CRP) levels are elevated in patients with advanced cancer. OBJECTIVES: To investigate CRP as a prognostic marker in palliative settings. METHODS: This multicenter prospective cohort study comprised 2426 patients. Laboratory data were obtained at baseline, and all patients were followed until death or six months after their enrollment. A total of 1511 patients were eligible for the analyses. They were divided into four groups: low-CRP (CRP < 1 mg/dL), moderate-CRP (1 ≤ CRP <5 mg/dL), high-CRP (5 ≤ CRP <10 mg/dL), and very high-CRP (10 mg/dL ≤ CRP) groups. Survival was investigated by the Kaplan-Meier method with the log-rank test. The 30-, 60-, and 90-day mortality rates were tested by Chi-squared tests. Univariate- and multivariate-adjusted hazard ratios (HRs) and 95% CIs in each group were calculated using Cox proportional hazard models. RESULTS: Survival rate decreased and mortality rate increased with increasing CRP level. The differences in survival and 30-, 60-, and 90-day mortality rates among the groups were statistically significant (P < 0.001). Baseline CRP level was significantly associated with a higher risk of mortality after adjustment for age, gender, primary tumor site, metastasis, chemotherapy, Eastern Cooperative Oncology Group Performance Status, and setting of care (moderate-CRP: HR 1.47 [95% CI 1.24-1.73], high-CRP: HR 2.09 [95% CI 1.74-2.50], and very high-CRP: HR 2.55 [95% CI 2.13-3.05] vs. low-CRP). CONCLUSION: Clear dose-effect relationships between elevated CRP levels and prognoses indicate that CRP could be useful in predicting prognoses in patients with advanced cancer.

Effect of continuous deep sedation on survival in patients with advanced cancer (J-Proval): a propensity score-weighted analysis of a prospective cohort study.

BACKGROUND: Continuous deep sedation (CDS) before death is a form of palliative sedation therapy that has become a focus of strong debate, especially with respect to whether it shortens survival. We aimed to examine whether CDS shortens patient survival using the propensity score-weighting method, and to explore the effect of artificial hydration during CDS on survival. METHODS: This study was a secondary analysis of a large multicentre prospective cohort study that recruited and followed up patients between Sept 3, 2012, and April 30, 2014, from 58 palliative care institutions across Japan, including hospital palliative care settings, inpatient palliative care units, and home-based palliative care services. Adult patients (aged ≥ 20 years) with advanced cancer who received care through the participating palliative care services were eligible for this secondary analysis. Patients with missing data for outcome variables or who lived for more than 180 days were excluded. We compared survival after enrolment between patients who did and did not receive CDS. We used a propensity score-weighting method to control for patient characteristics, disease status, and symptom burden at enrolment. FINDINGS: Of 2426 enrolled patients with advanced cancer, we excluded 289 (12%) for living longer than 180 days and 310 (13%) with missing data, leaving an analysis population of 1827 patients. 269 (15%) of 1827 patients received CDS. Unweighted median survival was 27 days (95% CI 22-30) in the CDS group and 26 days (24-27) in the no CDS group (median difference -1 day [95% CI -5 to 4]; HR 0·92 [95% CI 0·81-1·05]; log-rank p=0·20). After propensity-score weighting, these values were 22 days (95% CI 21-24) and 26 days (24-27), respectively (median difference -1 day [95% CI -6 to 4]; HR 1·01 [95% CI 0·87-1·17]; log-rank p=0·91). Age (p(interaction)=0·67), sex (p(interaction)=0·26), performance status (p(interaction)=0·90), and volume of artificial hydration (p(interaction)=0·14) did not have an effect modification on the association between sedation and survival, although care setting did have a significant effect modification (p(interaction)=0·021). INTERPRETATION: CDS does not seem to be associated with a measurable shortening of life in patients with advanced cancer cared for by specialised palliative care services, and could be considered a viable option for palliative care in this setting. FUNDING: Japanese National Cancer Center Research and Development Fund.

Survival prediction for advanced cancer patients in the real world: A comparison of the Palliative Prognostic Score, Delirium-Palliative Prognostic Score, Palliative Prognostic Index and modified Prognosis in Palliative Care Study predictor model.

PURPOSE: The aim of this study was to investigate the feasibility and accuracy of the Palliative Prognostic Score (PaP score), Delirium-Palliative Prognostic Score (D-PaP score), Palliative Prognostic Index (PPI) and modified Prognosis in Palliative Care Study predictor model (PiPS model). PATIENTS AND METHODS: This multicentre prospective cohort study involved 58 palliative care services, including 19 hospital palliative care teams, 16 palliative care units and 23 home palliative care services, in Japan from September 2012 to April 2014. Analyses were performed involving four patient groups: those treated by palliative care teams, those in palliative care units, those at home and those receiving chemotherapy. RESULTS: We recruited 2426 participants, and 2361 patients were finally analysed. Risk groups based on these instruments successfully identified patients with different survival profiles in all groups. The feasibility of PPI and modified PiPS-A was more than 90% in all groups, followed by PaP and D-PaP scores; modified PiPS-B had the lowest feasibility. The accuracy of prognostic scores was ⩾69% in all groups and the difference was within 13%, while c-statistics were significantly lower with the PPI than PaP and D-PaP scores. CONCLUSION: The PaP score, D-PaP score, PPI and modified PiPS model provided distinct survival groups for patients in the three palliative care settings and those receiving chemotherapy. The PPI seems to be suitable for routine clinical use for situations where rough estimates of prognosis are sufficient and/or patients do not want invasive procedure. If clinicians can address more items, the modified PiPS-A would be a non-invasive alternative. In cases where blood samples are available or those requiring more accurate prediction, the PaP and D-PaP scores and modified PiPS-B would be more appropriate.

Surprise Questions for Survival Prediction in Patients With Advanced Cancer: A Multicenter Prospective Cohort Study.

BACKGROUND: Predicting the short-term survival in cancer patients is an important issue for patients, family, and oncologists. Although the prognostic accuracy of the surprise question has value in 1-year mortality for cancer patients, the prognostic value for short-term survival has not been formally assessed. The primary aim of the present study was to assess the prognostic value of the surprise question for 7-day and 30-day survival in patients with advanced cancer. PATIENTS AND METHODS: The present multicenter prospective cohort study was conducted in Japan from September 2012 through April 2014, involving 16 palliative care units, 19 hospital-based palliative care teams, and 23 home-based palliative care services. RESULTS: We recruited 2,425 patients and included 2,361 for analysis: 912 from hospital-based palliative care teams, 895 from hospital palliative care units, and 554 from home-based palliative care services. The sensitivity, specificity, positive predictive value, and negative predictive value of the 7-day survival surprise question were 84.7% (95% confidence interval [CI], 80.7%-88.0%), 68.0% (95% CI, 67.3%-68.5%), 30.3% (95% CI, 28.9%-31.5%), and 96.4% (95% CI, 95.5%-97.2%), respectively. The sensitivity, specificity, positive predictive value, and negative predictive value for the 30-day surprise question were 95.6% (95% CI, 94.4%-96.6%), 37.0% (95% CI, 35.9%-37.9%), 57.6% (95% CI, 56.8%-58.2%), and 90.4% (95% CI, 87.7%-92.6%), respectively. CONCLUSION: Surprise questions are useful for screening patients for short survival. However, the high false-positive rates do not allow clinicians to provide definitive prognosis prediction. IMPLICATIONS FOR PRACTICE: The findings of this study indicate that clinicians can screen patients for 7- or 30-day survival using surprise questions with 90% or more sensitivity. Clinicians cannot provide accurate prognosis estimation, and all patients will not always die within the defined periods. The screened patients can be regarded as the subjects to be prepared for approaching death, and proactive discussion would be useful for such patients.

Independent Validation of the Japanese Version of the EORTC QLQ-C15-PAL for Patients With Advanced Cancer.

CONTEXT: Although the psychometric properties of the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) have been examined previously, that study had several limitations, for example, small sample size. OBJECTIVES: To examine the validity and reliability, including test-retest reliability, of the Japanese version of EORTC QLQ-C15-PAL for cancer patients with metastasis or recurrence. METHODS: A cross-sectional anonymous questionnaire was administered to cancer patients who were being treated on an oncology inpatient ward, in an oncology outpatient clinic, and in seven inpatient palliative units in Japan, from August 2007 to March 2008. RESULTS: Data from a total of 312 cancer patients were analyzed. The proportion of missing values was less than 4% for all items. The factor structure was reproduced identically with the original EORTC QLQ-C15-PAL, English version. The correlation of subscales showed a reasonable matrix. Cronbach's alpha coefficients were 0.76 to 0.86, and intraclass correlation coefficients, which indicate test-retest reliability, ranged from 0.52 to 0.77. All subscales, especially physical functioning, fatigue, and pain, were significantly correlated with self-reported Eastern Cooperative Oncology Group performance status. CONCLUSION: The Japanese version of EORTC QLQ-C15-PAL has sufficient validity, acceptable reliability, and feasibility for patients with advanced cancer.

Assessment of reasons for referral and activities of hospital palliative care teams using a standard format: a multicenter 1000 case description.

CONTEXT: The many benefits of hospital palliative care teams (PCTs) are well known. However, their specific activities have not been fully clarified, and no standardized methods for reporting PCT activities are available. OBJECTIVES: The aim of this study was to investigate, through the use of a standard format, the activities performed by hospital PCTs in Japan. METHODS: This was a prospective observational study. A total of 21 hospital PCTs were included in this study, and each recruited approximately 50 consecutively referred patients. Participating PCTs filled in a standard form for reporting activities. RESULTS: We obtained data from 1055 patients who were referred to PCTs. Of the 1055 patients, 1005 patients (95%) had cancer. The median number of reasons for referral and problems identified by PCTs was two (0-22) and four (0-18), respectively. The two major reasons for referral were pain (63%) and anxiety/depression/grief/emotional burden (22%). The major recommendations were pharmacological treatment (74%), care for the patient's physical symptoms (49%), and support for patient's decision making (38%). The major activities performed by the PCTs were comprehensive assessment (90%), care for the patient's physical symptoms (77%), and pharmacological treatment (74%). CONCLUSION: The components of hospital PCT activities were successfully measured using the Standard Format for Reporting Hospital PCT Activity. The results of this study and the format for reporting hospital PCT activity could be effective in improving hospital PCT practice and for the education of new hospital PCT members.

Sublingually administered scopolamine for nausea in terminally ill cancer patients.

PURPOSE: The primary aim of this study was to clarify the effect of sublingual scopolamine on the intensity of nausea. PATIENTS AND METHODS: This was an open uncontrolled study, and the study participants were cancer patients consecutively admitted to a palliative care unit in Japan. When the patients had nausea, they were administered a solution of scopolamine at 0.15 mg sublingually. The intensities of nausea were assessed using the 6-point Numerical Rating Scale (NRS 0 = no nausea to 5 = worst nausea) before and 15, 30, and 60 min after administration. Primary endpoints were (1) changes in the NRS of nausea and (2) percentage of patients who achieved a decrease in NRS of 1 or more points 15 min after treatment. RESULTS: Twenty-six patients were recruited for this study. The median NRS significantly decreased from 3.0 (range, 1-5) to 1.5 (0-5) after 15 min, and 84 % (n = 21) of the patients achieved a decrease in NRS of 1 or more points after 15 min. In addition, the median NRS significantly decreased from 3.0 (before) to 0 (30 min) and 0 (60 min). The percentage of patients who achieved a decrease in NRS over 1 point was 96 % (n = 25) in 30 min and 100 % (n = 26) in 60 min. Fifteen percent (n = 4) showed drowsiness. No other adverse effects were reported. CONCLUSION: Sublingually administered scopolamine may be effective for managing nausea in terminally ill cancer patients. Randomized controlled trials are promising.

Multicenter prospective study on efficacy and safety of octreotide for inoperable malignant bowel obstruction.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of octreotide for malignant bowel obstruction in a multicenter study. METHODS: Terminally ill patients diagnosed with inoperable malignant bowel obstruction were treated with octreotide 300 microg/day. The primary endpoint was the overall improvement rate of subjective abdominal symptoms. The degrees of nausea, vomiting, abdominal pain, distension, anorexia, fatigue, thirst and overall quality of life were evaluated by the self-rating scores selected from the MD Anderson Symptoms Inventory and Kurihara's Face Scale. RESULTS: Forty-nine patients were enrolled in the study, and 46 patients received study treatment, including 17 gastric, 13 colorectal, 7 ovarian and other cancers. The median survival time was 25 days. The number of vomiting episodes significantly correlated with the MD Anderson Symptoms Inventory nausea and vomiting scores (P< 0.001) before octreotide treatment. Of 43 patients evaluable for efficacy, the scores of all the MD Anderson Symptoms Inventory items except abdominal pain and the number of vomiting episodes improved during the first 4 days of octreotide treatment (P< 0.0062). The MD Anderson Symptoms Inventory scores were decreased in 59-72% of patients, and overall quality-of-life scores improved in 56% of patients. No serious adverse events were observed. CONCLUSIONS: The high improvement rate in abdominal symptoms suggested the efficacy of octreotide in terminally ill patients with malignant bowel obstruction.