Yoko Tarumi

Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate in the Management of Constipation in Hospice Patients

CONTEXTnThe stool softener docusate is widely used in the management of constipation in hospice patients. There is little experimental evidence to support this practice, and no randomized trials have been conducted in the hospice setting.nnnOBJECTIVESnTo assess the efficacy of docusate in hospice patients.nnnMETHODSnThis was a 10-day, prospective, randomized, double-blind, placebo-controlled trial of docusate and sennosides vs. placebo and sennosides in hospice patients in Edmonton, Alberta. Patients were included if they were age 18 years or older, able to take oral medications, did not have a gastrointestinal stoma, and had a Palliative Performance Scale score of 20% or more. The primary outcome measures were stool frequency, volume, and consistency. Secondary outcomes were patient perceptions of bowel movements (difficulty and completeness of evacuation) and bowel-related interventions.nnnRESULTSnA total of 74 patients were randomized into the study (35 to the docusate group and 39 to the placebo group). There were neither significant differences between the groups in stool frequency, volume, or consistency, nor in difficulty or completeness of evacuation. On the Bristol Stool Form Scale, more patients in the placebo group had Type 4 (smooth and soft) and Type 5 (soft blobs) stool, whereas in the docusate group, more had Type 3 (sausage like) and Type 6 (mushy) stool (P=0.01).nnnCONCLUSIONnThere was no significant benefit of docusate plus sennosides compared with placebo plus sennosides in managing constipation in hospice patients. Docusate use should be considered on an individual basis.

Evaluation of the Palliative Prognostic Score (PaP) and routinely collected clinical data in prognostication of survival for patients referred to a palliative care consultation service in an acute care hospital.

CONTEXTnPatients, caregivers, and clinicians require high levels of information regarding prognosis when conditions are incurable.nnnOBJECTIVESn1) To validate the Palliative Prognostic Score (PaP) and 2) to evaluate prognostic capacity of used clinical tools and the diagnosis of delirium, in a population referred to a palliative care consultation service at a Canadian acute care hospital.nnnMETHODSnThis was a prospective observational cohort study on survival prediction based on the PaP and routinely collected clinical data, including the Palliative Performance Scale (PPS) and the Folstein Mini-Mental State Examination (MMSE). Kaplan-Meier survival curves, log-rank tests for significant differences between survival curves, and the Cox proportional hazards model were used to identify the relationship between the hazard ratio for death and the above variables.nnnRESULTSnNine hundred fifty-eight cases underwent final analysis, of which 181 (19%) had a noncancer diagnosis. Median and mean survival were 35 and 131 days, respectively. The three groups, divided based on different ranges of PaP, had significantly different survival curves, with 30-day-survival rates of 78%, 55%, and 11%. Age, PPS, and PaP remained significantly associated with survival, whereas diagnosis group, MMSE, and delirium became insignificant, despite lower hazard of death for cancer vs. noncancer and higher hazard for abnormal vs. normal MMSE and presence vs. absence of delirium.nnnCONCLUSIONnThe PaP was successfully validated in a population with characteristics that extend beyond those of the population in which it was originally developed. This is the largest sample in which the PaP has been validated to date.

A Randomized Double-Blind Crossover Comparison of Continuous and Intermittent Subcutaneous Administration of Opioid for Cancer Pain

ABSTRACT Although the preferred route of opioid administration is oral, patients with cancer often require an alternative route. Options include continuous subcutaneous infusion (CSCI) or regularly scheduled intermittent subcutaneous injections (ISCI). CSCI maintains steady drug levels, theoretically avoiding the bolus effect of nausea and sedation immediately post-dose, and breakthrough pain prior to the next dose. However, portable infusion pumps can be costly to use. The Edmonton Injector is an inexpensive portable device for ISCI. CSCI and ISCI have not been directly compared. The objective of this trial was to compare CSCI and ISCI of opioid for treatment of cancer pain. Patients were recruited from two tertiary palliative care units. Eligibility criteria included stable cancer pain requiring opioid therapy, need for parenteral route, and normal cognition. Patients were randomly assigned to receive opioid by CSCI by portable pump or ISCI by Edmonton Injector for 48 hours, followed by crossover to the alternative modality for 48 hours. During each phase, placebo was administered by the alternative modality. The study was closed after 12 patients were entered, due to slow accrual. Eleven patients completed the study. There were no differences between CSCI and ISCI in mean visual analogue score (VAS) for pain, nausea or drowsiness; categorical rating score of pain; number of breakthrough opioid doses per day; global rating of treatment effectiveness; or adverse effects. In all cases, patients and investigators expressed no preference for one modality over another. Further research is required to confirm that opioid administration by CSCI and ISCI provide similar analgesic and adverse effects.

Validation of the Japanese Version of the Edmonton Symptom Assessment System–Revised

CONTEXTnThe Edmonton Symptom Assessment System-revised (ESAS-r) is a brief and widely used symptom measurement tool.nnnOBJECTIVESnTo validate the Japanese version of the ESAS-r in Japanese patients with cancer.nnnMETHODSnWe assessed the internal consistency, test-retest reliability, concurrent validity, and known-group validity in 292 Japanese adult patients with cancer. They completed Japanese versions of the ESAS-r, M. D. Anderson Symptom Inventory, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Corexa030.nnnRESULTSnCronbachs alpha coefficient of the Japanese version of the ESAS-r was 0.87. The intraclass correlation coefficient in the test-retest examination ranged from 0.82 to 0.91 for each symptom score and was 0.90 for the total score. Pearson correlation coefficients of each ESAS-r symptom score with corresponding M. D. Anderson Symptom Inventory and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items ranged from 0.45 to 0.80. The total score of the ESAS-r was significantly higher in patients with an Eastern Cooperative Oncology Group performance status of 2-4 than in those with a performance status of 0 and 1 (Pxa0<xa00.0001).nnnCONCLUSIONnThe Japanese version of the ESAS-r is a reliable and valid tool for measuring symptoms in Japanese adult patients with cancer.

Establishing Cutoff Points for Defining Symptom Severity Using the Edmonton Symptom Assessment System-Revised Japanese Version

CONTEXTnSymptom screening is important for appropriate symptom management. It remains uncertain as to which scores on the Edmonton Symptom Assessment System-Revised (ESAS-r) comprise the optimal cutoff points to determine symptom severity for Japanese cancer patients.nnnOBJECTIVESnTo investigate optimal cutoff points for individual ESAS-r items for detecting symptom severity and to evaluate the screening performance of the ESAS-r depression item in Japanese cancer patients.nnnMETHODSnWe recruited cancer patients receiving palliative care from five tertiary acute hospitals in Japan. We asked participants to complete the ESAS-r Japanese version, Verbal Rating Symptom Severity Scale, and Quick Inventory of Depressive Symptomatology-Self-Report Japanese version. We calculated sensitivity and specificity for detecting severe and moderate/severe symptoms evaluated by the Verbal Rating Symptom Severity Scale at different cutoff points of the ESAS-r. We also calculated sensitivity and specificity for detecting both the presence of depression and moderate/severe depression evaluated by the Quick Inventory of Depressive Symptomatology-Self-Report at various cutoff points for the depression item of the ESAS-r Japanese version.nnnRESULTSnA total of 292 participants completed the questionnaire. For most of the ESAS-r symptoms, cutoff points to achieve the best balance between sensitivity and specificity were 5-7 for determining severe intensity and 3-4 for determining moderate/severe intensity. For the ESAS-r depression item, a cutoff point of 2 achieved the best balance between sensitivity and specificity for detecting both the presence of depression and moderate/severe depression.nnnCONCLUSIONnThe ESAS-r Japanese version can accurately represent the severity of many symptoms. The cutoff points established for determining the level of symptom severity using ESAS-r provides a guide for symptom management in Japanese cancer patients.

What is stable pain control? A prospective longitudinal study to assess the clinical value of a personalized pain goal:

Background: A universal consensus regarding standardized pain outcomes does not exist. The personalized pain goal has been suggested as a clinically relevant outcome measure. Aim: To assess the feasibility of obtaining a personalized pain goal and to compare a clinically based personalized pain goal definition versus a research-based study definition for stable pain. Design: Prospective longitudinal descriptive study. Measures: The attending physician completed routine assessments, including a personalized pain goal and the Edmonton Classification System for Cancer Pain, and followed patients daily until stable pain control, death, or discharge. Stable pain for cognitively intact patients was defined as pain intensity less than or equal to desired pain intensity goal (personalized pain goal definition) or pain intensity ⩽3 (Edmonton Classification System for Cancer Pain study definition) for three consecutive days with <3 breakthroughs per day. Setting/participants: A total of 300 consecutive advanced cancer patients were recruited from two acute care hospitals and a tertiary palliative care unit. Results: In all, 231/300 patients (77%) had a pain syndrome; 169/231 (73%) provided a personalized pain goal, with 113/169 (67%) reporting a personalized pain goal ⩽3 (median = 3, range = 0–10). Using the personalized pain goal definition as the gold standard, sensitivity and specificity of the Edmonton Classification System for Cancer Pain definition were 71.3% and 98.5%, respectively. For mild (0–3), moderate (4–6), and severe (7–10) pain, the highest sensitivity was for moderate pain (90.5%), with high specificity across all three categories (95%–100%). Conclusion: The personalized pain goal is a feasible outcome measure for cognitively intact patients. The Edmonton Classification System for Cancer Pain definition closely resembles patient-reported personalized pain goals for stable pain and would be appropriate for research purposes. For clinical pain management, it would be important to include the personalized pain goal as standard practice.

Survival Prediction of End Stage Cancer Patients: A Quick Review

Survival prediction for end stage cancer patientsremains an important task in Palliative Medicine. Previously more of an art form, survival prediction has now become increasingly objective, utilizing statistical estimates of survival. Both clinician prediction survival and actuarial estimation of survival have their uses and drawbacks. This article examines the pros and cons of each and how both can be utilized at the bedside.

Re: Clinical Pastoral Education: A Physician’s Experience and Reflection on the Meaning of Spiritual Care in Palliative Care

Clinical Pastoral Education (CPE) has become a well-known trademark in healthcare chaplaincy. Not only does the program serve the educational needs of those in the health care chaplaincy profession, but CPE has become a program model for schools that offer Supervised Ministry programs (practicum); however, a keen review of the juxtaposition of the CPE curriculum with its corporate identity reveals inconsistency and disparity. A logical conclusion: this calls for a change to the corporate or program name.

Single-Nucleotide Polymorphisms in TAOK3 Are Associated With High Opioid Requirement for Pain Management in Patients With Advanced Cancer Admitted to a Tertiary Palliative Care Unit

PURPOSEnDifferent amounts of opioid are required for the relief of cancer pain in different individuals, raising the possibility that genetic factors play a role. We tested the hypothesis that genetic variations in the TAOK3 (TAO kinase 3, encoding serine/threonine-protein kinase) explain some of the interindividual variations related to the morphine-equivalent daily dose (MEDD) in patients with cancer.nnnEXPERIMENTAL DESIGNnWe selected two single-nucleotide polymorphisms (SNPs) in the TAOK3, reported earlier to associate with higher MEDD in postoperative pain based on genome-wide association study. We investigated their association with MEDD in Canadian patients with cancer (nxa0=xa0110) admitted to a tertiary palliative care unit. SNPs analyzed were rs1277441 (C/T, Cxa0=xa0minor allele) and rs795484 (A/G, Axa0=xa0minor allele).nnnRESULTSnMinor allele frequencies in our population were 0.29 (rs1277441) and 0.28 (rs795484). These SNPs were in perfect linkage disequilibrium (r2xa0=xa00.97). SNPs in TAOK3 showed a significant association with mean MEDD ≥800xa0mg. For rs795484, MEDD values ≥800xa0mg occurred in patients who were GG (7%), GA (18%), and AA (57%) (Pxa0=xa00.004; Fishers exact test); similar results were obtained for rs1277441. Homozygous variants for either SNP had received higher numbers of different opioids (Pxa0=xa00.021).nnnCONCLUSIONnIn this cohort of patients with advanced cancer pain, TAOK3 SNPs were associated with opioid doses. This result supports the original findings from a GWAS in postoperative patients. The proportions of variant homozygotes (8.2% of patients) and their requirement for higher doses of opioids would appear potentially clinically important and should be validated in further studies.

Validation of the Edmonton Symptom Assessment System: Ascites Modification.

CONTEXTnFew patient-reported outcomes are available to measure the symptoms associated with malignant-related ascites in patient care and clinical research. Although the Edmonton Symptom Assessment System: Ascites Modification (ESAS:AM) is a brief tool to measure symptoms associated with malignant-related ascites, it remains to be fully validated.nnnOBJECTIVESnThe objective of the study was to validate the ESAS:AM in Japanese cancer patients.nnnMETHODSnWe assessed the internal consistency, test-retest reliability, concurrent validity, and construct validity in 292 Japanese adult patients with cancer. They completed Japanese versions of the ESAS:AM, M.D. Anderson Symptom Inventory, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, and abdominal pain/ascites subscales of the EORTC Core Quality of Life Questionnaire, 26-item pancreatic cancer module.nnnRESULTSnCronbachs alpha coefficient of the ESAS:AM was 0.89. The intraclass correlation coefficient on test-retest examination of its total score was 0.93 (Pxa0<xa00.001). Pearson correlation coefficients of the total score of the ESAS:AM with the total score of the M.D. Anderson Symptom Inventory and abdominal pain/ascites subscales of the EORTC Core Quality of Life Questionnaire, 26-item pancreatic cancer module ranged from 0.44 to 0.81 (Pxa0<xa00.001) and those with global health status/quality of life and functional subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 ranged from -0.40 to -0.61 (Pxa0<xa00.001). The total scores of the ESAS:AM were significantly higher in 20 patients with symptomatic ascites (34 [SD, 26]) than 267 patients without symptomatic ascites (23 [SD, 19]) (Pxa0=xa00.018).nnnCONCLUSIONnThe ESAS:AM is a reliable and valid tool for measuring symptoms associated with malignant-related ascites and can be used in daily patient care and future epidemiological studies and clinical trials.