Association between tumor response to systemic therapy and patient-reported disease symptoms.

BACKGROUND: The association of treatment-induced tumor shrinkage with symptom palliation for patients with lung cancer remains unknown. We investigated this correlation using the Edmonton Symptom Assessment System-Revised. METHODS: Using the in-hospital cancer registry, we identified patients receiving chemotherapy and/or immunotherapy for newly diagnosed advanced or metastatic lung cancer. Tumor response and post-treatment Edmonton Symptom Assessment System-Revised were obtained after 2-3 treatment cycles. Patients were divided into groups with or without >30% unidirectional tumor shrinkage (objective response [OR] or non-OR [N-OR] groups, respectively). They were further classified as good-objective response (>50% unidirectional tumor shrinkage), moderate-objective response (30-50% shrinkage), progressive disease (>20% tumor growth or new lesion) or stable disease (SD; N-objective response and non-progressive disease). The primary endpoint was change in the total Edmonton Symptom Assessment System-Revised score from baseline. The Mann-Whitney U test was used for analysis. RESULTS: In total, 113 patients were enrolled. The total Edmonton Symptom Assessment System-Revised score was significantly more improved in the OR group versus the N-OR group (median: 5 vs. 2, respectively; P = 0.013). This association was more prominent in patients with small-cell lung cancer and large-cell neuroendocrine tumor than those with other histology. Sensitivity analyses showed that the total Edmonton Symptom Assessment System-Revised score was more improved in the OR group versus the SD group (median: 5 vs. 3, respectively; P = 0.029) and in the 'good-OR' group versus the 'moderate-OR and SD' group (median: 7.5 vs. 2, respectively; P = 0.003), suggesting that greater tumor shrinkage led to more symptom amelioration. CONCLUSIONS: Tumor shrinkage was associated with Edmonton Symptom Assessment System-Revised score improvement in patients with lung cancer receiving systemic therapy.

Evaluating symptom burden in kidney transplant recipients: validation of the revised Edmonton Symptom Assessment System for kidney transplant recipients - a single-center, cross-sectional study.

We assessed the validity of the Edmonton Symptom Assessment System (ESAS-r) in kidney transplant recipients (KTR). A cross-sectional sample of 252 KTR was recruited. Individual ESAS-r symptom scores and symptom domain scores were evaluated. Internal consistency, convergent validity, and construct validity were assessed with Cronbach's α, Spearman's rank correlations, and a priori-defined risk group comparisons. Mean (SD) age was 51 (16), 58% were male, and 58% Caucasian. ESAS-r Physical, Emotional, and Global Symptom Scores demonstrated good internal consistency (α > 0.8 for all). ESAS-r Physical and Global Symptom Scores strongly correlated with PHQ-9 scores (0.72, 95% CI: 0.64-0.78 and 0.74, 95% CI: 0.67-0.80). For a priori-defined risk groups, individual ESAS-r symptom score differed between groups with lower versus higher eGFR [pain: 1 (0-3) vs. 0 (0-2), delta = 0.18; tiredness: 3 (1-5) vs. 1.5 (0-4), delta = 0.21] and lower versus higher hemoglobin [tiredness: 3 (1-6) vs. 2 (0-4), delta = 0.27]. ESAS-r Global and Physical Symptom Scores differed between groups with lower versus higher hemoglobin [13 (6-29) vs. 6.5 (0-18.5), delta = 0.3, and 9 (2-19) vs. 4 (0-13), delta = 0.24] and lower versus higher eGFR [11 (4-20) vs. 6.5 (2-13), delta = 0.21, and 7 (2-16) vs. 3 (0-9), delta = 0.26]. These data support reliability and construct validity of ESAS-r in KTR. Future studies should explore its clinical utility for symptom assessment among KTR.

Could symptom burden predict subsequent healthcare use in patients with end stage kidney disease on hemodialysis care? A prospective, preliminary study.

Context: Patients treated with maintenance hemodialysis experience significant symptom burden resulting in impaired quality of life. However, the association of patient reported symptom burden and the risk of healthcare use for patients with end stage kidney disease on hemodialysis has not been fully explored.Objectives: To investigate if higher symptom burden, assessed by the Edmonton Symptom Assessment System-revised (ESASr), is associated with increased healthcare use in patients with end stage kidney disease on hemodialysis.Methods: Prospective, single-center, study of adult patients on HD. Participants completed the ESASr questionnaire at enrollment. Baseline demographic, clinical information as well as healthcare use events during the 12-month following enrollment were extracted from medical records. The association between symptom burden and healthcare use was examined with a multivariable adjusted negative binomial model.Results: Mean (SD) age of the 80 participants was 71 (13) years, 56% diabetic, and 70% male. The median (IQR) dialysis vintage was 2 (1-4) years. In multivariable adjusted models, higher global [incident rate ratio (IRR) 1.02, 95% confidence interval (CI) 1.00-1.04, p = .025] and physical symptom burden score [IRR 1.03, CI 1.00-1.05, p = .034], but not emotional symptom burden score [IRR 1.05, CI 1.00-1.10, p = .052] predicted higher subsequent healthcare use.Conclusions: Our preliminary evidence suggests that higher symptom burden, assessed by ESASr may predict higher risk of healthcare use amongst patients with end stage kidney disease on hemodialysis. Future studies need to confirm the findings of this preliminary study and to assess the utility of ESASr for systematic symptom screening.

Integration of a Clinical Pharmacist into an Interdisciplinary Palliative Care Outpatient Clinic.

OBJECTIVES: The primary objective of this quality improvement (QI) project was to determine if the Interdisciplinary Palliative Care Outpatient Clinic (IPCOC) at the West Palm Beach Veterans Affairs Medical Center offered improved symptom assessment and palliative care treatment outcomes. Secondary objectives were to identify, classify, and resolve medication problems and calculate the number of pharmacist recommendations accepted by prescribing providers. METHODS: An IPCOC was created by selecting disciplines for a core group including a nurse practitioner, clinical pharmacist, social worker, chaplain, and physician. Consult referrals were recruited by providing educational sessions. The patient assessments were completed using the Edmonton Symptom Assessment System: (revised version; ESAS-R). The clinical pharmacist classified and resolved drug-related problems. The pharmacy resident telephoned veterans for completion of the "Patient Assessment: Overall Satisfaction with Outpatient Palliative Care Clinic." RESULTS: Seventeen consults were received, 6 patients were excluded, and 11 were seen in clinic. One (9%) of 11 patients met the outcomes measure of system assessment documentation in the past year. At completion, 11 (100%) of 11 patients met the outcomes data measure. The Patient Satisfaction Assessment revealed veterans strongly agree to recommend the IPCOC. The clinical pharmacist identified 20 drug-related problems, made 16 recommendations, had a 93.7% implementation rate, and facilitated implementation of medication changes. CONCLUSION: This QI project demonstrates that an IPCOC improved symptom assessment and palliative care outcomes in addition to resolution of medication prescribing issues in veterans with advanced cancer by integration of a clinical pharmacist into the core team.

Development of a French Version of the Edmonton Symptom Assessment System-Revised: A Pilot Study of Palliative Care Patients' Perspectives.

BACKGROUND: The Edmonton Symptom Assessment System-revised (ESAS-r) is a nine-item self-report symptom intensity tool developed for palliative care patients, with the option of adding a 10th patient-specific symptom. Due to growing international uptake, the ESAS-r has been translated into different languages. There has not been agreement, however, regarding a standard process for translation into multiple languages, which also includes patients' perspectives. OBJECTIVE: The purpose of this study was to develop a French version of the ESAS-r, using a standardized translation protocol, and to obtain palliative care patients' perspectives regarding this translated tool. DESIGN: We developed a French version of the ESAS-r, using a standard translation method, involving both professional translators (n = 2) and bilingual palliative care experts (n = 3). Fifteen Francophone participants recruited from palliative care sites in two urban centers in Canada completed the ESAS-r and provided feedback on the translation, in the presence of a trained interviewer. Descriptive statistics and thematic analysis were used to analyze the quantitative and qualitative data, respectively. SETTING/SUBJECTS: Fifteen Francophone participants were recruited from palliative care sites in two urban centers in Canada. MEASUREMENTS: Participants completed the ESAS-r and provided feedback on the translation in the presence of a trained interviewer. Descriptive statistics and thematic analysis were used to analyze the quantitative and qualitative data, respectively. RESULTS: Based on participants' concerns, translations for four of the nine symptoms were revised: drowsiness, nausea, lack of appetite, and shortness of breath. Concerns expressed for three additional symptoms (depression, anxiety, and well-being) were related to overall difficulty rating these symptoms, not specific to the translation. CONCLUSION: The French version of the ESAS-r is a credible tool for symptom assessment in Francophone patients. The study findings provide a vital step in the development of a standardized translation protocol, including patients' perspectives, which can be applied to other languages.

Validation of the Japanese Version of the Edmonton Symptom Assessment System-Revised.

CONTEXT: The Edmonton Symptom Assessment System-revised (ESAS-r) is a brief and widely used symptom measurement tool. OBJECTIVES: To validate the Japanese version of the ESAS-r in Japanese patients with cancer. METHODS: We 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-Core 30. RESULTS: Cronbach's 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 (P < 0.0001). CONCLUSION: The Japanese version of the ESAS-r is a reliable and valid tool for measuring symptoms in Japanese adult patients with cancer.