Validation of the Edmonton Symptom Assessment System: Ascites Modification.

CONTEXT: Few 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. OBJECTIVES: The objective of the study was to validate the ESAS:AM in Japanese cancer patients. METHODS: We 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. RESULTS: Cronbach's alpha coefficient of the ESAS:AM was 0.89. The intraclass correlation coefficient on test-retest examination of its total score was 0.93 (P < 0.001). 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 (P < 0.001) 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 (P < 0.001). 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]) (P = 0.018). CONCLUSION: The 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.

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

CONTEXT: Symptom 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. OBJECTIVES: To 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. METHODS: We 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. RESULTS: A 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. CONCLUSION: The 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.

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.