The ability of existing questionnaires to measure symptom change after paracentesis for symptomatic ascites

Background: Symptomatic malignant ascites is a problem for patients with advanced intra-abdominal malignancy. Although the goal of paracentesis, the most common therapeutic intervention, is symptom palliation, the best method of assessing symptom improvement is unknown. The aim of this study was to assess the ability of existing symptom and quality-of-life questionnaires to detect change in symptoms after paracentesis. Methods: Patients with symptomatic ascites completed four questionnaires before and 24 hours after paracentesis. These tests were Edmonton Symptom Assessment System-Ascites Modification (ESAS:AM), Memorial Symptom Assessment Scale-Short Form, European Organization for the Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), and the EORTC Core Quality of Life Questionnaire, 26-item pancreatic cancer module (QLQ-PAN26). Sensitivity, validity, reliability, and responsiveness of the questionnaires were evaluated. Results: Sixty-one patients completed the baseline and 44 the follow-up questionnaire. Most patients had ovarian (41%) or gastrointestinal cancer (25%); Eastern Cooperative Oncology Group performance status was 2 (26%) and 3 (49%). Patients reported major symptoms at baseline; symptom scores were highest for the clinically recognized symptoms of ascites. Most patients (78%) reported that their symptoms improved after paracentesis. All questionnaires showed strong sensitivity, validity, and reliability. Subscales that included the most distressing symptoms were most responsive; great improvement was seen in abdominal bloating (42% to 54%), anorexia (20% to 37%), dyspnea (33% to 43%), insomnia (29% to 31%), fatigue (14% to 17%), and mobility (25%). The amount of fluid removed (median, 3.5 L; range, .3% to 9.7 L) did not correlate with symptom improvement (r = .29, P = -.10). Conclusions: Paracentesis provides symptom relief that can be measured by existing questionnaires. For future clinical trials of symptomatic ascites, the QLQ-C30 and the ESAS:AM together, or the QLQ-C30 with the addition of the QLQ-PAN26 ascites and abdominal pain subscales could be used.