Validation and Application of MD Anderson Symptom Inventory Module for Patients with Bladder Cancer in the Perioperative Setting

Abstract

Objectives: We developed and validated a disease-specific tool for perioperative patient-reported outcomes assessment for bladder cancer (BLC) patients undergoing radical cystectomy, The MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). Methods: Patients who underwent radical cystectomy were recruited. We used qualitative interviews and experts’ input to generate disease/treatment-specific items of the MDASI-PeriOp-BLC module; conducted item reduction; examined the psychometric properties of the resultant items for reliability, validity, and clinical interpretability; and conducted cognitive debriefing interviews to assess the tool’s performance. Results: A total of 150 BLC patients contributed to psychometric validation. We identified and defined eight BLC-specific module items (blood in urine, leaking urine, frequent urination, urinary urgency, burning with urination, constipation, changes in sexual function, and stomal problems). We included those 8 items in addition to 13 MDASI core symptoms and 6 interference items to form the MDASI-PeriOp-BLC module. Cronbach alphas were 0.89 and 0.90 for the 21 severity items and the 6 interference items, respectively. Test–retest reliability (intra-class correlation) was 0.92 for the 21 severity items. The MDASI-PeriOp-BLC module significantly differentiated the patients by performance status (p < 0.0001). Conclusions: The MDASI-PeriOp-BLC is a valid, reliable, and concise tool for monitoring symptom burden during perioperative care in BLC patients undergoing radical cystectomy.

Utility of Patient-Reported Symptom and Functional Outcomes to Indicate Recovery after First 90 Days of Radical Cystectomy: A Longitudinal Study

“…PRO measures were either completed online by the patients or over the phone by a trained study coordinator. In this longitudinal study, we utilized REDCap [14] as the data collection platform to administer the validated MDASI-PeriOp-BLC module (8) and to track electronic PROs (ePROs) perioperatively, daily during hospitalization, on the day of discharge, post-discharge on days 3 and 7, weekly during first 12 weeks after surgery and at the end of the study.…”

“…The symptom assessment tool MDASI-PeriOp-BLC [8] was developed and psychometrically validated for use in perioperative care for patients with BLC, followed with FDA guidance for development and validation of PRO tools [17]. MDASI-PeriOp-BLC includes 13 common cancer-related symptoms (fatigue, pain, sleep disturbance, poor appetite, distress, drowsiness, dry mouth, shortness of breath, sadness, numbness/tingling, nausea, vomiting, difficulty remembering) and 8 PeriOp-BLC module items (including blood in urine, leaking urine, frequent urination, urinary urgency, constipation, burning with urination, changes in sexual function and stomal problems).…”

“…While uniform reporting standards for PRO use in BLC are important to fully utilize such data [5], disease/treatment-specific PRO tools are also critical. The MD Anderson Symptom Inventory (MDASI-PeriOpBLC) has been specifically developed and psychometrically validated for assessing symptom burden and functioning in the perioperative period for BLC patients [8], and this was utilized in the current study.…”