No abstract

A self-report questionnaire module consisting of 24 items, comprising 5 scales and 7 single items, has been developed for measuring health-related quality of life in patients with brain cancer. Module development proceeded through several stages, including a listing of patient, family and health care professional concerns, the writing of items, field testing in 105 patients with brain cancer and subsequent item reduction and scale construction after multitrait scaling analysis and assessment of internal consistency (Cronbach's coefficient alpha). The final version of the module exhibits reasonable test-retest stability over a period of one week. Differences in the responses between patients with recently-diagnosed and recurrent cancer and between patients with a Karnofsky Performance Score (KPS) of 50-70 and 80-100 were in the expected direction, indicating that the module of questions is responsive to differing conditions. Patients with either mental confusion, motor deficit or dysphasia indicated problems in several domains and single items as compared to patients without these neurological deficits. Thus, differences in the responses to the items in the brain cancer module appear to reflect differences in neurological status. In addition, deteriorating neurological status was accompanied by a marked increase in emotional distress, future uncertainty and motor dysfunction. A comparison of the responses in the module with the KPS and with a modified Barthel Activities of Daily Living Index (BADLI) shows moderate correlations, primarily with scales and items that pertain to motor dysfunction, while other scales (such as emotional distress, visual disorder and communication deficit) and most single items are not associated with the KPS or BADLI. Since the emotional distress scale of the module was found to be highly correlated with the emotional function scale of the EORTC QLQ-C30, it could be omitted when the module is used in combination with the QLQ-C30. This would reduce the module to a total of 20 items with four scales and seven single items. The intention is to combine this module of questions with other core or general quality-of-life questionnaires when studying patients with brain cancer in clinical trials.

In general, patients and their significant others provide similar ratings of the patients' quality of life. Lower levels of agreement and more biased ratings can be expected among those patients for whom the need for proxies is most salient. It is argued, however, that discrepancies between patient-proxy ratings should not be interpreted, a priori, as evidence of the inaccuracy or biased nature of proxy-generated data. Future studies are needed to examine the relative validity and reliability of patient-versus proxy-generated health-related quality of life scores.

Several minor changes were made to the RUD instrument to improve the accuracy and precision of the data while maintaining comparability with the original version and reflecting current medical practice. The RUD Complete Version 4.0 is now available for use in future AD clinical trials.

The 22 item MDASI-BT demonstrated validity and reliability in patients with PBT. This instrument can be used to identify symptom occurrence throughout the disease trajectory and to evaluate interventions designed for symptom management.