BACKGROUND Fatigue is a major disease and treatment burden for cancer patients. Several scales have been created to measure fatigue, but many are long and difficult for very ill patients to complete, or they are not easy to translate for non‐English speaking patients. The Brief Fatigue Inventory was developed for the rapid assessment of fatigue severity for use in both clinical screening and clinical trials. METHODS The study enrolled 305 consecutive, consenting adult inpatients and outpatients with cancer who could understand and complete the self‐report measures used in the study. The same instruments also were administered to 290 community‐dwelling adults to obtain a comparison sample. Research staff completed a form that indicated the primary site and stage of the cancer, rated the Eastern Cooperative Oncology Group performance status of the patient, described the characteristics of the pain, and described the current pain treatment being provided to the patients. RESULTS The BFI was shown to be an internally stable (reliable) measure that tapped a single dimension, best interpreted as severity of fatigue. It correlated highly with similar fatigue measures. Greater than 98% of patients were able to complete it. A range of scores defining severe fatigue was identified. CONCLUSIONS The BFI is a reliable instrument that allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Cancer 1999;85:1186–96. © 1999 American Cancer Society.

As a way of delineating different levels of cancer pain severity, we explored the relationship between numerical ratings of pain severity and ratings of pain's interference with such functions as activity, mood, and sleep. Interference measures were used as critical variable to grade pain severity. We explored the possibility that pain severity could be classified into groupings roughly comparable to mild, moderate, and severe. Our hypothesis was that mild, moderate, and severe pain would differentially impair cancer patients' function. We were able to identify boundaries among these categories of pain severity in terms of their interference with function. We also examined the extent to which cancer patients from different language and cultural groups differ in their self-reported interference as a function of pain severity level. We found optimal cutpoints that form 3 distinct levels of pain severity that can be defined on a 0-10-point numerical scale. We determined that, based on the degree of interference with cancer patients' function, ratings of 1-4 correspond to mild pain, 5-6 to moderate pain, and 7-10 to severe pain. Our analysis illustrates that the pain severity-interference relationship is non-linear. These cutpoints were the same for each of the national samples in our analysis, although there were slight differences in the specific interference items affected by pain. These cutpoints might be useful in clinical evaluation, epidemiology, and clinical trials.

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Results support the validity of the BPI as a measure of pain in patients without cancer and, in particular, as a measure of pain for arthritis and LBP patients.

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.