Tito R. Mendoza

The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory.

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.

Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory.

The purpose of this project was to develop the M. D. Anderson Symptom Inventory (MDASI), a brief measure of the severity and impact of cancer‐related symptoms.

Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain.

Objectives:The Brief Pain Inventory (BPI) is a short, self-administered questionnaire that was developed for use in cancer patients. While most empirical research with the BPI has been in pain of that etiology, the questionnaire is increasingly evident in published studies of patients with non-cancer pain. The current research addresses the need for formal evaluation of the reliability and validity of the BPI for use in non-cancer pain patients. Methods:Approximately 250 patients with arthritis or low back pain (LBP) self-administered a number of generic and condition-specific health status measures (including the BPI) in the clinic of their primary care provider at 2 time points: the initial clinic visit and the first visit following treatment. Results:The reliability of BPI data collected from non-cancer pain patients was comparable to that reported in the literature for cancer patients and sufficient for group-level analyses (coefficient alphas were greater than 0.70). The factor structure of the BPI was replicated in this sample and the relationship of the BPI to generic measures of pain was strong. The BPI exhibited similar relationships to general and condition-specific measures of health as did a generic pain scale (SF-36 Bodily Pain). Finally, the BPI discriminated among levels of condition severity and was sensitive to change in condition over time in arthritis and LBP patients. Discussion: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.

Minority cancer patients and their providers : Pain management attitudes and practice

The goals of the current studies were: 1) to determine the pain treatment needs of socioeconomically disadvantaged African‐American and Hispanic patients with recurrent or metastatic cancer and 2) to assess the attitudes of health care professionals who treat them.

The Norwegian brief pain inventory questionnaire: translation and validation in cancer pain patients.

The European Association of Palliative Care recommends the Brief Pain Inventory questionnaire (BPI) as a pain assessment tool in clinical studies. After translation into Norwegian, we administered the BPI to 300 hospitalized cancer patients. Cronbachs alphas were computed to assess reliability, and factor analysis was utilized to ascertain construct validity. The BPI interference and pain severity scales were validated against items on pain intensity and pain influence on daily function in the European Organization for Research and Therapy of Cancer (EORTC) QLQ-C30 questionnaire. In total, 235 patients (78%) were able to complete the BPI questionnaire, but 82 (35%) of these questionnaires had one or more missing items. Cronbachs alphas were 0.87 for the pain severity and 0.92 for the interference scales. A factor analysis identified three factors; pain intensity, interference with physical function, and interference with psychological functions/sleep. These three factors explained 82% of the variance. The correlation between BPI pain severity index and the EORTC QLQ-C30 item on pain intensity was 0.70 (P < 0.001). The correlation between BPI interference index and the EORTC QLQ-C30 item on pain influence on daily living was 0.62 (P < 0.001). We conclude that BPI has satisfactory psychometric properties, but is not completed by a significant proportion of patients. Further research is needed to establish pain assessment tools for patients unable to answer a comprehensive pain questionnaire, to establish routines for analysis of missing values, and to investigate if pain interference items also reflect disease-related impairment.

The chinese version of the brief pain inventory (BPI-C): its development and use in a study of cancer pain

&NA; We describe the development of a Chinese version of the Brief Pain Inventory (BPI‐C) and demonstrate its reliability and validity. We also report the use of the BPI‐C in a three hospital study of cancer pain and its treatment. As with other language versions of the BPI, factor analysis of the BPI‐C items results in a two factor solution that satisfies the criteria of reproducibility, interpretability and fit in a confirmatory setting. The first factor consists of the four pain severity scales, while the seven pain interference scales comprised the second factor. The BPI‐C proved to be a reliable measure of both the severity and impact of pain in patients with cancer. Coefficient alphas for the pain severity and pain interference items were 0.894 and 0.915, respectively. The sample (N = 147) was gathered at three cancer treatment hospitals in Beijing. The patients from these hospitals reported higher levels of pain severity and pain interference compared with patients in similar studies done at the same time (1991–1992) in the United States and France. This was in keeping with the finding that a larger proportion (67%) of the cancer patients in these Beijing hospitals were judged to have inadequate analgesia as assessed by the Pain Management Index (PMI), an estimate of adherence to the World Health Organization (WHO) guidelines for cancer pain management.

Dimensions of the impact of cancer pain in a four country sample: New information from multidimensional scaling

&NA; We investigated the question of how cultural and linguistic backgrounds affect relationships among ratings (reported by patients with metastatic cancer) of pains reference with such functions as activity, mood, and sleep. Multidimensional scaling (MDS) was used to analyze ratings of pain interference from a sample consisting of four culturally and linguistically different groups from the US (n = 1106), France (n = 324), the Philippines (n = 267), and China (n = 146). Patients all completed the Brief Pain Inventory, a self‐report measure of pain and its interference with function. For each of these samples, MDS solutions consistently revealed two interpretable dimensions. In all samples, one dimension represented affect and the other dimension represented activity. The dimensions were consistently interpretable across all four samples and across three levels of pain severity (‘mild’, ‘moderate’, and ‘severe’). The dimensions were most prominent when pain was moderate, rather than mild (when little interference was produced) or severe (when all domains were highly interfered with). These dimensions may have utility in the study of the epidemiology of pain and of the effectiveness of pain treatment. They may also be useful in clinical assessment to describe different patterns of pain interference.

Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institutes (NCIs) 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.

Cancer pain management among underserved minority outpatients: Perceived needs and barriers to optimal control

Minority patients with cancer are at risk for undertreatment of cancer‐related pain. Most studies of patient‐related barriers to pain control have surveyed primarily non‐Hispanic Caucasian patients. The purpose of the current study was to explore barriers to optimal pain management among African‐American and Hispanic patients with cancer through the use of structured patient interviews. Structured interviews allowed the authors to probe for previously unidentified barriers to pain management in these populations.

Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis

The Brief Pain Inventory short form (BPI‐sf) is a validated, widely used, self‐administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions. A modified version was used daily in randomised control trials of patients with arthritis undergoing treatment with cyclooxygenase‐2 specific inhibitors and non‐steroidal anti‐inflammatory drugs. Results indicate that the modified BPI‐sf, much like the original scale, was internally reliable, consistent over time, and had good construct, as well as convergent and predictive validity in assessment of patients suffering from conditions of chronic pain. Each scale and individual pain intensity item refers to changes in osteoarthritis pain associated with medication use. The modified BPI‐sf, like the parent scale, is a valid and reliable tool for situations in which pain is assessed daily and minimises the burden placed on patients to record information necessary for scientific investigations.