Charles S. Cleeland

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

AbstractObjective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of d

Development of the Wisconsin brief pain questionnaire to assess pain in cancer and other diseases

Abstract This paper reports the development of a self‐report instrument designed to assess pain in cancer and other diseases. It is argued that issues of reliability and validity should be considered for every pain questionnaire. Most research on measures of pain examine reliability to the relative neglect of validity concerns. The Wisconsin Brief Pain Questionnaire (BPQ) is evaluated with regard to both reliability and validity. Data from patients with cancer at 4 primary sites and from patients with rheumatoid arthritis suggest that the BPQ is sufficiently reliable and valid for research purposes. Additional methodological and theoretical issues related to validity are discussed, and the need for continuing evaluation of the BPQ and other measures of clinical pain is stressed.

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.

Core outcome domains for chronic pain clinical trials

&NA; Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

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.

Relationship between Changes in Hemoglobin Level and Quality of Life During Chemotherapy in Anemic Cancer Patients Receiving Epoetin Alfa Therapy

Hemoglobin increases have been associated with quality of life (QOL) improvements in anemic cancer patients treated with epoetin alfa, but intervention generally has been reserved for symptomatic anemia or hemoglobin < 10 g/dL. Relationships among hemoglobin, functional status, and patient reported QOL have not been well characterized.

Are the symptoms of cancer and cancer treatment due to a shared biologic mechanism? A cytokine-immunologic model of cancer symptoms

Cancers and cancer treatments produce multiple symptoms that collectively cause a symptom burden for patients. These symptoms include pain, wasting, fatigue, cognitive impairment, anxiety, and depression, many of which co‐occur. There is growing recognition that at least some of these symptoms may share common biologic mechanisms.

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure

OBJECT The authors report data concerning the safety, effectiveness, and patterns of failure obtained in a Phase I/II study of stereotactic body radiotherapy (SBRT) for spinal metastatic tumors. METHODS Sixty-three cancer patients underwent near-simultaneous computed tomography-guided SBRT. Spinal magnetic resonance imaging was conducted at baseline and at each follow-up visit. The National Cancer Institute Common Toxicity Criteria 2.0 assessments were used to evaluate toxicity. RESULTS The median tumor volume of 74 spinal metastatic lesions was 37.4 cm3 (range 1.6-358 cm3). No neuropathy or myelopathy was observed during a median follow-up period of 21.3 months (range 0.9-49.6 months). The actuarial 1-year tumor progression-free incidence was 84% for all tumors. Pattern-of-failure analysis showed two primary mechanisms of failure: 1) recurrence in the bone adjacent to the site of previous treatment, and 2) recurrence in the epidural space adjacent to the spinal cord. Grade 3 or 4 toxicities were limited to acute Grade 3 nausea, vomiting, and diarrhea (one case); Grade 3 dysphagia and trismus (one case); and Grade 3 noncardiac chest pain (one case). There was no subacute or late Grade 3 or 4 toxicity. CONCLUSIONS Analysis of the data obtained in the present study supports the safety and effectiveness of SBRT in cases of spinal metastatic cancer. The authors consider it prudent to routinely treat the pedicles and posterior elements using a wide bone margin posterior to the diseased vertebrae because of the possible direct extension into these structures. For patients without a history of radiotherapy, more liberal spinal cord dose constraints than those used in this study could be applied to help reduce failures in the epidural space.

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.