Cleeland CS, Sloan JA, and the ASCPRO Steering Committee. Assessing the Symptoms of Cancer using Patient-Reported Outcomes (ASCPRO): Searching for Standards. J Pain Symptom Manage 39(6): 1077-1085, 2010.   [Link to PubMed]

Barsevick AM, Cleeland CS, Manning DC, O'Mara AM, Reeve BB, Scott JA, Sloan JA. ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials. J Pain Symptom Manage 39(6): 1086-1099, 2010.   [Link to PubMed]

Cleeland CS, Sloan JA, Cella D, Chen C, Dueck AC, Janjan NA, Liepa AM, Mallick R, O'Mara A, Pearson JD, Torigoe Y, Wang XS, Williams LA, Woodruff JF. Recommendations for including multiple symptoms as endpoints in oncology clinical trials: a report from the ASCPRO Multisymptom Task Force. Cancer: e-pub ahead of print, 2012.   [Link to PubMed]

 

Recommended Reading

Cleeland CS, Fisch MJ, Dunn AJ. Cancer Symptom Science: Measurement, Mechanisms, and Management. Cambridge UK: Cambridge University Press; 2011.

Cancer Symptom Science is the first interdisciplinary compilation of research on the mechanisms underlying the expression of cancer-related symptoms. It presents innovations in clinical, animal and in vitro research, research methods in brain imaging, and statistical-descriptive approaches to understanding the mechanistic basis of symptom expression. It also provides perspectives from patients, government and industry. By collecting and synthesizing the developing threads of new approaches to understanding cancer-related symptoms, the book promotes a pioneering framework for merging behavioral and biological disciplines to clarify mechanisms of symptom evolution, incorporating new technologies, testing novel agents for symptom control, and improving patient functioning and quality of life both during and after cancer treatment.

The editorial team includes MD Anderson faculty Charles Cleeland, PhD, chair of the Department of Symptom Research and Michael Fisch, MD, MPH, chair of the Department of General Oncology; and Adrian Dunn, PhD, of The University of Hawaii at Manoa. The book is targeted toward surgical, clinical and medical oncologists, nurses, academic researchers, fellows and nursing students, and pharmaceutical companies developing new agents to control symptom expression.

Cancer Symptom Science is available from Cambridge University Press and at bookstores online.

Broderick JE, Schwartz JE, Vikingstad G, Pribbernow M, Grossman S, Stone AA. The accuracy of pain and fatigue items across different reporting periods. Pain 139(1): 146-57, 2008.   [Link to PubMed]

ABSTRACT: The length of the reporting period specified for items assessing pain and fatigue varies among instruments. How the length of recall impacts the accuracy of symptom reporting is largely unknown. This study investigated the accuracy of ratings for reporting periods ranging from 1 day to 28 days for several items from widely used pain and fatigue measures (SF36v2, Brief Pain Inventory, McGill Pain Questionnaire, Brief Fatigue Inventory). Patients from a community rheumatology practice (N=83) completed momentary pain and fatigue items on average of 5.4 times per day for a month using an electronic diary. Averaged momentary ratings formed the basis for comparison with recall ratings interspersed throughout the month referencing 1-day, 3-day, 7-day, and 28-day periods. As found in previous research, recall ratings were consistently inflated relative to averaged momentary ratings. Across most items, 1-day recall corresponded well to the averaged momentary assessments for the day. Several, but not all, items demonstrated substantial correlations across the different reporting periods. An additional 7 day-by-day recall task suggested that patients have increasing difficulty actually remembering symptom levels beyond the past several days. These data were collected while patients were receiving usual care and may not generalize to conditions where new interventions are being introduced and outcomes evaluated. Reporting periods can influence the accuracy of retrospective symptom reports and should be a consideration in study design.
 

U.S. Food & Drug Administration perspective on oncology endpoints issues (prepared for October 2007 Steering Committee meeting)

Bren L. The importance of patient-reported outcomes: it's all about the patients. FDA Consumer Magazine 40(6): 27-32.   [Link to Web page (synopsis)]

Lai JS, Crane PK, Cella D. Factor analysis techniques for assessing sufficient unidimensionality of cancer related fatigue. Qual Life Res 15(7):1179-90, 2006.   [Link to PubMed]

ABSTRACT: BACKGROUND: Fatigue is the most common unrelieved symptom experienced by people with cancer. The purpose of this study was to examine whether cancer-related fatigue (CRF) can be summarized using a single score, that is, whether CRF is sufficiently unidimensional for measurement approaches that require or assume unidimensionality. We evaluated this question using factor analysis techniques including the theory-driven bi-factor model. METHODS: Five hundred and fifty five cancer patients from the Chicago metropolitan area completed a 72-item fatigue item bank, covering a range of fatigue-related concerns including intensity, frequency and interference with physical, mental, and social activities. Dimensionality was assessed using exploratory and confirmatory factor analysis (CFA) techniques. RESULTS: Exploratory factor analysis (EFA) techniques identified from 1 to 17 factors. The bi-factor model suggested that CRF was sufficiently unidimensional. CONCLUSIONS: CRF can be considered sufficiently unidimensional for applications that require unidimensionality. One such application, item response theory (IRT), will facilitate the development of short-form and computer-adaptive testing. This may further enable practical and accurate clinical assessment of CRF.

Wolfe F. Fatigue assessments in rheumatoid arthritis: comparative performance of visual analog scales and longer fatigue questionnaires in 7760 patients. J Rheumatol 31(10):1896-902, 2004.   [Link to PubMed]

ABSTRACT: OBJECTIVE: Fatigue has been recognized as an important domain in rheumatoid arthritis (RA) clinical trials and in patient care and outcome. However, lengthy fatigue questionnaires cannot be easily used in clinical care, and there are no data for the comparative performance of various short and long questionnaires. We compared a single-item visual analog scale (VAS) with 3 longer fatigue questionnaires, investigating 4 fatigues scales: the Multi-dimensional Assessment of Fatigue (MAF), the vitality scale from the Medical Outcomes Study Short Form 36 (SF-36), the Brief Fatigue Inventory (BFI), and the VAS. METHODS: Participants in a longitudinal outcome study of RA (N = 7760) completed the 4 questionnaires, and a subset of 5155 completed the same fatigue scales 6 months later. RESULTS: All questionnaires were highly correlated and were correlated at similar levels with clinical variables. The 3 longer questionnaires had slightly greater reliability in cross-sectional analyses, but the VAS was as good as or better than the longer questionnaires when sensitivity to change was considered. CONCLUSION: The single item VAS performs as well as or better than longer scales in respect to sensitivity to change, and is at least as well correlated with clinical variables as longer scales. The VAS fatigue scale is suitable for routine use in clinical care, an advantage that is lacking for the other scales. These results do not indicate advantages for longer fatigue scales compared with the VAS.

Seyidova-Khoshknabi D, Davis MP, Walsh D. A systematic review of cancer-related fatigue measurement questionnaires. Am J Hosp Palliat Care, e-pub ahead of print, 2010.   [Link to PubMed]

ABSTRACT: PURPOSE: Cancer-related fatigue (CRF) is a common symptom experienced by patients in all stages and in cancer survivors. The main objectives of this review were to identify validated CRF instruments, and populations in whom these tools have been validated. METHODS: We used a systematic review methodology. Three separate searches were performed using different MeSH terms in Pub Med and Ovid databases. Articles were analyzed for validation and reliability. RESULTS: A total of 1453 papers from 3 different searches identified 40 instruments (3 unidimensional and 37 multidimensional). Instruments varied by psychometric properties, items, scale, dimension, cancer site, and population. Five were optimally tested for validity and reliability. Completion rates, sensitivity to change, and test-retest reliability were reported for a few. Discussion: Most tools had been validated in mixed populations and are relatively insensitive to differences in fatigue to cancer stage. Most instruments are burdensome for those with advanced cancer. The Brief Fatigue Inventory and 3 fatigue items of the European Organization for Research and Treatment Quality of Life Questionnaire Fatigue Scale (EORTC QLQ-C30) are optimal instruments in advanced cancer. CONCLUSIONS: In all, 40 CRF instruments were identified. Validity and reliability varied by questionnaire. The ideal item numbers, scale, and domains are not established and may be population dependent.
 

Sloan JA (ed). Applying QOL Assessments: Solutions for Oncology Clinical Practice and Research, Part 2. Current Problems in Cancer, Volume 30, Issue 6, November-December 2006.   [Link to journal]

US Food and Drug Administration. Guidelines for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville MD, U.S. Department of Health and Human Services, 2009.   [Link to Web page]