ASCPRO Publications
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]
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]