TY - JOUR
T1 - ASCPRO Recommendations for the Assessment of Fatigue as an Outcome in Clinical Trials
AU - Barsevick, Andrea M.
AU - Cleeland, Charles S.
AU - Manning, Donald C.
AU - O'Mara, Ann M.
AU - Reeve, Bryce B.
AU - Scott, Jane A.
AU - Sloan, Jeff A.
N1 - Funding Information:
ASCPRO acknowledges the financial support from Alpharma; Amgen Inc.; Celgene Corporation; Cephalon, Inc.; Eli Lilly and Company; GlaxoSmithKline; Merck & Co., Inc.; Pfizer Inc.; and Purdue Pharma LP.
PY - 2010/6
Y1 - 2010/6
N2 - Context: Development of pharmacological and behavioral interventions for cancer-related fatigue (CRF) requires adequate measures of this symptom. A guidance document from the Food and Drug Administration offers criteria for the formulation and evaluation of patient-reported outcome measures used in clinical trials to support drug or device labeling claims. Methods: An independent working group, ASCPRO (Assessing Symptoms of Cancer Using Patient-Reported Outcomes), has begun developing recommendations for the measurement of symptoms in oncology clinical trials. The recommendations of the Fatigue Task Force for measurement of CRF are presented here. Results: There was consensus that CRF could be measured effectively in clinical trials as the sensation of fatigue or tiredness, impact of fatigue/tiredness on usual functioning, or as both sensation and impact. The ASCPRO Fatigue Task Force constructed a definition and conceptual model to guide the measurement of CRF. ASCPRO recommendations do not endorse a specific fatigue measure but clarify how to evaluate and implement fatigue assessments in clinical studies. The selection of a CRF measure should be tailored to the goals of the research. Measurement issues related to various research environments were also discussed. Conclusions: There exist in the literature good measures of CRF for clinical trials, with strong evidence of clarity and comprehensibility to patients, content and construct validity, reliability, and sensitivity to change in conditions in which one would expect them to change (assay sensitivity), and sufficient evidence to establish guides for interpreting changes in scores. Direction for future research is discussed.
AB - Context: Development of pharmacological and behavioral interventions for cancer-related fatigue (CRF) requires adequate measures of this symptom. A guidance document from the Food and Drug Administration offers criteria for the formulation and evaluation of patient-reported outcome measures used in clinical trials to support drug or device labeling claims. Methods: An independent working group, ASCPRO (Assessing Symptoms of Cancer Using Patient-Reported Outcomes), has begun developing recommendations for the measurement of symptoms in oncology clinical trials. The recommendations of the Fatigue Task Force for measurement of CRF are presented here. Results: There was consensus that CRF could be measured effectively in clinical trials as the sensation of fatigue or tiredness, impact of fatigue/tiredness on usual functioning, or as both sensation and impact. The ASCPRO Fatigue Task Force constructed a definition and conceptual model to guide the measurement of CRF. ASCPRO recommendations do not endorse a specific fatigue measure but clarify how to evaluate and implement fatigue assessments in clinical studies. The selection of a CRF measure should be tailored to the goals of the research. Measurement issues related to various research environments were also discussed. Conclusions: There exist in the literature good measures of CRF for clinical trials, with strong evidence of clarity and comprehensibility to patients, content and construct validity, reliability, and sensitivity to change in conditions in which one would expect them to change (assay sensitivity), and sufficient evidence to establish guides for interpreting changes in scores. Direction for future research is discussed.
KW - Cancer-related fatigue
KW - clinical trials
KW - patient-reported outcomes
KW - self-report measures
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U2 - 10.1016/j.jpainsymman.2010.02.006
DO - 10.1016/j.jpainsymman.2010.02.006
M3 - Article
C2 - 20538190
AN - SCOPUS:77953183548
SN - 0885-3924
VL - 39
SP - 1086
EP - 1099
JO - Journal of pain and symptom management
JF - Journal of pain and symptom management
IS - 6
ER -