ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.
ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.
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DOI：
10.1016/j.jpainsymman.2010.02.006
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发表时间：
2010-06
影响因子：
4.7
通讯作者：
Sloan, Jeff A.
中科院分区：
文献类型：
--
作者：
Barsevick, Andrea M.;Cleeland, Charles S.;Manning, Donald C.;O'Mara, Ann M.;Reeve, Bryce B.;Scott, Jane A.;Sloan, Jeff A.
针对癌症相关疲劳(CRF)的药物和行为干预措施的发展需要对这一症状采取适当的措施。美国食品和药物管理局的一份指导文件为临床试验中用于支持药物或设备标签声明的患者报告结果衡量标准的制定和评估提供了标准。一个独立的工作组，ASCPRO(使用患者报告的结果评估癌症症状)，已经开始制定在肿瘤学临床试验中衡量症状的建议。这里提出了疲劳特别工作组对CRF测量的建议。人们一致认为，CRF可以在临床试验中有效地测量为疲劳或疲倦的感觉，疲劳/疲劳对正常功能的影响，或同时作为感觉和影响。ASCPRO疲劳工作组构建了一个定义和概念模型来指导CRF的测量。ASCPRO的建议并不认可具体的疲劳措施，但阐明了如何在临床研究中评估和实施疲劳评估。CRF指标的选择应根据研究的目标进行调整。还讨论了与各种研究环境有关的测量问题。文献中存在临床试验CRF的良好测量方法，具有对患者的清晰度和可理解性、内容和结构的有效性、可靠性、对预期条件的变化的敏感性(分析敏感性)，以及建立用于解释分数变化的指南的足够证据。并对今后的研究方向进行了展望。
Development of pharmacologic 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. 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. 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 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. 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, 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.
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影响因子：
5.8
作者：
Jean-Pierre, Pascal;Figueroa-Moseley, Colmar D.;Morrow, Gary R.
通讯作者：
Morrow, Gary R.
影响因子：
2.5
作者：
Ahlberg, Karin;Ekman, Tor;Gaston-Johansson, Fannie
通讯作者：
Gaston-Johansson, Fannie
DOI：
10.1016/0197-2456(89)90005-6
发表时间：
1989-12-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
JAESCHKE, R;SINGER, J;GUYATT, GH
通讯作者：
GUYATT, GH
影响因子：
7.4
作者：
Broderick, Joan E.;Schwartz, Joseph E.;Stone, Arthur A.
通讯作者：
Stone, Arthur A.
DOI：
10.1046/j.1523-5394.2000.82007.x
发表时间：
2000-03-01
期刊：
CANCER PRACTICE
影响因子：
--
作者：
Holley, S
通讯作者：
Holley, S