Addressing the "It Is Just Placebo" Pitfall in CAM: Methodology of a Project to Develop Patient-Reported Measures of Nonspecific Factors in Healing.
Addressing the "It Is Just Placebo" Pitfall in CAM: Methodology of a Project to Develop Patient-Reported Measures of Nonspecific Factors in Healing.
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DOI：
10.1155/2013/613797
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Schneider MJ
中科院分区：
文献类型：
--
作者：
Greco CM;Glick RM;Morone NE;Schneider MJ
CAM疗法通常被认为“不比安慰剂好”;然而，这种信念可以通过仔细分析愈合中的非特异性因素来克服。为了改进试验方法，我们建议CAM（和传统）随机对照试验应评估和调整自我，人际和环境因素对结果的影响。然而，测量这些是具有挑战性的，并且没有适合在试验和临床环境中广泛使用的简单，精确的仪器。本文介绍了一个项目的方法，以开发一套病人报告的工具，将量化的非特异性或“安慰剂”的影响，实际上是特定的和活性成分的愈合。该项目采用了NIH-PROMIS倡议的严格的仪器开发方法。这些方法包括：（1）将患者和临床医生的意见与现有文献相结合;（2）开发相关项目;（3）在大样本上校准项目;（4）经典测试理论和现代心理测量学方法来选择最有用的项目;（5）开发计算机自适应测试（CAT），以最大限度地增加信息，同时最大限度地减少患者负担;（6）初步验证研究。这些仪器将有可能通过量化有助于愈合的背景因素来彻底改变CAM和传统医学的临床试验。
CAM therapies are often dismissed as “no better than placebo;” however, this belief may be overcome through careful analysis of nonspecific factors in healing. To improve trial methodology, we propose that CAM (and conventional) RCTs should evaluate and adjust for the effects of intrapersonal, interpersonal, and environmental factors on outcomes. However, measurement of these is challenging, and there are no brief, precise instruments that are suitable for widespread use in trials and clinical settings. This paper describes the methodology of a project to develop a set of patient-reported instruments that will quantify the nonspecific or “placebo” effects that are in fact specific and active ingredients in healing. The project uses the rigorous instrument-development methodology of the NIH-PROMIS initiative. The methods include (1) integration of patients' and clinicians' opinions with existing literature; (2) development of relevant items; (3) calibration of items on large samples; (4) classical test theory and modern psychometric methods to select the most useful items; (5) development of computerized adaptive tests (CATs) that maximize information while minimizing patient burden; and (6) initial validation studies. The instruments will have the potential to revolutionize clinical trials in both CAM and conventional medicine through quantifying contextual factors that contribute to healing.
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影响因子：
5.4
作者：
Kelner, M;Wellman, B
通讯作者：
Wellman, B
影响因子：
3.7
作者：
Kaptchuk TJ;Friedlander E;Kelley JM;Sanchez MN;Kokkotou E;Singer JP;Kowalczykowski M;Miller FG;Kirsch I;Lembo AJ
通讯作者：
Lembo AJ
影响因子：
3.8
作者：
Reise, SP;Henson, JM
通讯作者：
Henson, JM
影响因子：
--
作者：
KOES, BW;BOUTER, LM;KNIPSCHILD, PG
通讯作者：
KNIPSCHILD, PG
影响因子：
105.7
作者：
Kaptchuk, Ted J.;Kelley, John M.;Lembo, Anthony J.
通讯作者：
Lembo, Anthony J.