Freeman Hugh-J
Department of Medicine (Gastroenterology), University of British Columbia Hospital, 2211 Wesbrook Mall, Vancouver, British Columbia V6T 1W5, Canada.
World J Gastroenterol. 2008 Jul 14;14(26):4127-30. doi: 10.3748/wjg.14.4127.
The Crohn's disease activity index (CDAI) has been commonly used to assess the effects of treatment with different agents in Crohn's disease (CD). However, these studies may be compromised, if the results compared to a placebo or standard therapy group (in the absence of a placebo) substantially differ from the expected response. In addition, significant concerns have been raised regarding the reliability and validity of the CDAI. Reproducibility of the CDAI may be limited as significant inter-observer error has been recorded, even if measurements are done by experienced clinicians with expertise in the diagnosis and treatment of CD. Finally, many CDAI endpoints are open to subjective interpretation and have the potential for manipulation. This is worrisome as there is the potential for significant financial gain, if the results of a clinical trial appear to provide a positive result. Physicians caring for patients should be concerned about the positive results in clinical trials that are sponsored by industry, even if the trials involve respected centers and the results appear in highly ranked medical journals.
克罗恩病活动指数（CDAI）一直被广泛用于评估不同药物治疗克罗恩病（CD）的效果。然而，如果与安慰剂组或标准治疗组（无安慰剂时）相比的结果与预期反应存在显著差异，这些研究可能会受到影响。此外，人们对CDAI的可靠性和有效性也提出了重大担忧。即使测量由在CD诊断和治疗方面具有专业知识的经验丰富的临床医生进行，由于已记录到显著的观察者间误差，CDAI的可重复性可能会受到限制。最后，许多CDAI终点易于主观解读且存在被操纵的可能性。这令人担忧，因为如果临床试验结果似乎提供了阳性结果，就有可能获得巨大的经济利益。照顾患者的医生应该对由行业赞助的临床试验中的阳性结果感到担忧，即使这些试验涉及备受尊敬的中心且结果发表在高排名的医学期刊上。
