Pain Management Center of Paducah, Paducah, KY, USA.
Pain Physician. 2011 May-Jun;14(3):E249-82.
The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis. The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements which are vested in all 3 regulations including stakeholder involvement, public participation, and open transparent decision-making process. Overall, PCORI is much more elaborate with significant involvement of stakeholders, transparency, public participation, and open decision-making. However, there are multiple issues concerning the operation of such agencies in the United States including the predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others. The CER in the United States may be described at cross-roads or at the beginnings of a scientific era of CER and evidence-based medicine (EBM). However the United States suffers as other countries, including the United Kingdom with its National Health Services (NHS) and National Institute for Health and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design (placebo versus active control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to be disseminated. Consequently, PCORI and CER have been described as government-driven solutions without following the principles of EBM with an extensive focus on costs rather than quality. It also has been stated that the central planning which has been described for PCORI and CER, a term devised to be acceptable, will be used by third party payors to override the physician's best medical judgement and patient's best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on medical science, but rather on political science and not even under congressional authority, leading to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner that is incompatible with the principles of evidence-based practice.This manuscript describes the framework of PCORI, and the role of CER and its impact on interventional pain management.
患者中心的结果研究所（PCORI）是由 2010 年平价医疗法案成立的，旨在通过推进有关疾病、疾病和其他健康状况的有效和适当预防、诊断、治疗、监测和管理方式的证据的质量和相关性，促进比较效果研究（CER），以帮助患者、临床医生、购买者和政策制定者做出明智的健康决策。PCORI 的发展受医疗保险现代化法案（MMA）和美国复苏与再投资法案（ARRA）的约束。CER 和 PCORI 的框架描述了多项要素，这些要素受所有 3 项法规的约束，包括利益相关者的参与、公众的参与和开放透明的决策过程。总体而言，PCORI 更加详尽，利益相关者、透明度、公众参与和开放决策的参与度都很高。然而，在美国，此类机构的运作存在多个问题，包括医疗保健研究与质量局（AHRQ）的前身、医疗保健政策和研究局（AHCPR）、AHRQ 有效性医疗保健计划等。美国的 CER 可能被描述为处于十字路口或 CER 和循证医学（EBM）的科学时代的开端。然而，美国与其他国家一样，包括拥有国民保健服务（NHS）和国家卫生与临床优化研究所（NICE）的英国，在方法学上存在重大误解，过分关注方法学评估，缺乏对研究设计（安慰剂与活性对照）的理解，缺乏临床医生的参与，以及对继续传播的证据的错误解释。因此，PCORI 和 CER 被描述为没有遵循 EBM 原则的政府驱动的解决方案，而是广泛关注成本而不是质量。有人还指出，为 PCORI 和 CER 设计的中央规划，即一个被认为是可以接受的术语，将被第三方支付者用来推翻医生的最佳医疗判断和患者的最佳利益。此外，PCORI 的利益相关者不是科学家，他们不平衡，将制定一个最终的比较效果和 PCORI 问题的议程，它不是基于医学科学，而是基于政治科学，甚至不在国会的权力之下，导致医疗保健发生前所未有的负面变化。因此，PCORI 是以一种与循证实践原则不兼容的临时方式运作的。本文描述了 PCORI 的框架，CER 的作用及其对介入性疼痛管理的影响。
