The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research
The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research
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DOI：
10.1177/1740774512450097
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发表时间：
2012-08-01
期刊：
影响因子：
2.7
通讯作者：
Zwarenstein, Merrick
中科院分区：
文献类型：
--
作者：
Chalkidou, Kalipso;Tunis, Sean;Zwarenstein, Merrick
越来越多的人认识到，从希望做出基于证据的临床和卫生政策决定的患者、临床医生和付款人的角度来看，我们目前的临床研究方法在证据方面存在重大差距。这是对比较有效性研究（CER）的兴趣迅速增加的主要推动力，该研究旨在比较“现实世界”中替代卫生保健干预措施的收益、风险，有时还比较成本。虽然开展CER研究将使用广泛的实验和非实验方法，但许多重要问题可能需要实验方法-即随机对照试验（rct）。对rct的普遍性、可行性和成本的担忧在CER方法讨论中经常被提及。实用型随机对照试验（或“prct”）旨在保持随机对照试验的内部有效性，同时设计和实施的方式将更好地满足对真实世界风险和益处证据的需求，从而为临床和卫生政策决策提供信息。虽然人们对开展prct的兴趣和活动日益增加，但常规使用prct仍面临许多挑战。本文讨论了这些挑战，并提供了一些可能的前进方向。临床试验2012；9: 436 - 446。http://ctj.sagepub.com
There is a growing appreciation that our current approach to clinical research leaves important gaps in evidence from the perspective of patients, clinicians, and payers wishing to make evidence-based clinical and health policy decisions. This has been a major driver in the rapid increase in interest in comparative effectiveness research (CER), which aims to compare the benefits, risks, and sometimes costs of alternative health-care interventions in 'the real world'. While a broad range of experimental and nonexperimental methods will be used in conducting CER studies, many important questions are likely to require experimental approaches - that is, randomized controlled trials (RCTs). Concerns about the generalizability, feasibility, and cost of RCTs have been frequently articulated in CER method discussions. Pragmatic RCTs (or 'pRCTs') are intended to maintain the internal validity of RCTs while being designed and implemented in ways that would better address the demand for evidence about real-world risks and benefits for informing clinical and health policy decisions. While the level of interest and activity in conducting pRCTs is increasing, many challenges remain for their routine use. This article discusses those challenges and offers some potential ways forward. Clinical Trials 2012; 9: 436-446. http://ctj.sagepub.com