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理解癌症比较疗效研究数据需求的框架。

A framework for understanding cancer comparative effectiveness research data needs.

机构信息

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.

出版信息

J Clin Epidemiol. 2012 Nov;65(11):1150-8. doi: 10.1016/j.jclinepi.2012.06.005.

Abstract

OBJECTIVES

Randomized controlled trials remain the gold standard for evaluating cancer intervention efficacy. Randomized trials are not always feasible, practical, or timely and often don't adequately reflect patient heterogeneity and real-world clinical practice. Comparative effectiveness research can leverage secondary data to help fill knowledge gaps randomized trials leave unaddressed; however, comparative effectiveness research also faces shortcomings. The goal of this project was to develop a new model and inform an evolving framework articulating cancer comparative effectiveness research data needs.

STUDY DESIGN AND SETTING

We examined prevalent models and conducted semi-structured discussions with 76 clinicians and comparative effectiveness research researchers affiliated with the Agency for Healthcare Research and Quality's cancer comparative effectiveness research programs.

RESULTS

A new model was iteratively developed and presents cancer comparative effectiveness research and important measures in a patient-centered, longitudinal chronic care model better reflecting contemporary cancer care in the context of the cancer care continuum, rather than a single-episode, acute-care perspective.

CONCLUSION

Immediately relevant for federally funded comparative effectiveness research programs, the model informs an evolving framework articulating cancer comparative effectiveness research data needs, including evolutionary enhancements to registries and epidemiologic research data systems. We discuss elements of contemporary clinical practice, methodology improvements, and related needs affecting comparative effectiveness research's ability to yield findings clinicians, policy makers, and stakeholders can confidently act on.

摘要

目的

随机对照试验仍然是评估癌症干预疗效的金标准。随机试验并不总是可行、实用或及时的,而且往往不能充分反映患者的异质性和真实世界的临床实践。比较效果研究可以利用二次数据来帮助填补随机试验未解决的知识空白;然而,比较效果研究也面临着一些局限性。本项目的目标是开发一种新的模型,并为不断发展的框架提供信息,阐明癌症比较效果研究的数据需求。

研究设计和设置

我们检查了现有的模型,并与隶属于美国医疗保健研究与质量局癌症比较效果研究计划的 76 名临床医生和比较效果研究研究人员进行了半结构化讨论。

结果

一个新的模型被迭代开发,并在以患者为中心的纵向慢性护理模型中呈现癌症比较效果研究和重要措施,更好地反映了当代癌症护理在癌症护理连续体中的情况,而不是单一的急性护理视角。

结论

该模型立即适用于联邦资助的比较效果研究计划,为不断发展的框架提供了信息,阐明了癌症比较效果研究的数据需求,包括对登记处和流行病学研究数据系统的演进增强。我们讨论了影响比较效果研究能力的当代临床实践、方法改进和相关需求的要素,这些要素可以使临床医生、政策制定者和利益相关者对比较效果研究的发现有信心采取行动。

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