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选择癌症临床研究中的患者报告结局测量指标——实用原则和一个辅助非专业研究人员的算法。

Choosing patient-reported outcome measures for cancer clinical research--practical principles and an algorithm to assist non-specialist researchers.

机构信息

Psycho-oncology Co-operative Research Group, University of Sydney, Camperdown, NSW 2006, Australia.

出版信息

Eur J Cancer. 2010 Dec;46(18):3149-57. doi: 10.1016/j.ejca.2010.08.002. Epub 2010 Sep 23.

Abstract

AIM

The purpose of this article is to give practical advice to researchers wishing to choose measures of quality of life and other patient-reported outcomes (PROs) for cancer clinical research.

METHOD

Readers are guided through the process of selecting a patient-reported outcome measure (PROM) by means of six principles, illustrated with examples.

RESULTS

PROM selection should always be undertaken with consideration of specific objectives, samples, treatments and available resources. Guiding principles include: (1) always consider PROMs early in the design process within the context of other methodological decisions; (2) choose a primary PROM that is as proximal to the cancer and/or its treatment as will add to knowledge and inform practice; (3) identify candidate PROMs primarily on the grounds of scaling and content; (4) appraise the reliability, validity and 'track records' of candidate PROMs in studies similar to that planned; (5) look ahead to practical concerns; and (6) take a minimalist approach to ad hoc items.

CONCLUSION

The principles and algorithms presented in this article will assist cancer clinical researchers who lack specialist expertise in patient-reported outcome measurement to make appropriate choices when selecting PROMs for their next study.

摘要

目的

本文旨在为希望选择癌症临床研究中生命质量和其他患者报告结局(PRO)测量方法的研究人员提供实用建议。

方法

通过六个原则,并举例说明,引导读者选择患者报告结局测量工具(PROM)。

结果

PROM 选择应始终考虑特定目标、样本、治疗方法和现有资源。指导原则包括:(1)始终在设计过程中尽早考虑 PROM,使其在其他方法学决策的背景下进行;(2)选择与癌症及其治疗最接近的主要 PROM,以增加知识并为实践提供信息;(3)主要根据量表和内容来确定候选 PROM;(4)评估候选 PROM 在与计划研究相似的研究中的可靠性、有效性和“记录”;(5)着眼于实际问题;(6)对特定项目采取简约方法。

结论

本文提出的原则和算法将帮助癌症临床研究人员在为下一项研究选择 PROM 时做出适当选择,这些研究人员缺乏患者报告结局测量方面的专业知识。

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