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开展多中心临床研究的挑战:十点需考虑之处。

Challenges to conducting multicenter clinical research: ten points to consider.

作者信息

Irving Sharon Y, Curley Martha A Q

机构信息

School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA.

出版信息

AACN Adv Crit Care. 2008 Apr-Jun;19(2):164-9. doi: 10.1097/01.AACN.0000318119.67061.0f.

DOI:10.1097/01.AACN.0000318119.67061.0f
PMID:18560285
Abstract

Nursing care provided to patients and their families should be based on strong scientific evidence. In the quantitative research paradigm, the highest level of evidence is derived from conclusive randomized controlled clinical trials. Multicenter clinical research allows the accrual of sufficient numbers of diverse participants in a shorter period of time and improves the generalizability of the study findings. Clinical research is inherently complex; the complexity exponentially increases when conducting multicenter clinical trials. Investigators are challenged to maintain the internal validity of the study and the sustained commitment and collaboration of numerous disciplines over the study period. This article presents 10 essential points to consider when conducting multicenter clinical research.

摘要

为患者及其家属提供的护理应基于强有力的科学证据。在定量研究范式中,最高级别的证据来自确定性随机对照临床试验。多中心临床研究能够在更短的时间内招募到足够数量的多样化参与者,并提高研究结果的可推广性。临床研究本身就很复杂;在进行多中心临床试验时,复杂性会呈指数级增加。研究人员面临着维持研究的内部有效性以及在研究期间众多学科持续投入和协作的挑战。本文提出了进行多中心临床研究时需要考虑的10个要点。

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