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双胞胎同床:初步研究结果如何指导大型多中心试验规划的改进

Co-bedding twins: how pilot study findings guided improvements in planning a larger multicenter trial.

作者信息

Hayward Kathryn, Campbell-Yeo Marsha, Price Sheri, Morrison Della, Whyte Robin, Cake Heather, Vine Jocelyn

机构信息

Dalhousie University School of Nursing, Halifax, Nova Scotia, Canada.

出版信息

Nurs Res. 2007 Mar-Apr;56(2):137-43. doi: 10.1097/01.NNR.0000263967.24125.db.

DOI:10.1097/01.NNR.0000263967.24125.db
PMID:17356445
Abstract

BACKGROUND

Co-bedding, a developmental care practice for twins and multiples, has been theorized as a strategy to decrease the adverse neurodevelopmental effects that may be associated with hospitalization.

OBJECTIVE

The aim of this study was to determine the feasibility of study design, methods, and the measurement of desired outcomes for the development of a larger multicentered study.

RESULTS

Study findings were used to estimate effect size, determine staff and bedside care organization, evaluate feasibility of data collection measures, and identify issues related to recruitment and follow-up. Results were incorporated in the development of a larger multicentered trial grant proposal.

DISCUSSION

Pilot studies can play an important role in the development of a competitive grant proposal and efficient conduct of a research trial. Pilot studies strengthen a proposal by providing essential baseline information. A general overview of the purpose of pilot studies is provided here, along with a description of the process of using findings from a pilot study to inform the development of a larger multisite trial. Findings from this pilot study examining the effects of co-bedding on twins and their parents are used to revise the research protocol for a larger multisite trial. These changes, which lead to improvement to the protocol, and the rational for these changes are highlighted.

摘要

背景

同床护理是一种针对双胞胎及多胞胎的发育性护理实践,从理论上讲,它是一种可减少可能与住院相关的不良神经发育影响的策略。

目的

本研究的目的是确定研究设计、方法以及为开展更大规模的多中心研究测量预期结果的可行性。

结果

研究结果用于估计效应大小、确定工作人员和床边护理安排、评估数据收集措施的可行性,并识别与招募和随访相关的问题。结果被纳入到一份更大规模的多中心试验资助提案的制定中。

讨论

预试验在撰写有竞争力的资助提案以及高效开展研究试验方面可发挥重要作用。预试验通过提供必要的基线信息来加强提案。本文提供了预试验目的的总体概述,以及利用预试验结果为开展更大规模的多地点试验提供信息的过程描述。本预试验关于同床护理对双胞胎及其父母影响的研究结果被用于修订更大规模多地点试验的研究方案。这些导致方案改进的变化以及这些变化的理由都得到了强调。

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引用本文的文献

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Co-bedding in neonatal nursery for promoting growth and neurodevelopment in stable preterm twins.新生儿重症监护室中共同睡眠对稳定的早产双胞胎生长发育及神经发育的促进作用
Cochrane Database Syst Rev. 2016 Apr 14;4(4):CD008313. doi: 10.1002/14651858.CD008313.pub3.
2
Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial).双胎患儿疼痛处置时共置(Co-bedding)作为舒适干预措施(CComForT 试验)
BMC Pediatr. 2009 Dec 11;9:76. doi: 10.1186/1471-2431-9-76.