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知情同意与入组流程:实现产科研究的高入组率

Consent and enrollment process: achieving high enrollment rates for obstetric research.

作者信息

Harter Georgia, Darden Jennifer, McMenemy Nancy, McElvy Tiffany, Hendrich Ann

机构信息

Columbia St. Mary's Hospital, Milwaukee, WI 53211, USA.

Ascension Health, St. Louis, MO 63134, USA.

出版信息

Appl Nurs Res. 2016 Feb;29:101-6. doi: 10.1016/j.apnr.2015.05.011. Epub 2015 May 23.

DOI:10.1016/j.apnr.2015.05.011
PMID:26856497
Abstract

AIM

The aim was to study the development, design, and implementation of a patient consent and enrollment initiative to identify strategies that enhanced participation.

BACKGROUND

Consent and enrollment of patients, especially pregnant women, remains a challenge in healthcare research. Although many barriers have been identified, strategies to consistently improve consent and enrollment are less defined.

METHODS

A case study was conducted on a consent and enrollment approach aimed at optimizing participation of mothers who delivered their infants from July 1, 2010 through June 30, 2013. Data were gathered through practitioner interviews, focus groups, and documentation review for each year of the study.

RESULTS

A total of 19,236 mothers enrolled, representing an 85% enrollment rate at the five study sites. Enrollment rates improved over time with increased nursing engagement in patient recruitment, site specific adaptations and patient education strategies.

CONCLUSIONS

Nursing's active role in implementation and rapid feedback loop of a multifaceted consent and enrollment program showed promise.

摘要

目的

旨在研究一项患者同意与入组倡议的开展、设计与实施,以确定能提高参与度的策略。

背景

患者(尤其是孕妇)的同意与入组在医疗保健研究中仍是一项挑战。尽管已识别出许多障碍,但持续改善同意与入组的策略仍不太明确。

方法

针对一种旨在优化2010年7月1日至2013年6月30日期间分娩婴儿的母亲参与度的同意与入组方法进行了一项案例研究。通过从业者访谈、焦点小组以及对研究各年份的文档审查收集数据。

结果

共有19236名母亲入组,在五个研究地点的入组率为85%。随着护士在患者招募中的参与度增加、特定地点的调整以及患者教育策略的实施,入组率随时间有所提高。

结论

护理人员在多方面同意与入组计划的实施及快速反馈循环中的积极作用显示出前景。

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