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未来异位妊娠研究的核心结局集:一项国际共识发展研究。

A core outcome set for future research in ectopic pregnancy: an international consensus development study.

机构信息

Department of Obstetrics and Gynecology, Monash University, Clayton, Australia; Monash Women's, Monash Health, Clayton, Australia.

Institute for Women's Health, University College London, London, United Kingdom.

出版信息

Fertil Steril. 2023 May;119(5):804-812. doi: 10.1016/j.fertnstert.2023.01.042. Epub 2023 Feb 1.

Abstract

OBJECTIVE

To address methodological deficiencies in published randomized controlled trials and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy (EP).

DESIGN

To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in EP. Potential core outcomes were then entered into a 3-round Delphi survey. A total of 154 participants from 6 continents, comprising health care professionals, researchers, and individuals with lived experience in EP, completed all 3 rounds of the Delphi survey. Outcomes were prioritized at 3 consensus development meetings, and recommendations were developed on how to report these outcomes where possible.

SETTING

Not applicable.

PATIENT(S): Health care professionals, researchers, and individuals with lived experience in EP.

INTERVENTION(S): Not applicable.

MAIN OUTCOME MEASURE(S): Consensus for inclusion in core outcome set.

RESULT(S): Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.

CONCLUSION(S): The core outcome set with 6 outcomes for EP will help standardize reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient-centered care.

摘要

目的

为解决已发表的随机对照试验和系统评价中存在的方法学缺陷,本研究制定了异位妊娠(EP)核心结局集,以指导未来的研究。

设计

为了确定潜在的结局,我们进行了全面的文献回顾,并对 EP 患者进行了访谈。然后将潜在的核心结局纳入 3 轮 Delphi 调查。来自 6 大洲的 154 名参与者,包括医疗保健专业人员、研究人员和 EP 患者,完成了所有 3 轮 Delphi 调查。在 3 次共识发展会议上对结局进行了优先级排序,并就如何尽可能报告这些结局制定了建议。

设置

不适用。

患者

医疗保健专业人员、研究人员和 EP 患者。

干预措施

不适用。

主要观察指标

纳入核心结局集的共识。

结果

6 项结局达到完全共识,包括治疗成功率、缓解时间、需要的额外干预次数、不良事件、死亡率和严重发病率以及治疗满意度。

结论

EP 的 6 项核心结局集将有助于标准化临床试验报告,促进研究结果在临床实践中的实施,并增强以患者为中心的护理。

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