背景:评估异位妊娠的随机对照试验(RCT)具有不同的结局,以不同的方式定义和测量,这限制了他们为循证临床实践提供信息的能力。
目的:为了解决已发表的RCT和系统评价中的方法学缺陷,本研究建立了一套核心结果集,以指导异位妊娠的未来研究.
方法:为了确定潜在的结果,我们进行了全面的文献综述,并对有异位妊娠生活经验的个体进行了访谈.然后将潜在的核心结果输入到三轮Delphi调查中。来自六大洲的154名参与者,包括医疗保健专业人员,研究人员,和有异位妊娠经验的人,完成了德尔福调查的所有三轮。在三个共识发展会议上优先考虑了成果,并就如何在可能的情况下报告这些成果提出了建议。
方法:医疗保健专业人员,研究人员,和有异位妊娠生活经验的个体结果:六个结果达成完全共识,包括治疗成功,解决时间,额外干预措施的数量,不良事件,死亡率和严重发病率,和治疗满意度。
结论:异位妊娠六个结局的核心结局将有助于标准化临床试验报告,促进调查结果在临床实践中的实施,加强以病人为中心的护理。
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).
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.
Not applicable.
Health care professionals, researchers, and individuals with lived experience in EP.
Not applicable.
Consensus for inclusion in core outcome set.
Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.
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.