要开发最小数据集,被称为核心结果集,未来的流产随机对照试验。
我们从堕胎研究的定量和定性系统评价中提取结果,以使用改良的德尔菲法进行评估。通过电子邮件,我们邀请了研究人员,临床医生,病人,和具有堕胎专业知识的医疗机构代表以9点Likert量表对结果的重要性进行评分。经过2轮,我们使用描述性分析来确定哪些结局符合预定义的共识标准.我们在一系列共识发展会议上最终确定了核心成果集。
我们输入了42个结果,组织在15个领域,进入德尔福调查。251名受邀者中的118名(87%)对第一轮提供了答复(203份完整答复),218名受邀者中的118名(42%)完成了第二轮。16名专家参加了发展会议。最终结果集包括15个结果:10个结果适用于所有堕胎试验(成功堕胎,正在怀孕,死亡,出血,子宫感染,住院治疗,手术干预,疼痛,胃肠道症状,和患者的流产经验);2个结果仅适用于手术流产试验(子宫穿孔和宫颈损伤),一项仅适用于药物流产试验(子宫破裂);2项适用于评估麻醉流产的试验(过度镇静/呼吸抑制和局部麻醉全身毒性).
使用强大的共识科学方法,我们为未来的堕胎研究开发了核心结果集。
人工流产研究的标准化结果可以减少试验间的异质性,提高系统评价和临床指南的质量。研究人员应该选择,收集,并在未来的堕胎试验中报告这些核心结果。期刊编辑应倡导核心成果集报告。
To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials.
We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined
consensus criteria. We finalized the core outcome set during a series of
consensus development meetings.
We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients\' experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity).
Using robust
consensus science methods we have developed a core outcome set for future abortion research.
Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical
guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.