Core Outcome Sets in Miscarriage Trials (COSMisT) study: a study protocol.
Core Outcome Sets in Miscarriage Trials (COSMisT) study: a study protocol.
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DOI：
10.1136/bmjopen-2017-018535
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发表时间：
2017-11-16
期刊：
影响因子：
2.9
通讯作者：
Coomarasamy A
中科院分区：
文献类型：
--
作者：
Smith P;Cooper N;Dhillon-Smith R;O'Toole E;Clark TJ;Coomarasamy A
“核心结果集”是一个商定的标准化结果集，基于关键利益相关者（临床医生，患者，他们的合作伙伴，研究人员，服务开发人员，资助组织等）认为管理或预防疾病的重要结果。本文描述了流产试验核心结局集开发的基本原理和设计。将对患者及其伴侣进行系统评价、访谈和焦点小组，以确定将引入改良德尔菲调查的潜在核心结局。为了确保所有关键利益相关者都被纳入其中，将邀请患者、合作伙伴、临床医生、慈善机构和研究人员参加修改后的德尔菲调查。在德尔菲调查期间将进行三轮评分和重新评分，以便就纳入核心数据集的成果达成共识，随后将通过面对面的协商一致讨论对核心数据集进行完善。核心结果集的使用允许不同研究的结果进行比较和合并，从而减少不一致性并帮助解释研究结果。这也意味着研究更有可能报告相关结果，因此可以减少报告偏见。了解哪些结果对患者很重要，有可能成为提高流产服务质量和成本效益的驱动因素。
‘Core outcome sets’ are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations and so on) consider the important outcomes in the management or prevention of a condition. This paper describes the rationale and design for the development of Core Outcome Sets for Miscarriage Trials. Systematic reviews, interviews and focus groups with patients and their partners will be conducted to identify potential core outcomes that will be introduced into a modified Delphi survey. To ensure all key stakeholders are included, patients, partners, clinicians, charities and researchers will be invited to take part in the modified Delphi survey. There will be three rounds of scoring and rescoring during the Delphi survey to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions. The use of core outcome sets allows results from different studies to be compared and combined, thereby reducing inconsistency and aiding interpretation of study findings. It also means research is more likely to report relevant outcomes and so can reduce reporting bias. Understanding which outcomes are important to patients has the potential to act as a driver to improve both the quality and cost-effectiveness of miscarriage services.
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