Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity.
Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity.
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DOI：
10.1136/bmjopen-2020-044919
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发表时间：
2021-10-29
期刊：
影响因子：
2.9
通讯作者：
Black M
中科院分区：
文献类型：
--
作者：
Lee SI;Eastwood KA;Moss N;Azcoaga-Lorenzo A;Subramanian A;Anand A;Taylor B;Nelson-Piercy C;Yau C;McCowan C;O'Reilly D;Hope H;Kennedy JI;Abel KM;Locock L;Brocklehurst P;Plachcinski R;Brophy S;Agrawal U;Thangaratinam S;Nirantharakumar K;Black M
越来越多的孕妇生活在预先存在的多重疾病（≥两种长期的身体或精神健康状况）中。这可能会对母亲和后代的结果产生不利影响。本研究的目的是建立一个核心结果集（COS）的孕产妇和后代的结果与预先存在的多Morphoid。预期用于所有妊娠环境中的观察性和干预性研究。我们提出了四阶段研究设计：（1）系统性文献检索，（2）焦点小组，（3）德尔菲调查和（4）共识小组会议。研究将于2021年6月至2022年8月进行。首先，将通过对多胎妊娠妇女研究中报告的结局进行系统性文献检索，确定初步结局列表。我们将检索科克伦图书馆、Medline、EMBASE和CINAHL。这将补充来自已发表的COS的一般妊娠和分娩以及多胎妊娠的相关结局。其次，将在（1）有管理妊娠期既存多发性硬化症的生活经验的女性（和/或其伴侣）和（2）其医疗保健/社会护理专业人员中进行焦点小组，以确定对他们重要的结局。第三，将通过三轮在线德尔菲调查，使用预先确定的评分标准，对这些初步成果清单进行优先排序。将请与会者提出未列入初步清单的其他成果。最后，将举行一次使用名义组技术的共识会议，以商定最终的COS。利益相关者将包括（1）具有管理妊娠期多胎妊娠的生活经验的妇女（和/或其伴侣），（2）参与其护理的医疗保健/社会护理专业人员和（3）该领域的研究人员。这项研究已经得到伯明翰大学伦理审查委员会的批准。最终的COS将通过同行审查的出版物和会议向所有利益攸关方传播。
Increasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings. We propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field. This study has been approved by the University of Birmingham’s ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders.
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