The development of a core outcome set for studies of pregnant women with multimorbidity.
The development of a core outcome set for studies of pregnant women with multimorbidity.
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DOI：
10.1186/s12916-023-03013-3
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发表时间：
2023-08-21
期刊：
影响因子：
9.3
通讯作者：
Black, Mairead
中科院分区：
文献类型：
--
作者：
Lee, Siang Ing;Hanley, Stephanie;Vowles, Zoe;Plachcinski, Rachel;Moss, Ngawai;Singh, Megha;Gale, Chris;Fagbamigbe, Adeniyi Francis;Azcoaga-Lorenzo, Amaya;Subramanian, Anuradhaa;Taylor, Beck;Nelson-Piercy, Catherine;Damase-Michel, Christine;Yau, Christopher;McCowan, Colin;O'Reilly, Dermot;Santorelli, Gillian;Dolk, Helen;Hope, Holly;Phillips, Katherine M.;Abel, Kathryn;Eastwood, Kelly-Ann;Kent, Lisa;Locock, Louise;Loane, Maria;Mhereeg, Mohamed;Brocklehurst, Peter;McCann, Sharon;Brophy, Sinead;Wambua, Steven;Sudasinghe, Sudasing Pathirannehelage Buddhika Hemali;Thangaratinam, Shakila;Nirantharakumar, Krishnarajah;Black, Mairead
关键词：
报告结果的异质性可能会限制研究证据的合成。核心结果集告知哪些结果是重要的，并应在所有未来研究中作为最低限度进行衡量。我们报告了一个核心结果集的发展，该结果集适用于对患有多发病的孕妇进行观察性和干预性研究。我们分四个阶段制定了核心成果集：(I)系统的文献搜索，(Ii)与英国利益攸关方的三个焦点小组，(Iii)与国际利益攸关方的两轮德尔福调查和(Iv)两次国际虚拟共识会议。利益相关者包括在过去5年中患有多发病并有怀孕经历的妇女，或计划怀孕的妇女、她们的伴侣、卫生或社会护理专业人员和研究人员。研究广告通过利益相关者慈善机构和组织分享。26项研究被纳入系统的文献搜索(2017至2021年)，报告了185项成果。对重点小组的专题分析又增加了28项成果。209名利益相关者完成了第一次德尔福调查。116名利益相关者完成了第二次德尔福调查，其中45项结果达成了共识(所有参与者中有70%的人将结果评为极其重要)。13个利益攸关方在第一次协商一致会议上审查了15项边缘成果，并列入了另外7项成果。17个利益攸关方在第二次协商一致会议上审查了这52项成果，门槛是≥，所有参与者投票赞成纳入的比例为80%。最终的核心成果集包括11项成果。五项孕产妇结果如下：产妇死亡、产妇严重发病率、现有长期状况(身体和精神)的变化、护理的质量和体验以及新的心理健康状况的发展。这六个孩子的结果如下：婴儿存活、出生时胎龄、神经发育状况/损害、生活质量、出生体重和因保健需要而与母亲分开。妊娠期多病是一个新的复杂的临床研究领域。经过严格的过程，这一复杂性被有意义地降低为平衡不同利益攸关方群体观点的核心成果集。网上版载有补充材料，可在10.1186/s12916-023-03013-3查阅。
Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity. We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations. Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs. Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group. The online version contains supplementary material available at 10.1186/s12916-023-03013-3.
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