Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol.
Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol.
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DOI：
10.1186/s13063-018-3029-1
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发表时间：
2018-11-27
期刊：
影响因子：
2.5
通讯作者：
COSSOPP Investigators
中科院分区：
文献类型：
--
作者：
Dadouch R;Faheim M;Juando-Prats C;Parsons J;D'Souza R;COSSOPP Investigators
孕产妇肥胖是孕产妇、胎儿和新生儿不良事件的危险因素。目前，许多临床试验正在探索产前和围产期干预措施在改善妊娠结局方面的有效性，这可以为未来的临床实践提供信息。然而，结果报告的异质性限制了我们比较不同研究结果的能力，并且在结果选择中缺乏利益相关者的代表。解决这个问题的一个务实的解决方案是制定一个核心结果集（COS），它定义了在该人群中进行的临床试验结果报告的最低标准，并由相关利益相关者的参与达成。用于妊娠患者肥胖研究的 COS (COSSOPP) 的开发将包括五个步骤。首先，对已发表文献的系统回顾将确定一长串结果、其定义和测量（如果适用）以及结果报告质量。随后将对患者进行定性研究的荟萃分析，并在多伦多对患者、临床医生、研究人员、医院管理人员和政策制定者进行定性访谈，以确定未通过系统评价获得的新结果。第三，通过涉及国际患者群体和相关利益相关者的在线德尔菲调查，将缩小一长串结果的范围。随后将与所有利益相关群体的代表进行面对面的共识会议，以就最终的 COS 达成共识。最后，为了确定如何衡量已确定的核心成果，我们将进行另一次文献回顾和德尔菲过程。 COSSOPP 将让患者、临床医生、研究人员和其他相关利益相关者参与确定应报告和测量的核心结果集，以便协调评估肥胖孕妇产前和围产期干预措施有效性的研究中的结果报告。该协议详细概述了 COS 开发所涉及的步骤，以指导研究人员在其专业领域内开发 COS。 http://www.comet-initiative.org/studies/details/939。本文的在线版本 (10.1186/s13063-018-3029-1) 包含补充材料，可供授权用户使用。
Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice. A pragmatic solution to this problem is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials undertaken in this population, arrived at by the involvement of relevant stakeholders. The development of a COS for studies on obesity in pregnant patients (COSSOPP) will comprise five steps. First, a systematic review of published literature will identify the long list of outcomes, their definitions and measurements if applicable, and outcome reporting quality. This will be followed by a meta-synthesis of qualitative studies with patients, and qualitative interviews in Toronto with patients, clinicians, researchers, hospital administrators, and policy-makers, to identify novel outcomes that were not obtained through systematic review. Third, the long list of outcomes will be narrowed down through online Delphi surveys involving an international group of patients and relevant stakeholders. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Finally, in order to determine how the identified core outcomes should be measured, we will conduct another literature review and Delphi process. COSSOPP will engage patients, clinicians, researchers, and other relevant stakeholders in determining the core set of outcomes that should be reported and measured in order to harmonize outcome reporting in studies evaluating the effectiveness of antepartum and peripartum interventions in obese pregnant women. This protocol provides a detailed overview of the steps involved in the development of a COS, to guide researchers in developing COS within their areas of specialization. http://www.comet-initiative.org/studies/details/939. The online version of this article (10.1186/s13063-018-3029-1) contains supplementary material, which is available to authorized users.
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