Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection.
Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection.
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DOI：
10.1186/s12884-023-05366-2
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发表时间：
2023-02-11
影响因子：
3.1
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中科院分区：
文献类型：
--
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公共卫生和临床建议是通过系统评价和回顾性荟萃分析建立起来的，这些分析结合了效应大小，传统上是通过汇总数据，最近则使用已发表研究的个体参与者数据（IPD）。然而，试验的结果和其他元数据往往没有以标准化的方式定义和收集，这使得元分析存在问题。IPD荟萃分析只能部分弥补传统、回顾性、汇总荟萃分析的局限性；前瞻性荟萃分析进一步减少了这些问题。我们制定了一项倡议，包括在布基纳法索、埃塞俄比亚、印度、尼泊尔和巴基斯坦进行（或最近结束）的怀孕和/或哺乳期补充平衡能量蛋白（BEP）的七项临床干预研究，以测试BEP对婴儿和孕产妇结局的影响。这些研究是在一次专家磋商后委托进行的，该磋商为低收入和中等收入国家孕妇和哺乳期妇女使用的BEP产品设计了建议。该倡议的目标是协调研究中的变量，以促进对密切相关数据的IPD荟萃分析，通常称为前瞻性荟萃分析。我们这里的目标是描述协调变量定义和优先考虑研究问题的过程。2020年2月举行了为期两天的调查人员、内容专家和顾问研讨会，此后继续开展协调活动。工作包括一系列活动，从审查协议和数据收集计划到讨论外勤限制条件下的最佳做法。在统一之前，研究中有许多相似的结果和变量，如新生儿人体测量、胎龄和死胎，然而，定义和方案不同。此外，在一些但不是所有的研究中也进行了一些测量，例如粮食不安全。通过协调过程，我们就重要的共享变量（特别是结果）达成了共识，增加了新的测量方法，并改进了跨研究的方案。我们促进了来自不同研究的研究者之间的广泛交流，重要的是，在前瞻性荟萃分析框架内创建了一套大的协调变量定义。我们期望这一举措将改善每项研究的报告，并为一系列IPD荟萃分析提供机会。在线版本包含补充材料，可在10.1186/s12884-023-05366-2获得。
Public health and clinical recommendations are established from systematic reviews and retrospective meta-analyses combining effect sizes, traditionally, from aggregate data and more recently, using individual participant data (IPD) of published studies. However, trials often have outcomes and other meta-data that are not defined and collected in a standardized way, making meta-analysis problematic. IPD meta-analysis can only partially fix the limitations of traditional, retrospective, aggregate meta-analysis; prospective meta-analysis further reduces the problems. We developed an initiative including seven clinical intervention studies of balanced energy-protein (BEP) supplementation during pregnancy and/or lactation that are being conducted (or recently concluded) in Burkina Faso, Ethiopia, India, Nepal, and Pakistan to test the effect of BEP on infant and maternal outcomes. These studies were commissioned after an expert consultation that designed recommendations for a BEP product for use among pregnant and lactating women in low- and middle-income countries. The initiative goal is to harmonize variables across studies to facilitate IPD meta-analyses on closely aligned data, commonly called prospective meta-analysis. Our objective here is to describe the process of harmonizing variable definitions and prioritizing research questions. A two-day workshop of investigators, content experts, and advisors was held in February 2020 and harmonization activities continued thereafter. Efforts included a range of activities from examining protocols and data collection plans to discussing best practices within field constraints. Prior to harmonization, there were many similar outcomes and variables across studies, such as newborn anthropometry, gestational age, and stillbirth, however, definitions and protocols differed. As well, some measurements were being conducted in several but not all studies, such as food insecurity. Through the harmonization process, we came to consensus on important shared variables, particularly outcomes, added new measurements, and improved protocols across studies. We have fostered extensive communication between investigators from different studies, and importantly, created a large set of harmonized variable definitions within a prospective meta-analysis framework. We expect this initiative will improve reporting within each study in addition to providing opportunities for a series of IPD meta-analyses. The online version contains supplementary material available at 10.1186/s12884-023-05366-2.
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影响因子：
3.4
作者：
Lama, Tsering P.;Khatry, Subarna K.;Isanaka, Sheila;Moore, Katie;Jones, Leslie;Bedford, Juliet;Katz, Joanne;de Pee, Saskia;LeClerq, Steven C.;Tielsch, James M.
通讯作者：
Tielsch, James M.
影响因子：
11.8
作者：
Acosta, Angel Mendez;Chavez, Cesar Banda;Shrestha, Sanjaya Kumar
通讯作者：
Shrestha, Sanjaya Kumar
影响因子：
3.7
作者：
Gargon E;Gurung B;Medley N;Altman DG;Blazeby JM;Clarke M;Williamson PR
通讯作者：
Williamson PR
影响因子：
2.8
作者：
Imdad, Aamer;Bhutta, Zulfiqar A.
通讯作者：
Bhutta, Zulfiqar A.
影响因子：
3.4
作者：
Lama TP;Moore K;Isanaka S;Jones L;Bedford J;de Pee S;Katz J;Khatry SK;LeClerq SC;Tielsch JM
通讯作者：
Tielsch JM