Factors influencing use and choice of Core Outcome Sets and outcome measurement instruments in trials of interventions to prevent childhood obesity: A survey protocol

K. Matvienko-Sikar, Reindolf Anokye, Dimity Dutch, Moira Duffy, Eibhlin Looney, Vicki Brown, John Browne, Darren Dahly, Declane Devane, Janas Harrington, Catherine Hayes, Brittany Johnson, Patricia M Kearney, Jamie J Kirkham, Patricia Leahy-Warren, Andrew W Murphy, Sarah Redsell, A. Seidler, Helen Skouteris
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Abstract

Background Two core outcome sets for childhood obesity prevention have been developed; standardised sets of outcome measurement instruments for these core outcome sets are currently being developed. Core outcome sets and standardised measurement sets can reduce heterogeneity and improve evidence syntheses for trials of interventions to prevent childhood obesity and/or interventions to improve child health behaviours related to childhood obesity. Such benefits are only realised if core outcome sets and standardised measurement sets are used in trials. The aims of this study are 1) to examine trialists’ awareness and attitudes towards the two existing core outcome sets and factors influencing their use; 2) to explore the characteristics of outcome measurement instruments that trialists currently use; and 3) to better understand how trialists choose outcome measurement instruments and the factors that influence those choices. Methods A cross-sectional online survey will be conducted with researchers involved in the design and/or conduct of trials of interventions to prevent childhood obesity and/or to improve child health behaviours related to childhood obesity, in children aged 0 to 5 years (trialists). Trialists will be recruited using purposive sampling, and will complete a 22-item survey examining trialist characteristics, awareness of the existing core outcome sets, factors influencing use of the existing core outcome sets, characteristics of measurement instruments, how trialists choose measurement instruments, and factors influencing choice of measurement instrument. Quantitative data will be analysed descriptively; responses to open-ended questions will be analysed using qualitative content analysis. Conclusions Findings from this study will inform approaches to maximising use of core outcome sets and standardised measurement sets for childhood obesity prevention. Use of standardised approaches to what and how outcomes are measured in this area will reduce heterogeneity and research waste and enhance evidence syntheses to better determine intervention effects.
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影响预防儿童肥胖干预试验中使用和选择核心结果集和结果测量工具的因素:调查方案
背景 已开发出两套预防儿童肥胖症的核心结果集;目前正在开发针对这些核心结果集的标准化结果测量工具集。核心结果集和标准化测量工具集可以减少异质性,并改进预防儿童肥胖和/或改善与儿童肥胖有关的儿童健康行为干预试验的证据综合。只有在试验中使用核心结果集和标准化测量集,才能实现这些益处。本研究的目的是:1)考察试验人员对现有两套核心结果集的认识和态度以及影响其使用的因素;2)探讨试验人员目前使用的结果测量工具的特点;3)更好地了解试验人员如何选择结果测量工具以及影响这些选择的因素。方法 将对参与设计和/或开展干预试验的研究人员(试验人员)进行横断面在线调查,这些试验旨在预防儿童肥胖和/或改善与儿童肥胖相关的儿童健康行为,对象为 0 至 5 岁儿童。将采用有目的的抽样方式招募试验者,试验者将完成一项包含 22 个项目的调查,调查内容包括试验者的特征、对现有核心结果集的认识、影响现有核心结果集使用的因素、测量工具的特征、试验者如何选择测量工具以及影响测量工具选择的因素。将对定量数据进行描述性分析;对开放式问题的回答将采用定性内容分析法进行分析。结论 本研究的结果将为最大限度地利用核心结果集和标准化测量集预防儿童肥胖提供参考。在这一领域使用标准化方法来衡量结果的内容和方式将减少异质性和研究浪费,并加强证据综合,从而更好地确定干预效果。
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