Development of core outcome sets for effectiveness trials focused on infants and children with wasting and nutritional oedema.

IF 6.1 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Allison I Daniel, Kirrily de Polnay, Michael McCaul, Jaden Bendabenda, Zita Weise Prinzo, Celeste E Naude
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引用次数: 0

Abstract

Introduction: The 2023 WHO guideline on the prevention and management of wasting and nutritional oedema includes recommendations informed by best evidence from systematic reviews addressing critical and important outcomes. Multiple outcomes across trials were a challenge during guideline development, highlighting a need to establish core outcome sets (COS) for wasting and nutritional oedema. Informed by Core Outcome Measures in Effectiveness Trials (COMET) Initiative best practice methods, we aimed to develop six COS for effectiveness trials around prevention and management of wasting and nutritional oedema in infants and children.

Methods: Guideline Development Group and UNICEF/WHO Technical Advisory Group on Wasting and Nutritional Oedema members were invited to participate in a Delphi process to establish these COS. This involved scoring outcomes in two rounds of a survey (Likert scale from 1 to 9), with consensus in the second round defined as a minimum of 70% of the expert panel giving a score of at least 7 and <15% scoring 3 or below.

Results: Twenty-five of 36 invited participants completed each survey, followed by multiple consensus meetings to reach agreement on the outcomes. Through this Delphi process, we developed six COS for infants <6 months of age with wasting and/or nutritional oedema and/or underweight in (1) inpatient and (2) outpatient/community settings, infants and children 6-59 months of age with severe wasting and/or nutritional oedema in (3) inpatient and (4) outpatient/community settings, infants and children 6-59 months of age with moderate wasting in (5) outpatient/community settings and (6) prevention of wasting and nutritional oedema.

Conclusion: Primary research, future guidelines and related decision-making stand to be strengthened by these six COS, including the most critical outcomes from a child health perspective to be evaluated in future effectiveness trials on wasting and nutritional oedema. Uptake of these COS will inform their further development.

针对消瘦性和营养性水肿的婴儿和儿童的有效性试验的核心结局集的开发。
导论:2023年世卫组织关于预防和管理消瘦和营养性水肿的指南包括根据系统审查的最佳证据提出的建议,这些建议涉及关键和重要的结果。在指南制定过程中,跨试验的多结果是一个挑战,强调需要建立消耗性和营养性水肿的核心结果集(COS)。根据有效性试验的核心结果测量(COMET)倡议最佳实践方法,我们旨在为婴儿和儿童预防和管理消瘦和营养性水肿的有效性试验制定6个COS。方法:邀请指南制定小组和联合国儿童基金会/世界卫生组织消瘦和营养性水肿技术咨询小组成员参加德尔菲过程,以建立这些COS。这包括在两轮调查中对结果进行评分(李克特量表从1到9),第二轮的共识定义为至少70%的专家小组给出至少7分的分数。结果:36名受邀参与者中有25人完成了每次调查,随后举行了多次共识会议,就结果达成一致。结论:这6种COS可以加强初步研究、未来的指南和相关决策,包括从儿童健康角度出发的最关键结果,将在未来关于消瘦和营养性水肿的有效性试验中进行评估。吸收这些COS将有助于它们的进一步发展。
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来源期刊
BMJ Global Health
BMJ Global Health Medicine-Health Policy
CiteScore
11.40
自引率
4.90%
发文量
429
审稿时长
18 weeks
期刊介绍: BMJ Global Health is an online Open Access journal from BMJ that focuses on publishing high-quality peer-reviewed content pertinent to individuals engaged in global health, including policy makers, funders, researchers, clinicians, and frontline healthcare workers. The journal encompasses all facets of global health, with a special emphasis on submissions addressing underfunded areas such as non-communicable diseases (NCDs). It welcomes research across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialized studies. The journal also encourages opinionated discussions on controversial topics.
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