Department of Food, Nutrition and Dietetics, Uppsala University, Box 560, SE-75122 Uppsala, Sweden; Function Area Clinical Nutrition, Karolinska University Hospital, Norrbacka S1:03, SE-17176 Stockholm, Sweden.
Department of Food, Nutrition and Dietetics, Uppsala University, Box 560, SE-75122 Uppsala, Sweden.
Clin Nutr. 2018 Feb;37(1):61-71. doi: 10.1016/j.clnu.2017.03.024. Epub 2017 Mar 25.
BACKGROUND & AIMS: The effects of oral nutritional supplements (ONS) have been evaluated in several clinical trials and more studies have been requested. To facilitate replication, support accurate evaluations of research results and avoid research waste, high quality reporting of interventions in clinical trials is needed. The aim of this study is to assess the quality of reporting of interventions in publications describing randomised controlled trials of ONS in populations with malnutrition or at nutritional risk.
The PubMed database was searched for articles describing ONS trials published between January 2002 and December 2015. The quality of intervention descriptions was evaluated using the Template for Intervention Description and Replication (TIDieR) checklist and guide, which contains twelve items. Articles published before and after 2011 were compared.
Of 76 articles identified, only 3% reported all TIDieR items in sufficient detail. The most frequently missing elements were descriptions of the intervention procedures (e.g. how the ONS were to be taken and if participants were given a choice of flavours), which were adequately presented in only 26% of the articles. Less than half of the articles included a description of the intervention provider and sufficient information about the location(s) for the intervention. Information about adherence and mode of delivery was reported in 60-65% of the articles. Most frequently reported, in >70% of the articles, were items regarding the brief name of the intervention, the rationale for the intervention and the materials used (i.e. information about the specific ONS product(s) administered). The reporting quality for two of the items (materials and provider) was higher in articles published after 2011.
The quality of reporting of ONS interventions was found to be poor. The descriptions mostly lacked information about intervention procedures, provider and location(s). A moderately higher reporting quality was observed in articles published after 2011. These findings imply that an improvement in the descriptions of ONS interventions is required in future clinical trials of malnutrition treatment.
口服营养补充剂（ONS）的效果已在多项临床试验中得到评估，并且要求开展更多的研究。为了便于复制，支持对研究结果的准确评估并避免研究浪费，需要对临床试验中的干预措施进行高质量报告。本研究旨在评估描述营养不足或存在营养风险人群的 ONS 随机对照试验的出版物中干预措施报告的质量。
检索 2002 年 1 月至 2015 年 12 月期间发表的描述 ONS 试验的文章，检索数据库为 PubMed。使用干预描述和复制模板（TIDieR）检查表和指南评估干预描述的质量，该检查表和指南包含 12 个项目。比较了 2011 年前后发表的文章。
在确定的 76 篇文章中，只有 3%的文章详细报告了所有 TIDieR 项目。最常缺失的内容是干预措施程序的描述（例如，ONS 应如何服用以及参与者是否有口味选择），仅有 26%的文章对此进行了充分介绍。不到一半的文章包括对干预提供者的描述和干预地点的足够信息。关于依从性和交付方式的信息在 60-65%的文章中有所报道。大多数文章（>70%）报道了干预措施的简短名称、干预措施的理由和使用的材料（即管理的特定 ONS 产品的信息）。在 2011 年后发表的文章中，材料和提供者这两个项目的报告质量更高。
ONS 干预措施报告的质量较差。描述大多缺乏干预措施程序、提供者和地点的信息。在 2011 年后发表的文章中观察到报告质量略有提高。这些发现意味着需要在未来的营养不足治疗的临床试验中改进 ONS 干预措施的描述。
