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Incomplete descriptions of oral nutritional supplement interventions in reports of randomised controlled trials
E Liljeberg1, A Andersson2, E Lövestam2
1Department 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.
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.
Methods:
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.
Results:
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.
Conclusions:
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.
Insights
Reporting of oral nutritional supplements (ONS) interventions in clinical trials is poor. Key details on procedures, providers, and locations are frequently missing, hindering replication and research evaluation. Improvements are needed for future malnutrition studies.
Area of Science:
- Clinical Nutrition
- Evidence-Based Medicine
- Research Methodology
Background:
- Oral nutritional supplements (ONS) are crucial in managing malnutrition.
- Clinical trials evaluating ONS efficacy require high-quality reporting for replication and accurate assessment.
- Current reporting standards for ONS interventions in randomized controlled trials (RCTs) are suboptimal.
Purpose of the Study:
- To assess the quality of intervention reporting in RCTs of ONS for malnutrition.
- To identify specific areas of ONS intervention reporting that require improvement.
Main Methods:
- A systematic search of PubMed for ONS trials published between 2002 and 2015.
- Evaluation of intervention description quality using the Template for Intervention Description and Replication (TIDieR) checklist.
- Comparison of reporting quality for articles published before and after 2011.
Main Results:
- Only 3% of 76 identified articles fully reported all TIDieR items.
- Intervention procedures (e.g., administration, flavor choice) were poorly described (26%).
- Information on provider and location was insufficient in over half of the articles.
- Reporting quality for intervention materials and provider improved in articles published after 2011.
Conclusions:
- The reporting quality of ONS interventions in clinical trials is inadequate.
- Essential details regarding intervention procedures, providers, and locations are frequently omitted.
- Enhanced reporting of ONS interventions is necessary for future clinical trials in malnutrition treatment.