Research in Nursing and Nutrition

Baldi, Ileana; Soriani, Nicola; Lorenzoni, Giulia; Azzolina, Danila; Lago, Elisa Dal; Bardi, Sara De; Verduci, Elvira; Zanotti, Renzo; Gregori, Darío

doi:10.1097/sga.0000000000000246

Cited by 2 publications

(2 citation statements)

References 28 publications

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“…During the process of literature review [ 29 ], we have asked a panel of three evaluators to come up with a judgment on the quality of 57 randomized controlled trials (RCTs), assigning a score to each trial using the Jadad scale [ 9 ]. This scale assigns a score from zero to five to a trial and evaluates presence and adequacy of the double-blind design, presence and adequacy of randomization and a possible loss of subjects during the study.…”

Section: Methodsmentioning

confidence: 99%

High Agreement and High Prevalence: The Paradox of Cohen’s Kappa

Zec¹,

Soriani²,

Comoretto³

et al. 2017

TONURSJ

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Background:Cohen's Kappa is the most used agreement statistic in literature. However, under certain conditions, it is affected by a paradox which returns biased estimates of the statistic itself.Objective:The aim of the study is to provide sufficient information which allows the reader to make an informed choice of the correct agreement measure, by underlining some optimal properties of Gwet’s AC1 in comparison to Cohen’s Kappa, using a real data example.Method:During the process of literature review, we have asked a panel of three evaluators to come up with a judgment on the quality of 57 randomized controlled trials assigning a score to each trial using the Jadad scale. The quality was evaluated according to the following dimensions: adopted design, randomization unit, type of primary endpoint. With respect to each of the above described features, the agreement between the three evaluators has been calculated using Cohen’s Kappa statistic and Gwet’s AC1 statistic and, finally, the values have been compared with the observed agreement.Results:The values of the Cohen’s Kappa statistic would lead to believe that the agreement levels for the variables Unit, Design and Primary Endpoints are totally unsatisfactory. The AC1 statistic, on the contrary, shows plausible values which are in line with the respective values of the observed concordance.Conclusion:We conclude that it would always be appropriate to adopt the AC1 statistic, thus bypassing any risk of incurring the paradox and drawing wrong conclusions about the results of agreement analysis.

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Section: Methodsmentioning

confidence: 99%

High Agreement and High Prevalence: The Paradox of Cohen’s Kappa

Zec¹,

Soriani²,

Comoretto³

et al. 2017

TONURSJ

Self Cite

View full text Add to dashboard Cite

show abstract

“…However, it is no secret that there are varying complexities associated with clinical nutrition trials and challenges associated with the human relationship with food that differ largely from pharmaceutical clinical trials or other health-related trials [1]. These complexities have questioned the use of clinical trials as the "gold standard" in nutrition research and have highlighted the importance of evaluating various models to determine the ideal type of clinical studies that can be used in nutrition-based research [2].…”

Section: Introduction the Use Of Clinical Nutrition Trials Ismentioning

confidence: 99%

An assessment of clinical trials used in functional food science

Marecek¹,

Martirosyan²

2023

FFHD

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The emergence of chronic diseases with nutritional origin has rendered the wide use of clinical trials and intervention strategies necessary. Clinical trials have become a “gold standard” for testing the health impacts of different dietary changes; however, they also pose a potential risk to participants. Particularly with clinical trials used in food studies, there is an added complexity of food chemistry and food behavior as well as unique ethical issues related to clinical nutrition trials such as a potential violation of the right to be fed, disruption of food culture, and the need for food security. Thus, it becomes imperative to have a basic understanding of the key principles and methodology of different clinical trials to enable researchers to determine the best type of clinical trial for their functional food nutrition study. The progression of clinical nutrition trials is promising, but there is an increased importance of reviewing different models to determine the best method of performing nutrition-based research that minimizes the potential risk to participants while increasing current food knowledge. In this article, we aim to achieve two major goals: the first is analyzing various types of clinical trials and the second is using this analysis to figure out which type of clinical trial is ideally suited for research related to food and nutrition. Conclusion: We conclude that randomized trials are the most effective type of clinical trial used in functional food studies. Randomized cluster trials and randomized parallel-group trials are particularly effective in diminishing the challenges in functional food studies that are outlined in this paper as they reduce the effects one intervention has on another intervention.Keywords: Clinical trials, Functional Food Science, Clinical research, Functional Food, Food, Nutrition

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Research in Nursing and Nutrition

Cited by 2 publications

References 28 publications

High Agreement and High Prevalence: The Paradox of Cohen’s Kappa

High Agreement and High Prevalence: The Paradox of Cohen’s Kappa

An assessment of clinical trials used in functional food science

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