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Improving the reporting quality of intervention trials addressing the inter-individual variability in response to the consumption of plant bioactives : quality index and recommendations

Nikolic, Marina ; Konic Ristic, Aleksandra ; González-Sarrías, Antonio ; Istas, Geoffrey ; Urpi-Sarda, Mireia ; Dall’Asta, Margherita ; Monfoulet, Laurent Emmanuel ; Cloetens, Lieselotte LU ; Bayram, Banu and Tumolo, Maria Rosaria , et al. (2019) In European Journal of Nutrition 58(S2). p.49-64
Abstract

Purpose: The quality of the study design and data reporting in human trials dealing with the inter-individual variability in response to the consumption of plant bioactives is, in general, low. There is a lack of recommendations supporting the scientific community on this topic. This study aimed at developing a quality index to assist the assessment of the reporting quality of intervention trials addressing the inter-individual variability in response to plant bioactive consumption. Recommendations for better designing and reporting studies were discussed. Methods: The selection of the parameters used for the development of the quality index was carried out in agreement with the scientific community through a survey. Parameters were... (More)

Purpose: The quality of the study design and data reporting in human trials dealing with the inter-individual variability in response to the consumption of plant bioactives is, in general, low. There is a lack of recommendations supporting the scientific community on this topic. This study aimed at developing a quality index to assist the assessment of the reporting quality of intervention trials addressing the inter-individual variability in response to plant bioactive consumption. Recommendations for better designing and reporting studies were discussed. Methods: The selection of the parameters used for the development of the quality index was carried out in agreement with the scientific community through a survey. Parameters were defined, grouped into categories, and scored for different quality levels. The applicability of the scoring system was tested in terms of consistency and effort, and its validity was assessed by comparison with a simultaneous evaluation by experts’ criteria. Results: The “POSITIVe quality index” included 11 reporting criteria grouped into four categories (Statistics, Reporting, Data presentation, and Individual data availability). It was supported by detailed definitions and guidance for their scoring. The quality index score was tested, and the index demonstrated to be valid, reliable, and responsive. Conclusions: The evaluation of the reporting quality of studies addressing inter-individual variability in response to plant bioactives highlighted the aspects requiring major improvements. Specific tools and recommendations favoring a complete and transparent reporting on inter-individual variability have been provided to support the scientific community on this field.

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@article{00d2fc1a-7b29-4280-8b24-26a9eabe3be8,
  abstract     = {{<p>Purpose: The quality of the study design and data reporting in human trials dealing with the inter-individual variability in response to the consumption of plant bioactives is, in general, low. There is a lack of recommendations supporting the scientific community on this topic. This study aimed at developing a quality index to assist the assessment of the reporting quality of intervention trials addressing the inter-individual variability in response to plant bioactive consumption. Recommendations for better designing and reporting studies were discussed. Methods: The selection of the parameters used for the development of the quality index was carried out in agreement with the scientific community through a survey. Parameters were defined, grouped into categories, and scored for different quality levels. The applicability of the scoring system was tested in terms of consistency and effort, and its validity was assessed by comparison with a simultaneous evaluation by experts’ criteria. Results: The “POSITIVe quality index” included 11 reporting criteria grouped into four categories (Statistics, Reporting, Data presentation, and Individual data availability). It was supported by detailed definitions and guidance for their scoring. The quality index score was tested, and the index demonstrated to be valid, reliable, and responsive. Conclusions: The evaluation of the reporting quality of studies addressing inter-individual variability in response to plant bioactives highlighted the aspects requiring major improvements. Specific tools and recommendations favoring a complete and transparent reporting on inter-individual variability have been provided to support the scientific community on this field.</p>}},
  author       = {{Nikolic, Marina and Konic Ristic, Aleksandra and González-Sarrías, Antonio and Istas, Geoffrey and Urpi-Sarda, Mireia and Dall’Asta, Margherita and Monfoulet, Laurent Emmanuel and Cloetens, Lieselotte and Bayram, Banu and Tumolo, Maria Rosaria and Chervenkov, Mihail and Scoditti, Egeria and Massaro, Marika and Tejera, Noemi and Abadjieva, Desislava and Chambers, Karen and Krga, Irena and Tomás-Barberán, Francisco A. and Morand, Christine and Feliciano, Rodrigo and García-Villalba, Rocío and Garcia-Aloy, Mar and Mena, Pedro}},
  issn         = {{1436-6207}},
  keywords     = {{Clinical trials; Guidelines; Inter-individual variation; Plant bioactive; Quality index; Recommendations; Reporting quality}},
  language     = {{eng}},
  month        = {{11}},
  number       = {{S2}},
  pages        = {{49--64}},
  publisher    = {{Springer}},
  series       = {{European Journal of Nutrition}},
  title        = {{Improving the reporting quality of intervention trials addressing the inter-individual variability in response to the consumption of plant bioactives : quality index and recommendations}},
  url          = {{http://dx.doi.org/10.1007/s00394-019-02069-3}},
  doi          = {{10.1007/s00394-019-02069-3}},
  volume       = {{58}},
  year         = {{2019}},
}