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

Marina Nikolic; Aleksandra Konic Ristic; Antonio González-Sarrías; Geoffrey Istas; Mireia Urpi-Sarda; Margherita Dall'Asta; Laurent-Emmanuel Monfoulet; Lieselotte Cloetens; Banu Bayram; Maria Rosaria Tumolo; Mihail Chervenkov; Egeria Scoditti; Marika Massaro; Noemi Tejera; Desislava Abadjieva; Karen Chambers; Irena Krga; Francisco A Tomás-Barberán; Christine Morand; Rodrigo Feliciano; Rocío García-Villalba; Mar Garcia-Aloy; Pedro Mena

doi:10.1007/s00394-019-02069-3

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

Marina Nikolic, Aleksandra Konic Ristic, Antonio González-Sarrías, Geoffrey Istas, Mireia Urpi-Sarda, Margherita Dall'Asta, Laurent-Emmanuel Monfoulet, Lieselotte Cloetens, Banu Bayram, Maria Rosaria Tumolo, Mihail Chervenkov, Egeria Scoditti, Marika Massaro, Noemi Tejera, Desislava Abadjieva, Karen Chambers, Irena Krga, Francisco A Tomás-Barberán, Christine Morand, Rodrigo FelicianoRocío García-Villalba, Mar Garcia-Aloy, Pedro Mena

Norwich Medical School

Research output: Contribution to journal › Review article › peer-review

8 Citations (Scopus)

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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 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.

Original language	English
Pages (from-to)	49–64
Number of pages	16
Journal	European Journal of Nutrition
Volume	58
Early online date	6 Sep 2019
DOIs	https://doi.org/10.1007/s00394-019-02069-3
Publication status	Published - Nov 2019

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10.1007/s00394-019-02069-3Licence: CC BY

Published_MnauscriptFinal published version, 1.11 MBLicence: CC BY

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Nikolic, M., Konic Ristic, A., González-Sarrías, A., Istas, G., Urpi-Sarda, M., Dall'Asta, M., Monfoulet, L-E., Cloetens, L., Bayram, B., Tumolo, M. R., Chervenkov, M., Scoditti, E., Massaro, M., Tejera, N., Abadjieva, D., Chambers, K., Krga, I., Tomás-Barberán, F. A., Morand, C., ... Mena, P. (2019). Improving the reporting quality of intervention trials addressing the inter-individual variability in response to the consumption of plant bioactives: quality index and recommendations. European Journal of Nutrition, 58, 49–64. https://doi.org/10.1007/s00394-019-02069-3

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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 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.",

author = "Marina Nikolic and {Konic Ristic}, Aleksandra and Antonio Gonz{\'a}lez-Sarr{\'i}as and Geoffrey Istas and Mireia Urpi-Sarda and Margherita Dall'Asta and Laurent-Emmanuel Monfoulet and Lieselotte Cloetens and Banu Bayram and Tumolo, {Maria Rosaria} and Mihail Chervenkov and Egeria Scoditti and Marika Massaro and Noemi Tejera and Desislava Abadjieva and Karen Chambers and Irena Krga and Tom{\'a}s-Barber{\'a}n, {Francisco A} and Christine Morand and Rodrigo Feliciano and Roc{\'i}o Garc{\'i}a-Villalba and Mar Garcia-Aloy and Pedro Mena",

year = "2019",

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doi = "10.1007/s00394-019-02069-3",

language = "English",

volume = "58",

pages = "49–64",

journal = "European Journal of Nutrition",

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Nikolic, M, Konic Ristic, A, González-Sarrías, A, Istas, G, Urpi-Sarda, M, Dall'Asta, M, Monfoulet, L-E, Cloetens, L, Bayram, B, Tumolo, MR, Chervenkov, M, Scoditti, E, Massaro, M, Tejera, N, Abadjieva, D, Chambers, K, Krga, I, Tomás-Barberán, FA, Morand, C, Feliciano, R, García-Villalba, R, Garcia-Aloy, M & Mena, P 2019, 'Improving the reporting quality of intervention trials addressing the inter-individual variability in response to the consumption of plant bioactives: quality index and recommendations', European Journal of Nutrition, vol. 58, pp. 49–64. https://doi.org/10.1007/s00394-019-02069-3

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 et al.

In: European Journal of Nutrition, Vol. 58, 11.2019, p. 49–64.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - Improving the reporting quality of intervention trials addressing the inter-individual variability in response to the consumption of plant bioactives: quality index and recommendations

AU - Nikolic, Marina

AU - Konic Ristic, Aleksandra

AU - González-Sarrías, Antonio

AU - Istas, Geoffrey

AU - Urpi-Sarda, Mireia

AU - Dall'Asta, Margherita

AU - Monfoulet, Laurent-Emmanuel

AU - Cloetens, Lieselotte

AU - Bayram, Banu

AU - Tumolo, Maria Rosaria

AU - Chervenkov, Mihail

AU - Scoditti, Egeria

AU - Massaro, Marika

AU - Tejera, Noemi

AU - Abadjieva, Desislava

AU - Chambers, Karen

AU - Krga, Irena

AU - Tomás-Barberán, Francisco A

AU - Morand, Christine

AU - Feliciano, Rodrigo

AU - García-Villalba, Rocío

AU - Garcia-Aloy, Mar

AU - Mena, Pedro

PY - 2019/11

Y1 - 2019/11

N2 - 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.

AB - 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.

U2 - 10.1007/s00394-019-02069-3

DO - 10.1007/s00394-019-02069-3

M3 - Review article

C2 - 31492976

VL - 58

SP - 49

EP - 64

JO - European Journal of Nutrition

JF - European Journal of Nutrition

SN - 1436-6207

ER -

Nikolic M, Konic Ristic A, González-Sarrías A, Istas G, Urpi-Sarda M, Dall'Asta M et al. Improving the reporting quality of intervention trials addressing the inter-individual variability in response to the consumption of plant bioactives: quality index and recommendations. European Journal of Nutrition. 2019 Nov;58:49–64. Epub 2019 Sep 6. doi: 10.1007/s00394-019-02069-3