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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.

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.

SUBMITTER: Nikolic M

PROVIDER: S-EPMC6851030 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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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 M Konic Ristic Aleksandra A González-Sarrías Antonio A Istas Geoffrey G Urpi-Sarda Mireia M Dall'Asta Margherita M Monfoulet Laurent-Emmanuel LE Cloetens Lieselotte L Bayram Banu B Tumolo Maria Rosaria MR Chervenkov Mihail M Scoditti Egeria E Massaro Marika M Tejera Noemi N Abadjieva Desislava D Chambers Karen K Krga Irena I Tomás-Barberán Francisco A FA Morand Christine C Feliciano Rodrigo R García-Villalba Rocío R Garcia-Aloy Mar M Mena Pedro P

European journal of nutrition 20190906 Suppl 2

<h4>Purpose</h4>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. Recom ...[more]

PMID: 31492976

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Project description:BackgroundIndividual-based modeling is a growing technique in the HIV transmission and prevention literature, but insufficient attention has been paid to formally evaluate the quality of reporting in this field. We present reporting recommendations for individual-based models for HIV treatment and prevention, assess the quality of reporting in the existing literature, and comment on the contribution of this model type to HIV policy and prediction.MethodsWe developed reporting recommendations for individual-based HIV transmission mathematical models, and through a systematic search, used them to evaluate the reporting in the existing literature. We identified papers that employed individual-based simulation models and were published in English prior to December 31, 2012. Articles were included if the models they employed simulated and tracked individuals, simulated HIV transmission between individuals in a particular population, and considered a particular treatment or prevention intervention. The papers were assessed with the reporting recommendations.FindingsOf 214 full text articles examined, 32 were included in the evaluation, representing 20 independent individual-based HIV treatment and prevention mathematical models. Manuscripts universally reported the objectives, context, and modeling conclusions in the context of the modeling assumptions and the model's predictive capabilities, but the reporting of individual-based modeling methods, parameterization and calibration was variable. Six papers discussed the time step used and one discussed efforts to maintain internal validity in coding.ConclusionIndividual-based models represent detailed HIV transmission processes with the potential to contribute to inference and policy making for many different regions and populations. The rigor in reporting of assumptions, methods, and calibration of individual-based models focused on HIV transmission and prevention varies greatly. Higher standards for reporting of statistically rigorous calibration and model assumption testing need to be implemented to increase confidence in existing and future modeling results.

Project description:BACKGROUND:Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting results, which should strengthen evidence-based practice recommendations. This consensus should be derived from high quality clinical data collection, clinical expertise and summarizing patient feedback. The first step, which is addressed in this paper, aims to critically analyze the quality of published studies and to provide the recommendations for reporting clinical trials on electrochemotherapy. METHODS:The quality of reporting in published studies on electrochemotherapy was analyzed in order to produce procedure specific reporting recommendations. A comprehensive literature search of studies published from 2006 to 2015 was performed followed by qualitative analysis of manuscripts assessing for 47 quality criteria grouped into four major clusters: (1) trial design, (2) description of patient population, (3) description of treatment delivery and patient outcome, (4) analysis of results and their interpretation. The summary measure during literature assessment was the proportion of studies fulfilling each manuscript quality criteria. RESULTS:A total of 56 studies were screened, from the period 2006 to 2015, of which 33 were included in the qualitative analysis, with a total of 1215 patients. Overall, the quality of reporting was highly variable. Twenty-four reports (73%) were single-center, non-comparative studies, and only 15 (45%) were prospective in nature (only 2 of them were entered into a clinical trials registry). Electrochemotherapy technique was consistently reported, with most studies (31/33) adhering closely to published standard operating procedures. The quality of reporting the patient population was variable among the analyzed studies, with only between 45% and 100% achieving dedicated quality criteria. Reporting of treatment delivery and patient outcome was also highly variable with studies only fulfilling between 3% and 100%. Finally, reporting study results critically varied, fulfilling from 27% to 100% of the quality criteria. Based on the critical issues emerging from this analysis, recommendations and minimal requirements for reporting clinical data on electrochemotherapy were prepared and summarized into a checklist. CONCLUSIONS:There is an increasing body of published clinical data on electrochemotherapy, but more high quality clinical data are needed. Published papers often lack accurate description of study population, treatment delivery as well as patient outcome. Our recommendations, provided in the form of a summary checklist, are intended to ameliorate data reporting in future studies on electrochemotherapy and help researchers to provide a solid evidence basis for clinical practice.

Dataset Information

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

Publications

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

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