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. 2019 Sep 6;58(Suppl 2):49–64. doi: 10.1007/s00394-019-02069-3

Table 1.

Dictionary of conditions related to data reporting on IIV and associated scores for the evaluation of quality of data reporting in intervention studies dealing with plant bioactives

Category Parameters Condition Score
Statistics Sample size-power calculation Authors reported on: (1) power calculation focused on assessing inter-individual variation based on primary OR the most limiting outcome AND (2) on all the data used in power calculation (% of statistical power, significance level, expected dropout rate, expected difference between groups of the mean or % with the event) AND (3) the resulting sample size per each group 1
Authors did not describe sample size taking into account all the three previous conditions 0
Data distribution Authors specified the test used for normality (OR indicate something related to data normality, for instance, log transformation) 1
Authors did not report any information related to the normality or distribution of the data in general 0
p value Authors reported p value that support IIV (e.g., p value related to the examination of differences between two or more factors affecting IIV such as sex, age, genotypes, etc.) 1
Authors did not report any p values related to the IIV 0
Effect size Authors reported the magnitude of the IIV for the selected outcome(s) by standardized mean differences as an index of effect size (Cohen’s d, % of coefficient of variation, etc.) or any parameters related to the effect size suitable for the conducted statistical tests 1
Authors did not indicate any parameters related to the effect size i.e., magnitude of the IIV for the selected outcome(s) (any of standardized mean differences was not reported) 0
Reporting General characteristics of the subgroups where IIV was evaluated Authors reported on one or more general characteristics (for instance, ethnicity, BMI, age, gender, smoking status, etc.) for each of the subgroups where IIV was evaluated 1
Authors did not report any of general characteristics for the study sample (for instance, ethnicity, BMI, age, gender, smoking status, etc.) on each subgroup where IIV was evaluated 0
Data reporting for end-points by subgroups Both pre- and post-intervention data (or post-intervention data as % change with respect to a provided baseline value) were reported for different subgroups where IIV was evaluated 1
Post-intervention data (or % change without a provided baseline value) are provided by each subgroup where IIV was evaluated 0.5
Neither pre- nor post-intervention data were reported for different subgroups where IIV was evaluated 0
Measures of central tendencies and dispersion parameters Authors reported on one or more measures of central tendencies (mean, median, etc.) AND one or more dispersion parameters (standard deviations, standard error, interquartile range, 95% confidence interval, etc.) for EACH subgroup where IIV is evaluated 1
Authors did not report any measures of central tendencies or dispersion measures for subgroups where IIV was evaluated, regardless of reporting these parameters for the total sample 0
Outliers Authors indicated outliers AND described them (explained the reason for treating them as outliers) 1
Authors indicated that outliers existed and that were excluded from the analysis but without describing them 0.5
Authors did not indicate any information related to outliers 0
Data presentation Tables Tables contain additional measures of variability (min–max, interquartile range, outliers values, etc.) or individual measures (responders/non-responders, etc.) 1
Tables did not contain any extra measures of variability (min–max, interquartile range, outliers values, etc.) nor individual measures (responders/non-responders, etc.) 0
Graphs Authors presented data for the primary outcome by scatterplots, boxplots or heat maps 1
Authors presented data by histograms for a primary outcome OR as scatterplots and boxplots for secondary outcomes 0.5
Data are graphically presented as bar chart, curves, etc. (for any of the study point-before or after the intervention) but not as scatterplots, boxplots, heat maps or histograms 0
Individual data availability Presentation of full data and population characteristics Authors provided individual data for each end-point, together with the characteristics of the samples on the individual level, in the paper or in the supplemental material 2
Authors provided individual data at each end-point (even presented in the figures) but without any additional characteristics of the sample on the individual level 1
Authors did not provide individual data 0