Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p24
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 63633–66690

in humans for the proposed food-health relationship in tabular form, including objectives, sample size, participant characteristics, measurement methods, control for confounding, results and any adverse effects. If an existing systematic review is being updated, the tabulation must include studies from the existing systematic review as well as additional literature identified in the update. If the tabulation in the existing review covers. all the items, then it is acceptable to reproduce the table(s) from the existing review, or to expand them if one or more items are missing.

Each study must be assessed for quality. A description of the quality assessment method used must be provided.

Note:

Presentation of data from human studies

Relevant data from each of the included studies should be presented in tabulated form. Original studies (i.e. not reviews or pooled/meta-analyses) should be organised according to study design (e.g. intervention/experimental studies, observational studies) into one or more tables. Tables should include the following information for each study:

    (a) the study reference: reference by author/date for each study
    (b) the study design: e.g. randomised controlled trial, cohort study, nested case-control study
    (c) the objectives or hypothesis
    (d) the sample size in the study groups: including the numbers. in each group who were recruited, randomised, completed the study, and included in the analyses, and any power calculations. Include loss to follow up or non-response
    (e) the participants characteristics: including age, sex, setting, health status, background diets (including use of supplements if relevant) and other relevant aspects of lifestyle
    (f) the method used to measure the food or property of food including amount consumed: including additional dietary intake (including methodology for this), method and frequency of consumption, form of substance including the food matrix (where applicable), amount consumed per day, duration of intervention (or study) and period of follow-up
    (g) confounders. measured and method used to control for confounding
    (h) the method used to measure the health effect
    (i) the study results, including effect size and statistical significance
    (j) any adverse effects.

Where an application is based on an existing systematic review, data from the studies included in the existing review and the additional studies that update the review should be organised in one or more tables and provide the information listed under a-j above.

Updates of existing reviews should include commentary about how the update affects the conclusions drawn by the authors. of the existing reviews.

Empirical analysis of the data

A meta-analysis of the data can be undertaken. This may add to the weight of evidence in support of the food-health relationship.

     B.4 Assessment of the data from human studies

The application must include a scientific assessment about how the studies reviewed demonstrate, with a high degree of certainty,