Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p6
Version: federal_register_of_legislation:F2016C00156
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clearly enunciated along with the findings and the conclusions. Where surveys are designed to be targeted or selective, the basis for doing so should be clearly stated.

    (b) The survey should use a design that avoids biasing the results. The target population should be identified, and the sample frame described in terms of the target population. The survey should have a sample size that provides sufficient power to detect an effect. The sampling method used (e.g. simple random sampling, cluster sampling) should be described, and the reason for the method provided. Any deviations from the sampling method should be identified and the reasons for deviation provided. Data analysis and reporting should be consistent with the sampling method. If any observation/case is excluded from data analysis, the reason for exclusion should be defined and reported.

    (c) Surveys should include evidence of quality control/assurance systems. Information on limits of reporting should also be included.

     E.1.3 Data related to epidemiological/intervention studies in humans

    (a) Epidemiological/intervention studies should include comprehensive detail about:

       (i) the study design e.g. randomised controlled trial, cohort study, nested case-control study
       (ii) the objectives or hypothesis
       (iii) the sample size in the study groups including the numbers. in each group that were recruited, randomised, completed the study, and included in the analyses, and any power calculations
       (iv)  the participants' characteristics including age, sex, setting, health status
       (v) the methodology including duration of intervention (or study) and period of follow-up, measurement of outcomes and confounders, statistical analysis
       (vi) the study results including effect size and statistical significance, any adverse effects.

    (b) The studies should have a sample size that provides sufficient power to detect an intended effect.

Note:

Examples of the main types of intervention and epidemiological study designs include:

Intervention (experimental) studies:

     * clinical trials
     * field trials
     * individual level
     * aggregated level (community trials)

Observational (non-experimental) studies:

     * cohort studies
     * case-control studies
     * cross-sectional surveys
     * routine data-based studies:

–                individual level data
–                aggregated level data (ecological studies)

    Note:

A number of resources exist which provide guidance on how to report research methods and findings. These resources specify a minimum set of items required for a clear and transparent account of what was done and what was found in a research study, reflecting in particular, issues that might introduce bias into the research. Most widely recognised guidelines are based on the available evidence and reflect consensus opinion of experts in a particular field, including research methodologists and journal editors. These resources are all available online. A list of links to useful resources is provided below:

    (i) Equator Network: overview of reporting guidelines
    http://www.equator-network.org/index.aspx?o=1032
    (ii) GRADE: Grades of Recommendation, Assessment, Development, and Evaluation
    http://www.jclinepi.com/content/jce-GRADE-Series

    (iii) CONSORT Statement: