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DRAFT Australian Dietary Guidelines - Eat For Health

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Level III-2 - A comparative study with concurrent controls:<br />

Non-randomised experimental trial<br />

Cohort study<br />

Case-control study<br />

Interrupted time series with a control group<br />

Level III-3 - A comparative study without concurrent controls:<br />

Historical control study<br />

Two or more single arm study<br />

Interrupted time series without a parallel control group<br />

Level IV - Case series with either post-test or pre-test/post-test outcomes<br />

Data was extracted from included studies and assessed for strength of evidence, size of<br />

effect and relevance of evidence according to standardised NHMRC processes [34, 39-41]. The<br />

components of the body of evidence - evidence base (quantity, level and quality of evidence);<br />

consistency of the study results; clinical impact; generalisability; and applicability to the <strong>Australian</strong><br />

context) - were rated as excellent, good, satisfactory or poor according to standard NHMRC<br />

protocols [41]. The reviewers then translated the evidence into a draft body of evidence<br />

statement. The draft Evidence Statements were graded A to D according to standard NHMRC<br />

protocols [41] where:<br />

Grade A indicates that the body of evidence can be trusted to guide practice<br />

Grade B indicates that the body of evidence can be trusted to guide practice in most<br />

situations<br />

Grade C indicates that the body of evidence provides some support for the<br />

recommendations but care should be taken in its application<br />

Grade D indicates that the body of evidence is weak and any recommendation must be<br />

applied with caution.<br />

In order to reduce potential risks associated with advice being based on findings of single or only a<br />

few studies, the Working Committee and DAA Contractors advised that a minimum of five quality<br />

studies were required before a graded draft evidence statement could be made. The individual<br />

studies in included meta-analysis studies were considered as separate studies.<br />

Once the Evidence Statements and Grades had been drafted the NHMRC commissioned a<br />

methodologist through the NHMRC methodologist panel, Ms Phillippa Middleton from the<br />

University of Adelaide, to assist the Working Committee to ensure that the review activities had<br />

been undertaken in a transparent, accurate and unbiased manner. The methodologist and the<br />

Working Committee scrutinised each step of the review process by accessing the original papers<br />

and reviewing the rating of evidence components, and the wording and grading of each draft<br />

Evidence Statement. As a result, some Evidence Statements and Grades were amended using a<br />

Working Committee consensus approach, and the final Evidence Statements and Grades were<br />

agreed.<br />

<strong>DRAFT</strong> <strong>Australian</strong> <strong>Dietary</strong> <strong>Guidelines</strong>- December 2011 159

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