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WOMEN 'S HEALTH AND MENOPAUSE : - National Heart, Lung ...

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TABLE 1–1<br />

Evidence Categories<br />

Evidence Category<br />

A<br />

B<br />

C<br />

D<br />

Sources of Evidence<br />

Randomized, controlled trials<br />

(rich body of data)<br />

Randomized, controlled trials<br />

(limited body of data)<br />

Nonrandomized trials and/or<br />

observational studies<br />

Expert judgment<br />

Definition<br />

Evidence is from endpoints of well-defined RCTs<br />

(or trials that depart only minimally from randomization)<br />

that provide a consistent pattern of findings<br />

in the population for which the recommendation is<br />

made. Category A, therefore, requires substantial<br />

numbers of studies involving substantial numbers<br />

of participants.<br />

Evidence is from endpoints of intervention studies<br />

that include only a limited number of RCTs, post<br />

hoc or subgroup analysis of RCTs or meta-analysis<br />

of RCTs, controlled trials. In general, category B<br />

pertains when few randomized trials exist, they<br />

are small in size, and the trial results are somewhat<br />

inconsistent, or the trials were undertaken in a<br />

population that differs from the target population<br />

of the recommendation.<br />

Evidence is from outcomes of uncontrolled or<br />

nonrandomized trials or from observational studies.<br />

Expert judgment is based on the authors’ synthesis<br />

of evidence from research described in the literature<br />

that does not meet the above-listed criteria, taking<br />

into consideration critical advice by other members<br />

of the international panel of experts, external<br />

referees, and external reviewers. The category is<br />

used only in cases in which the provision of some<br />

guidance was deemed valuable but an adequately<br />

compelling clinical literature addressing the subject<br />

of the recommendation was deemed insufficient to<br />

justify placement in one of the other categories<br />

(A through C).<br />

Source: Adapted from the NIH. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The Evidence<br />

Report. Bethesda, MD, 1998; NIH publication no. 98–4083.<br />

3

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