"Safe" and "effective" are defined as follows: Safety is the condition of presenting a reasonably low risk of harm, injury, or loss when a technology is utilized in the specified indication; and effectiveness is the quality of producing a desired, beneficial effect under the conditions of actual use. The categories for response to a DATTA question are defined as follows: Established—a technology demonstrated and accepted as safe and effective by the practicing medical community; investigational—a technology largely confined to use under research protocol; unacceptable—the risk/benefit ratio is unfavorable; and indeterminate—the evidence is insufficient for a definitive decision, and no consensus exists to date; further study may be warranted.
χ2 Analysis of the responses of the DATTA panelists determined that the distribution of responses (established, investigational, indeterminate, or unacceptable) differs significantly from those expected due to chance alone (P<.05) for the four questions. Construction of the 95% confidence interval comparing the established category vs the combination of investigational, unacceptable, and indeterminate did not show a significant difference for any of the four questions. Twelve panelists had no opinion on questions 1A and 1B and 11 panelists had no opinion on questions 2A and 2B.
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