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 riskbenefit 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 distribution of panelists' responses for questions 1A, 1B, 2A, and 2B showed that the responses differed significantly from those expected by chance alone (P<.05). Comparison of the 95% confidence interval of the proportion of "unacceptable" responses to the combined responses of "established," "investigational," and "indeterminate" showed that a statistically significant majority of the panelists believe the answer should be "unacceptable" for questions 2A and 2B. For questions 1A and 1B the confidence intervals about the proportion voting "established" contained the 50% point, and no consensus was achieved. One panelist had no opinion for questions 1 and 2.
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