Safe and effective are defined as follows. Safety: the condition of presenting a reasonably low risk of harm, injury, or loss when utilized in the specified indication; and effectiveness: producing a desired, beneficial effect under the conditions of actual use. Categories for response to a DATTA question are defined as follows. Established: technology demonstrated and accepted as safe and effective by the practicing medical community; investigational: largely confined to use under research protocol; unacceptable: risk/benefit ratio is unfavorable; and indeterminate: no consensus to date— evidence insufficient for a definitive decision, and may warrant further study.
χ2 Analysis of the responses of the DATTA panelists determined that the frequencies of responses (established, investigational, unacceptable, or indeterminate) differ significantly from those expected due to chance alone for questions 1A, 1B, and 2B. Construction of the 95% confidence intervals comparing the established category with the combination of investigational, unacceptable, and indeterminate showed a significant difference between these two groups for questions 1B and 2B, indicating that the DATTA panelists did not believe that the procedure had been established as effective. Construction of the 95% confidence intervals comparing the established category with the combination of investigational, unacceptable, and indeterminate for question 1A did not show a significant difference. Eight DATTA panelists offered no opinion on question 1A, nine panelists offered no opinion on 1B, and ten DATTA panelists offered no opinion on questions 2A and 2B.
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