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 responses of the DATTA panelists determined that the frequencies of responses (established, investigational, unacceptable, and indeterminate) differ significantly from those expected due to chance alone for all questions. Construction of the 95% confidence intervals comparing the established category vs the combination of investigational, unacceptable, and indeterminate showed a significant difference between these two groups for all questions. The DATTA panelists believed that continuous subcutaneous insulin infusion is established as both a safe and an effective technique for controlling insulin-dependent diabetes. The panelists did not believe continuous subcutaneous insulin infusion is yet established for preventing or reversing diabetic complications. Seven panelists offered no opinion on questions 1A and 1B; eight panelists had no opinion on questions 2A and 2B and 3A and 3B.
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