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ARTICLE |

Questions and Answers

Nancy B. Esterly, MD
JAMA. 1990;263(6):881-887. doi:10.1001/jama.1990.03440060129046.
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"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—this technology has been adequately evaluated, and its (A) safety or (B) effectiveness is accepted as appropriate by the practicing medical community for the given indication in the specified patient population; promising—given current knowledge, the (A) safety or (B) effectiveness of this technology appears to be appropriate for the given indication in the specified patient population; as more experience and long-term follow-up are accumulated, this interim rating will change; investigational—there is no consensus on the (A) safety or (B) effectiveness of this technology to date, there is insufficient evidence to determine its appropriateness, or it warrants further study; use of this technology for the given indication in the specified patient population should be confined largely to research protocols; doubtful——given current knowledge, the (A) safety or (B) effectiveness of this technology appears to be inappropriate for the given indication in the specified patient population; as more experience and long-term follow-up are accumulated, this interim rating will change; and unacceptable—the (A) safety or (B) effectiveness of this technology is regarded by the practicing medical community as inappropriate for the given indication in the specified patient population.
χ2 analysis of the responses of the DATTA panelists determined that the frequency of responses (established, promising, investigational, doubtful, or unacceptable) differs from that due to chance alone for all questions in this survey. The responses were then examined for consensus.
A consensus is determined in a DATTA evaluation by examining the proportion of respondents voting for a particular category. The lower limit of the 95% confidence interval for the population proportion must be greater than 50% of responders for a definitive majority of all experts to be considered in support of a category and for that category to thus achieve consensus. Those categories marked by an asterisk in the accompanying figures met this criterion. Depending on the question, from 10 to 24 respondents offered no opinion.
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