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JAMA. 1990;263(11):1563-1568. doi:10.1001/jama.1990.03440110139041.
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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.
For each question, the response category receiving the most votes was tested for a consensus by assuming that the DATTA panel is a sample from a broader population of experts. Using exact binomial probabilities, the likelihood of the observed vote was calculated if exactly 50% of the total population of experts support that response for that question. Hence, the null hypothesis is that 50% of all experts support the response, and the alternative, one-tailed, hypothesis is that more than 50% of all experts support the response. Rejection of the null hypothesis, and acceptance of the alternative, is interpreted as evidence of a majority opinion in the total population of experts, and a consensus is achieved. P values for the survey responses are as follows: Question 1A, 39 "Established" responses out of 46, P<.0001, consensus for "Established"; question 1B, 33 "Established" responses out of 46, P =.0023, consensus for "Established"; question 2A, 40 "Established" responses out of 46, P<.0001, consensus for "Established"; question 2B, 26 "Appropriate" responses out of 46, P=.2307, no consensus; question 3A, 37 "Established" responses out of 46, P<.0001, consensus for "Established"; question 3B, 27 "Appropriate" responses out of 46, P=.1510, no consensus; question 4A, 37 "Established" responses out of 46, P<.0001, consensus for "Established"; question 4B, 29 "Appropriate" responses out of 46, P =.0519, no consensus.
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