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 is appropriate for the given indication in the specified patient population; 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 is inappropriate for the given indication in the specified patient population; 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, any response category receiving 50% or more of the panel's 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 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. If no consensus was found, the categories were reorganized and reanalyzed. The concept "appropriate" includes the categories "promising" and "established," while the concept "inappropriate" includes the categories "doubtful" and "unacceptable." The original five categories were thus, if necessary, reorganized into three categories, "appropriate," "investigational," and "inappropriate"; an analysis of any category with 50% or more of the vote was performed. P values for the survey responses are as follows: question A, 19 "appropriate" responses out of 23, P =.0013 consensus for appropriate; question B, 21 "appropriate" responses out of 23, P<.0001, consensus for appropriate. Eleven panelists offered no opinion for questions A and B.
Vasoactive intracavernous pharmacotherapy for impotence: papaverine and phentolamine . JAMA. 1990;;264:752-754. Diagnostic and Therapeutic Technology Assessment.
Stackl W, Hasun R, Marberger M. Intracavernous injection of prostaglandin E, in impotent men . J Urol. 1988;;140:66-68.
Waldhauser M, Schramek P. Efficiency and side effects of prostaglandin E1 in the treatment of erectile dysfunction . J Urol. 1988;;140:525-527.
Sarosdy MF, Hudnall CH, Erickson DR, Hardin TC, Novicki DE. A prospective double-blind trial of intracorporeal papaverine versus prostaglandin E, in the treatment of impotence . J Urol. 1989;;141:551-553.
Lee LM, Stevenson RW, Szasz G. Prostaglandin E, versus phentolamine/ papaverine for treatment of erectile impotence: a double-blind comparison . J Urol. 1989;;141:549-550.
Ishii N, Watanabe H, Irisawa C, et al. Intracavernous injection of prostaglandin E1 for the treatment of erectile impotence . J Urol. 1989;;141:323-325.
Earle CM, Keogh EJ, Wisniewski ZS, et el. Prostaglandin E1 therapy for impotence: comparison with papaverine . J Urol. 1990;;143:57-59.
Floth A, Schramek P. Intracavernous injection of prostaglandin E1 in combination with papaverine: enhanced effectiveness in comparison with papaverine plus phentolamine and prostaglandin E1 alone . J Urol. 1991;;145:56-59.
Gerrard JM. Prostaglandins and Leukotrienes . New York, NY: Marcel Dekker Inc; 1985;.
Drug Evaluations Subscription . Chicago, Ill: American Medical Association; 1990;;2(
Langer SZ. Presynaptic regulation of the release of catecholamines . Pharmacol Rev. 1981;;32:337-340.
Heymann MA. Pharmacologic use of prostaglandin E1 in infants with congenital heart disease . Am Heart J. 1981;;101:837-843.
Klinge E, Sjostrand ND. Comparative study of some isolated mammalian smooth muscle effectors of penile erection . Acta Physiol Scand. 1977;;100:354-367.
Hamberg M. Biosynthesis of prostaglandin E1 by human seminal vesicles . Lipids. 1976;;11:249-250.
Roy AC, Tan SM, Kottegoda SR, Ratman SS. Ability of human corpora cavernosa muscle to generate prostaglandins and thromboxanes in vitro . IRCS J Med Sci. 1984;;12:608-609.
Jeremy JY, Morgan RJ, Mikhailidis DP, Dandona P. Prostacyclin synthesis by the corpora cavernosa of the human penis: evidence for muscarine control and pathologic implications . Prostaglandins Leukot Med. 1986;;23:211-214.
Hedlund H, Andersson KE. Contraction and relaxation induced by some prostanoids in isolated human penile erectile tissue and cavernous artery . J Urol. 1985;;134:1245-1250.
Virag R. Intracavernous injection of papaverine for erectile failure . Lancet. 1982;;2:938.
Virag R, Adaikan PG. Effects of prostaglandin E1 on penile erection and erectile failure . J Urol. 1987;;137:1010.
Reiss H. Use of prostaglandin E, for papaverine-failed erections . Urology. 1989;;33:15-16.
Schramek P, Dorninger R, Waldhauser M, Konecny P, Porpaczy P. Prostaglandin E, in erectile dysfunction: efficiency and incidence of priapism . Br J Urol. 1990;;65:68-71.
Aboseif SR, Breza J, Bosca RJLH, et al. Local and systemic effects of chronic intracavernous injection of papaverine, prostaglandin E1, and saline in primates . J Urol. 1989;;142:403-408.