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 risk/benefit 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 distribution of responses (established, investigational, indeterminate, or unacceptable) differs significantly from those expected due to chance alone (P<.05) for the four questions. Construction of the 95% confidence interval comparing the established category vs the combination of investigational, unacceptable, and indeterminate did show a significant difference for all of the four questions. Therefore, a statistically significant majority of the panel answered all four questions as established. One panelist had no opinion on questions 1A and 1B.
Liskin L, Fox G.  IUDs: an appropriate contraceptive for many women . Population Rep. 1982;;No.
(4)
:101-135. Series B.
Richter R.  Ein mittel zur Verhutung der Konzeption . Deutsche Medizinische Wochenschr. 1909;;35:1525-1527.
Graefenberg E.  An intrauterine contraceptive method . In: Sanger M, Stone HM, eds. The Practice of Contraception: Proceedings of the 7th International Birth Control Conference, Zurich, Switzerland . Baltimore, Md: Williams & Wilkins; 1930;:33-47.
Ota T.  A study on the birth control with an intrauterine instrument . Jpn J Obstet Gynecol. 1934;;17:210-214.
Oppenheimer W.  Prevention of pregnancy by the Graefenberg ring method: a re-evaluation after 28 years' experience . Am J Obstet Gynecol. 1959;;78:446-454.
Breedlove B, Judy B, Martin N. Â Intrauterine devices (IUDs)Â . In: Hatcher RA, Stewart GK. Contraceptive Technology 1988-1989 . 14th revised ed. New York, NY: Irvington Publishers Inc; 1988;:267-294.
Zipper J, Medel M, Prager R.  Suppression of fertility by intrauterine copper and zinc in rabbits: a new approach to intrauterine contraception . Am J Obstet Gynecol . 1969;;105:529-534.
Scommegna A, Pandya GN, Christ M, Lee AW, Cohen MR.  Intrauterine administration of progesterone by a slow releasing device . Fertil Steril . 1970;;21:201-210.
Copper T Model TCU 380A Brand of Intrauterine Copper Contraceptive . New York, NY: The Population Council; 1987;. Patient information brochure.
Sivin I, Tatum HJ.  Four years of experience with the TCu 380A intrauterine contraceptive device . Fertil Steril . 1981;;36:159-163.
Mechanism of Action, Safety and Efficacy of Intrauterine Devices . Geneva, Switzerland: World Health Organization; 1987;;753:1-91. Technical Report Series.
Moyer DL, Mishell DR Jr.  Reactions of human endometrium to the intrauterine foreign body . Am J Obstet Gynecol. 1971;;111:66-80.
Sedlis A, Reyniak JV.  Endometrial leukocytes in patients using intrauterine contraceptive devices . Am J Obstet Gynecol. 1970;;108:1209-1212.
Kar AB, Engineer AD, Goel R, Kamboj VP, Dasgupta PR, Chowdhury SR.  Effect of an intrauterine contraceptive device on biochemical composition of uterine fluid . Am J Obstet Gynecol. 1968;;101:966-970.
Zipper JA, Tatum HJ, Medel M, Pastene L, Rivera M.  Contraception through the use of intrauterine metals, I: copper as an adjunct to the'T' device . Am J Obstet Gynecol. 1971;;109:771-774.
Oster G, Salgo MP.  The copper intrauterine device and its mode of action . N Engl J Med. 1975;;293:432-438.
El-Badrawi HH, Hafez ESE.  Physiological mechanisms of IUDs . In: Hafez ESE, Van Os WAA, eds. Developments in Obstetrics and Gynecology: Medicated Intrauterine Devices, Physiological and Clinical Aspects . The Hague, the Netherlands: Martinus Nijhoff Publishers; 1980;;5:60-83.
Progestasert, Intrauterine Contraceptive System . Palo Alto, Calif: Alza Corp;
(July)
1986;. Alza product information.
Brenner PF, Cooper DL, Mishell DR.  Clinical study of a progesterone-releasing intrauterine contraceptive device . Am J Obstet Gynecol. 1975;; 121:704-706.
Pizarro E, Gomez-Rogers C, Rowe PJ. Â Comparative study of the progesterone T (65 microgram daily) and copper 7 IUDÂ . Contraception . 1977;;16:313-323.
Hagenfeldt K, Landgren BM, Edstrom K, Johannisson E.  Biochemical and morphological changes in the human endometrium induced by the Progestasert device . Contraception . 1977;;16:183-197.
Martinez-Manautou J, Maqueo M, Aznar R, Pharriss B, Zaffaroni A.  Endometrial morphology in women exposed to uterine systems releasing progesterone . Am J Obstet Gynecol. 1975;;121:175-179.
Porter CW, Waife RS. Intrauterine Devices: Current Perspectives . 2nd ed. Chestnut Hill, Mass: Pathfinder Fund; 1982;.
Guillebaud J, Bonnar J.  Longer though lighter menstrual and intermenstrual bleeding with copper as compared to inert intrauterine devices . Br J Obstet Gynaecol. 1978;;85:707-712.
Sivin I, Stern J. Â Long-acting, more effective Copper T IUDs: a summary of US experience, 1970-1975Â . Stud Fam Plann. 1979;;10:263-281.
Edelman DA, Porter CW.  The intrauterine device and ectopic pregnancy . Contraception . 1987;;36:85-96.
Foreman H, Stadel BV, Schlesselman S.  Intrauterine device usage and fetal loss . Obstet Gynecol. 1981;;58:669-677.
Sivin I. Â IUD-associated ectopic pregnancies, 1974 to 1984Â . In: Zatuchni GI et al, ed. Intrauterine Conception: Advances and Future Prospects . Philadelphia, Pa: Harper & Row Publishers Inc; 1985;:340-353.
Grimes DA.  Intrauterine devices and pelvic inflammatory disease: recent developments . Contraception . 1987;;36:97-109.
Mardh PA.  An overview of infectious agents of salpingitis, their biology and recent advances in methods of detection . Am J Obstet Gynecol. 1980;;138:933-951.
Eschenbach DA, Buchanan TM, Pollock HM, Forsyth PS, Alexander ER, Lin JS.  Polymicrobial etiology of acute pelvic inflammatory disease . N Engl J Med. 1975;;293:166-171.
Toth A, O'Leary WM, Ledger W.  Evidence for microbial transfer by spermatozoa . Obstet Gynecol. 1982;;59:556-559.
Washington AE, Arno PS, Brooks MA.  The economic cost of pelvic inflammatory disease . JAMA . 1986;;255:1735-1738.
Westrom L.  Incidence, prevalence, and trends of acute pelvic inflammatory disease and its consequences in industrialized countries . Am J Obstet Gynecol. 1980;;138:880-892.
Cramer DW, Schiff I, Schoenbaum SC, Gibson M, Belisle S, Albrecht B.  Tubal infertility and the intrauterine device . N Engl J Med. 1985;;312:941-947.
Lee NC, Rubin GL, Borucki R.  The intrauterine device and pelvic inflammatory disease revisited: new results from the women's health study . Obstet Gynecol. 1988;;72:1-6.
Sharma OP: Sarcoidosis: Clinical Management . London, Butterworths, 1984;.
Vien NK:  Cutaneous sarcoidosis: Prognoses and treatment . Clin Dermatol 1986;;4:75-84.
Callen JP:  Relationship of cutaneous sarcoidosis to systemic disease . Clin Dermatol 1986;;4:46-53.
Verdegem TD, Sharma OP:  Cutaneous ulcers in sarcoidosis . Arch Dermatol 1987;;123:1531-1534.