Freda M C, DeVore N, Valentine-Adams N, Bombard A, Merkatz I R
Albert Einstein College of Medicine, Department of Obstetrics & Gynecology and Women's Health, Bronx, NY 10461, USA.
J Obstet Gynecol Neonatal Nurs. 1998 Jan-Feb;27(1):99-106. doi: 10.1111/j.1552-6909.1998.tb02597.x.
To determine if women who received information from a provider and viewed a videotape about maternal serum alpha-fetoprotein (MSAFP) screening understood enough to sign informed consent.
A prospective qualitative design using tape recorded interviews of women who were provided information regarding MSAFP testing from a provider and from viewing a videotape.
Fifty-three inner city pregnant women (58% Hispanic, 39% African-American, 3% white).
Two women answered all questions correctly; no one answered all questions incorrectly. Sixty-two percent correctly answered "What is MSAFP?" Sixteen percent thought "something has to be taken from my belly" for the test. Fifty-nine percent understood that children with spina bifida could have difficulty walking or urinary problems. Seventy-two percent thought their infant would be healthy in all respects if the test was negative. Only 45% could describe the follow-up to a positive test. Eighty percent planned to have the test. Many misconceptions were apparent, and for some knowledge items, as many as 80% of the women answered incorrectly.
Obtaining truly informed consent for a complex test is not a simple process. Participants met a few, but not all, of the criteria for informed consent. Women understood that the test was voluntary, but their comprehension of the meaning and implication of a positive test results was deficient. Despite this, they signed the informed consent document. The larger question of just how much comprehension is required to consider a woman "informed" has not been answered.
确定从医疗服务提供者处获取信息并观看了关于母血甲胎蛋白（MSAFP）筛查录像带的女性是否理解充分并能签署知情同意书。
采用前瞻性定性设计，对从医疗服务提供者处获取MSAFP检测信息并观看录像带的女性进行录音访谈。
53名市中心区的孕妇（58%为西班牙裔，39%为非裔美国人，3%为白人）。
两名女性所有问题回答正确；无人所有问题回答错误。62%的人正确回答了“什么是母血甲胎蛋白？”16%的人认为该项检测“必须从我肚子里取些东西”。59%的人明白脊柱裂患儿可能行走困难或有泌尿问题。72%的人认为如果检测结果为阴性，她们的婴儿在各方面都会健康。只有45%的人能描述阳性检测结果后的后续措施。80%的人计划进行该项检测。明显存在许多误解，对于一些知识项目，多达80%的女性回答错误。
就一项复杂检测获得真正的知情同意并非易事。参与者符合知情同意的部分而非全部标准。女性明白该项检测是自愿的，但她们对阳性检测结果的意义和影响理解不足。尽管如此，她们还是签署了知情同意文件。关于要达到何种理解程度才能认为女性“已充分知情”这个更大的问题尚未得到解答。
