Informed consent for maternal serum alpha-fetoprotein screening in an inner city population: how informed is it?
Informed consent for maternal serum alpha-fetoprotein screening in an inner city population: how informed is it?
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DOI：
10.1111/j.1552-6909.1998.tb02597.x
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发表时间：
1998-01-01
期刊：
影响因子：
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通讯作者：
Merkatz, I R
中科院分区：
文献类型：
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作者：
Freda, M C;DeVore, N;Merkatz, I R
目的：确定从提供者处获得信息并观看母体血清甲胎蛋白（MSAFP）筛查录像带的妇女是否足够理解并签署知情同意书。设计：一项前瞻性定性设计，使用磁带记录访谈的妇女，她们从提供者和观看录像带中获得有关MSAFP检测的信息。参与者：53名内城孕妇（58%西班牙裔，39%非洲裔，3%白人）。结果：2名女性正确回答了所有问题；没有人回答错所有的问题。62%的人正确回答了“什么是MSAFP?”16%的人认为，为了测试，“我必须从肚子里拿出一些东西”。59%的医生了解脊柱裂患儿可能有行走困难或泌尿系统问题。72%的人认为，如果检测结果为阴性，他们的孩子在各方面都是健康的。只有45%的人能描述出阳性检测后的后续情况。80%的人计划进行测试。许多误解是显而易见的，在一些知识项目中，多达80%的女性回答错误。结论：为一项复杂的试验获得真正的知情同意并不是一个简单的过程。参与者符合知情同意的一些标准，但不是全部。妇女知道这项检测是自愿的，但她们对阳性检测结果的意义和含义的理解不足。尽管如此，他们还是签署了知情同意书。更大的问题是，需要多少理解力才能认为一个女人“见多识广”，这个问题还没有答案。
OBJECTIVE: 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.DESIGN: 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.PARTICIPANTS: Fifty-three inner city pregnant women (58% Hispanic, 39% African-American, 3% white).RESULTS: 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.CONCLUSIONS: 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.