Effect of Enhanced Information, Values Clarification, and Removal of Financial Barriers on Use of Prenatal Genetic Testing A Randomized Clinical Trial
Effect of Enhanced Information, Values Clarification, and Removal of Financial Barriers on Use of Prenatal Genetic Testing A Randomized Clinical Trial
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DOI：
10.1001/jama.2014.11479
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发表时间：
2014-09-24
影响因子：
120.7
通讯作者：
Norton, Mary E.
中科院分区：
文献类型：
--
作者：
Kuppermann, Miriam;Pena, Sherri;Norton, Mary E.
重要性产前基因检测指南建议为患者提供详细信息，以便做出知情的、基于偏好的筛查和诊断检测决定。目的分析决策支持指南和消除检测的经济障碍对不同识字和算术水平的孕妇产前基因检测和决策的影响。设计、设置和参与者2010-2013年在旧金山湾区3家县医院、1家社区诊所、1家学术中心和3家医疗中心的产前诊所进行的随机试验。参与者是尚未接受筛查或诊断测试的讲英语或西班牙语的妇女(n=710)，她们在怀孕11周时仍处于怀孕状态(n=710)。干预措施一种计算机化的交互式决策支持指南，可获得产前检查，无需自付费用(n=357)或根据当前指南进行常规护理(n=353)。主要结果和衡量主要结果是通过医疗记录审查获得的侵入性诊断测试。结果与随机进入对照组的妇女相比，随机进入干预组的妇女接受侵入性诊断试验的可能性较低(5.9%比12.3%；优势比[OR]，0.45[95%CI，0.25~0.80])，而更有可能完全放弃试验(25.6%比20.4%；或3.30[95%可信区间1.43-7.64]，参考人群筛查后进行有创检测)。被随机分到干预组的妇女也有更高的知识得分(9.4vs8.6，满分为15分；平均组间差异，0.82[95%可信区间，0.34-1.31])，并且更有可能正确估计与羊膜穿刺术相关的流产风险(73.8%vs 59.0%；OR，1.95[95%CI，1.39-2.75])和她们估计的年龄调整后怀上21三体胎儿的几率(58.7%vs46.1%；或，1.66[95%CI，1.22-2.28])。在决策冲突或遗憾方面没有出现显著差异。结论和相关性在没有财务障碍的情况下，充分实施产前检测指南，使用计算机化的交互式决策支持指南，可以减少检测的使用和更多的知情选择。如果在更多的人群中得到验证，这种方法可能会导致更多的知情和基于偏好的产前检测决策，并减少接受检测的妇女。
IMPORTANCE Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood.OBJECTIVE To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels.DESIGN, SETTING, AND PARTICIPANTS Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English-or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks' gestation (n = 710).INTERVENTIONS A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n = 357) or usual care as per current guidelines (n = 353).MAIN OUTCOMES AND MEASURES The primary outcomewas invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks' gestation.RESULTS Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret.CONCLUSIONS AND RELEVANCE Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing.