Division of Neonatology, Christiana Care Health System, Newark, DE.
Division of Neonatology, Christiana Care Health System, Newark, DE.
J Pediatr. 2019 Jun;209:52-60.e1. doi: 10.1016/j.jpeds.2019.02.023. Epub 2019 Apr 2.
To assess decisional conflict and knowledge about prematurity among mothers facing extreme premature delivery when the counseling clinicians were randomized to counsel using a validated decision aid compared with usual counseling.
In this randomized trial, clinicians at 5 level III neonatal intensive care units in the US were randomized to supplement counseling using the decision aid or to counsel mothers in their usual manner. We enrolled mothers with threatened premature delivery at 22 to 25 weeks of gestation within 7 days of their counseling. The primary outcome was the Decisional Conflict Scale (DCS) score. One hundred mothers per group were enrolled to detect a clinically relevant effect size of 0.4 in the Decisional Conflict Scale. Secondary outcomes included knowledge about prematurity; scores on the Preparedness for Decision Making scale; and acceptability.
Ninety-two clinicians were randomized and 316 mothers were counseled. Of these, 201 (64%) mothers were enrolled. The median gestational age was 24.1 weeks (IQR 23.7-24.9). In both groups, DCS scores were low (16.3 ± 18.2 vs 16.8 ± 17, P = .97) and Preparedness for Decision Making scores were high (73.4 ± 28.3 vs 70.5 ± 31.1, P = .33). There was a significantly greater knowledge score in the decision aid group (66.2 ± 18.5 vs 57.2 ± 18.8, P = .005). Most clinicians and parents found the decision aid useful.
For parents facing extremely premature delivery, use of a decision aid did not impact maternal decisional conflict, but it significantly improved knowledge of complex information. A structured decision aid may improve comprehension of complex information.
Clinicaltrials.gov: NCT01713894.
评估在为面临极早产的产妇提供咨询时，临床医生随机使用经过验证的决策辅助工具与常规咨询相比，产妇的决策冲突和对早产的认识情况。
这是一项在美国 5 家三级新生儿重症监护病房进行的随机试验，临床医生被随机分为使用决策辅助工具补充咨询或按照常规方式为产妇提供咨询。我们招募了妊娠 22 至 25 周、在咨询后 7 天内有早产威胁的产妇。主要结局指标是决策冲突量表（DCS）评分。每组纳入 100 名产妇，以检测 DCS 中 0.4 的临床相关效应量。次要结局指标包括对早产的认识；决策准备量表的评分；以及可接受性。
92 名临床医生被随机分组，316 名产妇接受了咨询。其中 201 名（64%）产妇被纳入研究。中位妊娠周数为 24.1 周（IQR 23.7-24.9）。两组的 DCS 评分均较低（16.3±18.2 分比 16.8±17 分，P=0.97），决策准备量表的评分均较高（73.4±28.3 分比 70.5±31.1 分，P=0.33）。决策辅助组的知识评分显著更高（66.2±18.5 分比 57.2±18.8 分，P=0.005）。大多数临床医生和家长认为决策辅助工具很有用。
对于面临极早产的产妇，使用决策辅助工具并未影响产妇的决策冲突，但显著提高了对复杂信息的了解。结构化的决策辅助工具可能会提高对复杂信息的理解。
Clinicaltrials.gov：NCT01713894。
