研究背景：产前筛查与产前诊断是降低新生儿出生缺陷的重要手段。羊膜腔穿刺术是我国最常用的产前诊断技术，被誉为诊断的“金标准”，但它作为一项侵入性操作，存在流产的潜在风险。孕妇需要在获取准确诊断和承担风险之间权衡，加之临床就诊时间有限，往往难以充分了解各方案优劣便需做出决策，从而陷入决策冲突。患者决策辅助工具是一种为患者解释各治疗方案利弊并澄清价值观的工具，它在多个领域的实践被证明可以有效帮助患者减少决策冲突，提高决策质量。目前，我国缺乏针对孕妇羊膜腔穿刺术决策的患者决策辅助工具。

研究目的：基于渥太华决策支持框架，依托微信小程序平台，构建一个符合我国国情的孕妇羊膜腔穿刺术决策辅助工具，并进行初步的可用性评估。

研究方法：本研究遵循以下步骤构建孕妇羊膜腔穿刺术决策辅助工具。首先，明确决策问题并构建多学科研究团队。其次，对具有羊膜腔穿刺术指征的孕妇以及从事产前诊断领域的医生进行访谈，了解其决策困境及决策需求。接着，通过系统评价确定工具应涵盖的核心要素与分级指标，并进一步通过证据总结整合文献中的相关循证内容细节，在此基础上形成工具的初稿。随后，通过两轮专家函询法对工具内容进行评价与修订，形成最终定稿。最后，依托微信小程序平台实现工具的数字化开发与呈现，并邀请孕妇和产科医生对开发完成的工具进行可用性评估。

研究结果：本研究首先通过访谈揭示了孕妇在羊穿决策过程中面临的决策困境以及对权威信息、价值观澄清和社会支持的决策需求。随后基于系统评价结果，初步构建了包含6个一级指标和24个二级指标的内容框架，并通过证据总结的方法整合循证信息形成工具初稿。该初稿经产前诊断领域专家两轮函询评估进一步修订，最终形成包含6个一级指标和13个二级指标的终稿。最后基于微信小程序平台成功开发了电子化工具，并邀请孕妇和产科医生进行可用性评估，结果表明本工具具有较高的临床应用潜力和用户接受度。

研究结论：本研究成功开发了一个基于渥太华决策支持框架的电子化孕妇羊膜腔穿刺术决策辅助工具，它系统整合了循证证据与我国孕妇的决策需求，初步的可用性评估也显示其具有良好的接受度。

Background: Prenatal screening and diagnosis are critical measures for reducing birth defects in newborns. Amniocentesis, recognized as the "gold standard" for prenatal diagnosis, is the most commonly used prenatal diagnostic technique in China. However, as an invasive procedure, it carries a potential risk of miscarriage. Pregnant women must balance obtaining accurate diagnosis against assuming this risk. Limited clinical consultation time often prevents women from fully understanding the advantages and disadvantages of available options before making decisions, resulting in decision conflict. Patient Decision Aids (PtDAs) are tools designed to explain treatment options and clarify values for patients. Currently, China lacks a specific patient decision aid for amniocentesis decision-making among pregnant women. Objective: To develop a patient decision aid for amniocentesis decision-making that aligns with China's national context based on the Ottawa Decision Support Framework and implemented through a WeChat mini-program platform, and to conduct a preliminary usability assessment. Methods: This study followed a systematic approach to develop the amniocentesis decision aid. First, the decision problem was clarified and a multidisciplinary research team was established. Second, interviews were conducted with pregnant women who had indications for amniocentesis and prenatal diagnosis specialists to understand their decision dilemmas and needs. Next, a systematic review was performed to determine the core elements and hierarchical indicators that should be included in the tool, followed by evidence summaries to integrate relevant evidence-based content details from the literature, forming the initial draft. Subsequently, the content was evaluated and revised through two rounds of expert consultation to produce the final version. Finally, the tool was digitally developed and presented through a WeChat mini-program platform, and pregnant women and obstetricians were invited to evaluate the tool's usability. Results: The study first revealed, through interviews, the decision dilemmas faced by pregnant women during amniocentesis decision-making and their needs for authoritative information, value clarification, and social support. Based on systematic review results, an initial content framework comprising 6 primary indicators and 24 secondary indicators was developed, and evidence-based information was integrated through evidence summary methods to form a preliminary draft. This draft underwent further revision through two rounds of expert consultation in the field of prenatal diagnosis, ultimately resulting in a final version containing 6 primary indicators and 13 secondary indicators. Finally, an electronic tool was successfully developed based on the WeChat mini-program platform, and usability assessment by pregnant women and obstetricians indicated that the tool has high potential for clinical application and user acceptance. Conclusion: This study successfully developed a web-based patient decision aid for amniocentesis based on the Ottawa Decision Support Framework. Preliminary usability assessment demonstrated good acceptability of the tool.