Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
BMJ Open. 2021 Mar 22;11(3):e046021. doi: 10.1136/bmjopen-2020-046021.
Decision analysis is a quantitative approach to decision making that could bridge the gap between decisions based solely on evidence and the unique values and preferences of individual patients, a feature especially important when existing evidence cannot support clear recommendations and there is a close balance between harms and benefits for the treatments options under consideration. Low molecular weight heparin (LMWH) for the prevention of venous thromboembolism (VTE) during pregnancy represents one such situation. The objective of this paper is to describe the rationale and methodology of a pilot study that will explore the application of decision analysis to a shared decision-making process involving prophylactic LMWH for pregnant women or those considering pregnancy who have experienced a VTE.
We will conduct an international, mixed methods, explanatory, sequential study, including quantitative data collection and analysis followed by qualitative data collection and analysis. In step I, we will ask women who are pregnant or considering pregnancy and have experienced VTE to participate in a shared decision-making intervention for prophylactic LMWH. The intervention consists of three components: a direct choice exercise, a values elicitation exercise and a personalised decision analysis. After administration of the intervention, we will ask women to make a treatment decision and measure decisional conflict, self-efficacy and satisfaction. In step II, which follows the analysis of quantitative data, we will use the results to inform the qualitative interview. Step III will be a qualitative descriptive study that explores participants' experiences and perceptions of the intervention. In step IV, we will integrate findings from the qualitative and quantitative analyses to obtain meta-inferences.
Site-specific ethics boards have approved the study. All participants will provide informed consent. The research team will take an integrated approach to knowledge translation.
决策分析是一种定量决策方法，可以弥合仅基于证据的决策与个体患者独特价值观和偏好之间的差距，当现有证据无法支持明确的建议且考虑中的治疗方案的利弊之间存在紧密平衡时，这种方法尤为重要。低分子肝素（LMWH）用于预防妊娠期间的静脉血栓栓塞症（VTE）就是这种情况之一。本文的目的是描述一项试点研究的原理和方法，该研究将探索将决策分析应用于涉及有 VTE 病史或有妊娠计划的孕妇预防性使用 LMWH 的共享决策制定过程。
我们将进行一项国际性、混合方法、解释性、序贯研究，包括定量数据收集和分析，随后是定性数据收集和分析。在步骤 I 中，我们将邀请已经经历 VTE 的正在怀孕或有妊娠计划的女性参与预防性 LMWH 的共享决策干预。干预措施包括三个部分：直接选择练习、价值评估练习和个性化决策分析。在干预措施实施后，我们将要求女性做出治疗决策，并测量决策冲突、自我效能和满意度。在步骤 II 中，紧随定量数据分析之后，我们将使用结果来为定性访谈提供信息。步骤 III 将是一项定性描述性研究，旨在探讨参与者对干预措施的体验和看法。在步骤 IV 中，我们将整合定性和定量分析的结果，以获得元推断。
特定地点的伦理委员会已经批准了这项研究。所有参与者都将提供知情同意。研究团队将采取综合方法进行知识转化。
