Division of Hematology and Hematological Malignancies, Department of Medicine, University of Calgary, Calgary, Canada.
Department of Community Health Sciences, University of Calgary, Calgary, Canada.
Thromb Haemost. 2021 Oct;121(10):1353-1360. doi: 10.1055/a-1366-9261. Epub 2021 Apr 14.
Antiphospholipid syndrome is associated with recurrent pregnancy loss. Low-molecular-weight heparin (LMWH) and/or aspirin (ASA) prophylaxis during pregnancy to prevent future loss is based on limited trial data with mixed results.
Given the clinical equipoise, we sought to understand how patients and physicians navigate the decision-making process for use of LMWH and/or ASA in pregnancy.
We interviewed 10 patients and 10 thrombosis physicians in Ottawa, Canada from January 2017 to March 2018. Patients who had ≥1 late pregnancy loss or ≥2 early losses and persistently positive antiphospholipid antibodies based on the revised Sapporo/Sydney criteria were identified in the a Thrombosis Clinic. Patients were also identified by the TIPPS Study screening logs of excluded patients. Data collection and analysis occurred iteratively, in keeping with constructivist grounded theory methodology.
Our analysis generated three themes, present across both patient and physician interviews, which captured a patient-led decision-making experience: (1) managing high stakes, (2) accepting uncertainty, and (3) focusing on safety. Patients and physicians acknowledged the high emotional burden and what was at stake: avoiding further pregnancy loss. Patients responded to their situation by taking action (i.e., using LMWH injections became a "ritual"), whereas physicians reacted by removing themselves from the final decision by "[leaving] it up to the patient."
Our findings should be considered when designing future research on studying the role for LMWH/ASA in this population, as it suggests that the perceived benefits of treatment go beyond improving pregnancy rates. Rather, patients described potential benefit from the process of taking action, even in the absence of a guaranteed good outcome.
抗磷脂综合征与复发性妊娠丢失有关。在妊娠期间使用低分子肝素（LMWH）和/或阿司匹林（ASA）预防以防止未来的损失是基于有限的临床试验数据，结果不一。
鉴于临床平衡，我们试图了解患者和医生如何在妊娠期间使用 LMWH 和/或 ASA 的决策过程中进行导航。
我们于 2017 年 1 月至 2018 年 3 月在加拿大渥太华采访了 10 名患者和 10 名血栓形成医生。在血栓形成诊所，根据修订后的 Sapporo/Sydney 标准，确定了具有≥1 次晚期妊娠丢失或≥2 次早期丢失且持续存在抗磷脂抗体阳性的患者。患者也可以通过 TIPPS 研究排除患者的筛选记录进行识别。数据收集和分析是迭代进行的，符合建构主义扎根理论方法。
我们的分析产生了三个主题，这些主题贯穿于患者和医生的访谈中，捕捉到了一个以患者为中心的决策体验：（1）管理高风险，（2）接受不确定性，（3）关注安全性。患者和医生都承认高情绪负担和风险所在：避免进一步的妊娠丢失。患者通过采取行动（即，使用 LMWH 注射成为一种“仪式”）来应对自己的情况，而医生则通过将最终决定留给患者来做出反应。
在设计针对该人群的 LMWH/ASA 作用的未来研究时，应考虑我们的发现，因为它表明治疗的预期益处不仅在于提高妊娠率。相反，患者描述了采取行动的过程中的潜在益处，即使没有保证良好的结果。
