目前建议在妊娠期间或分娩后6周(产褥期)被评估为静脉血栓栓塞高风险的妇女进行预防静脉血栓栓塞的药物预防。提供血栓预防的决定包括权衡益处,危害和代价,根据个体的静脉血栓栓塞风险而变化。目前尚不清楚英国目前的风险分层方法是否可以通过进一步的研究得到改善。
为了量化当前与选择怀孕或产褥期妇女进行血栓预防相关的决策不确定性,并评估一项或多项潜在的未来研究的价值,这些研究将减少这种不确定性,同时患者和临床医生也是可行和可接受的。
■通过对风险评估模型的系统评价,开发了一种决策分析模型,用于预测怀孕或产褥期妇女的静脉血栓栓塞。使用完美信息分析的期望值来确定哪些因素与高决策不确定性相关,并且应该成为未来研究的目标。为了确定未来的研究是否可以接受和可行,我们与经历过血凝块或接受过血液稀释药物的妇女举行了研讨会,并对医疗保健专业人员进行了调查。样本信息分析的期望值被用来估计潜在的未来研究的价值。
■系统评价包括17项研究,包括19个独特的外部验证的风险评估模型和1个内部验证的模型。敏感性和特异性的估计在0%至100%和5%至100%的范围内差异很大,分别。大多数研究有不清楚或高风险的偏倚和适用性问题。决策分析发现,使用风险评估模型选择高危妇女进行产前预防和肥胖产后妇女进行产后预防存在很大的决策不确定性。决策不确定性的主要来源是孕妇或产褥期预防静脉血栓栓塞的有效性的不确定性。我们发现,与招募先前有静脉血栓栓塞的女性相比,肥胖产后女性血栓预防的随机对照试验可能具有重要价值,并且更可能是可接受和可行的。在未经选择的产后妇女和剖腹产后的妇女中,风险评估模型的性能较差,这意味着基于这些模型提供的预防措施的成本效益较差,决策不确定性较低.
■肥胖产后妇女风险评估模型的性能尚未得到外部验证。
■未来的研究应该集中在评估妊娠和产褥期预防血栓的药效。临床试验在以前没有静脉血栓栓塞的女性中更容易被接受.
■本研究注册为PROSPEROCRD42020221094。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:NIHR131021)资助,并在《卫生技术评估》中全文发表;卷。28号9.有关更多奖项信息,请参阅NIHR资助和奖励网站。
怀孕或在过去6周内分娩的妇女患血凝块的风险增加,血凝块可能导致严重疾病或死亡。注射小剂量的血液稀释剂在怀孕期间是安全的,可以降低血栓的风险,但是它们会稍微增加出血的风险。医疗保健专业人员使用风险评估工具来确定女性是否有血栓的高风险,并应提供血液稀释剂。我们想找出哪些研究有助于帮助他们做出更好的决策。我们回顾了以前的研究,以确定哪些风险评估工具最适合预测谁会有血凝块。然后,我们创建了一个数学模型来预测使用不同的风险评估工具来决定应该向谁提供血液稀释剂时会发生什么,在怀孕期间和分娩后。我们发现,应该向哪些女性提供血液稀释剂存在很多不确定性。这主要是因为只有少数小型研究将血液稀释剂与孕妇或最近分娩的妇女的治疗进行了比较。我们估计了将血液稀释剂与不治疗进行比较的未来研究的价值,在具有不同危险因素的女性群体中,通过预测我们将获得什么信息以及如何将其用于改善使用血液稀释剂的决策。为了确定这些研究是否可以接受和可行,我们与经历过血凝块或接受过血液稀释剂的妇女举行了研讨会,并接受了医疗保健专业人员的调查。我们发现,对最近分娩的肥胖妇女的研究将具有实质性的价值,并且可能比对先前有血凝块的孕妇的研究更容易接受。
UNASSIGNED: Pharmacological prophylaxis to prevent venous thromboembolism is currently recommended for women assessed as being at high risk of venous thromboembolism during pregnancy or in the 6 weeks after delivery (the puerperium). The decision to provide
thromboprophylaxis involves weighing the benefits, harms and costs, which vary according to the individual\'s venous thromboembolism risk. It is unclear whether the United Kingdom\'s current risk stratification approach could be improved by further research.
UNASSIGNED: To quantify the current decision uncertainty associated with selecting women who are pregnant or in the puerperium for thromboprophylaxis and to estimate the value of one or more potential future studies that would reduce that uncertainty, while being feasible and acceptable to patients and clinicians.
UNASSIGNED: A decision-analytic model was developed which was informed by a systematic
review of risk assessment models to predict venous thromboembolism in women who are pregnant or in the puerperium. Expected value of perfect information analysis was used to determine which factors are associated with high decision uncertainty and should be the target of future research. To find out whether future studies would be acceptable and feasible, we held workshops with women who have experienced a blood clot or have been offered blood-thinning drugs and surveyed healthcare professionals. Expected value of sample information analysis was used to estimate the value of potential future research studies.
UNASSIGNED: The systematic
review included 17 studies, comprising 19 unique externally validated risk assessment models and 1 internally validated model. Estimates of sensitivity and specificity were highly variable ranging from 0% to 100% and 5% to 100%, respectively. Most studies had unclear or high risk of bias and applicability concerns. The decision analysis found that there is substantial decision uncertainty regarding the use of risk assessment models to select high-risk women for antepartum prophylaxis and obese postpartum women for postpartum prophylaxis. The main source of decision uncertainty was uncertainty around the effectiveness of
thromboprophylaxis for preventing venous thromboembolism in women who are pregnant or in the puerperium. We found that a randomised controlled trial of
thromboprophylaxis in obese postpartum women is likely to have substantial value and is more likely to be acceptable and feasible than a trial recruiting women who have had a previous venous thromboembolism. In unselected postpartum women and women following caesarean section, the poor performance of risk assessment models meant that offering prophylaxis based on these models had less favourable cost effectiveness with lower decision uncertainty.
UNASSIGNED: The performance of the risk assessment model for obese postpartum women has not been externally validated.
UNASSIGNED: Future research should focus on estimating the efficacy of pharmacological thromboprophylaxis in pregnancy and the puerperium, and clinical trials would be more acceptable in women who have not had a previous venous thromboembolism.
UNASSIGNED: This study is registered as PROSPERO CRD42020221094.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR131021) and is published in full in Health Technology Assessment; Vol. 28, No. 9. See the NIHR Funding and Awards website for further award information.
Women who are pregnant or who have given birth in the previous 6 weeks are at increased risk of developing blood clots that can cause serious illness or death. Small doses of blood thinners given by injection are safe in pregnancy and can reduce the risk of blood clots, but they can slightly increase the risk of bleeding. Healthcare professionals use risk assessment tools to decide if a woman is at high risk of blood clots and should be offered blood thinners. We wanted to find out what research would be useful to help them make better decisions. We reviewed previous research to establish which risk assessment tools are best at predicting who will have a blood clot. We then created a mathematical model to predict what would happen when using different risk assessment tools to decide who should be offered blood thinners, both during pregnancy and after giving birth. We found that there was a lot of uncertainty about which women should be offered blood thinners. This was mainly because there have only been a few small studies comparing blood thinners to no treatment in pregnant women or women who have recently given birth. We estimated the value of future studies comparing blood thinners to no treatment, in groups of women with different risk factors, by predicting what information we would gain and how this would be used to improve decisions about using blood thinners. To find out whether these studies would be acceptable and feasible, we held workshops with women who have experienced a blood clot or have been offered blood thinners and surveyed healthcare professionals. We found that a study in obese women who have recently given birth would have substantial value and may be more acceptable than a study in pregnant women with a previous blood clot.