Dataset Information

Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol.

ABSTRACT:

Background

Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Low molecular weight heparin (LWMH) reduces the risk of pregnancy-related VTE. LMWH prophylaxis is, however, inconvenient, uncomfortable, costly, medicalizes pregnancy, and may be associated with increased risks of obstetrical bleeding. Further, there is uncertainty in the estimates of both the baseline risk of pregnancy-related recurrent VTE and the effects of antepartum LMWH prophylaxis. The values and treatment preferences of pregnant women, crucial when making recommendations for prophylaxis, are currently unknown. The objective of this study is to address this gap in knowledge.

Methods

We will perform a multi-center cross-sectional interview study in Canada, USA, Norway and Finland. The study population will consist of 100 women with a history of lower extremity deep vein thrombosis (DVT) or pulmonary embolism (PE), and who are either pregnant, planning pregnancy, or may in the future consider pregnancy (women between 18 and 45 years). We will exclude individuals who are on full dose anticoagulation or thromboprophylaxis, who have undergone surgical sterilization, or whose partners have undergone vasectomy. We will determine each participant's willingness to receive LMWH prophylaxis during pregnancy through direct choice exercises based on real life and hypothetical scenarios, preference-elicitation using a visual analog scale ("feeling thermometer"), and a probability trade-off exercise. The primary outcome will be the minimum reduction (threshold) in VTE risk at which women change from declining to accepting LMWH prophylaxis. We will explore possible determinants of this choice, including educational attainment, the characteristics of the women's prior VTE, and prior experience with LMWH. We will determine the utilities that women place on the burden of LMWH prophylaxis, pregnancy-related DVT, pregnancy-related PE and pregnancy-related hemorrhage. We will generate a "personalized decision analysis" using participants' utilities and their personalized risk of recurrent VTE as inputs to a decision analytic model. We will compare the personalized decision analysis to the participant's stated choice.

Discussion

The preferences of pregnant women at risk of VTE with respect to the use of antithrombotic therapy remain unexplored. This research will provide explicit, quantitative expressions of women's valuations of health states related to recurrent VTE and its prevention with LMWH. This information will be crucial for both guideline developers and for clinicians.

SUBMITTER: Alonso-Coello P

PROVIDER: S-EPMC3495041 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol.

Alonso-Coello Pablo P Ebrahim Shanil S Guyatt Gordon H GH Tikkinen Kari A O KA Eckman Mark H MH Neumann Ignacio I McDonald Sarah D SD Akl Elie A EA Bates Shannon M SM

BMC pregnancy and childbirth 20120530

<h4>Background</h4>Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Low molecular weight heparin (LWMH) reduces the risk of pregnancy-related VTE. LMWH prophylaxis is, however, inconvenient, uncomfortable, costly, medicalizes pregnancy, and may be associated with increased risks of obstetrical bleeding. Further, there is uncertainty in the estimates of both the baseline risk of pregnancy-related recurrent VTE and the effects of antepartum LMWH prophylaxis. The va ...[more]

PMID: 22646475

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Project description:IntroductionDecision 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.Methods and analysisWe 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.Ethics and disseminationSite-specific ethics boards have approved the study. All participants will provide informed consent. The research team will take an integrated approach to knowledge translation.

Project description:BackgroundDespite a national focus on post-acute care brought about by recent payment reforms, relatively little is known about how hospitalized older adults and their caregivers decide whether to go to a skilled nursing facility (SNF) after hospitalization.ObjectiveWe sought to understand to what extent hospitalized older adults and their caregivers are empowered to make a high-quality decision about utilizing an SNF for post-acute care and what contextual or process elements led to satisfaction with the outcome of their decision once in SNF.DesignQualitative inquiry using the Ottawa Decision Support Framework (ODSF), a conceptual framework that describes key components of high-quality decision-making.ParticipantsThirty-two previously community-dwelling older adults (≥ 65 years old) and 22 caregivers interviewed at three different hospitals and three skilled nursing facilities.Main measuresWe used key components of the ODSF to identify elements of context and process that affected decision-making and to what extent the outcome was characteristic of a high-quality decision: informed, values based, and not associated with regret or blame.Key resultsThe most important contextual themes were the presence of active medical conditions in the hospital that made decision-making difficult, prior experiences with hospital readmission or SNF, relative level of caregiver support, and pressure to make a decision quickly for which participants felt unprepared. Patients described playing a passive role in the decision-making process and largely relying on recommendations from the medical team. Patients commonly expressed resignation and a perceived lack of choice or autonomy, leading to dissatisfaction with the outcome.ConclusionsUnderstanding and intervening to improve the quality of decision-making regarding post-acute care supports is essential for improving outcomes of hospitalized older adults. Our results suggest that simply providing information is not sufficient; rather, incorporating key contextual factors and improving the decision-making process for both patients and clinicians are also essential.

Dataset Information

Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol.

Background

Methods

Discussion

Publications

Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol.

Similar Datasets

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