Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy : a study protocol
Alonso-Coello, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Ebrahim, Shanil (McMaster University (Canadà))
Guyatt, Gordon (McMaster University (Canadà))
Tikkinen, Kari A.O. (University of Helsinki (Finlàndia))
Eckman, Mark H. (University of Cincinnati (Estats Units))
Neumann, Ignacio (Pontificia Universidad Católica de Chile)
McDonald, Sarah D. (McMaster University (Canadà))
Akl, Elie A. (State University of New York at Buffalo (Estats Units))
Bates, Shannon M. (Thrombosis and Atherosclerosis Research Institute)
Universitat Autònoma de Barcelona

Fecha:	2012
Resumen:	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. © 2012 Alonso-Coello et al. ; licensee BioMed Central Ltd.
Ayudas:	Ministerio de Ciencia e Innovación CP09/00137
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	BMC pregnancy and childbirth, Vol. 12 (30 2012) , p. 40, ISSN 1471-2393

DOI: 10.1186/1471-2393-12-40
PMID: 22646475

12 p, 1.5 MB

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