Development of a core outcome set for studies on prevention and management of pregnancy-associated venous thromboembolism (COSPVenTE): a study protocol

Abstract

IntroductionPregnancy and post partum are times of heightened risk for the development of venous thromboembolism (VTE), which in turn is one of the leading causes of maternal mortality and long-term morbidity. The current research aimed at improving health guidelines for women with pregnancy-associated VTE is limited by inconsistency in outcome reporting preventing comparison across studies, and lack of input from patients with respect to outcomes they propose are most important to measure. A suggested solution is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials and prospective studies. COSs function to facilitate data harmonisation and increase homogeneity in outcome reporting while incorporating the voice of women in this population in the planning of research to inform their ongoing care.Methods and analysisThe development of a COS for studies on pregnancy-associated VTE will comprise five steps. First, a systematic review of the published literature will identify currently reported outcomes, their definitions and measurements if applicable. This will be followed by in-person interviews with patients, clinicians, researchers, hospital administrators and policy-makers to identify outcomes they consider important. Third, the long list of outcomes obtained from steps I and II will be condensed through online Delphi surveys involving an international group of relevant stakeholders including patients. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Lastly, to determine how the identified core outcomes should be measured, another literature review and Delphi process will be carried out as necessary.Ethics and disseminationThis study has been approved by the Mount Sinai Hospital Research Ethics Board (REB 18-0314-E). Study results will be published in open-access journals and presented at obstetrics, maternal–fetal medicine and haematology conferences. All progress will be documented on the international prospective register of systematic reviews (PROSPERO) and Core Outcome Measures in Effectiveness Trials databases.PROSPERO registration numberCRD42019111479.

Patients and Health Care Providers Identify Important Outcomes for Research on Pregnancy and Heart Disease

“… 10 Patient and stakeholder interviews which enable researchers to obtain first-hand information from those directly affected by a condition and proposed interventions, and about how they would prioritize outcomes while making medical decisions, have therefore been the focus of recent publications. 15 , 16 , 17 , 18 While conducting these interviews, in keeping with the primary intention of eliciting outcomes, attention must be paid to the use of a semistructured interview guide and the liberal use of prompts to redirect patients and family members to focus on outcomes. Interpretive analysis, wherein quotes, anecdotes, experiences, and perceptions are translated into measurable outcomes, forms an integral part of the research process, especially for patient interviews, as the concept of outcomes can be difficult to explain and discuss with those who do not work and think in a health intervention context.…”

Uncaptured rates of postpartum venous thromboembolism: a US national analysis

“…To capture the risk of VTE readmission during this period, 60‐ and 90‐day outcomes were also selected. A core outcome set for pregnancy‐related VTE is currently in development and, as such, could not be used in this study 25 …”

“…A core outcome set for pregnancy-related VTE is currently in development and, as such, could not be used in this study. 25 Categorical variables were compared using the chi-square test. Univariate analysis was performed for 30-, 60-and 90day readmissions to identify significant variables, with the level of significance set at P < 0.2.…”

Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed methods pilot study protocol

“… 3 Women with prior VTE are at an increased risk of thrombosis during subsequent pregnancies, 4 5 although the magnitude of this risk remains uncertain given that the existing evidence base is informed by studies with major limitations. 6 …”