There is increasing recognition that health systems need to measure and improve the value of care they provide patients by measuring outcomes that matter most to them. To support the shift towards value-based health care in venous thromboembolism (VTE), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international working group of 31 clinical VTE experts, researchers, and patient representatives from 15 countries to develop a standardised minimum set of outcomes for benchmarking care delivery in supporting clinical decision-making and facilitating quality improvement and research.
Potential outcomes for consideration were sourced from 3 key domains: existing ICHOM standard sets; international patient focus groups; and multiple systematic publication and registry searches. Using an online-modified Delphi process, outcomes important to patients and health professionals were selected and relevant measurement instruments were evaluated. A risk adjustment model was created using case-mix variables that takes into consideration the effects of different risk profiles that impact outcomes when compared across different populations, modalities, and institutions. The process occurred over 12 months, employing 8 international teleconferences. Measures were appraised for their feasibility in routine clinical practice (ie, brevity, free availability, validation, and language translation) and psychometric performance (ie, validity, reliability, and sensitivity to change).
A systematic scoping review identified 83 possible outcomes and 42 relevant measurement tools. Following a three-round Delphi study, 15 core outcomes important to patients and health professionals were selected and categorized into 4 domains: (i) patient-reported outcomes, (ii) long-term consequences of disease, (iii) disease-specific complications; and (iv) treatment-related complications. These measures were designed to include patients 16 years of age or older with VTE. The working group agreed that all outcomes were relevant for all patient categories, without the need for specific adjustment for certain subgroups. The standard set contains a selection of 4 core outcome tools and predefined time points (index event, 3 months, 6 months, and 1 year) for outcome measurement. A cascade opt-in system allows for further assessment if required and ensures that a minimum number of items captures all core outcomes.
Implementation of a minimum standard set of patient-centred outcomes for VTE could help institutions to monitor, compare and improve the quality and delivery of VTE care. Standardization of outcomes and measures could also improve the implementation of more patient-centric clinical outcomes research in VTE.