Introduction: We recently proposed a scale for assessment of patient-relevant functional limitations following an episode of venous thromboembolism (VTE). Further development of this post-VTE... Show moreIntroduction: We recently proposed a scale for assessment of patient-relevant functional limitations following an episode of venous thromboembolism (VTE). Further development of this post-VTE functional status (PVFS) scale is still needed.Methods: Guided by the input of VTE experts and patients, we refined the PVFS scale and its accompanying manual, and attempted to acquire broad consensus on its use.Results: A Delphi analysis was performed involving 53 international VTE experts with diverse scientific and clinical backgrounds. In this process, the number of scale grades of the originally proposed PVFS scale was reduced and descriptions of the grades were improved. After these changes, a consensus was reached on the number/definitions of the grades, and method/timing of the scale assessment. The relevance and potential impact of the scale was confirmed in three focus groups totaling 18 VTE patients, who suggested additional changes to the manual, but not to the scale itself. Using the improved manual, the.-statistics between PVFS scale self-reporting and its assessment via the structured interview was 0.75 (95%CI 0.58-1.0), and 1.0 (95%CI 0.83-1.0) between independent raters of the recorded interview of 16 focus groups members.Conclusion: We improved the PVFS scale and demonstrated broad consensus on its relevance, optimal grades, and methods of assessing among international VTE experts and patients. The interobserver agreement of scale grade assignment was shown to be good-to-excellent. The PVFS scale may become an important outcome measure of functional impairment for quality of patient care and in future VTE trials. Show less
The main objectives of therapeutic trials in venous thromboembolism (VTE) are to prevent recurrent VTE, major bleeding and death. While these outcomes are indeed highly relevant, they are also rare... Show moreThe main objectives of therapeutic trials in venous thromboembolism (VTE) are to prevent recurrent VTE, major bleeding and death. While these outcomes are indeed highly relevant, they are also rare and do not fully capture the overall functional outcome of VTE patients. Importantly, functional limitations after VTE are prevalent after both deep vein thrombosis and pulmonary embolism occurring in up to 50% of patients. These post-VTE syndromes are associated with a decreased quality of life, higher risk of depressive disorders, unemployment and increased utilization of healthcare resources. Because of the major impact of functional limitations on individual patients and society as a whole, development of tools able to capture functional outcomes in clinical trials are urgently needed. We anticipate that a standardized post-VTE functional status scale will aid in demarcating effective and ineffective VTE therapies on functional outcomes in trials with appropriately powered sample sizes, as well as pave the road for value-based healthcare. The scale that we have in mind covers the entire spectrum of functional outcomes ranging from no symptoms to death. Moreover, it focuses on both limitations in usual activity as well as changes in lifestyle. The scale is not meant to replace current diagnostic or prognostic scores for post-VTE syndromes, but to be used as an outcome measure to evaluate the overall consequences of VTE on functional status. This review is a call for action to the VTE community to join forces and support further development of the proposed scale, a process of which we summarize the necessary steps. Show less
