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Measuring Functional Limitations after Venous Thromboembolism: Optimization of the Post-VTE Functional Status (PVFS) Scale

G.J.A.M. Boon1, S. Barco2,3, L. Bertoletti4,5, W. Ghanima6, M.V. Huisman1, S.R. Kahn7, S. Noble8, P. Prandoni9, R.P. Rosovsky10, A.K. Sista11, B. Siegerink12,13, F.A. Klok1

1Leiden University Medical Center, Department of Medicine - Thrombosis and Hemostasis, Leiden, the Netherlands, 2University Medical Center Mainz, Center for Thrombosis and Hemostasis (CTH), Mainz, Germany, 3University Hospital of Zurich, Clinic of Angiology, Zurich, Switzerland, 4CHU de St-Etienne, Service de Médecine Vasculaire et Thérapeutique, Saint-Étienne, France, 5Université Jean-Monnet, INSERM UMR 1059 and CIC 1408, Saint-Étienne, France, 6Østfold Hospital Trust, Departments of Oncology, Medicine and Research, Kalnes, Norway, 7Jewish General Hospital, Division of Clinical Epidemiology and Department of Medicine, Montreal, QC, Canada, 8Cardiff University, Marie Curie Palliative Care Research Centre, Cardiff, United Kingdom, 9Arianna Foundation on Anticoagulation, Bologna, Italy, 10Massachusetts General Hospital, Department of Hematology/Oncology, Boston, MA, United States, 11New York University School of Medicine, Department of Radiology, New York, NY, United States, 12Charité Universitätsmedizin Berlin, Center for Stroke Research Berlin, Berlin, Germany, 13Leiden University Medical Center, Department of Clinical Epidemiology, Leiden, the Netherlands

Abstract Number: PB2203

Meeting: ISTH 2020 Congress

Theme: Venous Thromboembolism and Cardioembolism » Post-thrombotic Syndrome

Background: We recently proposed the post-VTE functional status (PVFS) scale for assessment of patient-relevant functional limitations following an episode of venous thromboembolism (VTE).

Aims: To further develop this PVFS scale.

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. We also quantified the reproducibility of PVFS scale assessment.

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 (Table 1), and method/timing of the scale assessment (Figure 1). 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 κ-statistics between the 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.

Conclusions: We improved the PVFS scale and demonstrated broad consensus on its relevance, optimal grades, and methods of assessing the PVFS scale among international VTE experts and patients. We improved the PVFS scale and its manual. 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.

PVFS scale grade Description
0: No functional limitations All usual duties/activities at home or at work can be carried out at the same level of intensity. Symptoms, pain and anxiety are absent.
1: Negligible functional limitations All usual duties/activities at home or at work can be carried out at the same level of intensity, despite some symptoms, pain, or anxiety.
2: Slight functional limitations Some usual duties/activities at home or at work are carried out at a lower level of intensity or are occasionally avoided due to symptoms, pain, or anxiety.
3: Moderate functional limitations Usual duties/activities at home or at work have been structurally modified (reduced) due to symptoms, pain, or anxiety.
4: Severe functional limitations Assistance needed in activities of daily living due to symptoms, pain, or anxiety: nursing care and attention are required.
D: Death Death occurred before the scheduled assessment.
Full manual for structured interview and patient self-report is available. Providing a reference value (pre-VTE grade) is optional and should refer to the functional status 1 month prior to the VTE diagnosis.

[Table 1: Final post-VTE functional status scale as agreed upon by the Delphi panel and patient focus groups]


[Figure 1: Flowchart for patient self-report, one of the two methods for self-reporting of the post-VTE functional status scale ]

To cite this abstract in AMA style:

Boon GJAM, Barco S, Bertoletti L, Ghanima W, Huisman MV, Kahn SR, Noble S, Prandoni P, Rosovsky RP, Sista AK, Siegerink B, Klok FA. Measuring Functional Limitations after Venous Thromboembolism: Optimization of the Post-VTE Functional Status (PVFS) Scale [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/measuring-functional-limitations-after-venous-thromboembolism-optimization-of-the-post-vte-functional-status-pvfs-scale/. Accessed November 29, 2023.

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