Measuring functional limitations after venous thromboembolism: Optimization of the Post-VTE Functional Status (PVFS) Scale

Thrombosis Research, vol. 190, pp. 45–51

Abstract

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 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 κ-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.

Authors 12

1. Gudula J.A.M. Boon Aachen Dept of Medicine - Thrombosis and Hemostasis

   Leiden University Medical Center

   Affiliation as printed

   Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

   Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

2. Stefano Barco

   University Medical Center of the Johannes Gutenberg University Mainz · University Hospital Zurich

   Affiliation as printed

   Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany; Clinic of Angiology, University Hospital of Zurich, Zurich, Switzerland

   Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany

   Clinic of Angiology, University Hospital of Zurich, Zurich, Switzerland

3. Laurent Bertoletti

   Inserm · Centre Hospitalier Universitaire de Saint-Étienne · Centre d'Investigation Clinique - Epidémiologie Clinique Saint-Etienne · Université Jean Monnet · Université Jean Monnet

   Affiliation as printed

   Service de Médecine Vasculaire et Thérapeutique, CHU de St-Étienne, Saint-Étienne, France; INSERM UMR 1059 and CIC 1408, Université Jean-Monnet, Saint-Étienne, France

   INSERM UMR 1059 and CIC 1408, Université Jean-Monnet, Saint-Étienne, France

   Service de Médecine Vasculaire et Thérapeutique, CHU de St-Étienne, Saint-Étienne, France

4. Waleed Ghanima

   Østfold Hospital Trust

   Affiliation as printed

   Department of Oncology, Østfold Hospital Trust, Kalnes, Norway; Department Medicine and Research, Østfold Hospital Trust, Kalnes, Norway

   Department Medicine and Research, Østfold Hospital Trust, Kalnes, Norway

   Department of Oncology, Østfold Hospital Trust, Kalnes, Norway

5. Menno Volkert Huisman Aachen Dept of Medicine - Thrombosis and Hemostasis

   Leiden University Medical Center

   Affiliation as printed

   Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

   Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

6. Susan Rebecca Kahn

   Jewish General Hospital

   Affiliation as printed

   Division of Clinical Epidemiology, Department of Medicine, Jewish General Hospital, Montreal, QC, Canada

7. Simon I. R. Noble

   Cardiff University

   Affiliation as printed

   Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, UK

8. Paolo Prandoni
   Affiliation as printed

   Arianna Foundation on Anticoagulation, Bologna, Italy

9. Rachel Pam Greenerger Rosovsky

   Massachusetts General Hospital

   Affiliation as printed

   Department of Medicine, Hematology/Oncology, Massachusetts General Hospital, Boston, MA, United States

10. Akhilesh Keshav Sista

    New York University

    Affiliation as printed

    Department of Radiology, New York University School of Medicine, New York, NY, United States

11. Bob Siegerink Aachen Department of Clinical Epidemiology

    Leiden University Medical Center · Center for Stroke Research Berlin · Charité - Universitätsmedizin Berlin

    Affiliation as printed

    Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands

    Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany

    Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands

12. Frederikus Albertus Klok corresponding Aachen Dept of Medicine - Thrombosis and Hemostasis

    Leiden University Medical Center · University Medical Center of the Johannes Gutenberg University Mainz

    Affiliation as printed

    Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany. Electronic address: f.a.klok@lumc.nl

    Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany

    Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands