G J A M Boon1, S Barco2, L Bertoletti3, W Ghanima4, M V Huisman1, S R Kahn5, S Noble6, P Prandoni7, R P Rosovsky8, A K Sista9, B Siegerink10, F A Klok11. 1. Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands. 2. Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany; Clinic of Angiology, University Hospital of Zurich, Zurich, Switzerland. 3. 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. 4. Department of Oncology, Østfold Hospital Trust, Kalnes, Norway; Department Medicine and Research, Østfold Hospital Trust, Kalnes, Norway. 5. Division of Clinical Epidemiology, Department of Medicine, Jewish General Hospital, Montreal, QC, Canada. 6. Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, UK. 7. Arianna Foundation on Anticoagulation, Bologna, Italy. 8. Department of Medicine, Hematology/Oncology, Massachusetts General Hospital, Boston, MA, United States. 9. Department of Radiology, New York University School of Medicine, New York, NY, United States. 10. Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands. 11. 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.
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.
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 VTEpatients, 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: Marieke J H A Kruip; Suzanne C Cannegieter; Hugo Ten Cate; Eric C M van Gorp; Nicole P Juffermans; Frederikus A Klok; Coen Maas; Anton Vonk-Noordegraaf Journal: Res Pract Thromb Haemost Date: 2021-03-08
Authors: Frederikus A Klok; Walter Ageno; Cihan Ay; Magnus Bäck; Stefano Barco; Laurent Bertoletti; Cecilia Becattini; Jørn Carlsen; Marion Delcroix; Nick van Es; Menno V Huisman; Luis Jara-Palomares; Stavros Konstantinides; Irene Lang; Guy Meyer; Fionnuala Ní Áinle; Stephan Rosenkranz; Piotr Pruszczyk Journal: Eur Heart J Date: 2022-01-25 Impact factor: 29.983
Authors: Robert J C M F de Kleijn; Ludo Schropp; Eline S van Hattum; Çagdas Ünlu; Saskia Middeldorp; Mathilde Nijkeuter; Jan Westerink; Bart-Jeroen Petri; Gert J de Borst Journal: J Thromb Haemost Date: 2022-06-20 Impact factor: 16.036
Authors: Frederikus A Klok; Gudula J A M Boon; Stefano Barco; Matthias Endres; J J Miranda Geelhoed; Samuel Knauss; Spencer A Rezek; Martijn A Spruit; Jörg Vehreschild; Bob Siegerink Journal: Eur Respir J Date: 2020-07-02 Impact factor: 16.671