Thromb Haemost 2022; 122(08): 1379-1383
DOI: 10.1055/a-1738-1313
New Technologies, Diagnostic Tools and Drugs

External Validation of the Patient-Reported Villalta Scale for the Diagnosis of Postthrombotic Syndrome

Sara Ng
1   Division of Hematology, Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
2   Department of Haematology, Liverpool Hospital, Liverpool, New South Wales, Australia
,
Marc A. Rodger
3   Department of Medicine, Faculty of Medicine, McGill University, Montréal, Quebec, Canada
,
Waleed Ghanima
4   Department of Research, Ostfold Hospital Trust, Norway
5   Institute of Clinical Medicine, University of Oslo, Oslo, Norway
,
Michael J. Kovacs
6   Division of Hematology, Department of Medicine, University of Western Ontario, London, Ontario, Canada
,
Sudeep Shivakumar
7   Division of Hematology, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
,
Susan R. Kahn
8   Department of Medicine, McGill University, Montreal, Quebec, Canada
9   Division of Clinical Epidemiology, Lady Davis Institute, Montreal, Quebec, Canada
,
10   Department of Haematology, University of Oslo and Oslo University Hospital, Oslo, Norway
,
Clive Kearon
11   Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
Ranjeeta Mallick
12   The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
,
1   Division of Hematology, Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
› Author Affiliations
Funding This study was funded by the Canadian Institutes of Health Research (CIHR # PJT 148716) and the Southern and Eastern Norway Regional Health Authority (Grant # 2015112).

Abstract

Introduction The Villalta scale is the endorsed tool to diagnose and grade the severity of postthrombotic syndrome (PTS); however, assessing presence and severity of PTS is time-consuming and relies on both the clinician and patient's assessments. The patient-reported Villalta scale version 2 (PRV2) is a visually assisted form that enables patients to self-assess presence and severity of PTS. Herein, we report on external validation of this tool.

Methods We assessed the agreement and kappa values of PRV2 to diagnose and assess severity of PTS compared with the original Villalta score in a cohort of 181 patients (196 limbs) who participated in the SAVER pilot randomized control trial. Presence of PTS was defined as PRV2 ≥5 or a Villalta score ≥5.

Results PTS prevalence was 42% using PRV2 and 33% using the Villalta scale. The corresponding kappa and percentage agreement were 0.60 (95% confidence interval [CI]: 0.49–0.71) and 81% (95% CI: 76–87), respectively. Kappa values and percentage agreements between PRV2 and Villalta scale increased with increasing severity of PTS. The sensitivity of PRV2 to detect PTS of any severity was 84% (95% CI: 73–92) with a specificity of 79% (95% CI: 71–86).

Conclusion We conclude that the PRV2 is an acceptable tool for diagnosing and grading the severity of PTS.



Publication History

Received: 23 June 2021

Accepted: 10 January 2022

Accepted Manuscript online:
12 January 2022

Article published online:
04 March 2022

© 2022. Thieme. All rights reserved.

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  • References

  • 1 Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol 2009; 145 (03) 286-295
  • 2 Vedantham S. Valvular dysfunction and venous obstruction in the post-thrombotic syndrome. Thromb Res 2009; 123 (Suppl. 04) S62-S65
  • 3 Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost 2009; 7 (05) 879-883
  • 4 Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost 2009; 7 (05) 884-888
  • 5 Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost 2016; 115 (02) 361-367
  • 6 Delluc A, Ghanima W, Kovacs MJ. et al. Statins for venous event reduction in patients with venous thromboembolism: a multicenter randomized controlled pilot trial assessing feasibility. J Thromb Haemost 2022; 20 (01) 126-132
  • 7 Kahn SR. The post-thrombotic syndrome. Hematology (Am Soc Hematol Educ Program) 2016; 2016 (01) 413-418
  • 8 Villalta S, Bagatella P, Piccioli A, Lensing A, Prandoni P. Assessment of validity and reproducibility of a clinical scale for the post-thrombotic syndrome. Haemostasis 1994; 24: 158a
  • 9 Rodger MA, Kahn SR, Wells PS. et al. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ 2008; 179 (05) 417-426
  • 10 Rodger MA, Kahn SR, Le Gal G. et al. Inter-observer reliability of measures to assess the post-thrombotic syndrome. Thromb Haemost 2008; 100 (01) 164-166
  • 11 Petrie KJ, Weinman J. Patients' perceptions of their illness. Curr Dir Psychol Sci 2012; 21 (01) 60-65