Validation of Outcome Instruments for Pediatric Postthrombotic Syndrome: Introducing the Peds-VEINES-QOL, a New Health-Related Quality of Life Instrument

Julie Smith; Dianne Thornhill; Neil A. Goldenberg; Leonardo Brandão; Rhonda Knapp-Clevenger; Beth Boulden Warren; Lillian Sung; Susan R. Kahn; Marilyn Manco-Johnson

doi:10.1055/s-0041-1725199

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2021; 121(10): 1367-1375
DOI: 10.1055/s-0041-1725199

Stroke, Systemic or Venous Thromboembolism

Validation of Outcome Instruments for Pediatric Postthrombotic Syndrome: Introducing the Peds-VEINES-QOL, a New Health-Related Quality of Life Instrument

Julie Smith

¹Hemophilia and Thrombosis Center, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

,

Dianne Thornhill

¹Hemophilia and Thrombosis Center, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

,

Neil A. Goldenberg

²Department of Pediatrics and Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

³Johns Hopkins All Children's Institute for Clinical and Translational Research, St. Petersburg, Florida, United States

,

Leonardo Brandão

⁴The Hospital for Sick Children (SickKids), University of Toronto, Toronto, Canada

,

Rhonda Knapp-Clevenger

⁵University of Rochester Medical Center, School of Nursing, University of Rochester, Rochester, New York, United States

,

Beth Boulden Warren

¹Hemophilia and Thrombosis Center, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

,

Lillian Sung

⁴The Hospital for Sick Children (SickKids), University of Toronto, Toronto, Canada

⁶Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, Canada

,

Susan R. Kahn

⁷Department of Medicine, Lady Davis Institute, McGill University, Montreal, Quebec, Canada

,

Marilyn Manco-Johnson

¹Hemophilia and Thrombosis Center, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

› Author Affiliations

Abstract

Background There is need for validated outcome measures for postthrombotic syndrome (PTS) following pediatric venous thromboembolism (VTE), with a focus on quality of life (QoL).

Aims This article assesses reliability and validity of two PTS and two QoL scales for children following lower extremity VTE.

Methods Pediatric patients following lower extremity VTE were recruited from three thrombosis clinics. The Manco–Johnson (MJ) and the modified Villalta (MV) PTS scales were compared with each other and with the generic pediatric health-related QoL, PedsQL, and a newly developed pediatric venous-specific QoL, the Peds-VEINES-QOL.

Results Eighty children following VTE and 60 healthy control children were enrolled. Internal consistency measured by Cronbach's α was high for the two QoL scales, and moderate for the two PTS scales. Inter-rater reliability using intraclass correlation coefficients was moderate to high for the MJ, MV, and Peds-VEINES-QOL, and moderate for the PedsQL. Evidence of high internal consistency by Cronbach's α coefficients, and moderate to high interitem correlations support the premise that a single construct was measured by each instrument. Correlations between the four instruments indicate convergent validity.

Conclusion The MJ and MV scales detect similar outcomes in children following VTE. As used, the MJ is slightly more sensitive to QoL because a positive diagnosis requires pain which is the leading factor in reduced QoL following deep vein thrombosis. When using the MV, a requirement for pain or abnormal use to diagnose PTS would make the MV a better predictor of QoL.

Keywords

Manco–Johnson instrument - modified Villalta instrument - Peds-VEINES-QOL - PedsQL - pediatric VTE outcomes

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References

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Supplementary Material

Supplementary Material