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

Thromb Haemost. 2021 Oct;121(10):1367-1375. doi: 10.1055/s-0041-1725199. Epub 2021 Mar 11.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Validation Study

MeSH terms

  • Adolescent
  • Age Factors
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Male
  • North America
  • Pain / diagnosis*
  • Pain / etiology
  • Pain Measurement*
  • Postthrombotic Syndrome / diagnosis*
  • Postthrombotic Syndrome / etiology
  • Predictive Value of Tests
  • Quality of Life*
  • Reproducibility of Results
  • Severity of Illness Index
  • Surveys and Questionnaires*
  • Venous Thromboembolism / complications*
  • Venous Thromboembolism / diagnosis
  • Young Adult