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

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 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 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.