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DOI: 10.1055/s-0041-1725199
Validation of Outcome Instruments for Pediatric Postthrombotic Syndrome: Introducing the Peds-VEINES-QOL, a New Health-Related Quality of Life Instrument
Funding This study was supported by the NIH U34 5U34HL114988, which included salary support for N.A.G. and M.M.J. J.S., D.T., B.B.W., N.G., and M.M.J. received salary support from the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS), Maternal Child Health Bureau (MCHB) (2H30MC24049). S.R.K. is a Tier 1 Canada Research Chair holder, and an investigator of the CanVECTOR Network, which receives grant funding from the Canadian Institutes of Health Research (Funding Reference: CDT-142654).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 outcomesPublikationsverlauf
Eingereicht: 09. September 2020
Angenommen: 23. Januar 2021
Artikel online veröffentlicht:
11. März 2021
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