Subscribe to RSS
Validation of Outcome Instruments for Pediatric Postthrombotic Syndrome: Introducing the Peds-VEINES-QOL, a New Health-Related Quality of Life InstrumentFunding 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).
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.
KeywordsManco–Johnson instrument - modified Villalta instrument - Peds-VEINES-QOL - PedsQL - pediatric VTE outcomes
Received: 09 September 2020
Accepted: 23 January 2021
11 March 2021 (online)
© 2021. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Goldenberg NA, Brandão L, Journeycake J. et al; Perinatal And Paediatric Haemostasis Subcommittee Of The Scientific And Standardization Committee Of The International Society On Thrombosis And Haemostasis. Definition of post-thrombotic syndrome following lower extremity deep venous thrombosis and standardization of outcome measurement in pediatric clinical investigations. J Thromb Haemost 2012; 10 (03) 477-480
- 2 Kachroo S, Boyd Bookhart BK. et al. Quality of life and economic costs associated with postthrombotic syndrome. Am J Health-Syst Pharmacy 2012; 69 (07) 567-572
- 3 Goldenberg NA, Donadini MP, Kahn SR. et al. Post-thrombotic syndrome in children: a systematic review of frequency of occurrence, validity of outcome measures, and prognostic factors. Haematologica 2010; 95 (11) 1952-1959
- 4 Kuhle S, Koloshuk B, Marzinotto V. et al. A cross-sectional study evaluating post-thrombotic syndrome in children. Thromb Res 2003; 111 (4-5): 227-233
- 5 Raffini L, Davenport J, Bevilacqua L, Iosifescu S. Comparison of 3 postthrombotic syndrome assessment scales demonstrates significant variability in children and adolescents with deep vein thrombosis. J Pediatr Hematol Oncol 2015; 37 (08) 611-615
- 6 Goldenberg NA, Durham JD, Knapp-Clevenger R, Manco-Johnson MJ. A thrombolytic regimen for high-risk deep venous thrombosis may substantially reduce the risk of postthrombotic syndrome in children. Blood 2007; 110 (01) 45-53
- 7 Kahn SR, Lamping DL, Ducruet T. et al; VETO Study investigators. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol 2006; 59 (10) 1049-1056
- 8 Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care 2001; 39 (08) 800-812
- 9 Manco-Johnson MJ. Postthrombotic syndrome in children. Acta Haematol 2006; 115 (3-4): 207-213
- 10 Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs 1988; 14 (01) 9-17
- 11 Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain 2001; 93 (02) 173-183
- 12 Garra G, Singer AJ, Domingo A, Thode Jr HC. The Wong-Baker pain FACES scale measures pain, not fear. Pediatr Emerg Care 2013; 29 (01) 17-20
- 13 von Baeyer CL. Children's self-reports of pain intensity: scale selection, limitations and interpretation. Pain Res Manag 2006; 11 (03) 157-162
- 14 Chambers CT, Giesbrecht K, Craig KD, Bennett SM, Huntsman E. A comparison of faces scales for the measurement of pediatric pain: children's and parents' ratings. Pain 1999; 83 (01) 25-35
- 15 Eklöf B, Rutherford RB, Bergan JJ. et al; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40 (06) 1248-1252
- 16 Goldenberg NA, Branchford B, Wang M, Ray Jr C, Durham JD, Manco-Johnson MJ. Percutaneous mechanical and pharmacomechanical thrombolysis for occlusive deep vein thrombosis of the proximal limb in adolescent subjects: findings from an institution-based prospective inception cohort study of pediatric venous thromboembolism. J Vasc Interv Radiol 2011; 22 (02) 121-132
- 17 Wik HS, Enden TR, Ghanima W, Engeseth M, Kahn SR, Sandset PM. Diagnostic scales for the post-thrombotic syndrome. Thromb Res 2018; 164: 110-115
- 18 Varni JW, Burwinkle TM, Seid M. The PedsQL as a pediatric patient-reported outcome: reliability and validity of the PedsQL Measurement Model in 25,000 children. Expert Rev Pharmacoecon Outcomes Res 2005; 5 (06) 705-719
- 19 Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med 2002; 162 (10) 1144-1148
- 20 Kahn SR, Elman EA, Bornais C, Blostein M, Wells PS. Post-thrombotic syndrome, functional disability and quality of life after upper extremity deep venous thrombosis in adults. Thromb Haemost 2005; 93 (03) 499-502
- 21 Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg 2003; 37 (02) 410-419
- 22 Goldenberg NA, Abshire T, Blatchford PJ. et al; Kids-DOTT Trial Investigators. Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids-DOTT trial): pilot/feasibility phase findings. J Thromb Haemost 2015; 13 (09) 1597-1605
- 23 Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO task force report. Value Health 2009; 12 (08) 1075-1083
- 24 DeVellis RF. Scale Development: Theory and Applications. 4th ed.. Los Angeles: SAGE Publications, Inc.; 2017
- 25 Le May S, Ballard A, Khadra C. et al. Comparison of the psychometric properties of 3 pain scales used in the pediatric emergency department: Visual Analogue Scale, Faces Pain Scale-Revised, and Colour Analogue Scale. Pain 2018; 159 (08) 1508-1517
- 26 Avila ML, Brandão LR, Williams S. et al. Pediatric post-thrombotic syndrome in children: toward the development of a new diagnostic and evaluative measurement tool. Thromb Res 2016; 144: 184-191