Quality of Life in Children Requiring Antithrombotic Therapy: Development of a Measure

ABSTRACT

Measurement of quality of life (QOL) has been accepted as an important outcome measure in therapeutic clinical trials. Long-term antithrombotic therapy is hypothesized to induce treatment dissatisfaction and influence QOL. Health-related quality of life (HRQOL) can be measured by an inventory developed specific to the patient condition. Pediatric QOL inventory for children on long-term antithrombotic therapy should assess constructs salient for this population. Creation of an HRQOL measurement inventory requires rigor and methodological adherence. Identification and evaluation of QOL constructs is critical to improve care and is accepted as the “gold standard” measurement for patient-centered outcomes in clinical research. The use of a valid and reliable HRQOL inventory specific for the antithrombotic therapy is required for upcoming clinical trials as it will provide a method to measure change in HRQOL specific to the antithrombotic agent. In this way, it will be possible to provide the child/family with information to make safe and effective therapeutic choices, define future antithrombotic therapy research strategies, and inform decision makers to change policies to improve health care.

KEYWORDS

Pediatrics - quality of life - antithrombotic therapy - measurement

REFERENCES

• 1 De Geest S, Sabaté E. Adherence to long-term therapies: evidence for action.  Eur J Cardiovasc Nurs. 2003;  2 (4) 323
• 2 Kuyken W. The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization.  Soc Sci Med. 1995;  41 (10) 1403-1409
• 3 Marino B S, Shera D, Wernovsky G et al.. The development of the pediatric cardiac quality of life inventory: a quality of life measure for children and adolescents with heart disease.  Qual Life Res. 2008;  17 (4) 613-626
• 4 Colver A. Quality of life and participation.  Dev Med Child Neurol. 2009;  51 (8) 656-659
• 5 Rosenbaum P. Children's quality of life: separating the person from the disorder.  Arch Dis Child. 2008;  93 (2) 100-101
• 6 Albrecht R. MCOs following innovative CMS remote monitoring initiative: self-testing service is designed to lower costs and improve outcomes for anticoagulation therapy.  Manag Care Q. 2006;  14 (1) 13-16
• 7 Monagle P, Chalmers E, Chan A American College of Chest Physicians et al. Antithrombotic therapy in neonates and children: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).  Chest. 2008;  133 (6, Suppl) 887S-968S
• 8 Bruce A A, Bauman M E, Black K, Newton A, Legge L, Massicotte M P. Development and preliminary evaluation of the KIDCLOT PAC QL: a new health-related quality of life measure for pediatric long-term anticoagulation therapy.  Thromb Res. 2010;  126 (2) e116-e121
• 9 Samsa G, Matchar D B, Dolor R J et al.. A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.  Health Qual Life Outcomes. 2004;  2 22
• 10 Samsa G P, Matchar D B. Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management.  J Thromb Thrombolysis. 2000;  9 (3) 283-292
• 11 Jones S, Newall F, Manias E, Monagle P. Assessing outcome measures of oral anticoagulation management in children.  Thromb Res. 2011;  127 (2) 75-80
• 12 Sabaté E. Adherence to Long-Term Therapies: Evidence for Action. World Health Organization. Geneva; 2003
• 13 Chan VHT, Monagle P, Massicotte P, Chan A K. Novel paediatric anticoagulants: a review of the current literature.  Blood Coagul Fibrinolysis. 2010;  21 (2) 144-151
• 14 Massicotte M P, Sofronas M, deVeber G. Difficulties in performing clinical trials of antithrombotic therapy in neonates and children.  Thromb Res. 2006;  118 (1) 153-163
• 15 Sofronas M, Ichord R N, Fullerton H J et al.. Pediatric stroke initiatives and preliminary studies: What is known and what is needed?.  Pediatr Neurol. 2006;  34 (6) 439-445
• 16 Streif W, Andrew M, Marzinotto V et al.. Analysis of warfarin therapy in pediatric patients: A prospective cohort study of 319 patients.  Blood. 1999;  94 (9) 3007-3014
• 17 Massicotte P, Julian J A, Gent M REVIVE Study Group et al. An open-label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in children: the REVIVE trial.  Thromb Res. 2003;  109 (2-3) 85-92
• 18 Massicotte P, Julian J A, Gent M PROTEKT Study Group et al. An open-label randomized controlled trial of low molecular weight heparin for the prevention of central venous line-related thrombotic complications in children: the PROTEKT trial.  Thromb Res. 2003;  109 (2-3) 101-108
• 19 McCrindle B W, Cochrane A, Roberts R et al.. Factors associated with thrombotic complications in the first 2 years after the Fontan procedure: a multicentre prospective study.  Circulation. 2009;  120 S591
• 20 Eiser C, Morse R. Can parents rate their child's health-related quality of life? Results of a systematic review.  Qual Life Res. 2001;  10 (4) 347-357
• 21 Guyatt G, Drummond M, Feeny D et al.. Guidelines for the clinical and economic evaluation of health care technologies.  Soc Sci Med. 1986;  22 (4) 393-408
• 22 Guyatt G H, Bombardier C, Tugwell P X. Measuring disease-specific quality of life in clinical trials.  CMAJ. 1986;  134 (8) 889-895
• 23 Fanikos J, Stapinski C, Koo S, Kucher N, Tsilimingras K, Goldhaber S Z. Medication errors associated with anticoagulant therapy in the hospital.  Am J Cardiol. 2004;  94 (4) 532-535
• 24 Marks S D, Massicotte M P, Steele B T et al.. Neonatal renal venous thrombosis: clinical outcomes and prevalence of prothrombotic disorders.  J Pediatr. 2005;  146 (6) 811-816
• 25 Varni J W, Limbers C A. The pediatric quality of life inventory: measuring pediatric health-related quality of life from the perspective of children and their parents.  Pediatr Clin North Am. 2009;  56 (4) 843-863
• 26 Burkhart P V, Sabaté E. Adherence to long-term therapies: evidence for action.  J Nurs Scholarsh. 2003;  35 (3) 207
• 27 Campbell J D. Illness is a point of view; the development of children's concept of illness.  Child Dev. 1975;  46 (1) 92-100
• 28 Hart C, Chesson R. Children as consumers.  BMJ. 1998;  316 (7144) 1600-1603
• 29 Limbo R, Petersen W, Pridham K. Promoting safety of young children with guided participation processes.  J Pediatr Health Care. 2003;  17 (5) 245-251
• 30 Valderas J M, Kotzeva A, Espallargues M et al.. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature.  Qual Life Res. 2008;  17 (2) 179-193
• 31 Erikson E. Childhood and Society. New York, NY: W.W. Norton; 1985
• 32 Klaassen R J, Blanchette V S, Barnard D et al.. Validity, reliability, and responsiveness of a new measure of health-related quality of life in children with immune thrombocytopenic purpura: the Kids' ITP Tools.  J Pediatr. 2007;  150 (5) 510-515, 515, e1
• 33 Eiser C, Morse R. A review of measures of quality of life for children with chronic illness.  Arch Dis Child. 2001;  84 (3) 205-211
• 34 van Doorn C, Yates R, Tunstill A, Elliott M. Quality of life in children following mitral valve replacement.  Heart. 2000;  84 (6) 643-647
• 35 Gonzalez B E, Teruya J, Mahoney Jr D H et al.. Venous thrombosis associated with staphylococcal osteomyelitis in children.  Pediatrics. 2006;  117 (5) 1673-1679