title: Quality of life assessment in children commencing home INR self-testing.
abstract: BACKGROUND
  Management of oral anticoagulant therapy (OAT) in children is complex and frequent testing of the International Normalised Ratio (INR) is a significant burden. This study evaluates the impact of a home INR self-testing (home ST) program on the quality of life (QoL) of children and their families. The aim of the study was to determine if participation in a home ST program improves QoL for children requiring long-term OAT and their families.
  
  
  METHODS
  Children aged eight to 18 years requiring long-term OAT and parents of children participated. Quantitative methods comprised three validated QoL questionnaires; the anticoagulation specific PAC QL©, the PedsQL™ and the PedsQL FIM™. Questionnaires were completed before commencing home ST and 6-12 months later. Qualitative methods consisted of open-ended questions which participants answered when completing the questionnaires for the second time. Results of INRs tested at home were collected.
  
  
  RESULTS
  Fifty-five parents and 35 children participated. The percentage of time the children's INRs were in their target therapeutic range was 71.3. Parents reported statistically significant improvements in QoL for themselves (mean increase 6.9), their family (mean increase 8.6) and their child (mean increase 11.1) following the commencement of home ST (difference p≤0.003 on all questionnaires). The children did not report a statically significant improvement in QoL.
  
  
  CONCLUSIONS
  Parents reported significant improvement for their child's QoL, their QoL and the families' function following commencement of home ST. Children did not report a significant improvement in their QoL, but clearly identified satisfaction with home ST.
authors.affiliation: Department of Clinical Haematology, Royal Children's Hospital, Australia. sophie.jones@rch.org.au
authors.forename: Sophie
authors.initials: S
authors.lastname: Jones
authors.forename: Paul
authors.initials: P
authors.lastname: Monagle
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Manias
authors.forename: Aisha A K
authors.initials: AA
authors.lastname: Bruce
authors.forename: Fiona
authors.initials: F
authors.lastname: Newall
mesh_terms: D000293:Adolescent; D000925:Anticoagulants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D011788:Quality of Life; D012648:Self Care; D011795:Surveys and Questionnaires; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D014859:Warfarin
keywords: Anticoagulation; Children; HRQoL; ICC; INR; International Normalised Ratio; MCID; OAT; PAC QL©; Pediatric Anticoagulation Quality of Life inventory©; Pediatric Generic Core Scales Quality of Life inventory™; Pediatric Quality of Life Family Impact module™; PedsQL FIM™; PedsQL™; QoL; Quality of life; ST; Self-testing; TTR; Warfarin therapy; health-related quality of life; intraclass correlation coefficient; minimal clinically important difference; oral anticoagulant therapy; quality of life; self-testing; time in therapeutic range