title: Reasons for non-completion of health related quality of life evaluations in pediatric acute myeloid leukemia: a report from the Children's Oncology Group.
abstract: BACKGROUND
  Health related quality of life (HRQL) assessments during therapy for pediatric cancer are important. The objective of this study was to describe reasons for failure to provide HRQL assessments during a pediatric acute myeloid leukemia (AML) clinical trial.
  
  
  METHODS
  We focused on HRQL assessments embedded in a multicenter pediatric AML clinical trial. The PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and Pediatric Inventory for Parents were obtained from parent/guardian respondents at a maximum of six time points. Children provided self-report optionally. A central study coordinator contacted sites with delinquent HRQL data. Reasons for failure to submit the HRQL assessments were evaluated by three pediatric oncologists and themes were generated using thematic analysis.
  
  
  RESULTS
  There were 906 completed and 1091 potential assessments included in this analysis (83%). The median age of included children was 12.9 years (range 2.0 to 18.9). The five themes for non-completion were: patient too ill; passive or active refusal by respondent; developmental delay; logistical challenges; and poor knowledge of study processes from both the respondent and institutional perspective.
  
  
  CONCLUSIONS
  We identified reasons for non-completion of HRQL assessments during active therapy. This information will facilitate recommendations to improve study processes and future HRQL study designs to maximize response rates.
authors.affiliation: Division of Hematology/Oncology, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
authors.forename: Donna L
authors.initials: DL
authors.lastname: Johnston
authors.forename: Rajaram
authors.initials: R
authors.lastname: Nagarajan
authors.forename: Mae
authors.initials: M
authors.lastname: Caparas
authors.forename: Fiona
authors.initials: F
authors.lastname: Schulte
authors.forename: Patricia
authors.initials: P
authors.lastname: Cullen
authors.forename: Richard
authors.initials: R
authors.lastname: Aplenc
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
mesh_terms: D000293:Adolescent; D001897:Boronic Acids / Q000627:therapeutic use; D000069286:Bortezomib; D002648:Child; D002675:Child, Preschool; D005260:Female; D006126:Group Processes; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000401:mortality / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D008297:Male; D009536:Niacinamide / Q000031:analogs & derivatives / Q000627:therapeutic use; D010290:Parents; D010671:Phenylurea Compounds / Q000627:therapeutic use; D011719:Pyrazines / Q000627:therapeutic use; D011788:Quality of Life / Q000523:psychology*; D057566:Self Report; D000077157:Sorafenib; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D001897:Boronic Acids; D010671:Phenylurea Compounds; D011719:Pyrazines; D009536:Niacinamide; D000069286:Bortezomib; D000077157:Sorafenib
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