Abstract
BackgroundHealth 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.MethodsWe 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.ResultsThere 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.ConclusionsWe 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.
Highlights
Health related quality of life (HRQL) assessments during therapy for pediatric cancer are important
As of January 25, 2013, there were 253 patients enrolled on AAML1031 who were eligible for the HRQL aspect of the study
Given the activation date of AAML1031, the number of individual HRQL assessments that were completed and the number that should have been completed at each time point from parents and patients combined were as follows: 1 (n = 959/1133); 2 (n = 749/ 923); 3 (n = 624/741); 4 (n = 454/578); 5 (n = 273/304); 6 (n = 64/ 85); 7 (n = 0); and 8 (n = 0)
Summary
Health related quality of life (HRQL) assessments during therapy for pediatric cancer are important This information is needed to better understand the patient experience and to identify if, when, and how interventions should be considered to improve HRQL [1,2]. The advantages of embedding HRQL assessments into a therapeutic trial include efficiency in trial conduct and data management [3]. This approach has the potential for observing interactions among symptoms, calculating quality adjusted survival and cost-effectiveness, and generating new hypotheses [3]. The objective of this study was to describe reasons for failure to provide HRQL assessments during a pediatric acute myeloid leukemia (AML) clinical trial
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