Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2013 Sep 6;8(9):e74549.
doi: 10.1371/journal.pone.0074549. eCollection 2013.

Reasons for non-completion of health related quality of life evaluations in pediatric acute myeloid leukemia: a report from the Children's Oncology Group

Donna L Johnston  1 , Rajaram Nagarajan, Mae Caparas, Fiona Schulte, Patricia Cullen, Richard Aplenc, Lillian Sung
Affiliations
Clinical Trial

Reasons for non-completion of health related quality of life evaluations in pediatric acute myeloid leukemia: a report from the Children's Oncology Group

Donna L Johnston et al. PLoS One. .

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.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Reasons for HRQL Non-Completion.
Diagram of the reasons for non-completion of health-related quality of life assessment completion.
See this image and copyright information in PMC

References

    1. Lipscomb J, Reeve BB, Clauser SB, Abrams JS, Bruner DW, et al. (2007) Patient-reported outcomes assessment in clinical trials: taking stock, moving forward. J Clin Onc 25: 5133–5140. - PubMed
    1. O’Mara AM, Denicoff AM (2010) Health related quality of life in NCI-sponsored cancer treatment trials. Semin Oncol Nurs 26: 68–78. - PubMed
    1. Buchanan DR, O’Mara AM, Kelaghan JW, Sgambati M, McCaskill-Stevens W, et al. (2007) Challenges and recommendations for advancing state-of-the-science of quality of life assessment in symptom management trials. Cancer 110: 1621–1628. - PubMed
    1. Minasian LM. O’Mara AM, Reeve BB, Denicoff AM, Kelaghan J, et al. (2007) Health-related quality of life and symptom management research sponsored by the National Cancer Institute. J Clin Oncol 25: 5128–5132. - PubMed
    1. Tremolada M, Bonichini S, Altoe G, Pillon M, Carli M, et al. (2011) Parental perceptions of health-related quality of life of children with leukemia in the second week after diagnosis: a quantitative model. Support Care Cancer 19: 591–598. - PubMed

Publication types

MeSH terms