Patient-Reported Outcome Coordinator Did Not Improve Quality of Life Assessment Response Rates: A Report from the Children's Oncology Group.
OBJECTIVE
Health related quality of life (HRQL) assessments during therapy for pediatric cancer provide valuable information to better understand the patient experience. Our objective was to determine the impact of a patient-reported outcome (PRO) coordinator on HRQL questionnaire completion rates during a pediatric acute myeloid leukemia (AML) trial.


METHODS
AAML1031 is a multicenter Children's Oncology Group therapeutic trial for de novo AML with a secondary aim to assess HRQL of children and adolescents treated with chemotherapy and hematopoietic stem cell transplantation (HSCT). Parents/guardians are the primary respondents and four questionnaires are administered at eight time points. The questionnaires are the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents. To improve response rates, a central PRO coordinator was instituted and reminded sites about upcoming and delinquent questionnaires. The proportion of HRQL questionnaires completed were compared prior to, and following institution of the PRO coordinator. This analysis evaluated the first five assessment time points.


RESULTS
There were231 families who consented to participate in the HRQL aim. Overall response rates for all questionnaires were 73-83%. At time point 1, within 14 days of chemotherapy initiation, post-PRO coordinator completion rates were significantly higher for three of four questionnaires. However, the effect was not sustained and at time point 4, one month following last chemotherapy or HSCT, completion rates were significantly lower post-PRO coordinator for all four questionnaires.


CONCLUSIONS
Addition of a central PRO coordinator did not result in sustained improvement in HRQL questionnaire completion rates. Efforts to improve response rates must consider other strategies.
Division of Hematology/Oncology, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
Donna
D
Johnston
Children's Oncology Group, Monrovia, California, United States of America.
Robert
R
Gerbing
Department of Preventive Medicine, University of Southern California, Los Angeles, California, United States of America.
Todd
T
Alonzo
Pediatric Oncology/Stem Cell Transplant, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America.
Richard
R
Aplenc
Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States of America.
Rajaram
R
Nagarajan
Departments of Oncology and Pediatrics, University of Calgary, Calgary, Alberta, Canada.
Fiona
F
Schulte
Loretto Heights School of Nursing, Regis University, Denver, Colorado, United States of America.
Patricia
P
Cullen
Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Lillian
L
Sung
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000523:psychology* / Q000628:therapy; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012108:Research Personnel; D035842:Research Subjects / Q000523:psychology; D011795:Surveys and Questionnaires