TY - JOUR
T1 - The Added Value of Analyzing Pooled Health-Related Quality of Life Data: A Review of the EORTC PROBE Initiative
AU - Zikos, Efstathios
AU - Coens, Corneel
AU - Quinten, Chantal
AU - Ediebah, Divine E.
AU - Martinelli, Francesca
AU - Ghislain, Irina
AU - King, Madeleine T.
AU - Gotay, Carolyn
AU - Ringash, Jolie
AU - Velikova, Galina
AU - Reeve, Bryce B.
AU - Greimel, Eva
AU - Cleeland, Charles S.
AU - Flechtner, Henning
AU - Taphoorn, Martin J. B.
AU - Weis, Joachim
AU - Schmucker-Von Koch, Joseph
AU - Sprangers, Mirjam A. G.
AU - Bottomley, Andrew
PY - 2016
Y1 - 2016
N2 - Background: The European Organisation for Research and Treatment of Cancer (EORTC) Patient-Reported Outcomes and Behavioural Evidence (PROBE) initiative was established to investigate critical topics to better understand health-related quality of life (HRQOL) of cancer patients and to educate clinicians, policy makers, and healthcare providers. Methods: The aim of this paper is to review the major research outcomes of the pooled analysis of HRQOL data along with the clinical data. We identified 30 pooled EORTC randomized controlled trials (RCTs), 18 NCIC-Clinical Trials Group RCTs, and two German Ovarian Cancer Study Group RCTs, all using the EORTC QLQ-C30. All statistical tests were two-sided. Results: Evidence was found that HRQOL data can offer prognostic information beyond clinical measures and improve prognostic accuracy in cancer RCTs (by 5.9%-8.3%). Moreover, models that considered both patient-and clinician-reported scores gained more prognostic overall survival accuracy for fatigue (P <.001), vomiting (P=.01), nausea (P <.001), and constipation (P=.01). Greater understanding of the association between symptom and/or functioning scales was developed by identifying physical, psychological, and gastrointestinal clusters. Additionally, minimally important differences in interpreting HRQOL changes for improvement and deterioration were found to vary across different patient populations and disease stages. Finally, HRQOL scores are statistically significantly affected by deviations from the intended time point at which the questionnaire is completed. Conclusions: The use of existing pooled data shows that it is possible to learn about general aspects of cancer HRQOL and methodology. Our work shows that setting up international pooled datasets holds great promise for understanding patients' unmet psychosocial needs and calls for additional empirical investigation to improve clinical care and understand cancer through retrospective HRQOL analyses
AB - Background: The European Organisation for Research and Treatment of Cancer (EORTC) Patient-Reported Outcomes and Behavioural Evidence (PROBE) initiative was established to investigate critical topics to better understand health-related quality of life (HRQOL) of cancer patients and to educate clinicians, policy makers, and healthcare providers. Methods: The aim of this paper is to review the major research outcomes of the pooled analysis of HRQOL data along with the clinical data. We identified 30 pooled EORTC randomized controlled trials (RCTs), 18 NCIC-Clinical Trials Group RCTs, and two German Ovarian Cancer Study Group RCTs, all using the EORTC QLQ-C30. All statistical tests were two-sided. Results: Evidence was found that HRQOL data can offer prognostic information beyond clinical measures and improve prognostic accuracy in cancer RCTs (by 5.9%-8.3%). Moreover, models that considered both patient-and clinician-reported scores gained more prognostic overall survival accuracy for fatigue (P <.001), vomiting (P=.01), nausea (P <.001), and constipation (P=.01). Greater understanding of the association between symptom and/or functioning scales was developed by identifying physical, psychological, and gastrointestinal clusters. Additionally, minimally important differences in interpreting HRQOL changes for improvement and deterioration were found to vary across different patient populations and disease stages. Finally, HRQOL scores are statistically significantly affected by deviations from the intended time point at which the questionnaire is completed. Conclusions: The use of existing pooled data shows that it is possible to learn about general aspects of cancer HRQOL and methodology. Our work shows that setting up international pooled datasets holds great promise for understanding patients' unmet psychosocial needs and calls for additional empirical investigation to improve clinical care and understand cancer through retrospective HRQOL analyses
U2 - https://doi.org/10.1093/jnci/djv391
DO - https://doi.org/10.1093/jnci/djv391
M3 - Review article
C2 - 26714759
SN - 0027-8874
VL - 108
SP - djv391
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 5
ER -