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The Added Value of Analyzing Pooled Health-Related Quality of Life Data: A Review of the EORTC PROBE Initiative
Efstathios Zikos1, Corneel Coens2, Chantal Quinten2
1European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium (EZ, CC, DEE, FM, IG, AB); European Centre for Disease Prevention and Control, Surveillance and Response Support, Epidemiological Methods Unit, Stockholm, Sweden (CQ); School of Psychology and Sydney Medical School, University of Sydney, New South Wales, Australia (MTK); School of Population and Public Health, University of British Columbia, Vancouver, Canada (CG); The Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (JR); Leeds Institute of Cancer and Pathology, University of Leeds, St. James's Hospital, Leeds, UK (GV); Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC (BBR); Obstetrics and Gynecology, Medical University Graz, Graz, Austria (EG); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (CSC); Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany (HF); VU University Medical Center / Medical Center Haaglanden, Amsterdam/The Hague, the Netherlands (MJBT); Tumor Biology Center, University of Freiburg, Freiburg, Germany (JW); Philosophical Faculty, University of Regensburg, Regensburg, Germany (JSvK); The Academic Medical Center, Amsterdam, the Netherlands (MAGS) efstathios.zikos@eortc.be.
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.
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