Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
-
Review Meta Analysis Comparative Study
Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G).
The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs. ⋯ The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.