Quality of life assessment in surgical oncology trials.

Integrating health-related quality of life (HRQOL) as an endpoint for randomized surgical trials provides valuable insight into the patients' perspective on treatment outcome. Health related quality of life data also play a role in ensuring fully informed consent, determining treatment options and informing treatment decision making. However, few randomized surgical trials have been conducted that meet the minimum requirements for rigorous HRQL assessment and, despite increasing efforts to improve the reporting of randomized trials, many are still not adequately performed. Such methodologic limitations may influence trial findings for HRQL outcomes and undermine the ability of the data collected to inform clinical practice. This review describes key methodological aspects of HRQL assessment that are required in randomized trials to ensure that data are robust. This includes choice of HRQL instrument, the method and timing of assessments and data analysis and presentation. The review also makes recommendations for future research in this area.