Evaluation and reporting of quality of life outcomes in phase III chemotherapy trials for poor prognosis malignancies.

ABSTRACT

BACKGROUND: Quality of life (QoL) should be included in trials where treatment is expected to have a limited impact on long-term survival. We set out to determine whether phase III chemotherapy trials addressing solid malignancies with a poor prognosis include QoL as a study objective and to assess the extent to which these data have been published. METHODS: We performed a search of the National Institutes of Health clinical trial registry website to identify phase III chemotherapy trials for poor prognosis solid malignancies. The retrieved protocols were subsequently reviewed, to assess whether QoL was included as an outcome measure. Subsequently, a Medline, Embase and world-wide-web search was performed to identify any full text publication or conference abstract regarding the outcome of trials including QoL, which were then reviewed to determine whether and to what extend quality of life results were included. RESULTS: For the 201 included studies, we found that 57 % of trials did not include QoL as a study objective. Of the remaining trials, 50 % have not reported the QoL results in a full text publication, or presented these only as a single sentence statement. CONCLUSION: Evaluation and publication of QoL results of phase III chemotherapy trials for poor prognosis solid malignancies remains limited. This must be improved in order to provide patients suffering from these malignancies with adequate information regarding the benefits and risks of the treatment in terms of both prolongation and quality of life.