Insights from using patient-reported outcomes as an intervention during cancer treatment in Denmark: potential reasons for limited effectiveness.

backgroundIn this comment, we discuss the differences between four Danish randomized controlled trials (RCTs) exploring the effect of electronic patient-reported outcomes (ePROs) as an intervention during cancer treatment and the seven studies included as the basis for the ESMO clinical practice guideline on ePRO in cancer care. We aim to elucidate possible reasons for the lack of effect in a Danish context, which is relevant if ePRO is to be applied in oncological clinical practice on a larger scale. MAIN TEXT: The RCTs underpinning the ESMO guideline demonstrated how the use of ePROs as an intervention improved symptom control, reduced emergency use, hospitalizations, unplanned healthcare episodes, and promoted better physical function. Notably, one study reported an improvement in overall survival. In the Danish studies, the effects were less clear. None of the Danish RCTs investigating ePRO as an intervention during cancer therapy, compared to standard care, showed a significant impact on primary clinical outcomes. We compared the design and performance concerning the number of patients, the questionnaire used for PRO, software, symptom management algorithm, designated staff capacity, primary outcome, and results reported. The Danish studies included fewer patients (138–682) than the ESMO guideline studies (252–1191). A variety of questionnaires and software were used. Six of seven ESMO guideline studies had designated staff to handle the ePROs, whereas three out of four Danish trials lacked this key component.

conclusionWe believe that one possible explanation for the lack of effect in the Danish RCTs can be explained by the absence of designated staff capacity to handle ePROs. It is important to take such matters into account before the large-scale application of PRO in health care practice if the effect of PROs in clinical practice is to be achieved.