Effect of mode of delivery of patient reported outcomes in patients with breast disease: a randomised controlled trial

Abstract

Background: Patient Reported Outcomes (PROs) have an integral role on how to improve patients’ overall experience. The optimal PROs delivery in patients with breast disease is an important issue since PROs are steadily integrated in routine care. Methods: An institutional phase 3 randomised controlled, open-label trial. Eligible candidates were adult women with perceived or confirmed breast disease. Computer generated randomisation was used to allocate interventions: collection of PROs in electronic or paper form. Our objective was the effectiveness of electronic versus paper form of PROs. The main outcome measures were: response rate, reported experience, administrative resources and carbon dioxide emissions. Results: 238 patients were randomised. After loss-to-follow-up and consent withdrawals, 218 participants (median age, iqr=55, 21; n=110 / n=108) were included in the per-intention-to-treat analysis. Response rate was 61.8% for electronic patient reported outcomes (ePROs) and 63.9% for paper patient reported outcomes (pPROs) (difference=−2.1%, 95% CI: -15.8%, 11.7%). Only known breast cancer at recruitment was predictive for response in multivariable analysis. ePROs were associated with 57% reduction in administrative time required, 95% reduction in incremental costs and 84% reduction in carbon dioxide emissions, all differences being significant. No difference was detected in perception of PRO significance or ease of completion, but participants experienced that they needed less time to complete ePROs [median, (iqr) 10 (9) respectively 15(10)]. Finally, respondents would prefer ePROs over pPROs (difference 48.1%, 95%CI 32.8%, 63.4%). Conclusion: ePROs do not increase response rate in patients with perceived or confirmed breast disease. However, they can enhance patient experience, reduce incremental costs, facilitate administrative logistics and are more sustainable. On the basis of these findings, both modalities should continue to be available.