Capturing the patient voice in radiotherapy trials: An analysis of trends and future directions of patient-reported outcomes.
216 Background: The importance of patient-reported outcomes (PROs) has been recognized and this data is increasingly being incorporated into modern radiotherapy (RT) trial design. Despite this, there is a lack of published data regarding collection and reporting of PRO data in the RT setting. We sought to systematically evaluate RT protocols to assess trends of PRO data collection and factors associated with reporting. Methods: We queried multi-institutional RT trials indexed on ClinicalTrials.gov, the Cochrane database, and MEDLINE and identified trials with full protocols available. We collected information in regards to study population, primary and secondary endpoints, quality of life measures, and PRO data. Descriptive and chi-squared analyses were employed to investigate trends and factors associated with PRO reporting. Results: 232 protocols were evaluable (1971-2014) from multiple cooperative groups. Of these, 198 were completed and 34 were in progress. Overall, only 41% of trials had protocol-specified collection of PROs. Of the 155 trials that had at least 1 published report, only 34 (22%) reported PRO data. All nine trials with PRO as a primary endpoint (9/9) had published reports with this information. Treatment era was associated with PRO collection, with 30% of trials collecting PRO data prior to 2005, 48% between 2006 and 2010, and 66% between 2011 and 2015 ( X2 [4, N = 232] = 15.79, p = 0.003). PROs were most likely to be collected in phase III trials ( X2 [4, N = 226] = 59.6, p < 0.0001). Conclusions: PROs are historically under collected and reported in cooperative group RT trials. Despite increasing PRO collection in modern trials, reporting remains suboptimal and may inaccurately inform survivorship issues. As digital literacy progresses, electronic PRO data may offer a potential avenue for improvement. Ultimately, PRO data will serve as a vital component to help define value in newly proposed payment models focused on improving quality of care while reducing cost of care.