Implementation and impact of an electronic patient reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer

• Published in: Journal of the American Medical Informatics Association : JAMIA 2024-08, Vol.32 (1), p.172
• Main Authors: Northrop, Anna, Christofferson, Anika, Umashankar, Saumya, Melisko, Michelle, Castillo, Paolo, Brown, Thelma, Heditsian, Diane, Brain, Susie, Simmons, Carol, Hieken, Tina, Ruddy, Kathryn J, Mainor, Candace, Afghahi, Anosheh, Tevis, Sarah, Blaes, Anne, Kang, Irene, Asare, Adam, Esserman, Laura, Hershman, Dawn L, Basu, Amrita
• Format: Article
• Language: English
• Subjects: Breast Neoplasms; Female; Humans; Middle Aged; Neoplasm Staging; Patient Reported Outcome Measures; Quality of Life; Surveys and Questionnaires; Workflow
• ISSN: 1067-5027; 1527-974X; 1527-974X
• DOI: 10.1093/jamia/ocae190

We describe the development and implementation of a system for monitoring patient-reported adverse events and quality of life using electronic Patient Reported Outcome (ePRO) instruments in the I-SPY2 Trial, a phase II clinical trial for locally advanced breast cancer. We describe the administration of technological, workflow, and behavior change interventions and their associated impact on questionnaire completion. Using the OpenClinica electronic data capture system, we developed rules-based logic to build automated ePRO surveys, customized to the I-SPY2 treatment schedule. We piloted ePROs at the University of California, San Francisco (UCSF) to optimize workflow in the context of trial treatment scenarios and staggered rollout of the ePRO system to 26 sites to ensure effective implementation of the technology. Increasing ePRO completion requires workflow solutions and research staff engagement. Over two years, we increased baseline survey completion from 25% to 80%. The majority of patients completed between 30% and 75% of the questionnaires they received, with no statistically significant variation in survey completion by age, race or ethnicity. Patients who completed the screening timepoint questionnaire were significantly more likely to complete more of the surveys they received at later timepoints (mean completion of 74.1% vs 35.5%, P