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
Department of Surgery, University of California San Francisco, San Francisco, CA 94158, United States.
Division of Hematology/Oncology, Department of Medicine, University of California San Francisco, San Francisco, CA 94158, United States.
J Am Med Inform Assoc. 2025 Jan 1;32(1):172-180. 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 < .0001). Baseline PROMIS social functioning and grade 2 or more PRO-CTCAE interference of Abdominal Pain, Decreased Appetite, Dizziness and Shortness of Breath was associated with lower survey completion rates.
By implementing ePROs, we have the potential to increase efficiency and accuracy of patient-reported clinical trial data collection, while improving quality of care, patient safety, and health outcomes. Our method is accessible across demographics and facilitates an ease of data collection and sharing across nationwide sites. We identify predictors of decreased completion that can optimize resource allocation by better targeting efforts such as in-person outreach, staff engagement, a robust technical workflow, and increased monitoring to improve overall completion rates.
我们描述了在I-SPY2试验（一项针对局部晚期乳腺癌的II期临床试验）中，使用电子患者报告结局（ePRO）工具监测患者报告的不良事件和生活质量的系统的开发与实施。我们描述了技术、工作流程和行为改变干预措施的实施及其对问卷完成情况的相关影响。
使用OpenClinica电子数据捕获系统，我们开发了基于规则的逻辑来构建自动化的ePRO调查，根据I-SPY2治疗计划进行定制。我们在加利福尼亚大学旧金山分校（UCSF）对ePRO进行了试点，以在试验治疗场景的背景下优化工作流程，并将ePRO系统逐步推广到26个站点，以确保该技术的有效实施。
提高ePRO完成率需要工作流程解决方案和研究人员的参与。在两年多的时间里，我们将基线调查完成率从25%提高到了80%。大多数患者完成了他们收到的问卷的30%至75%，按年龄、种族或民族划分，调查完成率没有统计学上的显著差异。完成筛查时间点问卷的患者在后续时间点更有可能完成更多他们收到的调查（平均完成率分别为74.1%和35.5%，P <.0001）。基线时PROMIS社会功能以及2级或更高级别的PRO-CTCAE对腹痛、食欲减退、头晕和呼吸急促的干扰与较低的调查完成率相关。
通过实施ePRO，我们有可能提高患者报告的临床试验数据收集的效率和准确性，同时改善护理质量、患者安全和健康结局。我们的方法适用于不同人群，并便于在全国范围内的站点进行数据收集和共享。我们确定了完成率下降的预测因素，这些因素可以通过更好地针对诸如面对面宣传、工作人员参与、强大的技术工作流程以及加强监测等努力来优化资源分配，以提高总体完成率。
