Tran Christine, Dicker Adam, Leiby Benjamin, Gressen Eric, Williams Noelle, Jim Heather
Thomas Jefferson University, Sidney Kimmel Medical College and Cancer Center, Jefferson Center for Digital Health & Data Science, Philadelphia, PA, United States.
Levine Cancer Institute at Atrium Health, Southeast Radiation Oncology Group, Charlotte, NC, United States.
J Med Internet Res. 2020 Mar 25;22(3):e12689. doi: 10.2196/12689.
Measuring patient-reported outcomes (PROs) requires an individual's perspective on their symptoms, functional status, and quality of life. Digital health enables remote electronic PRO (ePRO) assessments as a clinical decision support tool to facilitate meaningful provider interactions and personalized treatment.
This study explored the feasibility and acceptability of collecting ePROs using validated health-related quality of life (HRQoL) questionnaires for prostate cancer.
Using Apple ResearchKit software, the Strength Through Insight app was created with content from validated HRQoL tools 26-item Expanded Prostate Cancer Index Composite (EPIC) or EPIC for Clinical Practice and 8-item Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index. In a single-arm pilot study with patients receiving prostate cancer treatment at Thomas Jefferson University Hospital and affiliates, participants were recruited, and instructed to download Strength Through Insight and complete ePROs once a week over 12 weeks. A mixed methods approach, including qualitative pre- and poststudy interviews, was used to evaluate the feasibility and acceptability of Strength Through Insight for the collection and care management of cancer treatment.
Thirty patients consented to the study; 1 patient failed to complete any of the questionnaires and was left out of the analysis of the intervention. Moreover, 86% (25/29) reached satisfactory questionnaire completion (defined as completion of 60% of weekly questions over 12 weeks). The lower bound of the exact one-sided 95% CI was 71%, exceeding the 70% feasibility threshold. Most participants self-identified with having a high digital literacy level (defined as the ability to use, understand, evaluate, and analyze information from multiple formats from a variety of digital sources), and only a few participants identified with having a low digital literacy level (defined as only having the ability to gather information on the Web). Interviews were thematically analyzed to reveal the following: (1) value of emotional support and wellness in cancer treatment, (2) rise of social patient advocacy in online patient communities and networks, (3) patient concerns over privacy, and (4) desire for personalized engagement tools.
Strength Through Insight was demonstrated as a feasible and acceptable method of data collection for ePROs. A high compliance rate confirmed the app as a reliable tool for patients with localized and advanced prostate cancer. Nearly all participants reported that using the smartphone app is easier than or equivalent to the traditional paper-and-pen approach, providing evidence of acceptability and support for the use of remote PRO monitoring. This study expands on current research involving the value of digital health, as a social and behavioral science, augmented with technology, can begin to contribute to population health management, as it shapes psychographic segmentation by demographic, socioeconomic, health condition, or behavioral factors to group patients by their distinct personalities and motivations, which influence their choices.
ClinicalTrials.gov NC03197948; http://clinicaltrials.gov/ct2/show/NC03197948.
测量患者报告的结局（PROs）需要个人对其症状、功能状态和生活质量的看法。数字健康使远程电子PRO（ePRO）评估成为一种临床决策支持工具，以促进有意义的医患互动和个性化治疗。
本研究探讨了使用经过验证的前列腺癌健康相关生活质量（HRQoL）问卷收集ePROs的可行性和可接受性。
使用苹果ResearchKit软件，创建了“洞察力量”应用程序，其内容来自经过验证的HRQoL工具——26项扩展前列腺癌指数综合量表（EPIC）或临床实践用EPIC，以及8项癌症治疗功能评估前列腺症状高级指数。在一项单臂试点研究中，招募了在托马斯·杰斐逊大学医院及其附属医院接受前列腺癌治疗的患者，并指示他们下载“洞察力量”，并在12周内每周完成一次ePRO评估。采用混合方法，包括定性的研究前和研究后访谈，来评估“洞察力量”在癌症治疗数据收集和护理管理方面的可行性和可接受性。
30名患者同意参与该研究；1名患者未完成任何问卷，被排除在干预分析之外。此外，86%（25/29）的患者达到了满意的问卷完成率（定义为在12周内完成每周问题的60%）。精确单侧95%置信区间的下限为71%，超过了70%的可行性阈值。大多数参与者自认为具有较高的数字素养水平（定义为能够使用、理解、评估和分析来自各种数字来源的多种格式信息的能力），只有少数参与者自认为数字素养水平较低（定义为仅具有在网络上收集信息的能力）。对访谈进行了主题分析，结果显示：（1）癌症治疗中情感支持和健康的价值；（2）在线患者社区和网络中社会患者倡导的兴起；（3）患者对隐私的担忧；（4）对个性化参与工具的渴望。
“洞察力量”被证明是一种可行且可接受的ePRO数据收集方法。高依从率证实了该应用程序是局部和晚期前列腺癌患者的可靠工具。几乎所有参与者都报告说，使用智能手机应用程序比传统的纸笔方法更容易或相当，这为远程PRO监测的可接受性和支持提供了证据。本研究扩展了当前关于数字健康价值的研究，因为作为一门社会和行为科学，数字健康与技术相结合，可以开始为人群健康管理做出贡献，因为它根据人口统计学、社会经济、健康状况或行为因素对心理特征进行细分，以便根据患者独特的个性和动机对患者进行分组，而这些因素会影响他们的选择。
ClinicalTrials.gov NC03197948；http://clinicaltrials.gov/ct2/show/NC03197948
