Cole Amy, Richardson Daniel R, Adapa Karthik, Khasawneh Amro, Crossnohere Norah, Bridges John F P, Mazur Lukasz
Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
University of North Carolina Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
JMIR Res Protoc. 2022 Jun 29;11(6):e39586. doi: 10.2196/39586.
The approval of novel therapies for patients diagnosed with hematologic malignancies have improved survival outcomes but increased the challenge of aligning chemotherapy choices with patient preferences. We previously developed paper versions of a discrete choice experiment (DCE) and a best-worst scaling (BWS) instrument to quantify the treatment outcome preferences of patients with hematologic malignancies to inform shared decision making.
We aim to develop an electronic health care tool (EHT) to guide clinical decision making that uses either a BWS or DCE instrument to capture patient preferences. The primary objective of this study is to use both qualitative and quantitative methods to evaluate the perceived usability, cognitive workload (CWL), and performance of electronic prototypes that include the DCE and BWS instrument.
This mixed methods study includes iterative co-design methods that will involve healthy volunteers, patient-caregiver pairs, and health care workers to evaluate the perceived usability, CWL, and performance of tasks within distinct prototypes. Think-aloud sessions and semistructured interviews will be conducted to collect qualitative data to develop an affinity diagram for thematic analysis. Validated assessments (Post-Study System Usability Questionnaire [PSSUQ] and the National Aeronautical and Space Administration's Task Load Index [NASA-TLX]) will be used to evaluate the usability and CWL required to complete tasks within the prototypes. Performance assessments of the DCE and BWS will include the evaluation of tasks using the Single Easy Questionnaire (SEQ), time to complete using the prototype, and the number of errors. Additional qualitative assessments will be conducted to gather participants' feedback on visualizations used in the Personalized Treatment Preferences Dashboard that provides a representation of user results after completing the choice tasks within the prototype.
Ethical approval was obtained in June 2021 from the Institutional Review Board of the University of North Carolina at Chapel Hill. The DCE and BWS instruments were developed and incorporated into the PRIME (Preference Reporting to Improve Management and Experience) prototype in early 2021 and prototypes were completed by June 2021. Heuristic evaluations were conducted in phase 1 and completed by July 2021. Recruitment of healthy volunteers began in August 2021 and concluded in September 2021. In December 2021, our findings from phase 2 were accepted for publication. Phase 3 recruitment began in January 2022 and is expected to conclude in September 2022. The data analysis from phase 3 is expected to be completed by November 2022.
Our findings will help differentiate the usability, CWL, and performance of the DCE and BWS within the prototypes. These findings will contribute to the optimization of the prototypes, leading to the development of an EHT that helps facilitate shared decision making. This evaluation will inform the development of EHTs to be used clinically with patients and health care workers.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39586.
针对被诊断为血液系统恶性肿瘤的患者，新型疗法的获批改善了生存结果，但也增加了使化疗选择与患者偏好相匹配的挑战。我们之前开发了纸质版的离散选择实验（DCE）和最佳-最差标度法（BWS）工具，以量化血液系统恶性肿瘤患者的治疗结果偏好，为共同决策提供依据。
我们旨在开发一种电子医疗工具（EHT）来指导临床决策，该工具使用BWS或DCE工具来获取患者偏好。本研究的主要目的是使用定性和定量方法来评估包含DCE和BWS工具的电子原型的感知可用性、认知工作量（CWL）和性能。
这项混合方法研究包括迭代式协同设计方法，将涉及健康志愿者、患者-护理人员对以及医护人员，以评估不同原型中任务的感知可用性、CWL和性能。将进行出声思维会话和半结构化访谈，以收集定性数据，构建亲和图进行主题分析。将使用经过验证的评估工具（研究后系统可用性问卷 [PSSUQ] 和美国国家航空航天局任务负荷指数 [NASA-TLX]）来评估完成原型内任务所需的可用性和CWL。DCE和BWS的性能评估将包括使用单一简易问卷（SEQ）对任务进行评估、使用原型完成任务的时间以及错误数量。还将进行额外的定性评估，以收集参与者对个性化治疗偏好仪表板中使用的可视化的反馈，该仪表板展示了在原型内完成选择任务后的用户结果。
2021年6月获得了北卡罗来纳大学教堂山分校机构审查委员会的伦理批准。DCE和BWS工具于2021年初开发并纳入PRIME（偏好报告以改善管理和体验）原型，原型于2021年6月完成。在第一阶段进行了启发式评估，并于2021年7月完成。健康志愿者的招募于2021年8月开始，9月结束。2021年12月，我们第二阶段的研究结果被接受发表。第三阶段的招募于2022年1月开始，预计2022年9月结束。第三阶段的数据分析预计2022年11月完成。
我们的研究结果将有助于区分原型中DCE和BWS的可用性、CWL和性能。这些结果将有助于优化原型，从而开发出有助于促进共同决策的EHT。该评估将为临床上与患者和医护人员一起使用的EHT的开发提供信息。
国际注册报告标识符（IRRID）：DERR1-10.2196/39586。
