Center for Respiratory Biology and Therapeutics, Seattle Children's Research Institute, United States; Department of Pediatrics, University of Washington School of Medicine, United States.
University of Arkansas for Medical Sciences, United States.
J Cyst Fibros. 2024 Jul;23(4):739-743. doi: 10.1016/j.jcf.2024.06.014. Epub 2024 Jul 29.
We undertook a human-centered design approach to design the OUTREACH study of home spirometry as a CF clinical trial endpoint. We conducted a qualitative needs assessment to elicit the perspectives of people with CF (PwCF) and research coordinators (RCs) about home spirometry in the research setting and co-produced written and video home spirometry instructions in partnership with representatives from these stakeholder groups.
We conducted 7 focus groups of PwCF (N = 27), caregivers of children with CF (N = 6), or RCs (N = 24) to elicit current experiences, barriers and facilitators of home spirometry across 6 target areas, followed by discussion and prioritization. The co-production team, composed of 3 PwCF, 3 RCs and study team members created written and video training materials.
While most PwCF and caregivers found home spirometry convenient, many experienced technical barriers, reported a "learning curve", and expressed uncertainty about the quality and reliability of measurements. Major barriers identified by RCs included tailoring participant training to individual needs, scheduling remote coaching, and performing effective coaching remotely. Participants offered age-specific recommendations in key domains: training materials and procedures, remote coaching, monitoring progress and maintaining engagement. Co-produced training materials included handouts and videos on how to perform spirometry, and troubleshooting, cleaning, and maintaining home spirometers.
The OUTREACH design was improved by incorporating results of the needs assessment. The home spirometry training materials are freely available for public use. We hope our results and materials can help to inform the design and success of remote clinical trials of the future.
我们采用以患者为中心的设计方法来设计 OUTREACH 研究，将家庭肺量计测定作为 CF 临床试验的终点。我们进行了定性需求评估，以了解 CF 患者（PwCF）和研究协调员（RCs）对研究环境中家庭肺量计测定的看法，并与来自这些利益相关者群体的代表合作共同制定书面和视频家庭肺量计测定说明。
我们进行了 7 次 PwCF（N=27）、CF 儿童的照顾者（N=6）或 RCs（N=24）的焦点小组讨论，以了解家庭肺量计测定在 6 个目标领域的当前经验、障碍和促进因素，然后进行讨论和优先级排序。由 3 名 PwCF、3 名 RCs 和研究团队成员组成的共同制定团队创建了书面和视频培训材料。
虽然大多数 PwCF 和照顾者发现家庭肺量计测定很方便，但许多人遇到了技术障碍，报告了“学习曲线”，并对测量的质量和可靠性表示不确定。RCs 确定的主要障碍包括根据个人需求调整参与者培训、安排远程指导以及远程有效地进行指导。参与者在关键领域提供了特定年龄的建议：培训材料和程序、远程指导、监测进展和保持参与度。共同制定的培训材料包括如何进行肺量计测定、故障排除、清洁和维护家庭肺量计的讲义和视频。
通过纳入需求评估的结果，改进了 OUTREACH 的设计。家庭肺量计测定培训材料可供公众免费使用。我们希望我们的结果和材料能够为未来远程临床试验的设计和成功提供信息。
