Ross Julia T, Noonan Vanessa K, Chernesky John, Hektner James, Peter Richard, Hawes Spring, Forshner Andrew, Shekhar Shweta, Ray Tathagata, Raina Arushi, Laskin James J
Praxis Spinal Cord Institute 6400-818W 10th Ave, Vancouver, British Columbia, Canada.
Health Expect. 2025 Aug;28(4):e70369. doi: 10.1111/hex.70369.
The involvement of people with lived experience (PLEX) of spinal cord injury (SCI) is not common during medical innovation design, research and commercialization processes. To address the SCI community's needs and priorities, companies developing SCI-related innovations must include individuals living with SCI in all steps of the process. This study explores the importance of the involvement of PLEX groups in identifying key themes and priorities for SCI-related devices and therapeutics.
Focus groups were held virtually as part of the Praxis Innovation Program. Members of the Praxis PLEX team facilitated 90-min discussions with PLEX participants. A discussion guide was used which included the following topics: existing challenges & solutions, initial product impressions, likelihood of use, acceptance by SCI community, reimbursement/payment challenges & solutions, and potential improvements. Researchers observed the focus groups and took contemporaneous notes. Following each focus group, a deidentified summary was synthesized using researchers' notes, facilitator's key messages, and an audio transcript. The summaries from all focus groups were analyzed and themes common across the focus groups were identified.
Twenty-seven focus groups were conducted between 2020 and 2023, with an average of seven participants per session. Individuals from Canada, the United States, New Zealand, and Australia participated. Participants ranged in age from 21 to 73 years. 58% were male and 42% were female. Fourteen percent of participants had lived with SCI for less than 5 years, 17% for 6-10 years, 12% for 11-15 years, and 57% for greater than 16 years. Among participants, 59% were tetraplegic, while 41% were paraplegic. Six global themes emerged that reflected PLEX's considerations for new technologies; purchase and use decisions were identified in 96% of the focus groups, purpose in 93%, design in 89%, communication in 85%, time factors in 81%, and adaptation considerations in 81%.
This study describes the results of using a systematic approach and framework for SCI PLEX focus groups during the research, design and commercialization process. The themes identified: purchase and use decisions, purpose, design, communication, time factors, and adaptation considerations, are important topics regarding SCI innovations. Future studies should focus on measuring the impact of patient/PLEX engagement by comparing the success of devices that successfully reach consumer market after collaboration with PLEX versus products that are developed independently.
Members of the Praxis PLEX team provided significant feedback and input on developing the focus group discussion guides, facilitating the focus groups, interpreting the data, and producing the manuscript. They were all included as co-authors.
脊髓损伤（SCI）患者参与医学创新设计、研究和商业化过程的情况并不常见。为满足脊髓损伤群体的需求和优先事项，开发与脊髓损伤相关创新产品的公司必须让脊髓损伤患者参与到过程的每一步。本研究探讨了脊髓损伤患者群体参与确定脊髓损伤相关设备和治疗方法的关键主题和优先事项的重要性。
作为Praxis创新计划的一部分，以虚拟方式举行了焦点小组讨论。Praxis患者参与团队的成员与患者参与组的参与者进行了90分钟的讨论。使用了一份讨论指南，其中包括以下主题：现有挑战与解决方案、对产品的初步印象、使用可能性、脊髓损伤群体的接受度、报销/支付挑战与解决方案以及潜在改进。研究人员观察了焦点小组讨论并做了同步记录。在每个焦点小组讨论之后，利用研究人员的记录、主持人的关键信息和音频记录合成了一份去识别化的总结。对所有焦点小组讨论的总结进行了分析，并确定了各焦点小组讨论中共同的主题。
2020年至2023年期间共进行了27次焦点小组讨论，每次会议平均有7名参与者。来自加拿大、美国、新西兰和澳大利亚的个人参与了讨论。参与者年龄在21岁至73岁之间。58%为男性，42%为女性。14%的参与者脊髓损伤时间不到5年，17%为6至10年，12%为11至15年，57%超过16年。参与者中，59%为四肢瘫痪，41%为截瘫。出现了六个全球主题，反映了患者参与组对新技术的考虑；96%的焦点小组讨论中提到了购买和使用决策，93%提到了用途，89%提到了设计，85%提到了沟通，81%提到了时间因素，81%提到了适应性考虑。
本研究描述了在研究、设计和商业化过程中，对脊髓损伤患者参与组焦点小组讨论采用系统方法和框架的结果。确定的主题：购买和使用决策、用途、设计、沟通、时间因素和适应性考虑，是与脊髓损伤创新相关的重要话题。未来的研究应侧重于通过比较与患者参与组合作后成功进入消费市场的设备与独立开发的产品的成功情况，来衡量患者/患者参与组参与的影响。
患者参与组和/或公众贡献：Praxis患者参与团队的成员在制定焦点小组讨论指南、主持焦点小组讨论、解释数据和撰写稿件方面提供了重要反馈和投入。他们均被列为共同作者。
