Bishop Emily L, Bonhomme Justin, Baranec Deb, Wamsley Anita, Ronsky Janet L, Clark Marcia L
Department of Mechanical and Manufacturing Engineering, Schulich School of Engineering, University of Calgary, Calgary, AB, Canada.
McCaig Institute for Bone and Joint Health, University of Calgary, Calgary, AB, Canada.
Res Involv Engagem. 2024 Oct 24;10(1):108. doi: 10.1186/s40900-024-00640-9.
Patient oriented research (POR) invites patients to partner with researchers, clinicians, and other stakeholders, incorporating diverse perspectives to generate scientific evidence meaningful to all parties involved. We adopted a POR approach for this study evaluating the feasibility of conducting a randomized control trial of a novel tri-compartment offloader brace for knee osteoarthritis. We involved patients as partners to enhance study design, implementation and interpretation of key outcomes.
Patient involvement consisted of two patient leaders and five patient advisors. Patients participated in 2 virtual focus groups to discuss study outcomes, protocol, results and knowledge translation. Patients were involved in all aspects of the research cycle.
Patient feedback resulted in changes to study design, documentation, participant recruitment, data collection, results interpretation and knowledge dissemination, improving the participant experience and aligning study outcomes with patient priorities. Study participants showed a high level of protocol adherence and follow-up rates were excellent. We experienced several unexpected benefits including genuine friendships, a deeper understanding of the patient experience, a more pragmatic approach to clinical research, and leadership opportunities for patients.
We agreed on POR "non-negotiables" to ensure a positive experience for everyone, including creating a safe and comfortable environment, being genuinely receptive to patient feedback, and providing appropriate supports for patients. We strongly recommend that researchers (1) involve patients as early as possible, (2) provide ample and equal opportunities for all patients to be involved, and (3) address system hierarchy by involving patients as equals and fully considering all patient ideas from the beginning of the project.
While POR is a learning process that is often more challenging than the traditional clinical research approach, the benefits are well worth the additional time and effort required to do it well. Over time, our team experienced a cultural shift and evolution from a top-down research approach to a more inclusive approach considering patient voices as equal to those of researchers. Patient involvement in all aspects of the research process, from question development to results interpretation and dissemination is integral to clinical research advancing equitably.
以患者为导向的研究（POR）邀请患者与研究人员、临床医生及其他利益相关者合作，纳入不同观点以生成对所有相关方都有意义的科学证据。我们在这项研究中采用了POR方法，评估针对膝骨关节炎的新型三室卸载支具进行随机对照试验的可行性。我们让患者作为合作伙伴参与，以改进研究设计、实施以及关键结果的解读。
患者参与包括两名患者组长和五名患者顾问。患者参加了2次虚拟焦点小组讨论，以探讨研究结果、方案、结果及知识转化。患者参与了研究周期的各个方面。
患者反馈促使研究设计、文件记录、参与者招募、数据收集、结果解读及知识传播发生了改变，改善了参与者体验，并使研究结果与患者优先事项保持一致。研究参与者表现出高度的方案依从性，随访率也很高。我们还获得了一些意想不到的益处，包括真挚的友谊、对患者体验的更深入理解、更务实的临床研究方法以及患者的领导机会。
我们就POR的“不可协商事项”达成一致，以确保每个人都有积极的体验，包括营造安全舒适的环境、真正接受患者反馈以及为患者提供适当支持。我们强烈建议研究人员：（1）尽早让患者参与；（2）为所有患者提供充分和平等的参与机会；（3）通过平等对待患者并从项目一开始就充分考虑所有患者的想法来消除系统层级差异。
虽然POR是一个学习过程，通常比传统临床研究方法更具挑战性，但好处值得投入额外的时间和精力把它做好。随着时间的推移，我们的团队经历了文化转变，从自上而下的研究方法演变为更具包容性的方法，将患者的声音视为与研究人员的声音平等。患者参与研究过程的各个方面，从问题提出到结果解读和传播，对于临床研究公平推进至关重要。
