Skovlund Pernille Christiansen, Nielsen Berit Kjærside, Thaysen Henriette Vind, Schmidt Henrik, Finset Arnstein, Hansen Kristian Ahm, Lomborg Kirsten
Experimental Clinical Oncology, Department of Oncology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.
Department of Oncology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.
Res Involv Engagem. 2020 Jul 19;6:43. doi: 10.1186/s40900-020-00214-5. eCollection 2020.
The interest in patient and public involvement (PPI) in health research is increasing. However, the experience and knowledge of PPI throughout the entire research process and especially in the analysis are limited. We explored ways to embrace the perspectives of patients in a research process, and the impact and challenges our collaboration has had on patients, researchers, and the research outcomes.
This is an explorative single case study of a Danish, clinical, controlled intervention trial and a nested intervention fidelity study included herein. Five patient representatives with metastatic melanoma were part of designing, undertaking and disseminating the trial where the effect of using patient-reported outcome (PRO)-measures as a dialogue tool in the patient-physician consultation was tested. In the fidelity study, audio-recorded consultations were analyzed after training in the Verona Coding Definitions of Emotional Sequences (VR-CoDES). Results were jointly disseminated at an international scientific conference. The outcomes, impact, and challenges were explored through a workshop.
In the design phase, we selected PRO-measures and validated the dialogue tool. The information sheet was adjusted according to the patients' suggestions. The analysis of the fidelity study showed that patients and researchers had a high consensus on the coding of emotional cues and concerns. The patients contributed with a new vocabulary and perspective on the dialogue, and they validated the results. PPI caused considerations related to emotional (sadness/sorrow and existential thoughts), administrative (e.g. arranging meetings, balancing work and small talk) and intellectual (e.g. avoiding information harm, continuing activities despite the death of patients) investments. A limitation of the study was the lack of use of a solid evaluation tool to determine the impact of PPI.
PPI throughout the process and co-creation in the analysis was feasible and beneficial. The case is unique in the degree of workable details, sustainability, and transparency. Moreover, the co-creation provides ideas of ways to operationalize PPI. An evaluation workshop revealed considerations about emotional, administrative and intellectual investments - best described as tacit, yet important 'work'. This knowledge and experience can be applied to other studies where patients are partners in the research.
ClinicalTrials.gov ID: NCT03163433, registration date: 8th May 2017.
患者及公众参与健康研究的关注度日益提高。然而，在整个研究过程中，尤其是在分析阶段，患者及公众参与的经验和知识有限。我们探索了在研究过程中纳入患者观点的方法，以及我们的合作对患者、研究人员和研究结果产生的影响与挑战。
这是一项对丹麦的一项临床对照干预试验及其中嵌套的干预保真度研究的探索性单案例研究。五名转移性黑色素瘤患者代表参与了试验的设计、实施和传播，该试验测试了在医患咨询中使用患者报告结局（PRO）测量作为对话工具的效果。在保真度研究中，在接受维罗纳情感序列编码定义（VR-CoDES）培训后，对音频记录的咨询进行了分析。结果在一次国际科学会议上联合发布。通过一个研讨会探讨了结果、影响和挑战。
在设计阶段，我们选择了PRO测量并验证了对话工具。信息表根据患者建议进行了调整。保真度研究分析表明患者和研究人员在情感线索和关注点编码方面高度一致。患者为对话贡献了新的词汇和观点，并验证了结果。患者及公众参与引发了与情感（悲伤/悲痛和存在性思考）、行政（如安排会议、平衡工作和闲聊）和智力（如避免信息伤害、尽管患者死亡仍继续活动）投入相关的考量。该研究的一个局限性是缺乏使用可靠的评估工具来确定患者及公众参与的影响。
在整个过程中进行患者及公众参与并在分析中进行共同创造是可行且有益的。该案例在可行细节、可持续性和透明度方面具有独特性。此外,共同创造提供了将患者及公众参与付诸实践 的方法思路。一次评估研讨会揭示了对情感、行政和智力投入 的考量——最好描述为隐性但重要的“工作”。这些知识和经验可应用于患者作为研究伙伴的其他研究。
ClinicalTrials.gov标识符：NCT03163433，注册日期：2017年5月8日。
