Turner Grace M, McMullan Christel, Aiyegbusi Olalekan Lee, Hughes Sarah E, Walker Anita, Jeyes Felicity, Adler Yvonne, Chong Amy, Buckland Lewis, Stanton David, Davies Elin Haf, Haroon Shamil, Calvert Melanie
Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Centre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Res Involv Engagem. 2023 Mar 30;9(1):18. doi: 10.1186/s40900-023-00429-2.
The high incidence of COVID-19 globally has led to a large prevalence of Long COVID but there is a lack of evidence-based treatments. There is a need to evaluate existing treatments for symptoms associated with Long COVID. However, there is first a need to evaluate the feasibility of undertaking randomised controlled trials of interventions for the condition. We aimed to co-produce a feasibility study of non-pharmacological interventions to support people with Long COVID.
A consensus workshop on research prioritisation was conducted with patients and other stakeholders. This was followed by the co-production of the feasibility trial with a group of patient partners, which included the design of the study, the selection of interventions, and the production of dissemination strategies.
The consensus workshop was attended by 23 stakeholders, including six patients. The consensus from the workshop was to develop a clinical trial platform that focused on testing different pacing interventions and resources. For the co-production of the feasibility trial, patient partners selected three pacing resources to evaluate (video, mobile application, and book) and co-designed feasibility study processes, study materials and undertook usability testing of the digital trial platform.
In conclusion, this paper reports the principles and process used to co-produce a feasibility study of pacing interventions for Long COVID. Co-production was effective and influenced important aspects of the study.
全球范围内新冠病毒感染疾病(COVID-19)的高发病率导致了长期新冠症状的广泛流行,但缺乏循证治疗方法。有必要评估针对长期新冠相关症状的现有治疗方法。然而,首先需要评估针对该病症进行干预措施的随机对照试验的可行性。我们旨在共同开展一项针对支持长期新冠患者的非药物干预措施的可行性研究。
与患者及其他利益相关者举办了一场关于研究优先级的共识研讨会。随后与一组患者合作伙伴共同开展了可行性试验,包括研究设计、干预措施选择以及传播策略制定。
23名利益相关者参加了共识研讨会,其中包括6名患者。研讨会达成的共识是开发一个专注于测试不同节奏调整干预措施和资源的临床试验平台。在共同开展可行性试验过程中,患者合作伙伴选择了三种节奏调整资源进行评估(视频、移动应用程序和书籍),并共同设计了可行性研究流程、研究材料,还对数字试验平台进行了可用性测试。
总之,本文报告了用于共同开展针对长期新冠的节奏调整干预措施可行性研究的原则和流程。共同开展研究是有效的,并对研究的重要方面产生了影响。