Thombs Brett D, Adams Claire, Nassar Elsa-Lynn, Carrier Marie-Eve, Golberg Meira, Bharthi Kanika, Wurz Amanda, South Annabelle, Kwakkenbos Linda, Hoa Sabrina, Rice Danielle B, Guillot Geneviève, Lawrie-Jones Amanda, Sauvé Maureen, Bartlett Susan J, Fortune Catherine, Gietzen Amy, Gottesman Karen, Hudson Marie, Hummers Laura K, Malcarne Vanessa L, Mayes Maureen D, Richard Michelle, Stempel James, Wojeck Robyn K, Blagrave Kathleen, Boruff Jill T, Cook Vanessa, Culos-Reed Nicole, Fröbert Ole, Gillies Katie, Granikov Vera, Hemkens Lars G, Jimenez Elizabeth Yakes, Kocher Agnes, Leite Catarina, Lim Mathew A W T, Maltez Nancy, Michalski John, Mieszczak Tracy, Ndosi Mwidimi, Pope Janet, Rannou François, Rozee Ken, Straus Sharon E, Sydes Matthew R, Thabane Lehana, Varga John, Yap Tami, Zwarenstein Merrick, Mouthon Luc, Benedetti Andrea
Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, QC, H4.83H3 T 1E2, Canada.
Department of Psychiatry, McGill University, Montreal, QC, Canada.
Trials. 2025 May 8;26(1):149. doi: 10.1186/s13063-025-08846-2.
Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people. We will conduct the Scleroderma Patient-centered Intervention Network-Communicating Latest Evidence and Results (SPIN-CLEAR) trial series via the multi-national SPIN Cohort to compare tool effectiveness. Primary objectives of each RCT will be to compare tools based on (1) information completeness, (2) understandability, and (3) ease of use. We will additionally evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, outcomes by participant characteristics (gender, age, race or ethnicity, country, language, education level, health literacy).
An advisory team of people with systemic sclerosis (SSc, also known as scleroderma) participated in developing research questions, selecting outcomes, and designing the series of parallel-arm RCTs that will each compare two or more tools or tool variations to a plain-language summary comparator; the common comparator will facilitate across-trial comparisons. In each RCT, people with SSc and researchers will select a recent SSc research study to disseminate. Tools will be developed by experienced tool developers and people with SSc. SPIN Cohort participants (current N eligible = 1522 from 50 SPIN sites in Australia, Canada, France, UK, USA) and additional participants recruited via social media and patient organization partners who consent to participate will be randomized to a dissemination tool or plain-language summary comparator and complete outcomes. Analyses will be intent-to-treat and use linear regression models.
Each trial in the planned series of trials will build upon knowledge from previous trials. Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience.
ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).
研究结果往往未传达给研究参与者或其他有相关实际经验的人。有效地传达研究结果将有助于研究参与者理解他们对研究的贡献，并可能提高对研究的信任以及参与研究的可能性。然而，很少有随机对照试验（RCT）比较过研究传播工具的有效性，并且尚不清楚哪些工具对不同的人效果最佳。我们将通过多国硬皮病患者中心干预网络传播最新证据和结果（SPIN-CLEAR）试验系列，利用多国硬皮病队列比较工具的有效性。每个RCT的主要目标将是基于以下方面比较工具：（1）信息完整性，（2）可理解性，以及（3）易用性。我们还将评估对所传播研究关键方面的理解；参与者未来参与类似研究的可能性；以及对于所有主要和次要结果，按参与者特征（性别、年龄、种族或民族、国家、语言、教育水平、健康素养）划分的结果。
一个系统性硬化症（SSc，也称为硬皮病）患者咨询小组参与了研究问题的制定、结果的选择以及平行组RCT系列的设计，每个RCT将比较两种或更多工具或工具变体与一个通俗易懂的总结对照；通用对照将便于进行跨试验比较。在每个RCT中，SSc患者和研究人员将选择一项近期的SSc研究进行传播。工具将由经验丰富的工具开发者和SSc患者共同开发。硬皮病队列参与者（目前来自澳大利亚、加拿大、法国、英国、美国50个硬皮病队列研究点的符合条件的N = 1522人）以及通过社交媒体和同意参与的患者组织合作伙伴招募的其他参与者将被随机分配到一种传播工具或通俗易懂的总结对照，并完成相关结果评估。分析将采用意向性分析，并使用线性回归模型。
计划中的一系列试验中的每项试验都将基于先前试验的知识。研究结果将为如何最好地向研究参与者和其他有相关实际经验的人传播结果提供证据基础。
ClinicalTrials.gov NCT06373263。于2024年4月17日注册（系列中的首次试验）。
