Devane Declan, Briel Matthias, Bhagani Sanjay, Boesten Nadine, Buchholz Stephanie, De Luca Estefania Callejas, Guedj Jeremie, Koryakina Anastasia, Kothari Kavita, Lacombe Karine, Mallon Patrick W, Massonnaud Clément R, O'Dwyer Joanne, Olsen Inge Christoffer, Saif-Ur-Rahman K M, Schwenke Johannes M, Thomas James, Yazdanpanah Yazdan, Zgaga Lina, Louw Julia
Center for Health Research Methods, School of Nursing and Midwifery, University of Galway, Galway, Ireland.
Health Research Board-Trials Methodology Research Network (HRB-TMRN), University of Galway, Galway, Ireland.
PLoS One. 2025 Sep 9;20(9):e0330288. doi: 10.1371/journal.pone.0330288. eCollection 2025.
Acute viral respiratory infections (AVRIs) rank among the most common causes of hospitalisation worldwide, imposing significant healthcare burdens and driving the development of pharmacological treatments. However, inconsistent outcome reporting across clinical trials limits evidence synthesis and its translation into clinical practice. A core outcome set (COS) for pharmacological treatments in hospitalised adults with AVRIs is essential to standardise trial outcomes and improve research comparability.
To develop an internationally agreed COS for pharmacological treatments in hospitalised adults ≥18 years with acute viral respiratory infections (COSAVRI) through stakeholder agreement.
This protocol follows a four-stage development process in accordance with Core Outcome Set Handbook guidelines. Stage 1 comprises a rapid scoping review of randomised controlled trials (2015-2025) to systematically catalogue patient-relevant outcomes reported in pharmacological AVRI treatment studies. Semi-automated screening and data extraction will employ machine learning and large language models, with human verification. Stage 2 involves an online Real-Time Delphi survey with international stakeholders, including healthcare professionals, researchers, patients/caregivers, and policymakers, to prioritise identified outcomes using a 9-point scale. Stage 3 consists of structured online consensus meetings utilising anonymous electronic voting to finalise the COS. Stage 4 focuses on dissemination and implementation through academic publications, conferences, and stakeholder engagement.
COSAVRI will provide a standardised minimum set of outcomes for measuring and reporting in future pharmacological trials involving hospitalised adults with AVRIs. This initiative will enhance evidence synthesis, reduce research waste, support regulatory decision-making, and improve pandemic preparedness by facilitating the rapid deployment of harmonised outcomes in trial protocols.
急性病毒性呼吸道感染（AVRIs）是全球住院治疗最常见的病因之一，带来了巨大的医疗负担并推动了药物治疗的发展。然而，临床试验中结果报告不一致限制了证据综合及其转化为临床实践。制定住院成年AVRIs患者药物治疗的核心结局集（COS）对于规范试验结局和提高研究可比性至关重要。
通过利益相关者达成共识，为18岁及以上住院急性病毒性呼吸道感染成年患者（COSAVRI）的药物治疗制定一项国际认可的COS。
本方案遵循《核心结局集手册》指南的四阶段制定过程。第1阶段包括对随机对照试验（2015 - 2025年）进行快速范围综述，以系统编目药物AVRI治疗研究中报告的与患者相关的结局。半自动筛选和数据提取将采用机器学习和大语言模型，并进行人工验证。第2阶段涉及与国际利益相关者进行在线实时德尔菲调查，包括医疗保健专业人员、研究人员、患者/护理人员和政策制定者，使用9分制对确定的结局进行优先排序。第3阶段包括利用匿名电子投票的结构化在线共识会议，以最终确定COS。第4阶段侧重于通过学术出版物、会议和利益相关者参与进行传播和实施。
COSAVRI将为未来涉及住院成年AVRIs患者的药物试验提供一套标准化的最小结局集，用于测量和报告。该倡议将加强证据综合，减少研究浪费，支持监管决策，并通过促进在试验方案中快速部署统一结局来改善大流行防范能力。
