Influenza vaccination in patients with acute heart failure (PANDA II): study protocol for a hospital-based, parallel-group, cluster randomized controlled trial in China

Bibliographic Details
Title: Influenza vaccination in patients with acute heart failure (PANDA II): study protocol for a hospital-based, parallel-group, cluster randomized controlled trial in China
Authors: Yiqun Zhang, Rong Liu, Yangyang Zhao, Zhiyan Wang, Chi Wang, Qiang Li, Dorothy Han, Craig S. Anderson, Xin Du, Jianzeng Dong
Source: Trials, Vol 25, Iss 1, Pp 1-10 (2024)
Publisher Information: BMC, 2024.
Publication Year: 2024
Collection: LCC:Medicine (General)
Subject Terms: Influenza vaccine, Heart failure, Cluster randomized trial, Medicine (General), R5-920
More Details: Abstract Background Influenza vaccination confers broad benefits in the elderly and certain high-risk populations, but its effectiveness in patients with acute heart failure (HF) is uncertain. Rates of influenza vaccination are low in China due to poor awareness, cultural misunderstandings, and cost. Aims To determine the effectiveness of influenza vaccination in patients with acute HF admitted to hospitals in China. Methods The second Population Assessment of Influenza and Disease Activity (PANDA II) study is a two-arm, parallel-group, county-level hospital-based, cluster randomized controlled trial to determine the benefits and risks of full access to routine free influenza vaccination before hospital discharge, compared to routine limited use of influenza vaccination, on the primary endpoint of death or hospital readmission. Consecutive hospitalized patients at each site are enrolled to a target of 50 participants in each autumn–winter influenza outbreak period (October to March) over 3 consecutive years to reach the required sample size. Patients are centrally followed up at 1, 3, 6, and 12 months after hospital discharge (or death if earlier). Site numbers varied across year according to predicted influenza activity and logistical reasons. Conclusions This study offers a unique chance to clarify uncertainties surrounding the effectiveness of influenza vaccination in patients with HF and to lay the groundwork for future prevention strategies. Trial registration This trial was registered with the acronym PANDA II (Population Assessment of Influenza and Disease Activity) at ChiCTR.org.cn (ChiCTR2100053264). Registered on 17 November 2021.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 1745-6215
Relation: https://doaj.org/toc/1745-6215
DOI: 10.1186/s13063-024-08452-8
Access URL: https://doaj.org/article/a979185c22dd4699b18e22339ee100a1
Accession Number: edsdoj.979185c22dd4699b18e22339ee100a1
Database: Directory of Open Access Journals
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More Details
ISSN:17456215
DOI:10.1186/s13063-024-08452-8
Published in:Trials
Language:English