调整 COVID-19 研究基础设施以捕捉 2022/23 年冬季英国医护人员中的流感和 RSV 以及 SARS-CoV-2 病毒:SIREN 冬季压力试点研究评估

Katie Munro, Sophie Russell, Sarah Foulkes, Jonathan Broad, Dominic Sparkes, Ana Atti, Jasmin Islam, Susan Hopkins, Victoria Hall, SIREN study group
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摘要

研究背景2022 年,随着初冬呼吸道病毒的大量流行,监测 SARS-CoV-2 的前瞻性医护人员队列研究 SIREN 开展了一项试点研究,引入了针对 SARS-CoV-2、甲型/乙型流感和 RSV 的多重 PCR 检测,以调查冬季压力。试验采用了三种方法:(A) 现场拭抹,当地实验室检测;(B) 现场拭抹,英国卫生与健康服务协会委托实验室检测;(C) 邮寄拭抹,英国卫生与健康服务协会委托实验室检测。在此,我们比较了与招募、检测覆盖率、参与者接受度和英国人畜健康协会 SIREN 研究团队反馈有关的途径:我们使用质量保证和研究忠实性指标(参与者招募和保留;多重 PCR 检测时间和覆盖范围)、改编的 NIHR "研究参与者 "反馈问卷以及对英国卫生与健康协会 SIREN 研究团队研讨会的主题分析进行了混合方法评估:共招募了 7,774 名参与者,实现了招募目标(N=7,500)。39 个地点参与了该子研究(4289 名参与者)。有 33 人使用了路径 A,6 人使用了路径 B。有 3485 名参与者参加了路径 C(占受邀者的 27.8%)。每名参与者的检测次数中位数在不同途径中相似(6;4;5)。然而,使用当地实验室的医疗点在改用多重检测的日期(2022 年 11 月 28 日至 2023 年 3 月 16 日)上存在很大差异。因此,使用英国卫生与健康协会委托实验室的路径的流感和 RSV 检测覆盖率更高(100.0% 对当地实验室的 45.6%)。1,204/7,774(15.5%)名参与者完成了反馈调查。所有途径都被参与者接受;98.9%的邮寄参与者和 97.5%的现场参与者 "会考虑再次参加":结论:将 SARS-CoV-2 PCR 检测过渡到包括流感和 RSV 的检测,要在多个地点迅速完成具有挑战性。事实证明,邮寄检测途径更为灵活,而英国卫生与健康协会委托实验室进行的检测比当地实验室检测提供了更全面的数据收集。该子研究表明,邮寄方案是有效的,可根据进度进行调整,并为参与者所接受。
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Adapting COVID-19 research infrastructure to capture influenza and RSV alongside SARS-CoV-2 in UK healthcare workers winter 2022/23: Evaluation of the SIREN Winter Pressures pilot study
Background: In 2022, with high early winter respiratory virus circulation, SIREN, a prospective healthcare worker cohort study monitoring SARS-CoV-2, ran a pilot study introducing multiplex PCR testing for SARS-CoV-2, influenza A/B, and RSV to investigate winter pressures. Three pathways were trialled: (A) on-site swabbing with local laboratory testing, (B) on-site swabbing with UKHSA-commissioned laboratory testing, and (C) postal swabbing with UKHSA-commissioned laboratory testing. Here, we compare pathways in relation to recruitment, testing coverage, participant acceptability, and UKHSA SIREN research team feedback. Methods: We conducted a mixed methods evaluation using metrics of quality assurance and study fidelity (participant recruitment and retention; multiplex PCR testing timing and coverage), an adapted NIHR ‘participant in research’ feedback questionnaire, and thematic analysis of a UKHSA SIREN research team workshop. Results: With 7,774 participants recruited, target recruitment (N=7,500) was achieved. Thirty-nine sites took part in the sub-study (4,289 participants). Thirty-three used pathway A, and six used pathway B. 3,485 participants enrolled to pathway C (27.8% of invitees). The median number of tests per participant was similar across pathways (6; 4; 5). However, sites using local laboratories showed a wide variation in the date they switched to multiplex testing (28th November 2022 to 16th March 2023). Consequently, influenza and RSV testing coverage was higher for pathways using UKHSA-commissioned laboratories (100.0% vs 45.6% at local laboratories). 1,204/7,774 (15.5%) participants completed the feedback survey. All pathways were acceptable to participants; 98.9% of postal and 97.5% of site-based participants ‘would consider taking part again’. Conclusion: Transitioning SARS-CoV-2 PCR testing to include influenza and RSV was challenging to achieve rapidly across multiple sites. The postal testing pathway proved more agile, and UKHSA-commissioned laboratory testing provided more comprehensive data collection than local laboratory testing. This sub-study indicates that postal protocols are effective, adaptable at pace, and acceptable to participants.
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