在老年人中使用检测阴性设计比较纳入严重急性呼吸道感染患者的两种病例定义对流感与COVID-19疫苗有效性研究的影响：VEBIS医院网络，七个欧洲国家，2023/24年度
Comparing two case definitions for including severe acute respiratory infection patients in influenza and COVID-19 vaccine effectiveness studies among older adults using the test-negative design: VEBIS hospital network, seven European countries, 2023/24.
文献信息
| PMID | 42869874 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Diogo F P Marques |
| 作者单位 | Epiconcept, Paris, France; NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, NOVA University Lisbon, Lisbon, Portugal. Electronic address: d.marques@epiconcept.fr. |
| 期刊 | Vaccine |
| SCI 分区 | Q2 |
| IF | 3.5 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
引言： 在基于医院的检测阴性设计（TND）疫苗有效性（VE）研究中，常使用两种严重急性呼吸道感染（SARI）病例定义（CD）。SARI-CD1要求至少1种症状（咳嗽、发热、气短、嗅觉丧失、味觉丧失或味觉障碍）；SARI-CD2要求同时具备发热和咳嗽。利用VEBIS医院网络2023/24年度季末数据，我们比较了这些CD对欧洲流感与COVID-19 VE估计值的影响。
方法： 采用TND，我们将分析限制在七个使用SARI-CD1招募患者的国家；我们创建了同时满足SARI-CD2的SARI患者子集。病例为甲型流感A(H1N1)pdm09、A(H3N2)或SARS-CoV-2的RT-PCR阳性；对照为流感或SARS-CoV-2 RT-PCR阴性。我们使用logistic回归估计≥65岁患者的VE，并校正国家、发病日期、年龄、性别和慢性疾病。我们估计总体VE、按年龄组（65-79岁、≥80岁）以及按接种后时间（14-59天、60-119天、≥120天）的VE。绝对VE差异≥10%被认为具有相关性。
结果： 两种CD之间的患者特征和结局相似。SARI-CD1的接种病例略多，两种CD之间对照差异很小。对于流感，SARI-CD1与SARI-CD2之间的绝对VE差异为：甲型流感A(H1N1)pdm09为10%（34% vs 44%），≥80岁人群为19%（21% vs 40%），接种后60-119天为18%（4% vs 22%）。对于SARS-CoV-2，绝对VE差异为：总体11%（29% vs 40%），≥80岁人群11%（33% vs 44%），60-119天12%（34% vs 46%）。所有其他绝对VE差异均<10%。
结论： 对于甲型流感A(H3N2)、65-79岁成人以及接种后14-60天，VE相似。我们观察到SARI-CD2对甲型流感A(H1N1)pdm09和SARS-CoV-2的VE更高的信号，尤其是在≥80岁成人和接种后≥60天人群中，尽管95%置信区间重叠。这些信号提示CD可能导致VE变异性，VE研究应明确说明所使用的CD。
英文摘要
INTRODUCTION: Two severe acute respiratory infection (SARI) case definitions (CDs) are often used in test-negative design (TND) hospital-based vaccine effectiveness (VE) studies. SARI-CD1 requires ≥1 symptom (cough, fever, shortness of breath, anosmia, ageusia, or dysgeusia); SARI-CD2 requires both fever and cough. Using VEBIS hospital network end-of-season 2023/24 data, we compared the effect of these CDs on influenza and COVID-19 VE estimates in Europe.
METHODS: Using the TND, we restricted analysis to seven countries recruiting patients using SARI-CD1; we created a subset of SARI patients also meeting SARI-CD2. Cases were RT-PCR-positive for influenza A(H1N1)pdm09, A(H3N2), or SARS-CoV-2; controls were influenza or SARS-CoV-2 RT-PCR-negative. We estimated VE among patients ≥65 years using logistic regression adjusted for country, onset date, age, sex, and chronic conditions. We estimated VE overall, by age group (65-79, ≥80 years) and time since vaccination (14-59, 60-119, ≥120 days). Absolute VE differences ≥10% were considered relevant.
RESULTS: Patient characteristics and outcomes were similar across CDs. SARI-CD1 had slightly more vaccinated cases, with little difference in controls between the two CDs. For influenza, the absolute VE difference between SARI-CD1 and SARI-CD2 was 10% for influenza A(H1N1)pdm09 (34% vs 44%), 19% among those aged ≥80 years (21% vs 40%) and 18% at 60-119 days post-vaccination (4% vs 22%). For SARS-CoV-2, absolute VE differences were 11% overall (29% vs 40%), 11% among ≥80 years (33% vs 44%), and 12% at 60-119 days (34% vs 46%). All other absolute VE differences were < 10%.
CONCLUSIONS: VE was similar for influenza A(H3N2), adults 65-79 years and 14-60 days post-vaccination. We observed signals of higher VE with SARI-CD2 for influenza A(H1N1)pdm09 and SARS-CoV-2, particularly among adults ≥80 years and ≥ 60 days post-vaccination, although 95% CIs overlapped. These signals suggest CDs may contribute to VE variability and VE studies should clearly indicate CDs used.