Incorporating Real-time Influenza Detection Into the Test-negative Design for Estimating Influenza Vaccine Effectiveness: The Real-time Test-negative Design (rtTND)

被引：0

作者：

Feldstein, Leora R. ^{[1
]}

Self, Wesley H. ^{[2
]}

Ferdinands, Jill M. ^{[1
]}

Randolph, Adrienne G. ^{[3
,4
,5
]}

Aboodi, Michael ^{[6
]}

Baughman, Adrienne H. ^{[2
]}

Brown, Samuel M. ^{[7
,8
]}

Exline, Matthew C. ^{[9
]}

Files, D. Clark ^{[10
]}

Gibbs, Kevin ^{[10
]}

Ginde, Adit A. ^{[11
]}

Gong, Michelle N. ^{[12
]}

Grijalva, Carlos G. ^{[2
]}

Halasa, Natasha ^{[13
]}

Khan, Akram ^{[14
]}

Lindsell, Christopher J. ^{[2
]}

Newhams, Margaret ^{[3
,4
,5
]}

Peltan, Ithan D. ^{[7
,8
]}

Prekker, Matthew E. ^{[15
,16
,17
]}

Rice, Todd W. ^{[2
]}

Shapiro, Nathan, I ^{[18
]}

Steingrub, Jay ^{[19
]}

Talbot, H. Keipp ^{[2
]}

Halloran, M. Elizabeth ^{[20
,21
]}

Patel, Manish ^{[1
]}

机构：

[1] Ctr Dis Control & Prevent, Influenza Div, Atlanta, GA 30329 USA

[2] Vanderbilt Univ, Med Ctr, Nashville, TN USA

[3] Boston Childrens Hosp, Dept Anesthesiol Crit Care & Pain Med, Boston, MA USA

[4] Harvard Med Sch, Dept Anesthesia, Boston, MA USA

[5] Harvard Med Sch, Dept Pediat, Boston, MA USA

[6] Albert Einstein Coll Med, Div Crit Care Med, Bronx, NY 10467 USA

[7] Intermt Med Ctr, Dept Med, Div Pulm Crit Care, Murray, UT USA

[8] Univ Utah, Murray, UT USA

[9] Ohio State Univ, Coll Nursing, Columbus, OH 43210 USA

[10] Wake Forest Sch Med, Pulm Crit Care Allergy & Immunol Dis, Winston Salem, NC 27101 USA

[11] Univ Colorado, Dept Emergency Med, Sch Med, Aurora, CO USA

[12] Albert Einstein Coll Med, Dept Med, Dept Epidemiol & Populat Hlth, Div Crit Care Med,Div Pulm Med,Montefiore Healthc, Bronx, NY USA

[13] Vanderbilt Univ, Med Ctr, Dept Pediat, Nashville, TN 37232 USA

[14] Oregon Hlth & Sci Univ, Dept Pulm & Crit Care, Portland, OR 97201 USA

[15] Hennepin Cty Med Ctr, Dept Med, Div Pulm & Crit Care, Minneapolis, MN USA

[16] Hennepin Cty Med Ctr, Dept Emergency Med, Minneapolis, MN 55415 USA

[17] Univ Minnesota, Sch Med, Minneapolis, MN 55455 USA

[18] Beth Israel Deaconess Med Ctr, Dept Emergency Med, Boston, MA USA

[19] Baystate Med Ctr, Div Crit Care Pulm Med, Springfield, MA USA

[20] Univ Washington, Dept Biostat, Seattle, WA 98195 USA

[21] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, Seattle, WA 98104 USA

来源：

CLINICAL INFECTIOUS DISEASES | 2021年 / 72卷 / 09期

基金：

美国国家卫生研究院;

关键词：

influenza; vaccine effectiveness; test-negative design; real-time test-negative design; clinical testing; UNITED-STATES; HOSPITALIZATIONS;

D O I：

10.1093/cid/ciaa1453

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

With rapid and accurate molecular influenza testing now widely available in clinical settings, influenza vaccine effectiveness (VE) studies can prospectively select participants for enrollment based on real-time results rather than enrolling all eligible patients regardless of influenza status, as in the traditional test-negative design (TND). Thus, we explore advantages and disadvantages of modifying the TND for estimating VE by using real-time, clinically available viral testing results paired with acute respiratory infection eligibility criteria for identifying influenza cases and test-negative controls prior to enrollment. This modification, which we have called the real-time test-negative design (rtTND), has the potential to improve influenza VE studies by optimizing the case-to-test-negative control ratio, more accurately classifying influenza status, improving study efficiency, reducing study cost, and increasing study power to adequately estimate VE. Important considerations for limiting biases in the rtTND include the need for comprehensive clinical influenza testing at study sites and accurate influenza tests.

引用

页码：1669 / 1675

页数：7

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