Effect of propensity of seeking medical care on the bias of the estimated effectiveness of rotavirus vaccines from studies using a test-negative case-control design |
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| Institution: | 1. Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, USA;2. Department of Epidemiology, Emory University, Atlanta, GA, USA;3. Centers for Disease Control and Prevention, Atlanta, GA, USA;1. Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran;2. Research Center for Endemic Parasites of Iran, Tehran University of Medical Sciences, Tehran, Iran;3. Department of Medical Biotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran;4. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran;5. Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran;1. Orvis School of Nursing, University of Nevada-Reno, Reno, Nevada 89557, United States;2. School of Community Health Sciences, University of Nevada, Reno, Nevada 89557, United States;3. University of California, Davis, CA, United States;1. Departamento de Parasitología, Facultad de Medicina Veterinaria y Zootecnia, Universidad Nacional Autónoma de México, Av. Universidad 3000, Delegación Coyoacán, Ciudad de México C.P. 04510, Mexico;2. Departamento de inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, C.P. 04510 México, DF, Mexico;3. Departamento de Microbiología e Inmunología, Facultad de Medicina Veterinaria y Zootecnia, Universidad Nacional Autónoma de México, Av. Universidad 3000, Delegación Coyoacán, C.P. 04510 México, D.F, Mexico;4. Facultad de Medicina Veterinaria y Zootecnia, Benemérita Universidad Autónoma de Puebla, 4 Sur 304 Col. Centro, C.P. 75482, Tecamachalco, Puebla, Mexico |
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| Abstract: | BackgroundRotavirus is the leading cause of severe diarrhea among children worldwide, and vaccines can reduce morbidity and mortality by 50–98%. The test-negative control (TNC) study design is increasingly used for evaluating the effectiveness of vaccines against rotavirus and other vaccine-preventable diseases. In this study design, symptomatic patients who seek medical care are tested for the pathogen of interest. Those who test positive (negative) are classified as cases (controls).MethodsWe use a probability model to evaluate the bias of estimates of rotavirus vaccine effectiveness (VE) against rotavirus diarrhea resulting in hospitalization in the presence of possible confounding and selection biases due to differences in the propensity of seeking medical care (PSMC) between vaccinated and unvaccinated children.ResultsThe TNC-based VE estimate corrects for confounding bias when the confounder’s effects on the probabilities of rotavirus and non-rotavirus related hospitalizations are equal. If this condition is not met, then the estimated VE may be substantially biased. The bias is more severe in low-income countries, where VE is known to be lower. Under our model, differences in PSMC between vaccinated and unvaccinated children do not result in selection bias when the TNC study design is used.ConclusionsIn practice, one can expect the association of PSMC (or other potential confounders) with the probabilities of rotavirus and non-rotavirus related hospitalization to be similar, in which case the confounding effects will only result in small bias in the VE estimate from TNC studies. The results of this work, along with those of our previous paper, confirm the TNC design can be expected to provide reliable estimates of rotavirus VE in both high- and low-income countries. |
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| Keywords: | Rotavirus vaccines Test-negative design Vaccine effectiveness Confounding bias Selection bias Probability models |
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