Correction of vaccine effectiveness derived from test-negative case–control studies
Abstract Background Determining the vaccine effectiveness (VE) is an important part of studying every new vaccine. Test-negative case–control (TNCC) studies have recently been used to determine the VE. However, the estimated VE derived from a TNCC design depends on the test sensitivity and specifici...
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| Format: | Article |
| Language: | English |
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BMC
2023-06-01
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| Series: | BMC Medical Research Methodology |
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| Online Access: | https://doi.org/10.1186/s12874-023-01962-0 |
| _version_ | 1797806662944292864 |
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| author | Farrokh Habibzadeh |
| author_facet | Farrokh Habibzadeh |
| author_sort | Farrokh Habibzadeh |
| collection | DOAJ |
| description | Abstract Background Determining the vaccine effectiveness (VE) is an important part of studying every new vaccine. Test-negative case–control (TNCC) studies have recently been used to determine the VE. However, the estimated VE derived from a TNCC design depends on the test sensitivity and specificity. Herein, a method for correction of the value of VE derived from a TNCC study is presented. Methods An analytical method is presented to compute the corrected VE based on the sensitivity and specificity of the diagnostic test utilized. To show the application of the method proposed, a hypothetical TNCC study is presented. In this in silico study, 100 000 individuals referring to a healthcare system for COVID-19-like illness were tested with diagnostic tests with sensitivities of 0.6, 0.8, and 1.0, and specificities ranging from 0.85 to 1.00. A vaccination coverage of 60%, an attack rate of 0.05 for COVID-19 in unvaccinated group, and a true VE of 0.70, were assumed. In this simulation, a COVID-19-like illness with an attack rate of 0.30 could also affect all the studied population regardless of their vaccination status. Results The observed VE ranged from 0.11 (computed for a test sensitivity of 0.60 and specificity of 0.85) to 0.71 (computed for a test sensitivity and specificity of 1.0). The mean computed corrected VE derived from the proposed method was 0.71 (the standard deviation of 0.02). Conclusions The observed VE derived from TNCC studies can be corrected easily. An acceptable estimate for VE can be computed regardless of the diagnostic test sensitivity and specificity used in the study. |
| first_indexed | 2024-03-13T06:10:42Z |
| format | Article |
| id | doaj.art-aebe36b2ea23421ca8b24e50b4611966 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-03-13T06:10:42Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-aebe36b2ea23421ca8b24e50b46119662023-06-11T11:17:30ZengBMCBMC Medical Research Methodology1471-22882023-06-012311610.1186/s12874-023-01962-0Correction of vaccine effectiveness derived from test-negative case–control studiesFarrokh Habibzadeh0Global Virus Network, Middle East RegionAbstract Background Determining the vaccine effectiveness (VE) is an important part of studying every new vaccine. Test-negative case–control (TNCC) studies have recently been used to determine the VE. However, the estimated VE derived from a TNCC design depends on the test sensitivity and specificity. Herein, a method for correction of the value of VE derived from a TNCC study is presented. Methods An analytical method is presented to compute the corrected VE based on the sensitivity and specificity of the diagnostic test utilized. To show the application of the method proposed, a hypothetical TNCC study is presented. In this in silico study, 100 000 individuals referring to a healthcare system for COVID-19-like illness were tested with diagnostic tests with sensitivities of 0.6, 0.8, and 1.0, and specificities ranging from 0.85 to 1.00. A vaccination coverage of 60%, an attack rate of 0.05 for COVID-19 in unvaccinated group, and a true VE of 0.70, were assumed. In this simulation, a COVID-19-like illness with an attack rate of 0.30 could also affect all the studied population regardless of their vaccination status. Results The observed VE ranged from 0.11 (computed for a test sensitivity of 0.60 and specificity of 0.85) to 0.71 (computed for a test sensitivity and specificity of 1.0). The mean computed corrected VE derived from the proposed method was 0.71 (the standard deviation of 0.02). Conclusions The observed VE derived from TNCC studies can be corrected easily. An acceptable estimate for VE can be computed regardless of the diagnostic test sensitivity and specificity used in the study.https://doi.org/10.1186/s12874-023-01962-0VaccinesCase–control studiesDiagnostic testsSensitivity and specificitySARS-CoV-2 |
| spellingShingle | Farrokh Habibzadeh Correction of vaccine effectiveness derived from test-negative case–control studies BMC Medical Research Methodology Vaccines Case–control studies Diagnostic tests Sensitivity and specificity SARS-CoV-2 |
| title | Correction of vaccine effectiveness derived from test-negative case–control studies |
| title_full | Correction of vaccine effectiveness derived from test-negative case–control studies |
| title_fullStr | Correction of vaccine effectiveness derived from test-negative case–control studies |
| title_full_unstemmed | Correction of vaccine effectiveness derived from test-negative case–control studies |
| title_short | Correction of vaccine effectiveness derived from test-negative case–control studies |
| title_sort | correction of vaccine effectiveness derived from test negative case control studies |
| topic | Vaccines Case–control studies Diagnostic tests Sensitivity and specificity SARS-CoV-2 |
| url | https://doi.org/10.1186/s12874-023-01962-0 |
| work_keys_str_mv | AT farrokhhabibzadeh correctionofvaccineeffectivenessderivedfromtestnegativecasecontrolstudies |