Case-control vaccine effectiveness studies: Data collection, analysis and reporting results
Year: 2017
Type: review
Abstract: The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection, analysis and presentation of the data in order to best inform evidence-based vaccine policies.
Source: Vaccine
Authors: Jennifer R. Verani, Abdullah H. Baqui, Claire V. Broome, Thomas Cherian, Cheryl Cohen, Jennifer L. Farrar, Daniel R. Feikin, Michelle J. Groome, Rana A. Hajjeh, Hope L. Johnson, Shabir A. Madhi, Kim Mulholland, Katherine L. O'Brien, Umesh D. Parashar, Manish M. Patel, Laura C. Rodrigues, Mathuram Santosham, J. Anthony Scott, Peter G. Smith, Halvor Sommerfelt, Jacqueline E. Tate, J. Chris Victor, Cynthia G. Whitney, Anita K. Zaidi, Elizabeth R. Zell
Institutions: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Johns Hopkins University, Emory University, World Health Organization, National Institute for Communicable Diseases, University of the Witwatersrand, Gavi, Royal Children's Hospital, London School of Hygiene & Tropical Medicine, Murdoch Children's Research Institute, Kenya Medical Research Institute, KEMRI-Wellcome Trust Research Programme, Norwegian Institute of Public Health, University of Bergen, Aga Khan University, Program for Appropriate Technology in Health
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $3,620
Awards: Population impact of conjugate vaccine on pneumococcal transmission and disease in Kenya., G7888718989, Core Support for the East African Major Overseas Programme, RESEARCH ON THE EPIDEMIOLOGY,PREVENTION,VACCINE EFFECTIVENESS AND TREATMENT OF INFLUENZA AND OTHER RESPIRATORY VIRUSES IN SOUTH AFRICA.09
OpenAlex ID: W2606199614