bb Galeotti 2013.
Methods | Case‐control study testing the association between influenza vaccination and Guillain‐Barré syndrome | |
Participants | Cases (n = 140): adults with Guillain‐Barré syndrome defined according to the Brighton Collaboration definition (levels 1 to 3) recruited at 121 neurological centres in 7 Italian regions and having symptoms onset between 1 October 2010 and 15 May 2011. Controls (n = 308): were selected from among patients admitted to the emergency department of the same hospital as the cases for acute conditions unrelated to chronic diseases (e.g. trauma). Each control was individually matched to a case for admission date (i.e. the same date as the case or up to 30 days afterwards), sex, age (± 5 years), and region of residence. |
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Interventions | Exposure to influenza vaccination (date and brand of vaccine) was verified by contacting patients’ general practitioners by telephone. A neurologist (FG) closely verified and queried data quality. | |
Outcomes | Guillain‐Barré syndrome | |
Notes | The authors also performed data analysis with a controlled case series design, considering the 6 weeks following exposure as the risk time. Government funded |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
CC ‐ case selection All outcomes | Low risk | Consecutive series of cases |
CC ‐ control selection All outcomes | Low risk | Hospital control |
CC ‐ comparability All outcomes | Unclear risk | Matched analysis only for sex, age, region, admission date |
CC ‐ exposure All outcomes | Unclear risk | Unclear if interviewers were blinded to case‐control status |
Summary assessment | Unclear risk | Unclear risk of bias |