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. 2013 Jan 31;2013(1):CD000422. doi: 10.1002/14651858.CD000422.pub3

Sims 1988.

Methods Matched case‐control
Participants Immunocompetent older adults aged 55 years and above
Interventions Cases (n = 122) IPD cases from Jan 1980 to July 1986 
 Controls (n = 244) consecutive hospital admissions 
 Vaccine valency not specified
Outcomes B1. IPD (immunocompetent and immunocompetent elderly)
Notes Matched 2:1 according to hospital, admission date, comorbid conditions (number and severity) 
 Sample size based on vaccine efficacy at 50%, power 0.80, error 0.05 (one tailed) and 20% vaccination coverage in controls requires 164 cases and 328 controls 
 Controls excluded if they had radiographically proven pneumonia during the study period 
 Vaccinated definition (time since dose) not specified
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Non‐random study
Allocation concealment (selection bias) Low risk Study investigators determining participant inclusion unlikely to be aware of vaccination status
Confounding 
 All outcomes Low risk 3/6 important confounding factors covered, however, critical factors covered
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk NA
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Due to the specificity of outcome
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not described
Selective reporting (reporting bias) Low risk Limited extent to which analysis could have been manipulated to bias the findings