Vila‐Corcoles 2006.
Methods | Prospective cohort study | |
Participants | Community‐dwelling older adults aged 65 years and above, assigned to primary healthcare centres | |
Interventions | 11,241 members of the cohort. Study period from January 2002 until April 2005 23‐valent PPV | |
Outcomes | B1. IPD (immunocompetent and immunocompetent elderly) B2. Vaccine‐type IPD (immunocompetent and immunocompetent elderly) | |
Notes | Cohort observed until study completion or first occurrence of each outcome (maximum 3 years, 4 months) IPD incidence of study participants 0.64/1000 person‐years Model adjusted for age, sex, number of outpatient visits, history of hospitalisation for pneumonia in previous 24 months, influenza vaccination status, underlying medical conditions, current smoking status and immunocompromised status. Vaccination was a time variable factor; considered vaccinated from 14 days following administration Results for IPD by vaccine‐type only serotypes provided by personal communication with first author | |
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 | Investigators reviewing clinical data unaware of vaccination status |
Confounding All outcomes | Low risk | 6/6 important confounding factors considered |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | NA |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Due to 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 |
CAP: community‐acquired pneumonia FEV: forced expiratory volume FEV1: forced expiratory volume in first second HMO: health maintenance organisation IPD: invasive pneumococcal disease NA: not applicable PPV: pneumococcal polysaccharide vaccine RCT: randomised controlled trial