Treanor 1992.
Methods | Duration: 3 years Withdrawals: 8; 7 from intranasal group; deaths due to unrelated causes, discharges from institutions Follow‐up schedule: days 1 to 3 after each vaccination for adverse reactions and nasal sheddings; then daily staff nursing reports were used |
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Participants | Setting: 1987‐90, 3 large nursing homes in Rochester, NY, USA; St Ann's Home, St John's Home and Monroe Community Hospital Number: 523; 345 participant years in the intranasal group and 346 participant years in the control Characteristics: older adults; Mean age of 84.2 years. 32% had cardiac or pulmonary conditions; 75% female Baseline characteristics: Relatively well matched for disabilities, age, sex ratios. Mean age in the vaccine group was 84.1 years with 26% of participants randomised to this group suffering either a cardiac or pulmonary condition; 4% of the vaccine group had both a cardiac and pulmonary condition . Mean age in the placebo group was 83.8 years with 23% of participants in this group suffering either a cardiac or pulmonary condition; 2%of participants in this group had both a cardiac and pulmonary condition Comorbidities: only details of cardiovascular and pulmonary complications Diagnostic criteria: none; all residents at these institutions were invited Exclusion criteria:
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Interventions | Vaccination type:
Control:
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Outcomes | Early: days 1 to 3 post vaccination; adverse effects Late: years 1, 2, 3: serum antibody responses measured and occurrence of respiratory and flu‐like illnesses were measured to evaluate the efficacy of adding live intranasal vaccination to the inactivated type |
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Notes | Not specifically people with COPD | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient details on randomisation sequence provided. Re‐randomisation occurred every year |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to make determination |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient detail provided, although it is stated that this study was double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | See above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A low number of dropouts reported per year, evenly across groups. Independent analysis each study year |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make determination |
Other bias | Unclear risk | Insufficient information to make determination |