| Methods |
Single‐blind prospective study carried out during the 2003 to 2004 season in children from 8 day‐care nurseries around Ankara, Turkey. The study aim was to assess the effectiveness of TIV in preventing AOM and OME. Randomisation is not mentioned, comparator is do nothing, and denominators are uneven. The single‐blind design refers to the ear, nose, and throat (ENT) tympanomtrist. The influenza period was defined as 15 December 2003 to 31 January 2004 on the basis of influenza and RSV isolates in the community. 3 other influenza periods are also described. |
| Participants |
135 healthy children aged 6 to 60 months in day care. 16 children were excluded from the study (3 because of tympanostomy tubes, 11 because they could not complete the minimum of 3 follow‐up visits, and 3 due to failure to have the second vaccination). The authors report their analysis for 119 children (61 vaccinated and 58 UV, mean age 43 months). 22 children were aged less than 2 years. The arms were similar for breastfeeding, gender, dummy use, history of frequent URTIs, antibiotic use, allergy, asthma, previous OM, and passive smoking. |
| Interventions |
TIV containing A/Moscow/10/99 (H3N2), A/New Caledonia/20/99 (H1N1), or B/Hong Kong/330/2001 in 2 doses (Fluarix or Vaxigrip). No mention is made of the circulating strains, although the content of the vaccine was WHO recommended. |
| Outcomes |
Effectiveness
OM diagnosed at tympanometry and otoscopy by a blinded ENT surgeon: normal ear (no abnormality and type A and C1 curves on tympanometry), AOM (hyperaemia, opacity, bulging or immobility of the TM together with any of the following: fever, earache, irritability, and vomiting), OME (retraction, opacity, bulging or immobility of the TM without clinical signs and with C2 or B tympanometry curve), OM (any episode of either AOM or OME) |
| Funding Source |
Unclear |
| Notes |
The authors conclude that "The frequencies of AOM, OME and total otitis media episodes in vaccinated children were 2.3%, 22.8% and 25.2%, respectively and these frequencies were 5.2%, 31.1% and 36.3% in the UV group. The difference was statistically significant (P < 0.01). This difference was especially prominent in the influenza season (P < 0.05). Influenza vaccine is effective in reducing AOM and OME episodes in 6‐ to 60‐month‐old day care children, especially during influenza season". The message is mixed, as the authors point out that the relatively low effectiveness of TIV makes mass vaccination to prevent an OM (a syndrome) impractical. Report was not very detailed, likely to be a cohort or CCT. Confusingly reported outcome data in Table 2. Numerators were extracted from the text. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| PCS/RCS‐Selection Exposed cohort |
Unclear risk |
Insufficient description |
| PCS/RCS‐Selection Non Exposed cohort |
Unclear risk |
Insufficient description |
| PCS/RCS‐Comparability |
High risk |
Possibly confounding by indication |
| PCS/RCS‐Assessment of Oucome |
Unclear risk |
Secure record |
| Summary assessments |
High risk |
Possibly confounding by indication |
