Effect of pneumococcal vaccination on quality of life in children with recurrent acute otitis media: a randomized, controlled trial

Article Outline

• Copyright

Brouwer CN, Maille AR, Rovers MM, Veenhoven RH, Grobbee DE, Sanders EA, Schilder AG. Pediatrics 2005;115:273-9.

Context Limited effectiveness of current treatment strategies for recurrent acute otitis media (RAOM) and increasing antibiotic resistance have diverted attention to prevention of AOM by vaccination. Pneumococcal vaccination for AOM seems to have only modest clinical efficacy. Thus far, the effects on health-related quality of life (HRQoL) or functional health status (FHS) have not been studied.

Objective To assess the effect of vaccination on HRQoL or FHS.

Design Double-blind, randomized, controlled trial.

Setting Pediatric outpatient departments of a general hospital and an academic hospital in the Netherlands.

Participants 383 children 1 to 7 years old with RAOM.

Interventions Vaccination with either heptavalent pneumococcal conjugate vaccine followed by pneumococcal polysaccharide vaccine (pneumococcal group, n=190) or with hepatitis A or B vaccines (control group, n=193).

Main Outcome Measures Parents completed validated Dutch versions of 8 HRQoL and FHS instruments assessing generic FHS (Rand, Functional Status Questionnaire specific, and Functional Status Questionnaire generic), otitis media–specific FHS (OM-6), otitis media–specific child HRQoL (Numerical Rating Scale for Child), family functioning (Family Functioning Questionnaire), and otitis media–specific caregiver HRQoL (Numerical Rating Scale for Caregiver). Scores were compared at baseline and at 14 and 26 months' follow-up.

Results At baseline, the average AOM incidence in the pneumococcal and control group was 5.0 (SD: 2.8) and 4.9 (SD: 2.6) episodes per year, respectively, with 38.4% and 36.8% having suffered from >6 episodes per year. AOM frequency decreased 4.4 episodes per year in both groups, with a considerable and comparable improvement in HRQoL and FHS. No substantial differences in HRQoL or FHS were found between the pneumococcal and the control group at baseline or at 14 or 26 months' follow-up.

Conclusions Pneumococcal vaccination has no beneficial effect compared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM.

Comment Immunization with pneumococcal conjugate vaccine (PCV) in infancy has proven highly effective in preventing invasive disease, but has proven only mildly effective in preventing acute otitis media (AOM). The authors conducted a randomized, controlled trial of pneumococcal vaccination in children aged 1-7 years with known history of recurrent AOM to investigate clinical endpoints as well as quality-of-life (QOL) measures (functional health status; health-related QOL). Intervention and control children experienced similar declines in AOM rate during the study period, and QOL measures improved concomitantly (without significant differences between intervention and control).

Tracking QOL outcomes is common in instances where differences in clinical endpoints have proved elusive. The authors used parents as proxies for children's QOL measures, who are widely regarded as the most appropriate proxies but are not always used (some investigators use utilities estimated by physicians or other third parties). The problem with QOL measures in this trial, however, is that recurrent AOM occurred too infrequently to expect substantial variation in QOL in otherwise healthy children. QOL generally works better as a measure in individuals with chronic, not intermittent, conditions.

The negative findings of this trial suggest that continuing support for pneumococcal conjugate vaccination should be based on documented declines in rates of invasive pneumococcal disease in children and adults as well, rather than on effects related to otitis media.