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Effect of pneumococcal vaccination on quality of life in children with recurrent acute otitis media: a randomized, controlled trial.
Pediatrics. 2005 Feb; 115(2):273-9.Ped

Abstract

BACKGROUND

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.

METHODS

In a double-blind, randomized, controlled trial, 383 children 1 to 7 years old with RAOM were vaccinated 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). 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 > or =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.

CONCLUSION

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

Authors+Show Affiliations

Department of Pediatrics, Spaarne Hospital Haarlem, Haarlem, Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15687432

Citation

Brouwer, Carole N M., et al. "Effect of Pneumococcal Vaccination On Quality of Life in Children With Recurrent Acute Otitis Media: a Randomized, Controlled Trial." Pediatrics, vol. 115, no. 2, 2005, pp. 273-9.
Brouwer CN, Maillé AR, Rovers MM, et al. Effect of pneumococcal vaccination on quality of life in children with recurrent acute otitis media: a randomized, controlled trial. Pediatrics. 2005;115(2):273-9.
Brouwer, C. N., Maillé, A. R., Rovers, M. M., Veenhoven, R. H., Grobbee, D. E., Sanders, E. A., & Schilder, A. G. (2005). Effect of pneumococcal vaccination on quality of life in children with recurrent acute otitis media: a randomized, controlled trial. Pediatrics, 115(2), 273-9.
Brouwer CN, et al. Effect of Pneumococcal Vaccination On Quality of Life in Children With Recurrent Acute Otitis Media: a Randomized, Controlled Trial. Pediatrics. 2005;115(2):273-9. PubMed PMID: 15687432.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of pneumococcal vaccination on quality of life in children with recurrent acute otitis media: a randomized, controlled trial. AU - Brouwer,Carole N M, AU - Maillé,A Rianne, AU - Rovers,Maroeska M, AU - Veenhoven,Reinier H, AU - Grobbee,Diederick E, AU - Sanders,Elisabeth A M, AU - Schilder,Anne G M, PY - 2005/2/3/pubmed PY - 2005/5/6/medline PY - 2005/2/3/entrez SP - 273 EP - 9 JF - Pediatrics JO - Pediatrics VL - 115 IS - 2 N2 - BACKGROUND: 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. METHODS: In a double-blind, randomized, controlled trial, 383 children 1 to 7 years old with RAOM were vaccinated 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). 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 > or =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. CONCLUSION: Pneumococcal vaccination has no beneficial effect compared with control vaccination on either HRQoL or FHS in children 1 to 7 years old with RAOM. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/15687432/Effect_of_pneumococcal_vaccination_on_quality_of_life_in_children_with_recurrent_acute_otitis_media:_a_randomized_controlled_trial_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=15687432 DB - PRIME DP - Unbound Medicine ER -