Otitis media and the possible association with early school performance a prospective cohort study

Transcription

1 Otitis media and the possible association with early school performance a prospective cohort study Research protocol Research investigator: Vincent Fougner Supervisors: Preben Homøe Jesper Dammeyer Janni Niclasen Asbjørn Kørvel-Hanquist stud. med. Professor, overlæge, dr.med, ph.d. Lektor ph.d. Adjunkt, ph.d. assistent professor Cand.med 1

2 Table of contents: Rationale Background Research objectives Hypothesis Method Source population Exclusion criterias Exposure Outcome Power Data and analysis Ethical considerations Budget Time schedule Research investigators, supervisors and other collaborators References Rationale: Otitis media affects 60% of Danish preschool children(1). Hearing loss is the most common complication, and known to result in development impairment by itself if longstanding and remitting(2). The hearing loss due to otitis media might therefore also have an effect on a child s development and early school performance. Background: Otitis media is a common disease in childhood that can adversely affect cognitive and educational outcomes, however the literature in this area is equivocal(3). Regarding speech and language, a metaanalysis of prospective studies by Roberts et al only found no to very small associations of OME(otitis media with effusion) to speech and language development in most children(4). Yet, newer studies still show a negative association(5). The same applies for school performance, the literature is equivocal. Several skills and aspects of knowledge acquired at school have been studied. There is a tendency that older studies found a negative association(6 10) and that newer didn't (11 16). Other recent studies have found mixed results (13,17). This can be explained by the increased consideration of associated factors in the newer studies, such as SES. Yet, many of these studies still have lacks, especially regarding sample sizes but also the absence of analysis of important associated factor. We believe our study with its large sample size and its possibility to consider for an increased amount of confounders will contribute with important results. 2

3 Research objektives: Elucidate the association between parent reported otitis media and early school performance. Hypothesis: Primary hypothesis: Parent-reported otitis media in early childhood affects the child's self-rated school skills the first years of primary school. Method: The study design is a cohort study with prospective data collection, via computer assisted telephone interviews by trained interviewers. Source population: The population consists of children of pregnant women in Denmark in the period % of all these pregnant women were willing to participate in the cohort. The women were recruited through their own doctor, at the first consultation after detection of pregnancy. Then followed a series of interviews during and after pregnancy, and biological samples were collected. This project uses the answers from the following interviews: 6-month interview, 18-month interview, 7- year interview and 11-year interview. Exclusion criterias: The following groups are excluded: Children diagnosed with Downs syndrome due to congenital anatomical abnormalities that increase the risk of acquiring otitis media. Children born before 34 weeks of gestation are excluded due to lung maturation treatment with betamethasone. This treatment is standard for premature babies born before 34 weeks of gestation in Denmark. Exposure: Exposed participants were defined by answering the 3rd, 4th and 5th interview, respectively, 6 and 18 months and seven years after birth with the answer "yes" to questions C130, D068 and Z021. Further is recurrent otitis media defined as answering "more than 3" to the questions C131 and D069 in Interview 3 and 4, where the number of otitis media events is requested. Outcome: Statistical analysis will be done on the outcome that is defined by answers to questions in the 7-year interview and the 11-year interview. The latter is answered by both child and parents. "Failure" outcome is also retrieved from answered questions. Power: Variables used for statistical analysis are answered with a response rate of 63%, equivalent to 57,282 people. Level of statistical significance defined as

4 Calculating power with this sample size, we would be able to find a difference of 0.01 with a power / probability of 99%, provided a level of significance of We will conduct Bonferroni corrections to reduce the risk of type I errors by multiple calculations of significance. Data og analysis: For statistical calculation we will us SPSS 19 and SAS 9.4. Outcome variables regarding school skills and school problems will be treated as categorical data. Regression analysis will be used to adjust for confounders. Sex and socioeconomic status (SES) will be stratified for. In addition, we will take into account additional confounders found in the literature, assessed by DAG's Ethical considerations: The cohort is pre-approved by biomedical ethics committee: case no. (KF) /94 There is approval from the Data Inspectorate for: Primary cohorte approved: case no year follow up approved: case no Budget: Budget Scholarproject Costs Pre-grad scholarship 6 months á kr course fee estimated Publication costs estimated Conference participation estimated Total costs Funds Funding applications Total funds

5 Time schedule: Research investigator and supervisors: Vincent Fougner stud.med. Supervisors: Asbjørn Kørvel-Hanquist Preben Homøe Jesper Dammeyer Janni Niclasen Cand.med. Professor, overlæge, dr.med, ph.d. Lektor ph.d. Adjunkt, ph.d. assistent professor References: 1. Todberg T, Koch A, Andersson M, Olsen SF, Lous J, Homøe P. Incidence of Otitis Media in a Contemporary Danish National Birth Cohort. Schooling CM, editor. PLoS ONE Dec 29;9(12):e Bluestone CD, Klein JO, Paradise JL, Eichenwald H, Bess FH, Downs MP, et al. Workshop on Effects of Otitis Media on the Child. Pediatrics Jan 4;71(4): Williams CJ, Jacobs AM. The impact of otitis media on cognitive and educational outcomes. Med J Aust [Internet] [cited 2015 Mar 18];191(9). Available from: 4. Roberts JE, Rosenfeld RM, Zeisel SA. Otitis media and speech and language: a meta-analysis of prospective studies. Pediatrics Mar;113(3 Pt 1):e Winskel H. The effects of an early history of otitis media on children s language and literacy skill development. Br J Educ Psychol Dec;76(Pt 4): Howie VM, Jensen NJ, Fleming JW, Peeler MB, Meigs S. The effect of early onset of otitis media on educational achievement. Int J Pediatr Otorhinolaryngol Sep;1(2): Mirja Luotonen MU. A nation-wide, population-based survey of otitis media and school achievement. Int J Pediatr Otorhinolaryngol. 1998;43(1): Zinkus PW, Gottlieb MI. Patterns of perceptual and academic deficits related to early chronic otitis media. Pediatrics Aug;66(2): Mortensen M, Nielsen RB, Fisker N, Nørgaard M. Hospitalisation with otitis media in early childhood and cognitive function in young adult life: a prevalence study among Danish conscripts. BMC Pediatr Jan 15;13(1):1 8. 5

6 10. Paradise JL, Dollaghan CA, Campbell TF, Feldman HM, Bernard BS, Colborn DK, et al. Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life. Pediatrics May;105(5): Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Rockette HE, Pitcairn DL, et al. Tympanostomy Tubes and Developmental Outcomes at 9 to 11 Years of Age. N Engl J Med Jan 18;356(3): McCormick DP, Johnson DL, Baldwin CD. Early middle ear effusion and school achievement at age seven years. Ambul Pediatr Off J Ambul Pediatr Assoc Oct;6(5): Augustsson I, Engstand I. Otitis media and academic achievements. Int J Pediatr Otorhinolaryngol. 2001;57(1): Serbetcioglu B, Ugurtay O, Kirkim G, Mutlu B. No association between hearing loss due to bilateral otitis media with effusion and Denver-II test results in preschool children. Int J Pediatr Otorhinolaryngol Feb;72(2): Paradise JL, Campbell TF, Dollaghan CA, Feldman HM, Bernard BS, Colborn DK, et al. Developmental outcomes after early or delayed insertion of tympanostomy tubes. N Engl J Med Aug 11;353(6): Johnson DL, Swank PR, Owen MJ, Baldwin CD, Howie VM, McCormick DP. Effects of early middle ear effusion on child intelligence at three, five, and seven years of age. J Pediatr Psychol Feb;25(1): Roberts JE, Burchinal MR, Zeisel SA. Otitis media in early childhood in relation to children s school-age language and academic skills. Pediatrics Oct;110(4):