Von August 1997 bis Ende 2011 wurden in einem zweistufigen Neugeborenen-Hörscreening-Modell über 16994 Neugeborene mit dem MB 11 BERAphon® (MAICO, Diagnostic GmbH, Berlin) getestet. Anfangs wurde unter Verwendung des Zeitgang-BERA das Screening durchgeführt. Der akustische Reiz wurde im Laufe der Zeit verändert und optimiert. Aktuell wird mit einem breitbandigen akustischen CE-Chirp™ bei einem Screeningpegel von 35 dB-nHL gearbeitet. Von April 2008 bis September 2008 wurden im Rahmen dieser Arbeit Neugeborene mit der genannten Methode gescreent. Im Juli 2008 wurde zusätzlich eine Umfrage unter Eltern durchgeführt, deren Kinder ca. zwei Jahre zuvor in der Univ.-Frauenklinik Würzburg nach Hörstörungen untersucht worden waren. Das Ziel dieser Arbeit ist, die Qualität des Neugeborenen-Hörscreening-Modells zu überprüfen und somit auch die Ermittlung der Sensitivität und Spezifität des MB 11 BERAphons®. In dieser Studie werden Ergebnisse von 583 gescreenten Neugeborenen (1166 Ohren) dargestellt. Die mittlere Messzeit betrug 42,5s (SD = ± 34,24s). Die Messzeiten lagen zwischen 16s und 178s, im Median dauerte eine Messung 28s. Die Pass-Rate nach Stufe I betrug 97,69 % und nach Stufe II, bzw. nach den Kontrollscreenings 98,95 %. Eine pädaudiologische Diagnostik und Therapie fand bei 11 Ohren (8 Kinder) statt. Es wurden somit 0,94% der Ohren richtig-positiv ermittelt. Die falsch-positiv-Rate betrug 2,41 %. 0,69 % der Kinder gelten als Drop-outs. Insgesamt wurden 96,31% als richtig-negativ eingeordnet. Eine Spezifität von 97,57 % wurde erreicht. Im zweiten Teil der Arbeit wurde eine Umfrage unter 500 Elternpaaren durchgeführt. Zur Informationsermittlung wurde ein selbst entworfener Würzburger Fragebogen sowie der LittlEARS-Fragebogen der Firma MED-EL Medical Electronics verwendet. Der Würzburger Fragebogen erwies sich als sehr gut geeignet für die Sensitivitätsstudie. Es wurde eine Rücklaufquote von 71,57 % erreicht. Die durchschnittliche Antwortdauer war 16,3 Tage. Im Median dauerte eine Antwort 6 Tage. Die aus den Umfrageergebnissen ermittelte Sensitivität beträgt 100 %. Die bereits genannten Ziele dieser Arbeit wurden erreicht. Die in Würzburg angewandte Screeningmethode erwies sich als effizient und übertrifft damit die Anforderungen an eine vom G-BA geforderte Screening-Einrichtung. / From August 1997 until the end of 2011 more than 16994 newborns were tested in a two-stage newborn hearing screening model with the MB 11 BERAphon® (MAICO, Diagnostic GmbH, Berlin). Initially, the screening was performed using the “Zeitgang”-ABR stimulus. The acoustic stimulus was changed and optimized over the years. Currently we use a broadband acoustic CE-Chirp™ stimulus at a screening level of 35 dB nHL. From April 2008 to September 2008 as part of this study newborns were screened using the above method. Additionally in July 2008, a survey among parents was conducted, whose children had been screened for hearing disorders two years before at the clinic of Gynaecology, University of Würzburg, Germany. The aim of this study is to examine the quality of the newborn hearing screening model and thus the determination of the sensitivity and specificity of the 11 MB BERAphon®. In this study, results of 583 screened newborns (1166 ears) are presented. The average measurement time was 42.5s (SD = ± 34.24s). The acquisition time varied between 16s and 178s, with a median measurement of 28s. The pass rate was 97.69% for stage I and for stage II, and after the screening control, 98.95%. A paedaudiologic diagnosis and treatment took place in 11 ears (8 children). Thus, 0.94% were determined as true-positive ears. The false-positive rate was 2.41%. 0.69% of the children are considered dropouts. Overall, 96.31% were classified as true-negative. The achieved specificity was 97.57%. In the second part, a survey among 500 parents was carried out. To gather information a self-designed “Würzburger” questionnaire and the LittlEARS questionnaire designed by MED-EL Medical Electronics were used. The “Würzburger” questionnaire turn out to be very suitable for the sensitivity study. A return rate of 71.57% was achieved. The average response time was 16.3 days. The median response time was 6 days. Determined from the survey results, a sensitivity of 100% was obtained. The aforementioned objectives of this study were achieved. The screening method applied in Würzburg was proven to be efficient and exceeds the requirements, which are demanded by the G-BA to a screening facility.

Made available in DSpace on 2016-04-27T18:12:02Z (GMT). No. of bitstreams: 1 Fabiane Sousa Marques Leandro.pdf: 2306661 bytes, checksum: b076eac9940a87e618c52c4ced2f3505 (MD5) Previous issue date: 2013-08-29 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / Introduction: The technology brings positive outcomes for children with hearing impairment. However, it is needed viable tools that assess the auditory development of very young children who use individual amplification hearing aids or cochlear implant. Many questionnaires on language development and hearing have been applied to parents as an attempt to learn more about the child's performance. For this reason, the questionnaire LittlEars was developed by Coninx et al. (2003) to assess auditory skills of the population of infants and children with hearing age of up to two years old. Objective: The aim of this study is to contribute to the process of semantic and cultural adaptation of the preliminary version of the LittlEars questionnaire in Portuguese in families of children with hearing loss that have been attended by the hearing care network - SUS. Method: This research was conducted in CeAC (PUC-SP) and the subjects are parents of children with hearing loss up to two years old of hearing that received the AASI‟s in the CeAC-Derdic. The families of the children with hearing loss were instructed about the purpose of the instrument and the way of administrating (interview or questionnaire) was chosen according to the preference of the family. Afterwards, they answered the LittlEars questionnaire and they were also informed that the comments, doubts, suggestions, examples, critics or difficulty presented by them, would be useful to finalize the drafting of the adapted version of the questionnaire. In a second step, a group meeting of experts was held for a brainstorming session that discussed each item and the suggestions presented. Results and Discussion: The study included 32 children, being 25 male and 7 female, and 37 subjects answered the questionnaire; of these subjects, 23 were mothers, 5 were mother and father, 2 were fathers and 2 were grandmothers. Regarding the preference for the administration of the instrument, 4 parents chose to answer the search in a questionnaire format, while 28 in an interview format. Of the respondents, only six had no doubt responding to the questionnaire and 24 had doubts. Of the parents who chose to answer the questionnaire format, just a parent left some comments on some items. By applying the preliminary version of the LittlEars in an interview format, it was noted that parents had difficulty understanding some items, while those who answered the questionnaire format did not report difficulties in reading and interpreting the items. The comments of the families were collected and analyzed and a modified version was proposed. Conclusions: The doubts and suggestions on the items of the questionnaire that were presented by the parents were related to vocabulary, idioms and unknown examples. The results obtained from the questionnaire LittlEars in the group studied had varied depending on the hearing age and the SII, suggesting that the translation is sensitive to measure the auditory skills. The new version of the questionnaire being translated into English for equivalence verification, and to be considered appropriate. Important steps were taken in validating the LittlEars questionnaire in Portuguese. Further studies are required to apply the new version and to have a final validation / Introdução: A tecnologia traz resultados positivos para crianças com deficiência auditiva. No entanto, são necessárias ferramentas viáveis que avaliem o desenvolvimento auditivo de crianças muito pequenas que usam aparelhos de amplificação sonora individuais (AASI) ou implante coclear. Muitos questionários sobre o desenvolvimento da linguagem e audição têm sido aplicados aos pais como uma tentativa de aprender mais sobre o desempenho da criança. Por esta razão, o questionário LittlEars foi desenvolvido por Coninx et al. (2003) para avaliar as habilidades auditivas da população de bebês e crianças com idade auditiva de até dois anos. O objetivo deste estudo é contribuir para o processo de adaptação semântica e cultural da versão preliminar em português do questionário LittlEars em famílias de crianças com deficiência auditiva, atendidas na rede de saúde auditiva - SUS. Método: Esta pesquisa foi realizada no CeAC (PUC-SP) e os sujeitos são pais de crianças com deficiência auditiva com até dois anos de idade auditiva, que receberam os AASI‟s no CeAC-Derdic. As famílias das crianças com deficiência auditiva foram orientadas sobre o objetivo do instrumento e a forma de administração (entrevista ou questionário) foi escolhida de acordo com a preferência da família. Em seguida, responderam o questionário LittlEars e foram informados de que os comentários, dúvidas, sugestões, exemplos, críticas ou dificuldades apresentadas por eles, seriam úteis para a finalização da elaboração da versão adaptada do questionário. Numa segunda etapa, foi realizada reunião de grupo de especialistas para um brainstorming que discutiu cada item e as sugestões apresentadas. Resultados e discussão: Participaram deste estudo 32 crianças, sendo 25 do sexo masculino e sete do sexo feminino, e 37 sujeitos responderam o questionário; desses sujeitos, 23 foram as mães, cinco foram mãe e pai, dois foram os pais e dois foram as avós. Em relação à preferência pela administração do instrumento, quatro pais preferiram responder no formato de questionário, enquanto 28 no formato de entrevista. Dos entrevistados, apenas seis não tiveram nenhuma dúvida ao responder o questionário e 24 apresentaram dúvidas. Dos pais que preferiram responder no formato questionário, apenas um pai fez comentários em alguns itens. Ao aplicar a versão preliminar do LittlEars no formato entrevista, percebeu-se que os pais tiveram dificuldades de compreensão em alguns itens, enquanto no formato questionário, não relataram dificuldade na leitura e interpretação dos itens. Foi realizado o levantamento dos comentários das famílias e proposta uma versão modificada. Conclusões: As dúvidas, e sugestões nos itens do questionário apresentadas pelos pais estiveram relacionadas a vocabulário, expressões idiomáticas e exemplos desconhecidos. Os resultados obtidos com o questionário LittlEars no grupo estudado variou conforme a idade auditiva e o SII, o que sugere que a tradução tem sensibilidade para medir as habilidades auditivas. . A nova versão do questionário está sendo vertida para o inglês, para verificação de equivalência, para ser considerada adequada. Foram realizadas etapas importantes na validação do Questionário LittlEars em português. São necessários outros estudos para aplicar a nova versão e validação definitiva