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Acta Otorhinolaryngol Ital. 2011 Oct;31(5):273-80.

Analysis of the impact of professional involvement in evidence generation for the HTA Process, subproject "cochlear implants": methodology, results and recommendations.

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  • 1Operative Unit of Otorhinolaryngology, Audiology and Phoniatrics, University of Pisa, Italy.


The aim of Health Technology Assessment (HTA) is to provide decision-makers, distributors and recipients with information on the effectiveness, cost and impact of health technologies. The present study constitutes a subproject within the wider project "Analysis of the impact of professional involvement in evidence generation for the HTA process", which is part of the strategic programme "Transfer of the results of the research in clinical practice and organisation of healthcare services", coordinated by Laziosanità - Agency of Public Healthcare of the Lazio Region and AgeNaS (National Agency for Regional Healthcare Services). The objectives of the present subproject (cochlear implants) are as follows: a) to produce a report regarding the health impact of cochlear implants (CI) on their recipients, through a systematic review of literature and extensive selection of relative studies, combining the outcomes with metanalytical techniques. Output: report on the indications of usage in the groups of population for which benefits are controversial; b) to create a registry of patients using cochlear implants. The registry should contain a selection of anagraphic and clinical information relative to patient follow-up in order to assess factors associated with safety and impact on cochlear implant users. This source of information is essential for future observational studies. This was divided into 4 phases: 1(st) phase: definition of key participants in the assessment process; 2(nd) phase: definition of methods and timing of "Aims" (definition of the objective); 3(rd) phase: definition of the methods and times of the "assessment process", 4(th) phase: production of the final report. From the analysis of systematic reviews and italian and international guidelines, the Working Group members approved recommendations on the following topics: results after CI in children in relation to age at implantation, bilateral CI in children, CI in deaf children with associated disabilities, CI in adults with advanced age, bilateral CI in adults and CI in adults with pre-lingual deafness. These recommendations have also been evaluated by the Consulting Committee members and approved with minimal suggestions.


Clinical effectiveness; Cochlear implant; Cost-effectiveness; Health Tecnology Assessment; Registry

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