Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE)
Introduction Cochlear implantation (CI) is a (cost-)effective intervention for people with severe or profound hearing loss. Since its introduction experience increased and the technology evolved, leading to better results and relaxation of CI eligibility criteria. Meanwhile, with national healthcare...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/6/e072689.full |
| _version_ | 1797748917131018240 |
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| author | A Rogier T Donders Sophia E Kramer Gert Jan van der Wilt Hugo G B Nijmeijer Wendy J Huinck Emmanuel A M Mylanus |
| author_facet | A Rogier T Donders Sophia E Kramer Gert Jan van der Wilt Hugo G B Nijmeijer Wendy J Huinck Emmanuel A M Mylanus |
| author_sort | A Rogier T Donders |
| collection | DOAJ |
| description | Introduction Cochlear implantation (CI) is a (cost-)effective intervention for people with severe or profound hearing loss. Since its introduction experience increased and the technology evolved, leading to better results and relaxation of CI eligibility criteria. Meanwhile, with national healthcare costs increasing there is a need for evidence of healthcare technology’s value. This protocol describes a study to investigate clinical and participatory outcomes after CI for the currently (expanded) eligible hearing impaired population. The study adds to the current evidence base through its multicentre design, long-term follow-up and use of participatory outcomes alongside standard clinical outcomes.Methods This multicentre prospective observational cohort study will include at least 156 adult patients with severe-to-profound hearing loss, approximately evenly divided into two groups (1, ages 18–65 years and 2, age >65 years). The measurements consist of audiometry, cognition tests, listening effort tests and multiple generic and disease specific questionnaires. Questionnaires will be administered twice before CI, soon after inclusion at CI referral and shortly before CI surgery, with an annual follow-up of 3 years after CI. The Impact on Participation and Autonomy questionnaire will be used to assess participation. Generalised models (linear, logistic, Poisson) will be used. Mixed effects models will be used to investigate changes over time while exploring differences in subgroups and the influence of covariates.Ethics and dissemination The study has received ethical approval from the Medical Ethical Committee of all participating centres. The results could provide valuable insights into changes in participatory outcomes of people with severe-to-profound hearing loss after CI. Results will be disseminated through peer-reviewed journals, scientific conferences and professional and patient organisation meetings.Trial registration number NCT05525221. |
| first_indexed | 2024-03-12T16:11:46Z |
| format | Article |
| id | doaj.art-c0e6d1b4512d41e386c387104c177a58 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T16:11:46Z |
| publishDate | 2023-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-c0e6d1b4512d41e386c387104c177a582023-08-09T13:25:07ZengBMJ Publishing GroupBMJ Open2044-60552023-06-0113610.1136/bmjopen-2023-072689Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE)A Rogier T Donders0Sophia E Kramer1Gert Jan van der Wilt2Hugo G B Nijmeijer3Wendy J Huinck4Emmanuel A M Mylanus55 Department for Health Evidence, Radboudumc, Nijmegen, Netherlands3 Otolaryngology-Head and Neck Surgery, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands2 Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, Netherlands1 Department of Otorhinolaryngology, Radboudumc, Nijmegen, Netherlands1 Department of Otorhinolaryngology, Radboudumc, Nijmegen, Netherlands1 Department of Otorhinolaryngology, Radboudumc, Nijmegen, NetherlandsIntroduction Cochlear implantation (CI) is a (cost-)effective intervention for people with severe or profound hearing loss. Since its introduction experience increased and the technology evolved, leading to better results and relaxation of CI eligibility criteria. Meanwhile, with national healthcare costs increasing there is a need for evidence of healthcare technology’s value. This protocol describes a study to investigate clinical and participatory outcomes after CI for the currently (expanded) eligible hearing impaired population. The study adds to the current evidence base through its multicentre design, long-term follow-up and use of participatory outcomes alongside standard clinical outcomes.Methods This multicentre prospective observational cohort study will include at least 156 adult patients with severe-to-profound hearing loss, approximately evenly divided into two groups (1, ages 18–65 years and 2, age >65 years). The measurements consist of audiometry, cognition tests, listening effort tests and multiple generic and disease specific questionnaires. Questionnaires will be administered twice before CI, soon after inclusion at CI referral and shortly before CI surgery, with an annual follow-up of 3 years after CI. The Impact on Participation and Autonomy questionnaire will be used to assess participation. Generalised models (linear, logistic, Poisson) will be used. Mixed effects models will be used to investigate changes over time while exploring differences in subgroups and the influence of covariates.Ethics and dissemination The study has received ethical approval from the Medical Ethical Committee of all participating centres. The results could provide valuable insights into changes in participatory outcomes of people with severe-to-profound hearing loss after CI. Results will be disseminated through peer-reviewed journals, scientific conferences and professional and patient organisation meetings.Trial registration number NCT05525221.https://bmjopen.bmj.com/content/13/6/e072689.full |
| spellingShingle | A Rogier T Donders Sophia E Kramer Gert Jan van der Wilt Hugo G B Nijmeijer Wendy J Huinck Emmanuel A M Mylanus Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE) BMJ Open |
| title | Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE) |
| title_full | Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE) |
| title_fullStr | Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE) |
| title_full_unstemmed | Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE) |
| title_short | Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study – Societal Merit of Intervention on Hearing Loss Evaluation (SMILE) |
| title_sort | changes on clinical and participatory outcomes in people with severe to profound hearing loss after cochlear implantation protocol of a multicentre prospective observational cohort study societal merit of intervention on hearing loss evaluation smile |
| url | https://bmjopen.bmj.com/content/13/6/e072689.full |
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