1 Nijmeijer HGB, et al. BMJ Open 2023;13:e072689. doi:10.1136/bmjopen-2023-072689 Open access 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) Hugo G B Nijmeijer , 1,2 Wendy J Huinck, 1,2 Sophia E Kramer , 3,4 A Rogier T Donders, 5 Gert Jan van der Wilt, 2,5 Emmanuel A M Mylanus 1,2 To cite: Nijmeijer HGB, Huinck WJ, Kramer SE, et al. 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 2023;13:e072689. doi:10.1136/ bmjopen-2023-072689 ► Prepublication history for this paper is available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2023- 072689). Received 10 February 2023 Accepted 13 June 2023 For numbered affliations see end of article. Correspondence to Hugo G B Nijmeijer; hugo.nijmeijer@radboudumc.nl Protocol © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT 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 specifc 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 infuence 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, scientifc conferences and professional and patient organisation meetings. Trial registration number NCT05525221. INTRODUCTION Unilateral cochlear implantation (CI) is considered effective and cost-effective in rehabilitation of severe-to-profound bilateral sensorineural hearing loss. 1–3 Since its intro- duction experience increased and the tech- nology evolved leading to better results and relaxation of CI eligibility criteria. Meanwhile the healthcare system is under increasing pressure due to increasing national health- care costs resulting in a need for evidence of healthcare technology’s added value. Up until now, most studies have investi- gated the benefits of CI in terms of audiolog- ical assessments, pure tone thresholds, speech perception scores and health-related quality of life. 4–6 These outcomes generate valuable insights for clinicians, patients and healthcare policymakers. However, there is an additional need for investigations of outcomes that are more closely related to a person’s everyday experience and to investigate the long-term benefits of CI on societal and economic level for persons with hearing loss. 7 STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ Prospectively investigating long-term (participatory) outcomes of cochlear implantation (CI). ⇒ Inclusion of a study population refective of the current eligibility criteria for CI in The Netherlands, strengthening its ecological validity. ⇒ This observational study carries confounding risks, as a randomised design was considered neither eth- ical nor feasible. on February 8, 2024 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2023-072689 on 27 June 2023. Downloaded from