RESUMEN
Introduction: Early identification of mild hearing loss has resulted in early hearing amplification without adequate evidence of effectiveness. This paper describes learnings from a pilot trial, combined with a qualitative study, to highlight the importance of community engagement in designing research studies to determine whether early amplification benefits young children with bilateral mild hearing loss. Methods: PART 1 of the study is a proof-of-concept non-blinded multi-centre randomised controlled trial (RCT) of hearing device fitting vs. no fitting aimed to gather preliminary data and determine its acceptability/feasibility in children <2 years old with bilateral mild hearing loss. Results: PART 2 is a qualitative study to understand the barriers/enablers to RCT participation. Of 40 potentially eligible families, nine (23%) declined, three were uncontactable (7%), 26 (65%) ineligible: of these, nine (35%) did not meet hearing threshold inclusion criteria, 11 (42%) were already fitted or had made decisions on fitting hearing device, two (7%) had conductive loss and four (16%) were ineligible for other reasons. Two of 11 (18%) eligible families were randomised. With the limited sample size, outcome measures were not compared between groups. Both participants completed the trial, reported the RCT to be acceptable, and neither changed group post-enrolment. Discussion: Whilst recruitment uptake could potentially be increased by altering the eligibility criteria, better communication with and reimbursement of clinicians as recruiters, and improving awareness of the study amongst external stakeholders, the RCT methodology does not conform to family-centred practice, and potentially raises ethical concerns regarding potential adverse consequences of not offering early amplification. Parental perception of losing control over choice of management due to randomisation is not an easily modifiable factor. Alternative methodological approaches without randomisation are required to determine whether hearing amplification benefits infants with mild hearing loss.Clinical Trial Registration: identifier [ACTRN12618001608257].
RESUMEN
OBJECTIVE: Universal newborn hearing screening programs have led to early identification of infants with congenital mild bilateral hearing loss (MBHL). The current lack of evidence-based protocols to guide audiological management of infants with MBHL has led to clinical equipoise about fitting of hearing aids. The purpose of this study was to increase understanding about the perspectives of paediatric audiologists on factors influencing their management of MBHLin infants and young children. DESIGN: A qualitative descriptive research methodology involving semi-structured interviews with audiologists. STUDY SAMPLE: Twenty-three paediatric audiologists in diagnostic and rehabilitation settings in Victoria, Australia. RESULTS: Three main themes that influenced management were identified. These include: (1) evidence, or the lack of it, influences audiologists' practice; (2) audiologists recognise the need to be fluid; and (3) family characteristics and parents' perspectives. "Audiologists delivering family-centred practice" was identified as an overarching theme across these factors. CONCLUSIONS: Audiologists recognised the importance of adopting a family-centred approach in their management of MBHL in infants and young children. Embodied in their practice was the acknowledgement of limited evidence, the consideration of multiple child and family factors, and the incorporation of perspectives of parents and families in adopting a fluid approach to provide individualised services.
