The Auditory Rehabilitation Outcomes Network: an international initiative to develop core sets of patient‐centred outcome measures to assess interventions for hearing loss

Tysome, James R.; Hill-Feltham, Penny; Hodgetts, William E.; McKinnon, Brian J.; Monksfield, Peter; Sockalingham, R.; Johansson, Martina; Snik, A.F.M.

doi:10.1111/coa.12559

Cited by 8 publications

(6 citation statements)

References 19 publications

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“…A standardized, well-defined outcome measurement set would improve BAHS-related outcomes. The recently established AuroNet could aid in the creation of a standardized outcome set of this kind ( 34 ). Although all the surgeons were trained before the first MIPS surgery in the trial, experience between techniques differed.…”

Section: Discussionmentioning

confidence: 99%

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

Calon

Johansson

Bruijn

et al. 2018

Otology &Amp; Neurotology

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Objective:To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).Design:Sponsor-initiated multicenter, open, randomized, controlled clinical trial.Setting:Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.Participants:Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group.Primary and Secondary Outcome Measurements:Primary objective: compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks’ follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.Results:Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.Conclusion:No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

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Section: Discussionmentioning

confidence: 99%

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

Calon

Johansson

Bruijn

et al. 2018

Otology &Amp; Neurotology

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“…Most questionnaires and endpoints currently used to evaluate the BCHI from the perspective of the clinicians rather than that of the patients’ [30]. We know that studies using non-validated scales are prone to risk of bias [31].…”

Section: Introductionmentioning

confidence: 99%

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Calon

Hoof

Berge

et al. 2016

Trials

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BackgroundOver the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma.MethodsA multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression.The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.DiscussionThis is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement.Trial registrationRegistered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14. Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618. This trial is sponsored by Oticon Medical AB.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1662-0) contains supplementary material, which is available to authorized users.

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“…To address some of these issues, the AURONET group was formed as an international network with an aim to develop patient centred core outcome sets (COS) for mixed/conductive hearing loss (Tysome et al 2015). COS are defined as an agreed minimum set of outcome measures and are recommendations of what should be measured and reported in all trials in a specific area.…”

Section: Introductionmentioning

confidence: 99%

Hearing outcome measures for conductive and mixed hearing loss treatment in adults: a scoping review

Hill-Feltham

Johansson

Hodgetts

et al. 2020

International Journal of Audiology

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Objective: Rehabilitation options for conductive and mixed hearing loss are continually expanding, but without standard outcome measures comparison between different treatments is difficult. To meaningfully inform clinicians and patients core outcome sets (COS), determined via a recognised methodology, are needed. Following our previous work that identified hearing, physical, economic and psychosocial as core areas of a future COS, the AURONET group reviewed hearing outcome measures used in existing literature and assigned them into different domains within the hearing core area. Design: Scoping review. Study Sample: Literature including hearing outcome measurements for the treatment of conductive and/or mixed hearing loss. Results: The literature search identified 1434 studies, with 278 subsequently selected for inclusion. A total of 837 hearing outcome measures were reported and grouped into nine domains. The largest domain constituted pure-tone threshold measurements accounting for 65% of the total outcome measures extracted, followed by the domains of speech testing (20%) and questionnaires (9%). Studies of hearing implants more commonly included speech tests or hearing questionnaires compared with studies of middle ear surgery. Conclusions: A wide range of outcome measures are currently used, highlighting the importance of developing a COS to inform individual practice and reporting in trials/research.

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The Auditory Rehabilitation Outcomes Network: an international initiative to develop core sets of patient‐centred outcome measures to assess interventions for hearing loss

Cited by 8 publications

References 19 publications

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Hearing outcome measures for conductive and mixed hearing loss treatment in adults: a scoping review

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